Contraception Updates

Contraception Updates
Amr Nadim, MD Professor of Obstetrics & Gynecology Ain Shams Faculty of Medicine Maternity & Women’s Hospital

Definition Contraception (birth control) prevents pregnancy by interfering with the normal process of ovulation, fertilization, and implantation. There are different kinds of birth control that act at different points in the process. Unfortunately, there is no perfect form of birth control. Only abstinence can protect against unwanted pregnancy with 100% reliability.

Contraceptive Options
Hormonal Methods Progestin Only Injectables / Oral Contraceptives Combined Injectable / Oral Contraceptives Intrauterine Systems Vaginal rings Implants Patches

Non-Hormonal Methods IUD NFP methods Barriers

Sterilization Methods Tubal Occlusion Vas Ligation Tubal ligation

Effectiveness Safety Convenience
What are the concerns of any couple about the method of family planning they need? Convenience Safety Effectiveness

When correctly used, all methods are more effective than no method.
Safe methods are those without serious complications. Clients should be given their preferred (or desired) method if it is not medically contraindicated.

Risk Misperception & Patients
“…incorrect perceptions of excess risk of contraceptive products may lead women to use them less than effectively or not at all.” ‘ ‘ Talking Points Gardner and Miller assert that the following factors may lead women to use contraceptives less than effectively or not at all: Problems with uneven access Prescription requirements Conflicting information on the package instructions for initiating and continuing use Incorrect perceptions of excess risk Reference Gardner J, Miller L. Promoting the safety and use of hormonal contraceptives. J Womens Health. 2005;14:53-60. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Gardner J, Miller L. J Womens Health. 2005

Misperceptions Affect Health Decisions
1995 – Warning: possible increased risk of VTE among users of 3rd generation OCs Many women discontinued OC use Prescribing patterns changed Pregnancy and abortion numbers increased Deemed a “non-epidemic” Talking Points VTE = venous thromboembolism The negative consequences of an inaccurate perception of the risks associated with oral contraceptives played out in Europe to unfortunate effect. In 1995, the British Committee on Safety of Medicines issued a warning regarding a possible increased risk of venous thromboembolism among users of 3rd generation oral contraceptives (those containing newer progestins desogestrel and gestodene). Many women across Europe stopped taking their OCs or switched formulations. Providers changed prescribing patterns. There were 26,000 more pregnancies in Wales and England in 1996 than in 1995, with about 13,600 additional abortions. The abortion rate had been decreasing over the 5 years before to the event. It is now believed that preferential prescribing may have been responsible for at least part of the association between 3rd generation OCs and VTE; in any case, the risk appears to be small. Even if the reported increase in risk is true, it is clinically insignificant. Deemed a “non-epidemic” by some experts. References Chasen-Taber L, Stampfer M. Oral contraceptives and myocardial infarction—the search for the smoking gun. N Engl J Med. 2001;345: Furedi A, Paintin D. Conceptions and terminations after the 1995 warning about oral contraceptives. Lancet. 1998;352:323-4. Drife J. Oral contraception and the risk of thromboembolism: what does it mean to clinicians and their patients? Drug Saf. 2002;25: Spitzer WO. The 1995 pill scare revisited: anatomy of a non-epidemic. Hum Reprod. 1997;12: - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Chasen-Taber L. N Engl J Med Drife L. Drug Saf Furedi A. Lancet Spitzer WO. Hum Reprod

“The possibility of suffering
Definition of Risk ‘ ‘ “The possibility of suffering harm or loss.” Talking Points To effectively communicate about risk, it’s important to have a clear and accurate understanding of the basic statistics underlying risk comparisons. What is “risk”? Here’s a definition straight from The American Heritage Dictionary of the English Language. A risk is the possibility of suffering harm or loss.” Note that risk is the probability—or chance—of an event happening; it does not indicate certainty that it will occur. Reference The American Heritage Dictionary of the English Language. 3rd ed. Boston: Houghton Mifflin Company; 1996. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. The American Heritage Dictionary of the English Language

Risk Calculations Causality Weigh pros and cons Degree to which
attributable Talking Points By calculating the risk associated with a particular hazard: Researchers can hypothesize about causality Consumers and clinicians can weigh the pros and cons of treatment interventions Epidemiologists can calculate the degree to which a disease or event is attributable to a particular hazard Reference Hennekens CH, Buring JE. Epidemiology in Medicine. Boston: Little, Brown, and Company. 1987:77. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Hennekens CH. Epidemiology in Medicine

Associations vs. Causality
An association does not always mean exposure caused outcome It could be due to random chance or bias Making a decision about causality requires that a number of criteria be met, including (among others): Strength of the association (as measured by relative risk, for example) Consistency of the association over multiple studies Temporal sequence (exposure precedes outcome) The point is that a weak association found in a single study should not be taken as concrete evidence of a cause-and-effect relationship. Talking Points The existence of a statistical association does not necessarily mean that the exposure caused the outcome. Reasons for an association without a true underlying causal relationship include random chance, bias, and other factors. Making a decision about causality requires that a number of criteria be met, including (among others): Strength of the association (as measured by relative risk, for example) Consistency of the association over multiple studies Temporal sequence (exposure precedes outcome) The point is that a weak association found in a single study should not be taken as concrete evidence of a cause-and-effect relationship. Reference Grimes DA, Schulz KF. Bias and causal associations in observational research. Lancet. 2002;359: - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Grimes DA. Lancet

Commonly Used Risk Calculations
Absolute risk Absolute risk reduction Relative risk Talking Points There are some commonly used risk calculations that you should understand: Absolute risk Absolute risk reduction (attributable risk) Relative risk We’ll discuss these in some detail. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006.

Absolute Risk The percentage of people in a group who experience a discrete event Number of People With Event Total # of People At Risk Talking Points Absolute risk is the percentage of people in a group who experience a discrete event. Absolute risk = the # of people with the event divided by the total # of people at risk for the event. References Evidence Based Emergency Medicine at the New York Academy of Medicine. Definitions: absolute risk and its reduction. Available at: Accessed February 3, 2006. Misselbrook D, Armstrong D. Thinking about risk: can doctors and patients talk the same language? Fam Practice. 2002;19:1-2. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. NY Academy of Medicine Misselbrook D. Fam Practice

Example of Absolute Risk
Of 100,000 women on 3rd generation OCs, 30 will develop venous thromboembolism (VTE) per year Absolute risk Talking Points As an example, of 100,000 women taking 3rd generation OCs, approximately 30 will develop VTE per year. Absolute risk = 30 per 100,000 woman-years. As you know a woman (or person) year the total of the units of time, whether weeks, months, or years, that people were exposed to a condition or were actively involved in a study. One person-year can represent a single person who was exposed for one year or an accumulation, such as two people who were each exposed for half a year. In this example the person-time units are woman-years. Reference Mills, A. Combined oral contraception and the risk of venous thromboembolism. Hum Reprod. 1997;12: - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. 30 per 100,000 woman-years Mills A. Hum Reprod

Absolute Risk Reduction
The difference in risk of the outcome between those exposed and those not exposed Risk in exposed – risk in unexposed Reflects the reduction in risk associated with an intervention Talking Points Absolute risk reduction is the difference in risk of the outcome between those exposed (to an intervention) and those not exposed. Absolute risk reduction = risk in those exposed – risk in those who were not exposed. Reference Evidence Based Emergency Medicine at the New York Academy of Medicine Definitions: absolute risk and its reduction. Available at Accessed February 3, 2006. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. NY Academy of Medicine

Example of Absolute Risk Reduction
Of 100,000 women on 2nd generation OCs, 15 will develop VTE per year Absolute risk reduction Absolute risk = 15 per 100,000 woman-years 15 per 100,000 woman-years Talking Points The absolute risk of VTE for 2nd generation OCs users is 15 per 100,000 woman-years. Therefore, the absolute risk reduction is the difference in absolute risk for women taking 3rd generation and for women taking 2nd generation OCs. Absolute risk reduction = 30 – 15 = 15 per 100,000 woman-years Therefore, women taking 2nd generation OCs have a risk that is 15 per 100,000 lower than women taking 3rd generation OCs Reference Mills A. Combined oral contraception and the risk of venous thromboembolism. Hum Reprod. 1997;12: - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Mills A. Hum Reprod

Attributable Risk Similar to absolute risk reduction
Attributable risk is: The difference in risk of the outcome between those exposed and those not exposed Risk in exposed – rate in unexposed Reflects degree of risk associated with exposure Talking Points Attributable risk is the difference in risk of the outcome between those exposed and those not exposed Attributable risk = risk in exposed – risk in unexposed Similar to absolute risk reduction, but indicates degree of risk associated with exposure, rather than specifically the reduction of risk associated with an exposure Reference BMJ Collections: Comparing disease rates. Available at: Accessed March 22, 2006. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. BMJ Collections

Relative Risk Used to identify an association between exposure and outcome Exposure Outcome Talking Points Relative risk Is the frequency of the outcome in the exposed group divided by the frequency of the outcome in the unexposed group Reflects the likelihood of developing the outcome based on exposure Is used to identify an association between exposure and outcome Is similar to odds ratio References Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002;359:57-61. Hennekens CH, Buring JE. Epidemiology in Medicine. Boston: Little, Brown, and Company. 1987:77. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Grimes DA. Lancet Hennekens CH. Epidemiology in Medicine

Odds Ratio Used to identify an association between exposure and outcome in a case-control study Similar to relative risk X Exposure Outcome Talking Points Relative risk can be calculated for cohort studies, because the underlying incidence of the condition under study is known (the incidence in the unexposed group). For case-control studies, the underlying incidence is unknown, so relative risk cannot be calculated. Instead, an odds ratio is used. We won’t go into the calculation of an odds ratio; just understand that odds ratio quantifies risk for a case-control study as relative risk does for a cohort study. Reference Hennekens CH, Buring JE. Epidemiology in Medicine. Boston: Little, Brown, and Company. 1987:79-81. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Hennekens CH. Epidemiology in Medicine

Relative Risk: Example 1
Absolute risk Absolute risk 3rd Generation OCs 30 per 100,000 woman-years 2nd Generation OCs 15 per 100,000 woman-years Talking Points Absolute risk of VTE for women taking 3rd generation OCs = 30 per 100,000 woman-years Absolute risk of VTE for women taking 2nd generation OCs = 15 per 100,000 woman-years Relative risk = 30 divided by 15 = 2 Reference Mills A. Combined oral contraception and the risk of venous thromboembolism. Human Reproduction. 1997;12: - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Relative risk = 30 / 15 = 2 Mills A. Hum Reprod

Interpreting Relative Risk
No increase in risk in exposed group compared with unexposed group Increased risk in exposed group Decreased risk in exposed group Talking Points To interpret relative risk: Relative risk = 1: no increase in risk in the exposed group compared with the unexposed group Relative risk > 1: increased risk in the exposed group Relative risk < 1: decreased risk in exposed group Therefore, the data that triggered the 1995 pill scare showed that women who took 3rd generation OCs had a risk of VTE 2 times that of women who took 2nd generation OCs. Reference Hennekens CH, Buring JE. Epidemiology in Medicine. Boston: Little, Brown, and Company. 1987:79. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Hennekens CH. Epidemiology in Medicine

Risk & Health Decisions
‘ ‘ “Decisions about risk are not technical, but value decisions.” Talking Points Health decisions reflect a person’s values, not just his or her understanding of the technical aspects of risk. Thus, risk communication is not about providing more information or risk calculations to change risk perception. Reference Baker B. In: Bennett P, Calman K, eds. Risk Communication and Public Health. Oxford; Oxford University Press. 1999: preface, v. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Baker B. In: Risk Communication and Public Health

Risk of cesarean delivery with elective induction of labor 20% Risk of cesarean delivery with spontaneous onset of labor 10% Relative risk with induction: 20% 10% Talking Points Risk of cesarean delivery with elective induction of labor = 20% Risk of cesarean delivery with spontaneous onset of labor = 10% Therefore, the relative risk is 20 divided by 10 = 2 Reference Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002;359:57-61. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Relative risk = 20 / 10 = 2 more… Grimes DA. Lancet

Relative Risk: Example 2 (continued)
Interpretation: “The risk of cesarean delivery with elective induction of labor is 2 times that associated with spontaneous labor.” 2X Or, alternatively stated: Talking Points In this example, a relative risk of 2 means that the risk of cesarean delivery with elective induction of labor is 2 times that associated with spontaneous labor. Alternatively stated, the risk is twice as high. Reference Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002;359:57-61. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. “The risk is twice as high.” more… Grimes DA. Lancet

Graph of relative risk of 2 0.1 1 10 Relative risk (log scale) Increased risk Decreased risk Talking Points Reference Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002;359:57-61. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Grimes DA. Lancet

Rate with prophylactic antibiotics 6% Rate without prophylactic antibiotics: 12% Relative risk: 6% 12% = 0.5 Talking Points Risk of infection after cesarean delivery with prophylactic antibiotics = 6% Risk of infection after cesarean delivery without prophylactic antibiotics = 12% Relative risk = 6 divided by 12 = 0.5 Reference Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002;359:57-61. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Relative risk = 6 / 12 = 0.5 more… Grimes DA. Lancet

Graph of relative risk of 0.5 0.1 1 10 Relative risk (log scale) Increased risk Decreased risk Talking Points In this example, a relative risk of 0.5 means that the use of prophylactic antibiotics is associated with a 50% reduction in risk of infection. Alternatively stated, there is one-half the risk. Reference Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002;359:57-61. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Grimes DA. Lancet

Comparing Relative Risks of 2 and 0.5
Zone of increased risk Zone of reduced risk 2 0.5 0.1 1 10 Relative Risk (log scale) Talking Points Relative risks above and below 1.0 are reciprocally related: a relative risk of 2 is equal in strength but opposite in direction to a relative risk of 0.5 (they are both equidistant from 1.0 on the graph). RR of 0.5 is protective while a RR of 2 is harmful. Reference Grimes DA, Schulz KF. An overview of clinical research: the lay of the land. Lancet. 2002;359:57-61. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Grimes DA. Lancet

Comparative Risks of VTE
Incidence of VTE per 100,000 woman-years 20 40 60 Pregnancy High-dose OC Low-dose OC General Population Talking Points When communicating about risk, it’s important to discuss and compare risks associated with relevant alternatives. The alternative to effective contraception is unintended pregnancy, which is in itself associated with risk. In the US approximately 470 women die each year from pregnancy-related causes (11.8 per 100,000 live births) This slide shows one of the risks associated with unintended pregnancy: venous thromboembolism. References Shulman LP, Goldzieher JW. The truth about oral contraceptives and venous thromboembolism. J Reprod Med. 2003;48:930-8. Chang J, Elam-Evans LD, Berg CJ, et al. Pregnancy-related mortality surveillance—United States, In: Surveillance Summaries, February 21, MMWR. 2003;52(SS-2):1-8. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Shulman LP. J Reprod Med Chang J. In: Surveillance Summaries

Causes of Risk Misperception about Hormonal Contraceptives
Talking Points Risk misperception about combined hormonal contraceptives can exist for patients or providers. Risk misperception is probably caused by a number of factors, including Lack of understanding of statistics Psychological factors Media influences Factors that affect risk perception and interpretation Statistics is a complicated field, requiring a baseline of mathematical education that many people do not have. For this reason, it may be challenging for patients to fully comprehend the mathematical basis of risk calculations about effectiveness or adverse events associated with combined hormonal contraceptives. Psychological factors may influence a woman’s perception of risk. For example, ambivalent feelings about women’s sexuality—due to cultural or other influences—may induce a woman to avoid more effective contraceptive methods if they require advance planning. We’ll discuss in more detail the influence of media and other factors that affect risk perception and interpretation. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006.

Weighing the Risks & Benefits
Talking Points It is important to understand that for most women, the non-contraceptive benefits of combined hormonal contraceptives outweigh the potential risks. That said, smoking, hypertension, obesity, and diabetes are risk factors that must be considered when evaluating risks associated with combined hormonal contraceptives. Reference Burkman R, Schlesselman JJ, Zieman M. Safety concerns and health benefits associated with oral contraception. Am J Obstet Gynecol. 2004;190(4 Suppl):S5-22. - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. Burkman R. Am J Obstet Gynecol

The likelihood of Being Helped VS Harmed

Decision Aid for Risk Communication
Clarify situation Provide information Clarify patient’s values Screen for implementation problems Talking Points This decision aid may help you to discuss the risks and benefits of hormonal contraception with your patients. Clarify the situation. Provide information on benefits and harms. Clarify patient values. Screen for implementation problems. Reference O’Connor A, Legare F, Stacey D. Risk communication in practice: the contribution of decision aids. BMJ. 2003;327: - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. O’Connor A, Legare F, Stacey D. BMJ

“Two times a very rare event is still a very rare event.”
A Final Thought ‘ ‘ “Two times a very rare event is still a very rare event.” - - - Original content for this slide submitted by the Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006, a joint program of ARHP and Planned Parenthood® Federation of America (PPFA). Original funding received from Ortho Women’s Health and Urology through an unrestricted educational grant. Last reviewed/updated by the ARHP/PPFA Clinical Advisory Committee for You Decide: Making Informed Health Decisions about Hormonal Contraception in May 2006. David Grimes, MD 2006

WHO Eligibility Criteria for Contraceptive Use
Category Description When clinical judgment is available When clinical judgment is limited 1 No restriction for use Use the method under any circumstances Use the method 2 Benefits generally outweigh risks Generally use the method 3 Risks generally outweigh benefits Use of method not usually recommended, unless other methods are not available/acceptable Do not use the method 4 Unacceptable health risk Method not to be used Source: WHO, 2004.

New Methods Single-rod Implant Monthly Injectable LNG IUS Vaginal Ring
Talking Points LNG IUS Vaginal Ring Patch

Pill Generations High court ruling 2002 –failed to show increase of VTE odds ratio between 3rd and 2nd generation Medicines Committee Advice 1999 The absolute risk of VTE taking third generation pills is very small & is much less than the risk in pregnancy. There is a small excess risk of 10 cases of VTE per 100,000 women compared with those taking second generation pill. Provided women are fully informed of the small risks & do not have medical contraindications, it should be a matter of clinical judgement and personal choice which COC is prescribed.

1st, 2nd and 3rd Generation Progestins
The terms "new', "newer, "second generation" and "third generation" do not accurately describe OC progestins. Progestins are best classified into Gonanes (Levonorgestrel, desogestrel, gestodene and norgestimate) Estranes (Norethindrone, Lynestrenol) Estranes and gonanes differ in : Bioavailability The greater the posthepatic bioavailability , the lower is the dose needed to be used. Only norethindrone, gestodene and levonorgetrel are active as such. Other progestins are prodrugs and so need to be given in higher dosages to compensate for hepatic biotransformation.

Serum half-lives Long serum half life is associated with more consistent cycle control and greater contraceptive protection in the event of missed pills. The shortest half life is that of norethindrone (7 hours) and the longest is that of levonorgestrel (15 hours). Relative binding affinity to the progesterone receptors. Greater relative binding affinity means that a smaller dose is needed for a consistent clinical effect to be achieved. Among OC progestin, levonorgestrel has the highest relative binding affinity followed by the active metabolite of the desogestrel. Strong Evidence suggests that all progestins effectively reduce free testosterone levels by 40-50% in average women.

All OCs inhibit the 5 -reductase in the skin resulting in lower levels of active dihydrotestosterone with subsequent better control of acne and hirsutism. There is no evidence to support that one class of progestin is superior to another with regard to androgen related conditions.

Anti-androgenic Progestogens Cyproterone Acetate-(in Diane/ Brenda)
Anti-androgen with progestogenic qualities Binds strongly to androgen receptors and prevents action of testosterone Major indication is in those with significant hirsutism or acne Takes 3 months for effect on acne and 6 months for effect on hirsuitism Can accelerate effect by adding in extra Androcur initially

Anti-androgenic Progestogens Drosperinone-(in Yasmin)
Yasmin-Ethinyloestradiol 30 µg and drospirenone 3mg Drosperinone related to Spironolactone Has mild diuretic effects- less fluid retention Antiandrogenic effects Weight Loss ?- mainly due to fluid loss-0.5 kg over 12 months

New Oral Contraceptives
Yasmin 30mcg ethinylestradiol +3mg drosperinone Cerazette 75 mcg desogestrel ovulation inhibition efficacy same as for COCs ?12 hours leeway but current licence 3 hours as other POPs safe if migraine with aura or risk of VTE trend towards more amenorrhoea and less bleeding with time no effect on lactation

Cerazette A 75 mg POP containing desogestrel
Assumed to inhibit ovulation

Emergency Contraception
WHO Study in compared the older Yuzpe method using high dose Combined Pills (Nordiol 2 X 2) with high dose progestogen-only regime(0.75 mgs LNG X2) The POP regime was found to be more effective with less side effects. Yuzpe and the WHO trial both used divided doses (12 hours), up to 72 hours after USI

Emergency Contraception - Effectiveness

Both methods are more effective the earlier they are commenced after USI Less nausea on progestogen only method- 2% vrs 22% No need for routine anti-emetics

Microlut +25 pills where cost or confidentiality an issue 2 pill progestogen-only ECP: Postinor 2

Hot off the Presses! Lancet article published December 2002 showed
POP emergency contraception retained some effectiveness up to 120 hours (5 days) after unprotected sex A single stat dose of 1.5 mgs seemed to be slightly more effective than the divided dose Von Hertzen H et al. Lancet 2002; 360: FPA Health has now changed its Clinical Protocols on ECP to reflect this study TGA recently approved ECP as a pharmacist-supplied item

Absorption of oral preparations
hormones are absorbed from the upper small intestine. peak plasma levels reached within 2 hours vomiting within 2 hours of ingestion reduces the amount of hormones absorbed, & missed pill instructions should be followed during the attack and for the next 7 days. in the case of combined oral contraception, the pill free interval should be omitted if less than 7 pills remain in the packet. diarrhoea (unless severe) is unlikely to affect drug levels; there are no studies showing any pharmacological basis for failure.

Metabolism in the liver
Drugs which increase metabolism of EE and progestogens, during and up to one month after stopping treatment. anticonvulsants (with the exception of sodium valproate, clobazam, vigabactrin, gabapentin and lamotrigine), griseofulvin, barbiturates, ritonovir (and possibly other protease inhibitors amprenavir, indinavir, lopinavir, nelfinavir, and saquinavir)

Use of COC and liver enzyme inducing drugs
COC users need at least 50mcg of EE to ensure contraceptive action efficacy may be further increased by tricycling, and/or decreasing the pill free interval common practice (for which there is no evidence) to consider the absence of break through bleeding as a marker of sufficient contraceptive cover in this situation.

Use of progestogens and liver enzyme inducing drugs
POP users should switch to injectables or another form of contraception IUS no evidence of interaction most of its progestogenic effect is directly on the endometrium with little absorption EHC experts suggest that the dose is increased by 50% levonorgestrel 0.75 mg tablets or 3 tablets stat injectable progestogen methods are often given 2 weeks early data sheet for Depo-Provera states that no adjustment is needed

Powerful enzyme inducing drugs
Rifampicin and rifabutin are such powerful enzyme inducers that even short courses of 2 days of the former (used as prophylaxis in close contacts of cases of Neisseria meningitis) reduce contraceptive efficacy for a month. Longer courses may have an interactive effect for up to 2 months after stopping. Oral contraceptive methods should not be relied on during this time. The same principles should apply to injectables, implants and IUS

Broad spectrum antibiotics
EE is excreted into the bile; and reabsorbed into the circulation from the colon broad-spectrum antibiotics (mainly ampicillin and tetracycline)affect these bacteria accepted UK practice that COC used alone is unreliable while taking short courses of penicillins and tetracyclines and for 7 days after stopping; the pill free interval should be omitted if less than 7 pills remain in the pack when the drug is continued beyond 2 weeks, the gut flora appear to become resistant, allowing a return to reabsorption of EE. effectiveness of the POP, progestogen-only emergency contraception, injectables, implants and IUS are not affected by broad spectrum antibiotics.

The only drugs known to have a clinically significant impact on contraceptive efficacy
rifampicin and rifamycin, griseofulvin, some anticonvulsants topiramate, barbiturates, carbamazepine, primidone ritonovir, and in some women short courses of tetracyclines and ampicillin.

Why Another Contraceptive Method?
[Insert Lecture Name Here] Why Another Contraceptive Method? CHOICE Talking Points: Why do we need another contraceptive option in the United States? “Choice of contraception is essential to meet diverse user needs and preferences that may change with the user’s stage of life” (Varney) “Only by offering choice of method will the maximum number of women be protected and the greatest savings to health service be realized. ARHP advocates for the availability of as many safe, effective options in contraception as possible. Reference: Varney SJ, Guest JF. Relative cost effectiveness of Depo-Provera, Implanon, and Mirena in reversible long-term hormonal contraception in the UK. Pharmacoeconomics ;22(17): - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Varney SJ. Pharmacoeconomics. 2004 Slide 60

Why Implantable Contraception?
[Insert Lecture Name Here] Why Implantable Contraception? Long duration of action Not patient dependent Continuous steady state steroid levels Avoidance of first-pass effect from GI absorption and hepatic metabolism High bioavailability Talking Points: The rationale for subdermal implants is A long duration of action Not subject to patient error or imperfect use Continuous steady state steroid levels Avoidance of ‘first-pass’ peak effect via the hepatic portal system, which is associated with oral contraceptives Higher bioavailability, which yields lower doses with parallel decreases in adverse effects. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Slide 61

Why is it among the most effective?
[Insert Lecture Name Here] Why is it among the most effective? ‘ ‘ “Implants constitute one of the safest and most effective forms of contraception that exist.” Talking Points: According to the World Health Organization, all the evidence that has accumulated over the 30 to 40 years that contraceptive implants have been in existence indicates that they constitute one of the safest and most effective forms of contraception that exist. Reference: World Health Organization. Contraceptive implants come of age. Accessed 8/2/07. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at WHO, 2003 World Health Organization. 2003 Slide 62

Unmet Need for Contraceptive Method
[Insert Lecture Name Here] Unmet Need for Contraceptive Method Highly effective Safe No daily motivation Rapidly reversible Talking Points: Women have an unmet need for a contraceptive method that is: Highly effective Safe No daily motivation is required Rapidly reversible For some women, this list also includes the need for contraception that does not contain estrogen. Contraceptive implants can help fill this unmet need. Note that other contraceptive methods, such as the IUD, also have similar benefits. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Slide 63

Implant Systems 1-Rod Implanon 6-Rod Norplant 2-Rod Jadelle
[Insert Lecture Name Here] Implant Systems 1-Rod Implanon 6-Rod Norplant 2-Rod Jadelle Talking Points: Contraceptive implants have been available for several decades. The first marketed implant was Norplant having 6 rods. This many rods proved to be cumbersome and was associated with removal problems due to poor insertion technique and operator inexperience. Jadelle with only 2 rods was then developed but not marketed in the United States. The most recently US approved implant is Implanon having only 1 rod. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Slide 64

Contraceptive Implant Track Record
[Insert Lecture Name Here] Contraceptive Implant Track Record 1993 Norplant launch UK 1966 Implant R&D WHO acceptance 1968 Ongoing clinical trails 1990 Norplant launch US Talking Points: From this timeline you can see that subdermal implantable contraceptives have been around a while. Subdermal contraceptive implant research and development began at the Population Council laboratories in New York. 1968 – 1985 Ongoing clinical trails and licensing of Norplant in other countries with eventual approval from the World Health Organization. 1990 – Wyeth introduces Norplant in US 1993 – Norplant was launched in the UK Newer formulations with fewer rods meant less insertion and removal time and improved the ‘implant’ track record. Reference: Jadelle® Levonorgestrel Rod Implants: A Summary of Scientific Data and Lessons Learned from Programmatic Experience. Population Council. Available at Accessed October 22, 2007. Organon Data on File - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at more… Population Council. Organon Data on File Slide 65

Contraceptive Implant Track Record (continued)
[Insert Lecture Name Here] Contraceptive Implant Track Record (continued) 1998 Implanon enters international market 2002 Norplant removed from US 2002 Jadelle approved but not marketed in US 2006 FDA approves Implanon Talking Points: From this timeline you can see that subdermal implantable contraceptives have been around a while. 1998 – Implanon a 1 rod system enters the international market 2002 – Jadelle (Norplant 2) a two-rod system is approved but not marketed in the US just as Norplant is removed from the US market due to litigation issues over difficult removals. 2006 – FDA approved Implanon Newer formulations with fewer rods meant less insertion and removal time and improved the ‘implant’ track record. Reference: Jadelle® Levonorgestrel Rod Implants: A Summary of Scientific Data and Lessons Learned from Programmatic Experience. Population Council. Available at Accessed October 22, 2007. Organon Data on File - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Population Council. Organon Data on File Slide 66

Subdermal Implant Single-rod system with disposable inserter
Releases etonogestrel (3-ketodesogestrel) for three years As of July 2002 not approved by the FDA Talking Points The subdermal implant is a new contraceptive implant system consisting of a non-biodegradable, single rod. The product is supplied in a pre-loaded, sterile and disposable applicator which facilitates insertion. The active component in a single-rod implant is etonogestrel; it does not contain an estrogen. The core of the implant contains 68 mg of crystalline etonogestrel, dispersed in a matrix of ethylenevinylacetate (EVA) copolymer surrounded by a 0.06 EVA membrane.

Features of Contraceptive Implants
[Insert Lecture Name Here] Features of Contraceptive Implants Highly effective Not motivation dependent Can be used during lactation Discreet, virtually invisible Rapidly reversible Talking Points: These are some of the features of contraceptive implants that make them an ideal choice for many women. References: Reinprayoon D, Taneepanichskul S, Bunyavejchevin S, et al. Effects of the etonogestrel-releasing contraceptive implant (Implanon) on parameters of breastfeeding compared to those of an intrauterine device. Contraception 2000;62(5): Diaz S. Contraceptive implants and lactation. Contraception 2002;65:39-46. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at more… Reinprayoon D, et al. Contraception Diaz S. Contraception Slide 68

Features of Contraceptive Implants (continued)
[Insert Lecture Name Here] Features of Contraceptive Implants (continued) Stable hormone levels Extended protection Contain no estrogen Safe Talking Points: These are additional features of contraceptive implants that make them an ideal choice for many women. Because contraceptive implants do not contain estrogen, they can be used during lactation as soon as six weeks postpartum. This feature may be especially attractive to women with young infants who want highly effective contraception that does not require daily action. References: Reinprayoon D, Taneepanichskul S, Bunyavejchevin S, et al. Effects of the etonogestrel-releasing contraceptive implant (Implanon) on parameters of breastfeeding compared to those of an intrauterine device. Contraception 2000;62(5): Diaz S. Contraceptive implants and lactation. Contraception 2002;65:39-46. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Reinprayoon D, et al. Contraception Diaz S. Contraception Slide 69

Limitations of Contraceptive Implants
[Insert Lecture Name Here] Limitations of Contraceptive Implants Can cause irregular bleeding Requires clinician visits for insertion and removal Does not protect from STDs Talking Points: The challenge with implants includes the associated irregular vaginal bleeding and the need for clinician visits for insertion and removal. As a reminder, implants, like other non-barrier forms of contraception, do not protect from sexually transmitted diseases, including HIV infection. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Slide 70

Single-Rod Implant One rod 4 cm x 2 mm Core Rate-controlling membrane
[Insert Lecture Name Here] Single-Rod Implant One rod 4 cm x 2 mm Core 40% ethylene vinyl acetate (EVA) 60% etonogestrel (68 mg) Rate-controlling membrane 100% EVA Talking Points: The newest FDA approved implantable contraception is the single-rod implant called Implanon, which contains 68 mg of etonogestrel. Implanon is a single rod 4 cm long and 2 mm wide. The rod consists of an ethylene vinylacetate (EVA) copolymer core containing 68 mg of etonogestrel. This EVA rate-controlling membrane releases enough progestin each day to prevent ovulation. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Slide 71

Pharmacology Class Progestin-only Route Subdermal Formulation
[Insert Lecture Name Here] Pharmacology Class Progestin-only Route Subdermal Formulation Implantable rod; 68 mg etonogestrel Bioavailability ~100% Metabolism Hepatic via CYP3A4 Half-life ~ 25 h Excretion Primary urine; some fecal Talking Points: This table summarizes the pharmacology of the single-rod implant. Reference: ANON. A new progestin implant (Implanon) for long-term contraception. Obstet Gynecol Apr;109(4):990-1. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at ANON. Obstet Gynecol. 2007 Slide 72

Mechanism of Action Suppresses ovulation
[Insert Lecture Name Here] Mechanism of Action Suppresses ovulation Increases cervical mucus viscosity Alters endometrium Talking Points: The primary mechanism of action of the single-rod implant is suppression of ovulation. The single-rod implant also prevents pregnancy by increased viscosity of the cervical mucus. While the implant also alters the endometrial lining this is not a known contraceptive effect. Reference: Implanon Physician Insert. Roseland, NJ: Organon USA, Inc; 2006. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at IMPLANONTM Physician insert, 2006 Slide 73

Components of the Single-Rod Implant Insertion System
[Insert Lecture Name Here] Components of the Single-Rod Implant Insertion System Talking Points: This photograph shows the components of the single-rod implant, from top to bottom: The applicator The obturator The cannula The needle shield The implant rod The implant rod is located inside the needle of the cannula and should be visible as a white body inside the needle tip. Note that the implant rod can drop out of the applicator if it is tipped downward. Reference: Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter A, Schmidt J, Zampaglione E; The Implanon US Study Group. Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception May;71(5): - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Funk S. Contraception Slide 74

Preparation Tips Supine position
[Insert Lecture Name Here] Preparation Tips Supine position Nondominant arm, flexed and externally rotated Subdermal groove Hold applicator up (vertical) before insertion Talking Points: Tips: Place patient in a supine position with the non-dominant arm flexed at the elbow and externally rotated. The correct insertion site is subdermal in the groove between the biceps and triceps approximately 6 cm to 8 cm above the elbow crease. Keep the applicator pointing upward until insertion to prevent the rod from falling out of the applicator. After removing the applicator from the pack, visualize the rod inside the needle and then tap base of the applicator with the needle pointed up until the rod disappears. Insert the needle at no more than a 20-degree angle until the skin is penetrated, then lower the applicator until it is parallel to the arm. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Slide 75

Insertion Steps Overview
[Insert Lecture Name Here] Insertion Steps Overview 1 Mark site and sterilize 2 Inject local anesthetic just under skin 3 Remove applicator, maintain sterility 4 Talking Points: There are 11 basic insertion steps as shown here and in the next two slides. Insertion techniques and timing must be followed exactly as described in the product labeling. Careful and correct insertion is key to successful use and easy removal. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Verify implant is within needle of applicator 5 Remove needle cover more… Slide 76

Insertion Steps Overview (continued)
[Insert Lecture Name Here] Insertion Steps Overview (continued) 6 Stretch skin at insertion site (a) Lift or tent skin with needle tip while inserting and insert needle to full length (b) 7 Talking Points: Note that Implanon can fall out of the needle; keep applicator in the upright position until the moment of insertion. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Press the obturator support to break seal of applicator 8 more… Slide 77

Insertion Steps Overview (continued)
[Insert Lecture Name Here] Insertion Steps Overview (continued) Turn obturator 90 degrees and fix with one hand (c) 9 With other hand, pull needle out (d) 10 Talking Points: If correct placement is in doubt, a non-hormonal contraception should be used and the rod must be located. Palpate to confirm placement of implant subdermally in the groove between the biceps and triceps approximately 6 cm to 8 cm above the elbow crease. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at 11 Palpate to verify correct insertion Slide 78

Removal Tips Inject local anesthetic under rod
[Insert Lecture Name Here] Removal Tips Inject local anesthetic under rod Incision over distal end Use sharp or blunt dissection if encapsulated Insert new implant through same incision or opposite arm Talking Points: Removing the implant is not complex, but here are a few tips to make it easier. Tips: Inject local anesthetic under the rod to prevent displacing or obscuring it. Make incision in the longitudinal direction of the arm over the distal end of the implant. If it is encapsulated, remove the rod with sharp or blunt dissection. If continued use of the single-rod implant is desired, the new implant can be inserted through the same incision or in the opposite arm. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at Slide 79

Removal Steps Overview
[Insert Lecture Name Here] Removal Steps Overview 1 Locate rod and mark site (a) 2 Sterilize site Inject local anesthetic under distal end of rod (b) 3 Talking Points: Only providers trained in removal of the single-rod implant should perform removal. There are 7 basic steps to removal shown here and on the next slide. Before removal, the implant rod must be located, either by palpation or imaging. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at 4 Press down on proximal end of rod more… Slide 80

Removal Steps Overview (continued)
[Insert Lecture Name Here] Removal Steps Overview (continued) Use scalpel to make 2–3 mm incision over distal end (c) 5 Gently push rod toward incision, then grasp with mosquito forceps (d) 6 Talking Points: Curved mosquito forceps are recommended to grasp the implant after the incision is made. If the implant can not be pushed to the opening of the incision, the forceps can be inserted into the incision to grasp the implant. Encapsulated implants may require further dissection. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at 7 Close with steri-strip closure Slide 81

Trouble Shooting: Removals
[Insert Lecture Name Here] Trouble Shooting: Removals Unrecognized non-insertion Deep placement Significant weight gain Migration Talking Points: Problems may arise when the implant is non-palpable Non-palpable implants may be caused by Unrecognized non-insertion Deep placement Significant weight gain Migration The solution is to image the implant either by ultrasound or magnetic resonance imaging. Attempts to remove a non-palpable implant blindly might lead to scarring, nerve or vessel damage, and medico-legal action. References: James P, Trenery J. Ultrasound localisation and removal of non-palpable Implanon implants. Aust N Z J Obstet Gynaecol Jun;46(3):225-8. Piessens SG, Palmer DC, Sampson AJ. Ultrasound localisation of non-palpable Implanon. Aust N Z J Obstet Gynaecol Apr;45(2):112-6. - - - Original content for this slide submitted by Clinical Advisory Committee for New Developments in Contraception: The Single-Rod Implant in July Original funding received from Organon through an unrestricted educational grant. This slide is available at James P. Aust N Z J Obstet Gynecol Piessens SG. Aust N Z J Obstet Gynecol Slide 82

Vaginal Ring Steroid release
Progestin: Etonogestrel: 120 mcg/day (~1500 pg/ml) Estrogen: Ethinyl estradiol: 15 mcg/day (~20 pg/ml) Worn for three weeks out of four Approved by the FDA in October 2001 Talking Points The vaginal ring is a low-dose sustained release contraceptive system. Daily doses are less than those of OCPs. The peak serum concentrations reached are much less than with OCPs (less than a fifth of OCPs) One size of the ring fits everyone.

Vaginal Ring: Characteristics
Self administered Insertion every four weeks Foreign body in vagina Expulsions Limited published data on efficacy

Vaginal Ring: Efficacy
Number of women 16 Woman-cycles of use 16 cycles Cumulative pregnancy rate Limited published data Source Timmer CJ, Mulders TM. Pharmacokinetics of etonogestrel and ethinylestradiol released from a combined contraceptive vaginal ring. Clin Pharmacokinet 2000 Sep;39(3):233. Timmer and Mulders. Clin Pharmacokinet 2000;39:233

Contraceptive Patch Steroid release
Progestin: norelgestromin 150 mcg/day Estrogen: ethinyl estradiol 20 mcg/day Worn for three weeks out of four Approved by the FDA in November 2001 Talking Points The patch provides daily steroid doses equivalent to the lowest dose OCPs. Maximum serum concentrations are lower with the patch than with OCPs because the patch is a sustained release system. The size of the patch determines daily dose and maximum concentrations.

Contraceptive Patch: Characteristics
Self administered Once-a-week administration Hormonal side effects Efficacy similar to combined oral contraceptives Source Audet MC, Moreau M, Koltun WD, Waldbaum AS, Shangold G, Fisher AC, Creasy GW. Evaluation of contraceptive efficacy and cycle control of a transdermal contraceptive patch vs an oral contraceptive: a randomized controlled trial. JAMA May 9;285(18):2347. Audet et al. Jama 2001;258:2347

Patch: Efficacy Number of women 1,417 Woman-cycles of use 2,440
Cumulative pregnancy rate 1% Source Shangold G, Fisher AC, Rubin A. Pharmacodynamics of the contraceptive patch. Obstet Gynecol 2000 Apr 1;95(4 Suppl 1):S36. Shangold et al. Obstet Gynecol 2000;95:S36

History of Intrauterine Contraception
1909: Grafenberg develops ring-shaped IUD device 1967: "T" shaped device developed 1962: 1st international conference on IUDs; designs for plastic spiral and plastic loop presented Talking Points The first version of the modern intrauterine contraceptive was developed in 1909 by a German gynecologist and sex researcher named Ernst Grafenberg. It was a ring-shaped device made of silver wire and silkworm gut. It wasn’t widely used until the 1920s. Plastics became widely available in the 1950s and became very useful in the development of new forms of intrauterine contraception. A flurry of activity at The Population Council resulted in the First International Conference on Intrauterine Contraception in 1962, where Drs. Marguiles and Lippes introduced the intrauterine plastic spiral and intrauterine plastic loop. 1964: Bernard Berelson, vice president of The Population Council, at the Second International Conference states, “This simple device can and will change the history of the world.” 1967: Scientist at The Population Council developed "T" shaped device. Since 1960, nine intrauterine contraceptives have appeared on the US market. References Richter R. Ein mittel zur verhuntung der Konception. Deutsche Med Wochenschr. 1909;35: Grafenberg E. Die intrauterine methode der Konzeptions verhurtung. Proceedings of the Third Congress of the World League for Sexual Reform; [dates]; London, UK. [city:] Heinemann; 1929. Ishihama A. Clinical studies on intrauterine rings. Yokohama Med Bull .1959;10: Oppenheimer W. Prevention of pregnancy by the Grafenberg ring method. Am J Obstet Gynecol. 1959;78: Berelson B. Intrauterine contraception: Proceedings of the Second International Conference. Amsterdam: Excerpta Medica Foundation; 1964:13. Marguiles LC. Permanent reversible contraception with an intrauterine plastic spiral. Proceedings of the Conference on Intrauterine Contraceptive Devices. Amsterdam: Excerpta Medica Foundation; 1962:61-8. Lippes J. A study of intrauterine contraception: development of a plastic loop. Proceedings of the Conference on Intrauterine Contraceptive Devices. Amsterdam: Excerpta Medica Foundation; 1962:68-75. Hubacher D, Cheng D. Intrauterine devices and reproductive health: American women in feast and famine. Contraception. 2004;69: - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. more… Richter R. Deutsche Med Wochenschr ; Grafenberg E ; Ishihama A. Yokohama Med Bull ; Oppenheimer W. Am J Obstet Gynecol ; Berelson B. 1964; Marguiles LC ; Lippes J ; Hubacher D, Cheng D. Contraception

History of Intrauterine Contraception (continued)
1968: Contraceptive action of intrauterine copper reported 1980: LNG IUD tested in randomized clinical trials 1976: Copper T 200 becomes first copper IUD Talking Points 1968: Contraceptive action of intrauterine copper is reported. 1976: Copper T 200 becomes the first Copper T IUD. The Population Council worked with FEI Women’s Healthcare LLC to refine the IUD design to increase contraceptive duration and effectiveness. This research resulted in the Copper T 380A, which has copper collars on the arms and copper wire coiled around the stem. 1980: Levonorgestrel (LNG) IUD (commonly referred to as an intrauterine system or IUS) is tested in randomized clinical trials. Reference Lee NC. Type of intrauterine device and the risk of pelvic inflammatory disease. Obstet Gynecol. 1983;62:1-6. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Lee NC. Obstet Gynecol

History of Intrauterine Contraception (continued)
1988: Copper T 380 IUD available in the U.S. Today: Only 2% of US women use IUDs 2001: LNG IUD available in the U.S. Talking Points The copper T IUD (brand name ParaGard®) was approved by the Food and Drug Administration (FDA) in 1984 and has been available for use in the United States since 1988. Since 2005, DuraMed Pharmaceuticals, Inc., a division of Barr Pharmaceuticals, Inc., has marketed ParaGard. In 2000, the levonorgestrel (LNG) IUD (brand name Mirena) became available in the US. It is marketed by Berlex Inc. Reference Mosher WD, Martinez GM, Chandra A, et al. Use of contraception and use of family planning services in the United States: Advance Data From Vital and Health Statistics. No. 350, 2004. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Mosher WD, et al

Comparison of Copper IUDs
1st Year Failure per 100 women Recommended Lifespan TCu 380A 0.3 12 years Multiload Cu 250 1.2 3 years Multiload Cu 375 1.4 5 years TCu 200 2.3 Nova T 3.3 Source: FHI clinical trials,

Dispelling Common Myths About IUDs
In fact, IUDs: Are not abortifacients Do not cause ectopic pregnancies Do not cause pelvic infection Do not decrease the likelihood of future pregnancies Are not large in size Talking Points IUDs are not abortifacients; they prevent fertilization. IUDs do not increase the risk of ectopic pregnancy; rather, they decrease the risk of both ectopic and intrauterine pregnancy. However, IUDs are more efficient at preventing uterine than ectopic pregnancy, so that compared with other methods, a higher fraction of pregnancies that occur with an IUD are ectopic. A survey of ob/gyns shows that although attitudes toward the safety and effectiveness of the IUD are very positive, most respondents believe that a long-term causal relationship exists between the modern copper T IUD and PID. The truth is that IUD use, in properly selected patients, does not increase the risk of PID. Untreated pelvic infection is the most common cause of infertility; IUD use is not associated with infertility. The 2001 New England Journal of Medicine article by Hubacher et al., as well as others, confirms the overall benign impact on women who use copper IUDs. Some women are hesitant to use the IUD because they perceive it to be larger than it actually is. In truth, both types of IUD are small and can fit in the palm of the hand. References Hubacher D, Lara-Ricalde R, Taylor D. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. NEJM. 2001;345:561-7. Stanwood NL, Garrett JM, Konrad TR. Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice. Obstet Gynecol. 2002;99: Forrest JD. U.S. women’s perceptions of and attitudes about the IUD. Obstet Gynecol Surv. 1996;51(12 Suppl):S30-4. Lippes J. Pelvic actinomycosis: a review and preliminary look at prevalence. Am J Obstet Gynecol. 1999;180(2 Pt 1):265-9. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. more… Hubacher D, et al. N Engl J Med ; Stanwood NL, et al. Obstet Gynecol Forrest JD. Obstet Gynecol Surv ; Lippes J. Am J Obstet Gynecol

Dispelling Common Myths About IUDs (continued)
In fact, IUDs: Can be used by nulliparous women Can be used by women who have had an ectopic pregnancy Do not need to be removed for PID treatment Do not have to be removed if actinomyces-like organisms (ALO) are noted on a Pap test Talking Points: A 4-year study found that IUD failure and expulsion rates were lower for nulliparous than parous women. Another study that evaluated three types of IUDs in nulliparous women found low failure and expulsion rates. According to the World Health Organization’s Medical Eligibility Criteria for Contraceptive Use, nulliparity is considered a condition for which the advantages of using an IUD generally outweigh the theoretical or proven risks. IUD use in women with a previous ectopic pregnancy is appropriate but reflects off-label use. IUD users who develop an STI or PID should be tested for relevant organisms and treated with appropriate antibiotic therapy. Clinical guidelines state that removal of the IUD is not necessary unless symptoms fail to improve within 72 hours of the start of treatment. Actinomyces-like organisms (ALO) normally exist in the female genital tract and are sometimes identified on Pap tests. Current recommendations state that symptomatic women with a finding of ALO from a Pap or other test should be treated with appropriate antibiotics and the IUD should be removed (after the patient has begun antibiotics). Asymptomatic women require neither IUD removal nor antibiotic therapy. References: Duenas JL, Albert A, Carrasco F. Intrauterine contraception in nulligravid vs. parous women. Contraception 1996;53:23-4. Stanwood NL, Garrett JM, Konrad TR. Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice. Obstet Gynecol. 2002;99: Forrest JD. U.S. women’s perceptions of and attitudes about the IUD. Obstet Gynecol Surv. 1996;51(12 Suppl):S30-4. Lippes J. Pelvic actinomycosis: a review and preliminary look at prevalence. Am J Obstet Gynecol. 1999;180(2 Pt 1):265-9. Otero-Flores JB, Guerrero-Carreno FJ, Vazquez-Estrada LA. A comparative randomized study of three different IUDs in nulliparous Mexican women. Contraception. 2003;67(4):273-6. World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. Geneva: WHO; 2004. Penney G, Brechin S, de Souza A, et al. The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004;30(1):29-41. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Duenas JL. Contraception ; Stanwood NL. Obstet Gynecol Forrest JD. Obstet Gynecol Surv. 1996; Lippes J. Am J Obstet Gynecol Otero-Flores JB. Contraception ; WHO ; Penney G. J Fam Plann Reprod Health Care

Safety: IUDs Do Not Cause PID
PID incidence for IUD users is similar to that of the general population Risk is increased only during the first month after insertion Preexisting STI at time of insertion, not the IUD itself, increases risk Talking Point The presence of a preexisting sexually transmitted infection (STI) at time of insertion, not the IUD itself, increases the risk of PID. References Svensson L, Westrom L, Mardh PA. Contraceptives and acute salpingitis. JAMA. 1984;251(19): Sivin I, Stern J, Coutinho E, et al. Prolonged intrauterine contraception: a seven-year randomized study of the levonorgestrel 20 mcg/day (LNg 20) and the Copper T380 Ag IUDS. Contraception. 1991;44(5): Farley T, Rowe P, Meirik O, et al. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet. 1992;339:1904. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Svensson L, et al. JAMA Sivin I, et al. Contraception Farley T, et al. Lancet

Rate of PID by Duration of IUD Use
Rate per 1,000 woman years N = 20,000 women 1.6 9.25 <21 days of use 21 days - 8 years of use Talking Points Longer duration of IUD use is associated with a lower rate of pelvic inflammatory disease. Among approximately 20,000 women using the device for 21 days to 8 years, incidence of the disease was approximately 1 per 1000 woman-years, as opposed to a rate of nearly 10 in 1000 woman-years among women using the IUC for 20 days or less. Reference Farley T, Rowe P, Meirik O, Rosenber MJ, Chen J-H. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet 1992;339:1904. Adapted from Farley T, et al. Lancet

Risk of Fetal Abnormality
IUD is extra-amniotic No increase in birth defects for copper IUD Talking Points As shown in case-series reports, there is no increase in the incidence of birth defects in infants born at term with a copper or progesterone IUD left in place for the duration of the pregnancy. There are no data for the levonorgestrel intrauterine contraceptive. In a case-control study reported by the Centers for Disease Control and Prevention, IUDs left in place during pregnancy were not associated with an increased incidence of limb reduction defects in infants. This evidence suggests that there is no causal association between the retention of an IUD during pregnancy and an increased risk of birth defects. References Atrash HK, Frye A, Hogue CJR. Incidence of morbidity and mortality with IUD in situ in the 1980s and 1990s. In: Bardin CW, Mishell Dr Jr, eds. Proceedings from the Fourth International Conference on IUDs. Boston, MA: Butterworth-Heinemann; 1994:76-87. Layde PM, Goldberg MF, Safra MJ, Oakley GP Jr. Failed intrauterine device contraception and limb reduction deformities: a case-control study. Fertil Steril. 1979;31(1):18-20. Simpson JL. Do contraceptive methods pose fetal risks? Res Front Fertil Regul. 1985;3:1-11. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Atrash HK, et al Layde PM, et al. Fertil Steril Simpson JL. Res Front Fertil Regul

Safety: IUD Does Not Cause Infertility
IUD is not related to infertility Chlamydia is related to infertility Tubal infertility by previous copper T IUD use and presence of chlamydia antibodies, nulligravid women Talking Points Background: Previous studies of IUDs, many no longer in use, suggested that copper IUDs might cause tubal infertility, decreasing the use of this method in nulligravid women. Hubacher et al. enrolled 1,895 women in a case-control study: 358 women with primary infertility with tubal occlusion documented by hysterosalpingogram, 953 women who were infertile without tubal occlusion (infertile controls), and 584 primigravid women (pregnant controls). Information was obtained about the women’s past use of contraceptives including copper IUDs, previous sexual relationships, and history of STIs. Each subject had antibody testing for Chlamydia trachomatis. Stratified analysis and logistic regression analyses were employed. Results: Odds ratio for tubal occlusion associated with previous use of a copper IUD was 1.0 (95% CI, 0.6–1.7) using infertile controls. When the primigravid women served as controls, the odds ratio was 0.9 (95% CI, 0.5–1.6). Odds ratio for tubal occlusion associated with chlamydia was 2.4 (95% CI, 1.7–3.2). Conclusions: Previous use of a copper IUD is not associated with increased risk of tubal occlusion among nulligravid women; rather, chlamydial infection is. These results have been confirmed by others: Hov GG, Skjeldestad FE, Hilstad T. Use of IUD and subsequent fertility: Follow-up after participation in a randomized clinical trial. Contraception. 2007;75:88-92. Skjeldestad F, Bratt H. Fertility after complicated and non-complicated use of IUDs. A controlled prospective study. Adv Contracept. 1988;4: Wilson JC. A prospective New Zealand study of fertility after removal of copper intrauterine contraceptive devices for conception and because of complications: A four-year study. Am J Obstet Gynecol. 1989;160:391-6. Reference Hubacher D, Lara-Ricalde R, Taylor D, et al. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. NEJM. 2001;345:561-7. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Hubacher D, et al. NEJM

Fertility Rates in Parous Women After Discontinuation of Contraceptive
Pregnancies (%) Months After Discontinuation 20 40 60 80 100 12 18 24 30 36 42 IUC OC Diaphragm Other methods Talking Point Research indicates that return of fertility after IUD removal is rapid, similar to that after discontinuation of barrier methods. References Vessey MP, Lawless M, McPherson K, Yeates D. Fertility after stopping use of intrauterine contraceptive device. Br Med J (Clin Res Ed). 1983;286(6359):106. Andersson K, Batar I, Rybo G. Return to fertility after removal of a levonorgestrel releasing intrauterine device and Nova-T. Contraception. 1992;46:575. Belhadj H, Sivin I, Diaz S, et al. Recovery of fertility after use of the levonorgestrel 20 mcg/d or copper T 380 Ag intrauterine device. Contraception. 1986;34(3):261. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Vessey MP, et al. Br Med J Andersson K, et al. Contraception Belhadj H, et al. Contraception

Safety: IUDs May Be Used by HIV- Positive Women
No increased risk of complications compared with HIV-negative women No increased cervical viral shedding WHO Category 2 rating Talking Points A 1999 study in Kenya found that copper IUD insertion did not significantly change the shedding of HIV-infected cervical cells. WHO gives both the copper T and the levonorgestrel IUD a Category 2 medical eligibility rating, suggesting that the benefit of women with HIV infection using an effective contraceptive method outweighs potential risk of infection. Category 1: A condition for which there is no restriction for the use of the contraceptive method. Category 2: A condition where the advantages of using the method generally outweigh the theoretical or proven risks. Category 3: A condition in which the theoretical or proven risks usually outweigh the advantages of the method. Category 4: A condition which represents unacceptable health risk if the method is used (i.e., contraindications). References World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. Geneva: WHO; 2004. Morrison CS, Sekadde-Kigondu C, Miller WC. Is the intrauterine device appropriate contraception for HIV-infected women? Brit J Obstet Gynaecol. 2001;108: Richardson B, Morrison C, Sekadde-Kigondu C. Effect of intrauterine device use on cervical shedding of HIV-1 DNA. AIDS. 1999;13: - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. WHO. Medical Eligibility Criteria for Contraceptive Use Morrison CS, et al. Brit J Obstet Gynaecol Richardson B, et al. AIDS

Safety: LNG IUD Does Not Increase Breast Cancer Risk
Age Group (y) LNG users: Incidence rate per 100,000 woman-years Average Finnish population: Incidence rate per 100,000 woman-years 30–34 27.2 25.5 35–39 74.0 49.2 40–44 120.3 122.4 45–49 203.6 232.5 50–54 258.5 272.6 Talking Points Many women have concerns about the use of hormones and the risk of breast cancer. A 2005 Finnish postmarketing study of users of levonorgestrel-releasing IUDs (n=17,360) offers reassurance that use of this IUD is not associated with an increased risk of breast cancer. Reference Backman T, Rauramo I, Jaakkola K, et al. Use of the levonorgestrel-releasing intrauterine system and breast cancer. Obstet Gynecol. 2005;106: - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Backman T, et al. Obstet Gynecol

Safety: IUDs May Be Used in Nulligravid Women
No evidence of increased infertility Risk of PID and subsequent infertility dependent on non-IUD factors Talking Points The data are also reassuring that IUD use does not increase the risk of infertility in nulliparous women. The risk of PID and subsequent infertility is dependent on non-IUD factors ( e.g., a woman’s exposure to STIs). References World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. Geneva: WHO; 2004. Hubacher D, Lara-Ricalde R, Taylor D. Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women. NEJM. 2001;345:561-7. Delbarge W, Batar I, Bafort M, et al. Return to fertility in nulliparous and parous women after removal of the GyneFix intrauterine contraceptive system. Eur J Contracept Reprod Health Care. 2002;7(1):24-30. Hov GG, Skjeldestad FE, Hilstad T. Use of IUD and subsequent fertility—follow-up after participation in a randomized clinical trial. Contraception. 2007;75:88-92. Penney G, Brechin S, de Souza A, et al; Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. Penney Guidance (January 2004). The copper intrauterine device as long-term contraception. J Fam Plann Reprod Health Care. 2004;30(1):29-41. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. WHO ; Hubacher D, et al. NEJM ; Delbarge W, et al. Eur J Contracept Reprod Health Care ; Hov GG, et al. Contraception Penney G, et al. J Fam Plann Reprod Health Care

Screening: Appropriate Candidates for Intrauterine Contraception (continued)
Copper T IUD LNG IUD Women who don’t want hormonal contraception or want contraception for more than 5 years Women who request less menstrual flow and/or who experience dysmenorrhea or dysfunctional uterine bleeding - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007.

Screening: Poor Candidates for Intrauterine Contraception
Known or suspected pregnancy Puerperal sepsis Immediate post septic abortion Unexplained vaginal bleeding Cervical or endometrial cancer Talking Points Note that these screening guidelines differ from the manufacturer’s package insert. Few absolute contraindications to intrauterine contraception use exist. The listed conditions are rated Category 4, according to the WHO Medical Eligibility Criteria for Contraceptive Use. Conditions assigned to Category 4 are those that represent an unacceptable health risk if the contraceptive method is used. For complete information about relative contraindications, see the WHO criteria, available at: Reference World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. Geneva: WHO; Available at Accessed February 1, 2007. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. more… WHO. Medical Eligibility Criteria for Contraceptive Use

Screening: Poor Candidates for Intrauterine Contraception (continued)
Uterine fibroids that interfere with placement Uterine distortion (congenital or acquired) Current PID Current purulent cervicitis, chlamydia, or gonorrhea Known pelvic tuberculosis Talking Points Note that these screening guidelines differ from the manufacturer’s package insert. Few absolute contraindications to intrauterine contraception use exist. The listed conditions are rated Category 4, according to the WHO Medical Eligibility Criteria for Contraceptive Use. Conditions assigned to Category 4 are those that represent an unacceptable health risk if the contraceptive method is used. For complete information about relative contraindications, see the WHO criteria, available at: Reference World Health Organization. Medical Eligibility Criteria for Contraceptive Use. 3rd ed. Geneva: WHO; Available at Accessed February 1, 2007. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. WHO. Medical Eligibility Criteria for Contraceptive Use

IUD Insertion After Spontaneous or Induced Abortion
May be safely inserted immediately after spontaneous or induced abortions Not recommended after septic abortion Talking Points Intrauterine contraception may be safely inserted immediately after spontaneous or induced abortions of a routine nature. Event rates following first-trimester terminationexpulsion, pregnancy, and removals for medical reasonsare comparable to those found in studies in which the device was inserted during or immediately after menses. The shorter the period of gestation at the time of spontaneous or induced abortion, the lower the event rates after IUD insertion. Insertion of a copper T IUD is contraindicated after septic abortion. Package labeling for ParaGard recommends that insertion of a copper T IUD be delayed until involution of the uterus is complete. References Grimes D, et al. Cochrane Library. 2000;4:2. [FIRST 3 AUTHORS AND TITLE NEEDED] World Health Organization Task Force on Intrauterine Devices for Fertility Regulation, Special Programme of Research, Development and Research Training in Human Reproduction. Stud Fam Plann. 1983;14:99. ParaGard labeling, Duramed Pharmaceuticals, Inc., May 2006. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Grimes D, et al. Cochrane Library ParaGard label WHO

IUD for Postpartum Use May be safely inserted in postpartum women
Copper T IUD LNG IUD Within 48 hours postpartum OR After 4 weeks once uterus is involuted 6 weeks postpartum Talking Points Many clinicians postpone insertion of intrauterine contraception until 12 weeks postpartum because of concerns that earlier insertion may lead to higher rates of expulsion and more complications. However, copper T IUDs may be inserted safely as early as 4 weeks postpartum. Some suggest that the IUD may be safely inserted immediately after delivery of the placenta. Immediate postpartum insertion provides an opportunity for women to secure effective contraception at a convenient time. Early postpartum insertion—between 48 hours and 4 weeks postpartum—is associated with a higher rate of expulsion and perforation and is not generally recommended. Package labeling recommends that IUDs should not be inserted until involution of the uterus is complete. References Treiman K, Liskin L, Kols A, Rinehart W. IUDs—an update. Population Reports, Series B, no. 6. Baltimore, MD: Population Information Program, Johns Hopkins University; 1995. Mishell DR Jr, Roy S. Copper intrauterine contraceptive device event rates following insertion 4 to 8 weeks post partum. Am J Obstet Gynecol. 1982;143:29. Morrison C, Waszak C, Katz K, et al. Clinical outcomes of two early postpartum IUD insertion programs in Africa. Contraception. 1996;53(1):17-21. Darney PD. In: Intrauterine Contraception in the US: A Current Perspective. Conference Proceedings. 1996;37. Manufacturer’s prescribing information. Kennedy KI, Trussell J. Postpartum contraception and lactation. In: Hatcher RA, Trussell J, Stewart F, et al., eds. Contraceptive Technology. 18th revised ed. New York: Ardent Media; 2004. - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Treiman K, et al. Population Reports. 1995; Mishell DR, et al. Am J Obstet Gynecol. 1982; Kennedy KI, et al. In Hatcher RA, et al. Contraceptive Technology. 18th revised ed

IUD Use During Lactation
Effectiveness not decreased Uterine perforation risk unchanged Expulsion rates unchanged Decreased insertional pain Reduced rate of removal for bleeding and pain LNG comparable to copper T in breastfeeding parameters Talking Points Chi et al. assessed copper T IUD use during lactation in 559 breastfeeding women and 590 non-breastfeeding women. Results indicate that the device is at least as effective in women who are breastfeeding as in those who are not. Expulsion rates are similar in lactating and non-lactating women. However, pain at insertion as well as removals for pain and bleeding are lower in women who are breastfeeding than in those who are not. In this study, no cases of uterine perforation occurred in either group. A more recent study found that the LNG IUD is comparable to the copper T in rates of breastfeeding continuation, complete weaning, full breastfeeding, and partial breastfeeding and did not affect infant growth or development. References Chi I-C, Potts M, Wilkens L, et al. Performance of the TCu-380A device in breast-feeding and non-breastfeeding women. Contraception. 1989;39: Mirena labeling, Berlex, Inc., April 2006. Shaamash AH, Sayed GH, Hussein MM, et al. A comparative study of the levonorgestrel-releasing intrauterine system Mirena® versus the Copper T380A intrauterine device during lactation: breast-feeding performance, infant growth and infant development. Contraception. 2005;72(5): - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Chi I-C, et al. Contraception. 1989; Mirena label Shaamash AH, et al. Contraception

Checklist for STI Risk Assessment
Circle appropriate answer Yes No Is the client < 25 years old? 1 Is she currently living apart from her husband or partner? During the last year, has she had bleeding between periods or bleeding or spotting within 24 hours after sex? Is her school education < secondary level? Talking Points An algorithm was created for categorizing women’s risk for STIs before insertion of an IUD. The authors found it performed reasonably well at identifying women at low current risk of cervical infection. It performed as well as more complex algorithms and without a physical exam. Conclusion: The algorithm can be used in identifying appropriate candidates for an IUD in settings of moderate to high STI prevalence and where laboratory testing for STIs is not available. Reference Morrison CS, Murphy L, Kwok C, et al. Identifying appropriate IUD candidates in areas with high prevalence of sexually transmitted infections. Contraception Mar;75(3): - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. more… Morrison CS, et al. Contraception

Checklist for STI Risk Assessment (continued)
How many different sexual partners has she had during the last 3 months? None One > One If she has had one or more partners, how often has she used a condom in the last 3 months? Never used condoms 1 Sometimes used condoms Always used condoms Talking Points Circle the appropriate answer for each question. Then add up the circled scores to get a total score. Reference Morrison CS, Murphy L, Kwok C, et al. Identifying appropriate IUD candidates in areas with high prevalence of sexually transmitted infections. Contraception. 2007;75(3): - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Morrison CS, et al. Contraception

Scoring STI Risk Assessment
Recommended action Low cervical infection population (<10%) High cervical infection population (=10%) Counsel/refer for IUD insertion without any reservations If score is 0–2 If score is 0 Consider presumptive treatment for chlamydia/ gonorrhea (if available) or counsel/refer to use another contraceptive If score is 3+ If score is 1+ Talking Points Because the overall prevalence of cervical infection may vary widely by region, the authors suggest placing the total score into a low cervical infection category or a high cervical infection category, depending on the background prevalence of cervical infection in a particular clinic population. The algorithm suggests the following actions based on the total score: Counsel/refer patients for IUD insertion if your clinic has a low cervical infection prevalence and they have a score of 0–2, or if you have a high cervical infection population and they have a score of 0. Consider treating patients presumptively for STIs if available or counseling/referral to another birth control method if their score is 3+ in the former population (low cervical infection prevalence) or 1+ in the latter population (high cervical infection prevalence). Reference Morrison CS, Murphy L, Kwok C, et al. Identifying appropriate IUD candidates in areas with high prevalence of sexually trnsmitted infections. Contraception - - - Original content for this slide submitted by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in April Original funding received from Bayer HealthCare Pharmaceuticals through an unrestricted educational grant. Last reviewed/updated by the Clinical Advisory Committee for the Clinical Update on Intrauterine Contraception project in May 2007. Morrison CS, et al. Contraception

Levonorgestrel Intrauterine System (LNG IUS)
Steroid reservoir levonorgestrel 20 mcg/day 32 mm Talking Points The product is as wide (32mm) as it is long with its arms fully extended. Small T-shaped frame with a LNG-containing cylinder. Potent progestin found in many combination oral contraceptive, progestin-only pills, and implants. The LNG system releases LNG from the cylinder at 20 mcg per day into the uterine cavity for at least 5 years. Highly effective contraceptive protection. Published studies provide data on 12,000 women years of use . Two million women have used this method world-wide to date. Approved December 2000

LNG IUS: Characteristics
High efficacy Long-term reversible method Reduction in menstrual blood loss Low systemic levels of LNG Early spotting common Foreign body in the uterus Expulsions Requires professional insertion

LNG IUS: Mechanism of Action
Fertilization inhibition: Cervical mucus thickened Sperm motility and function inhibited Endometrium suppressed Weak foreign body reaction induced Ovulation inhibited (in some cycles) Talking Points The picture on the slide is just a schematic, so it is not anatomically proportional. The mechanism of action of the levonorgestrel intrauterine system is similar to that of LNG implants or LNG-containing mini-pills. As with other methods, thickening of the cervical mucus (1) and inhibition of sperm motility and function are the primary role (2). The LNG intrauterine system does not usually inhibit ovulation (3), but the pregnancy rate and the ectopic rate are extremely low, suggesting that a primary endometrial effect as the mechanism of action is unlikely. The endometrial atrophy which is a consequence of the high endometrial levels of LNG leads to the substantial decrease in menstrual flow and absence of bleeding in some women noted in users of this form of intrauterine contraception. A weak foreign-body effect is also noted. It is important to some patients that the LNG IUS mechanisms of action are all pre-conception. They prevent fertilization rather than disrupt implantation (a common misconception). Sources Jonsson B, Landgren B-M, Eneroth P. Effects of various IUDs on the composition of cervical mucus. Contraception 1991;43:447. Nilsson CG, Lahteenmaki PLA, Luukkainen T, et al. Ovarian function in amenorrheic and menstruating users of a levonorgestrel-releasing intrauterine device. Fertil Steril 1984;41:52. Videla-Rivero L, Etchepareborda J, Desseru E. Early chorionic activity in women bearing inert IUD, copper IUD and levonorgestrel-releasing IUD. Contraception 1987;36:217. Jonsson et al. Contraception 1991;43:447 Videla-Rivero et al. Contraception 1987;36:217

LNG IUS: Efficacy Overall failure rate 0.14 per 100 woman-years
Gross cumulative five-year rate is 0.71 per 100 women Talking Point According to Luukkainen et al., the 12-month net pregnancy rate with the LNG IUS is 0.1 per hundred women. Sources Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception 1994;49(1):56. Luukkainen T, Allonen H, Haukkamaa M, Holma P, Pyorala T, Terho J, Toivonen J, Batar I, Lampe L, Andersson K, et al. Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study. Contraception 1987 Aug;36(2):169. Andersson et al. Contraception 1994;49:56 Luukkainen et al. Contraception 1987;36:169

LNG IUS: Efficacy Luukkainen and Toivonen. Contraception 1995;52:269
Source Luukkainen T, Toivonen J. Levonorgestrel-releasing IUD as a method of contraception with therapeutic properties. Contraception 1995 Nov;52(5):269. Luukkainen and Toivonen. Contraception 1995;52:269

LNG IUS: Comparison to Sterilization
Talking Points Because the LNG IUS failure rate is comparable to that of sterilization, it could be viewed in this context as reversible sterilization, not just reversible contraception. Even though this schematic depicts a difference, there is no significant statistical difference between the Nova T and LNG IUS. These data are from the largest study. Other studies have even lower failure rates. Sources Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception 1994;49(1):56. Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol 1996 Apr;174(4):1161. Andersson et al. Contraception 1994;49:56 Peterson et al. Am J Obstet Gynecol 1996;174:1161

LNG IUS: Return to Fertility
20 40 60 80 100 3 6 9 12 Months Cumulative pregnancy rate (%) LNG IUS Copper IUD Talking Points The return to fertility with the LNG IUS is rapid, essentially equal to that of the copper IUD and much more rapid than that of methods such as contraceptive implants. Sources Andersson K, Batar I, Rybo G. Return to fertility after removal of a levonorgestrel releasing intrauterine device and Nova-T. Contraception 1992;46:575. Belhadj H, Sivin I, Diaz S, et al. Recovery of fertility after use of the levonorgestrel 20 mcg/d o copper T 380 Ag intrauterine device. Contraception 1986;34(3):261. Vessey MP, Lawless M, McPherson K, Yeates D. Fertility after stopping use of intrauterine contraceptive device. Br Med J (Clin Res Ed) 1983 Jan 8;286(6359):106. Andersson et al. Contraception 1992;46:575 Belhadj et al. Contraception 1986;34:261

Plasma Concentrations of Levonorgestrel
Talking Points The graph on the slide is a schematic that contrasts the plasma concentrations of “bolus” administration of oral mini-pills and combined OCs with the sustained release of LNG that occurs in the IUS and the LNG implant. At this level of plasma concentration, ovarian hormonal function is maintained. About 85% of cycles are ovulatory at the end of one year, and estrogen levels are normal. As noted earlier, although plasma concentrations are low, endometrial concentrations are high. The effects of the hormone are thus targeted to where they are needed, not spread systemically. With the low-dose LNG IUS, LNG is detected in the serum 15 minutes after insertion. After an initial higher concentration, LNG reaches a steady state in several weeks. LNG IUS has a lower plasma concentration than implants. For short periods, combined OCs produce serum concentrations 50 times those of the low-dose products. Sources Diaz S, Pavez M, Miranda P, Johansson ED, Croxatto HB. Long-term follow-up of women treated with Norplant implants. Contraception 1987 Jun;35(6):551. Kuhnz W, al-Yacoub G, Fuhrmeister A. Pharmacokinetics of levonorgestrel and ethinylestradiol in 9 women who received a low-dose oral contraceptive over a treatment period of 3 months and, after a wash-out phase, a single oral administration of the same contraceptive formulation. Contraception 1992 Nov;46(5):455. Luukkainen T, Lahteenmaki P, Toivonen J. Levonorgestrel-releasing intrauterine device. Ann Med 1990;22:85-90. Nilsson C G, Lahteenmaki P, Robertson D N, Luukkainen T. Plasma concentrations of levonorgestrel as a function of the release rate of levonorgestrel from medicated intra-uterine devices. Acta Endocrinol 1980;93:380. Nilsson et al. Acta Endocrinol 1980;93:380 Diaz et al. Contraception 1987;35:551

LNG IUS: Endometrial Effect
Months Ovulation Talking Points LNG is concentrated locally in the endometrium, targeting the effects where they are desired and minimizing systemic side effects. Suppression is complete in three months. Returns to normal stage one month after removal. Sources Pakarinen PI, Suvisaari J, Luukkainen T, Lahteenmaki P. Intracervical and fundal administration of levonorgestrel for contraception: endometrial thickness, patterns of bleeding, and persisting ovarian follicles. Fertil Steril 1997 Jul;68(1):59. Silverberg SG, Haukkamaa M, Arko H, Nilsson CG, Luukkainen T. Endometrial morphology during long-term use of levonorgestrel-releasing intrauterine devices. Int J Gynecol Pathol 1986;5(3):235. Days of cycle Changes in the endometrium during normal menstrual cycle

LNG IUS: Endometrial Effect
Months Ovulation Source Pakarinen PI, Suvisaari J, Luukkainen T, Lahteenmaki P. Intracervical and fundal administration of levonorgestrel for contraception: endometrial thickness, patterns of bleeding, and persisting ovarian follicles. Fertil Steril 1997 Jul;68(1):59. Days of cycle Endometrium in “resting state” with LNG IUS Pakarinen et al. Fertil Steril 1997;68:59

LNG IUS: Early Spotting
Endometrial suppression effect is not immediate Takes three months for full effect on the endometrium Spotting is common during this time Talking Points The effects of LNG IUS on menstrual bleeding are comparable to climbing a mountain. The spotting can be rough going for the first three months, but once the patient gets past that time, the bleeding patterns are very acceptable. Source Silverberg SG, Haukkamaa M, Arko H, Nilsson CG, Luukkainen T. Endometrial morphology during long-term use of levonorgestrel-releasing intrauterine devices. Int J Gynecol Pathol 1986;5(3):235. Silverberg et al. Int J Gynecol Pathol 1986;5:235

LNG IUS: Number of Bleeding Days
6 Copper IUD 4 2 Talking Points Note the dramatic reduction in bleeding days that occurs with LNG IUS over time vis-à-vis the copper IUD. This is a substantial benefit for many women. Source Luukkainen T, Toivonen J. Progestin IUD - its benefit for women´s health. In Sitruk R, Bardin CW, eds. Contraception: Newer Pharmacological Agents, Devices, and Delivery Systems. New York: Marcel Dekker 1992;90. LNG IUS 4 8 12 16 20 24 Months Luukkainen and Toivonen. 1992;90

LNG IUS: Bleeding Patterns
20 % of women will have no bleeding at all after 12 months Talking Points Mechanism on bleeding Anti-proliferative action decreases menstrual blood loss Absence of bleeding is due to local effect Pituitary and ovarian function are normal Sources Pekonen F, Nyman T, Lahteenmaki P, Haukkamaa M, Rutanen EM. Intrauterine progestin induces continuous insulin-like growth factor-binding protein-1 production in the human endometrium. J Clin Endocrinol Metab 1992 Aug;75(2):660. Luukkainen T, Allonen H, Haukkamaa M, Holma P, Pyorala T, Terho J, Toivonen J, Batar I, Lampe L, Andersson K, et al. Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study. Contraception 1987 Aug;36(2):169. Pekonen et al. J Clin Endocrinol Metab 1992;75:660 Luukkainen et al. Contraception 1987;36:169

LNG IUS: Non-contraceptive Therapeutic Uses
Alternative to hysterectomy Cancelled hysterectomy: 80 % LNG IUS vs. 9 % normal care Treatment of menorraghia 97 % decrease in menstrual blood loss (MBL) Both the alternative to hysterectomy and treatment of menorraghia statements are based on data from the cited “before-after” case studies Sources Andersson JK, Rybo G. Levonorgestrel-releasing intrauterine device in the treatment of menorrhagia. Br J Obstet Gynaecol Aug;97:690-4. Hurskainen R, Teperi J, Rissanen P, Aalto AM, Grenman S, Kivela A, Kujansuu E, Vuorma S, Yliskoski M, Paavonen J. Quality of life and cost-effectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial. Lancet Jan 27;357:273-7. Hurskainen et al. Lancet Jan 27;357:273 Andersson and Rybo. Br J Obstet Gynaecol Aug;97:690

LNG IUS: Non-contraceptive Therapeutic Uses (cont)
Hormone replacement therapy (HRT) Days of bleeding/spotting at 12 months: 2 LNG IUS vs. 6 oral LNG Adjuvant therapy for tamoxifen users Decidual change in endometrium of all women with LNG IUS Both statements based on the cited randomized controlled clinical trials. Source Barrington JW, Bowen-Simpkins P. The levonorgestrel intrauterine system in the management of menorrhagia. Br J Obstet Gynaecol May;104(5):614- Gardner FJ, Konje JC, Abrams KR, Brown LJ, Khanna S, Al-Azzawi F, Bell SC, Taylor DJ. Endometrial protection from tamoxifen-stimulated changes by a levonorgestrel-releasing intrauterine system: a randomised controlled trial. Lancet Nov 18;356: Barrington and Bowen-Simpkins. Br J Obstet Gynaecol May;104:614 Gardner et al. Lancet Nov 18;356:1711

US Preventive Services Task Force Ratings
LNG IUS Finding Strength of conclusion Increases concentration of hemoglobin A Effective treatment for menorraghia Well-accepted alternative to hysterectomy B Talking Points The US Preventive Services Task Force analyzed the body of medical research relating to various possible benefits of the LNG IUS to determine the level of scientific support for these assertions. They concluded the research provides fair to good supporting evidence about the benefits listed on this slide and the next slide. Only ratings of B or higher are shown in this table. A = good evidence to support the finding B = Fair evidence to support the finding Source Hubacher D, Grimes DA. Noncontraceptive health benefits of intrauterine devices: a systematic review. Obstet Gynecol Surv 2002 Feb;57:120-8 Hubacher and Grimes. Obstet Gynecol Surv 2002 Feb;57:120

US Preventive Services Task Force Ratings (cont)
LNG IUS Finding Strength of conclusion Prevents anemia A Can be used as a vehicle for hormone replacement therapy (HRT) Mitigates tamoxifen-induced endometrial effects B Source Hubacher D, Grimes DA. Noncontraceptive health benefits of intrauterine devices: a systematic review. Obstet Gynecol Surv 2002 Feb;57(2):120-8 Hubacher and Grimes. Obstet Gynecol Surv 2002 Feb;57:120

LNG IUS: Possible Complications
Symptoms Consider Return of menstruation Expulsion Fever/chills Infection Continuous bleeding and/or pain after first month post-insertion Perforation, infection, or partial expulsion

LNG IUS: Possible Complications (cont)
Symptoms Consider Irregular bleeding and/or pain in every cycle Dislocation or perforation Missing string Talking Point It is also important to evaluate the patients for missing strings, which may be a sign of expulsion or dislocation.

LNG IUS: Potential Contraindications
Pregnancy or suspicion of pregnancy Active cervical or endometrial infections Uterine anomaly Complete list included in the package labeling Talking Points Pregnancy is a contraindication whether it is known or suspected. The uterine abnormality may be a distorted uterine cavity, either congenital or acquired. Infected abortion is a contraindication only if it occurred within the last three months. Any bleeding of unknown etiology is included.

LNG IUS: Potential Complications
Expulsions Most occur during the first six months after insertion The five-year cumulative expulsion rate is 4.9 per 100 women Perforations Occur at the time of insertion Rare events, fewer than one per thousand Talking Points Expulsion rate higher immediate post-abortion than interval insertion No data on immediate post-partum insertion Recommend insertion six weeks post-partum Source Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception 1994;49(1):56. Andersson et al. Contraception 1994;49:56

LNG IUS: The Inserter

LNG IUS: Insertion Different insertion technique than other intrauterine contraception New, one-handed insertion Requires hands-on training Efficacy and user continuation dependent on skillful insertion Talking Points The principal difference in insertion between the LNG IUS and other is the IUS inserted through the cervix with T arms folded upward, and copper devices are inserted with the T arms folded down. The two types of intrauterine contraception have very different insertion techniques and devices. Well-trained providers will have lower expulsion rates and fewer complications.

LNG IUS: Counseling Efficacy Return to fertility Side effects
Changes in bleeding patterns Non-contraceptive health benefits Safety Insertion and follow-up Talking Points Counseling for the LNG IUS should include discussion about non-contraceptive health benefits such as reduction in bleeding, prevention of anemia, benefits of hormone therapy, mitigation of tamoxifen-induced endometrial affects Reduction in bleeding is more than a “side effect” of this product. It may be considered a health benefit to many women and it is useful to present it to the patient in this context.

LNG IUS Counseling: Efficacy
High efficacy In clinical studies failure rate about that of female and male sterilization Continuous contraception for up to five years

LNG IUS Counseling: Side Effects
Possible hormonal side effects Mood changes Acne Headache Breast tenderness Nausea No reported weight gain Talking Points Possible side effects are more common in the initial months. They occur less often over time. Breast tenderness and nausea are quite uncommon, and patients should understand this.

Mean Weight Change After Five Years
Source Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception 1994;49(1):56. Nova T LNG IUS Andersson et al. Contraception 1994;49:56

LNG IUS Counseling: Changes in Bleeding
Bleeding characteristics: 1 – 4 mo frequent spotting 1 – 6 mo reduced duration and amount of bleeding Reduction in menstrual blood loss After 12 mo, about 20 % have no bleeding Talking Points Absence of bleeding may be considered a benefit by many women. Source Pakarinen P I, Suvisaari J, Luukkainen T, Lahteenmaki P. Intracervical and fundal administration of levonorgestrel for contraception: endometrial thickness, patterns of bleeding, and persisting ovarian follicles. Fertil Steril 1997;68(1):59. Pakarinen et al. Fertil Steril 1997;68:59

LNG IUS Counseling: Absence of Bleeding
Local effect No proliferation of endometrium This is expected. It is not a sign of: Pregnancy Ovarian or pituitary dysfunction Menopause Rapid return to menstruation after removal Talking Points Patients should understand that no individual can be guaranteed a 90% reduction in blood loss; that is a group figure. However, marked reduction is likely for all women. Differentiate between bleeding and spotting. Many patients may be confused and perceive spotting as bleeding. Understanding what spotting is and that it is a short-term problem can help motivate continuation of use.

LNG IUS Counseling: Health Benefits
Reduction of Duration and amount of bleeding Ectopic pregnancies Menstrual pain Increase of Hemoglobin Iron storage Talking Points Note that a lack of bleeding is an expected effect, neither unusual nor harmful. Source Luukkainen T, Allonen H, Haukkamaa M, Holma P, Pyorala T, Terho J, Toivonen J, Batar I, Lampe L, Andersson K, et al. Effective contraception with the levonorgestrel-releasing intrauterine device: 12-month report of a European multicenter study. Contraception 1987 Aug;36(2):169. Luukkainen et al. Contraception 1987;36:169

LNG IUS Counseling: Safety
> Ten years experience in Europe > Two million users world wide Few serious side effects Highly effective Does not prevent acquisition of STDs Condoms advised for women at risk

LNG IUS Counseling: Insertion
Steps in the insertion process Pelvic and speculum exam Sensations produced by tenaculum Paracervical anesthesia, if needed Sensations of IUS as it is inserted Measures you will take for her comfort Talking Points Briefly describe the steps during the insertion process, including sensations she might experience. The clinician can provide an overview of these before the insertion as well as keep her informed of the process along the way. Letting the patient know she has permission to ask the clinician to slow down or stop may give her a degree of comfort for having some control during the insertion procedure. If there are other comfort measures that the clinician uses—such as offering paracervical anesthesia—describe these to the patient as well.

LNG IUS Counseling: Post-Insertion
Schedule a follow-up visit at 1 – 3 months post-insertion Check for partial or complete expulsion Address any questions or concerns Talking Points A follow-up visit can be scheduled from one to three months to check the placement of the device. Most importantly to determine if she has questions or concerns about her method. If she is unhappy with the system or experiencing side effects, provide appropriate counseling. Reassure her when side effects will diminish and let her know she can discontinue the method if she continues to be unhappy with it.

LNG IUS: Therapeutic Possibilities
Range of non-contraceptive benefits, including: Treatment of heavy menstrual bleeding Endometrial protection for women receiving estrogen replacement therapy Talking Points We are now transitioning to a discussion of potential non-contraceptive benefits of LNG IUS. Source Luukkainen T. The levonorgestrel intrauterine system: therapeutic aspects. Steroids 2000 Oct-Nov;65(10-11):699.

LNG IUS: Treatment of Heavy Bleeding
400 300 Menstrual blood loss (ml) 200 100 Talking Points Overall reduction in menstrual blood loss is 90–97% Before-after study of 25 women Decrease menorrhagia in women with adenomyosis Significant increase in hemoglobin and decrease in uterine volume at 12 months Sources Andersson JK, Rybo G. Levonorgestrel-releasing intrauterine device in the treatment of menorrhagia. Br J Obstet Gynaecol 1990 Aug;97(8):690-4. Fedele L, Bianchi S, Raffaelli R, Portuese A, Dorta M. Treatment of adenomyosis-associated menorrhagia with a levonorgestrel-releasing intrauterine device. Fertil Steril 1997;68(3):426. 3 6 12 Before treatment Months of use Andersson and Rybo. Br J Obstet Gynaecol 1990;97:690

LNG IUS: Percentage Reduction of Menstrual Blood Loss
Talking Points This slide represents the reduction over a 12-month period for all methods, although the patterns/timeframes of reduction differ among the methods. As this slide shows, the LNG IUS reduces menstrual bleeding substantially more than other contraceptive methods. Source Milsom I, Andersson K, Andersch B, Rybo G. A comparison of flurbiprofen, tranexamic acid and a levonorgestrel-releasing intrauterine device in the treatment of idiopathic menorrhagia. Am J Obstet Gynecol 1991;164:879. Milsom et al. Am J Obstet Gynecol 1991;164:879

LNG IUS vs. Endometrial Resection
500 400 300 200 100 Levonorgestrel intrauterine system Endometrial resection Pictorial blood loss assessment chart score Talking Points IUS provides contraception Reversible Preserves fertility Source Crosignani PG, Vercellini P, Mosconi P, Oldani S, Cortesi I, De Giorgi O. Levonorgestrel -releasing intrauterine device versus hysteroscopic endometrial resection in the treatment of dysfunctional uterine bleeding. Obstet Gynecol 1997;90(2):257. Baseline 6 months 12 months Crosignani et al. Obstet Gynecol 1997;90:257

LNG IUS as Alternative to Hysterectomy
Women Canceling Hysterectomy Talking Points 56 women ages 33-49, scheduled to have hysterectomy for heavy uterine bleeding, three hospitals in Finland Randomly assigned to LNG IUS or current medical treatment At an average follow-up of three years (range months), 13 of 27 women (48%) were still using the LNG IUS The system may provide a long-term alternative to hysterectomy A case-series report of 50 women in Britain shows similar results. Of 50 women scheduled for hysterectomy due to heavy bleeding, 41 who received LNG IUS were taken off the list after nine months, with four developing complete amenorrhea. Source Lahteenmaki P, Haukkamaa M, Puolakka J, Riikonen U, Sainio S, Suvisaari J, Nilsson CG. Open randomized study of use of levonorgestrel releasing intrauterine system as alternative to hysterectomy. BMJ 1998 Apr 11;316(7138):1122. Lahteenmaki et al. BMJ 1998;316:1122

LNG IUS: Hormone Replacement
Prevention of endometrial hyperplasia from estrogen therapy “Local is logical” Oral progestins can cause depression LNG IUS avoids systemic side effects of oral progestins Talking Points U.S. labeling does not include this use at this time. Source Girdler SS, O'Briant C, Steege J, Grewen K, Light KC. A comparison of the effect of estrogen with or without progesterone on mood and physical symptoms in postmenopausal women. J Womens Health Gend Based Med 1999 Jun;8(5):637. Girdler et al. J Womens Health Gend Based Med 1999;8:637

LNG IUS: Hormone Replacement
Bleeding is the most common reason why women discontinue HRT LNG IUS suppresses endometrium 83 – 88 % have no bleeding/ spotting at 12 months 82 % continuation rate at three years Talking Points U.S. labeling does not include this use at this time. Sources Andersson K, Mattson L-A, Rybo G, Stadberg E. Intrauterine release of levonorgestrel - a new way of adding progestogen in hormonal replacement therapy. Obstet Gynecol 1992;79(6):963. Ettinger B. Personal perspective on low-dosage estrogen therapy for postmenopausal women. Menopause 1999 Fall;6(3):273. Suhonen S, Holmstrom T, Lahteenmaki P. Three-year follow-up of the use of a levonorgestrel releasing intrauterine system in hormone replacement therapy. Acta Obstet Gynecol Scand 1997;76(2):145. Ettinger. Menopause 1999;6:273 Suhonen et al. Acta Obstet Gynecol Scand 1997;76:145

General Discussion New methods are coming to U.S. market
This should translate into more contraceptive choices, fewer unintended pregnancies These new methods share the common advantage of not requiring daily attention

Intrauterine Contraception in the U.S.
LNG IUS Copper IUD 20 mcg levonorgestrel/day copper ions Approved for 5 years 10 years Approved 2000 Approved 1988

PID Incidence Rate for All IUDs by Time Since Insertion
Combined WHO clinical trial data for all IUDs - 22,908 IUD insertions (per 1,000 woman-years) Talking Points 22,908 IUD insertions, 51,399 woman-years of use Overall rate of PID was 1.6 cases per 1000 woman years of use This graph shows an exponential decrease in risk after the first month. Even during the first month, the PID rate is only about one in 1,000 This is no different from the baseline of all women using no method of contraception An increased risk of PID with IUDs associated with insertion was not seen in the European LNG IUS/Nova T comparative trial Source Farley TM, Rosenberg MJ, Rowe PJ, Chen JH, Meirik O. Intrauterine devices and pelvic inflammatory disease: an international perspective. Lancet 1992 Mar 28;339(8796):785. Farley et al. Lancet 1992;339:785

Dispelling Myths: Intrauterine Contraception
Infections are a frequent problem Prevents implantation Women are not interested in intrauterine contraception

Prophylactic Antibiotics?
Any risk of infection associated with the IUD relates to insertion One woman in 1,000 will develop PID in the first three months Meta-analysis has not shown any overall benefit of prophylactic antibiotics Talking Points Asymptomatic IUS users with documented GC or chlamydia infections need treatment not IUD removal. Sources Grimes DA, Schulz KF. Prophylactic antibiotics for intrauterine device insertion: a metaanalysis of the randomized controlled trials. Contraception 1999 Aug;60(2):57. Walsh T, Grimes D, Frezieres R, Nelson A, Bernstein L, Coulson A, Bernstein G. Randomised controlled trial of prophylactic antibiotics before insertion of intrauterine devices. IUD Study Group. Lancet 1998 Apr 4;351(9108):1005. Grimes and Schulz. Contraception 1999;60:57 Walsh et al. Lancet 1998;351:1005

Myth: IUD Prevents Implantation
Most evidence now suggests that all IUDs induce a foreign body reaction that is spermicidal, preventing fertilization Today’s intrauterine contraceptives have other mechanisms of action that prevent fertilization Talking Points Studies found an absence of any detectable hCG in the sera of 30 users of non-medicated IUDs over a thirty-month period, which suggests that disruption of implantation is not a major mechanism Other mechanisms of action that prevent fertilization include thickening the cervical mucus and creating a barrier to sperm penetration. Sources Alvarez F, Brache V, Fernandez E, Guerrero B, Guiloff E, Hess R, Salvatierra AM, Zacharias S. New insights on the mode of action of intrauterine contraceptive devices in women. Fertil Steril 1988 May;49(5):768. Segal SJ, Alvarez-Sanchez F, Adejuwon CA, Brache de Mejia V, Leon P, Faundes A. Absence of chorionic gonadotropin in sera of women who use intrauterine devices. Fertil Steril 1985 Aug;44(2):214. Alvarez et al. Fertil Steril 1988;49:768

Use of Contraception by U.S. Women Physicians
Talking Points Recent survey shows that physicians are more likely to use IUD themselves IUD is a very popular method of contraception in Europe Source Erica Frank, MD MPH. Contraceptive use by female physicians in the United States. Obstet Gynecol 1999;94:666. Frank. Obstet Gynecol 1999;94:666

Incidence* of Ectopic Pregnancy
LNG IUS 0.20 Copper IUD 0.34 No method All U.S. women 2.00 Sources Andersson K, Odlind V, Rybo G. Levonorgestrel-releasing and copper-releasing (Nova T) IUDs during five years of use: a randomized comparative trial. Contraception 1994;49(1):56. Sivin I. IUDs and ectopic pregnancy. Stud Fam Plann 1983 Feb;14(2):57. ACOG, 2000. * Per 1,000 woman-years Andersson et al. Contraception 1994;49:56 Sivin. Stud Fam Plann 1983;14:57

Summary LNG IUS bleeding patterns:
1 – 4 mo frequent spotting 1 – 6 mo reduced duration and amount of bleeding > 12 mo, about 20 % have no bleeding Treatment of heavy menstrual bleeding and endometrial protection with HRT

Gynefix- Frameless IUD
Developed 1994 in Belgium- available in Europe and UK Frameless IUD-copper tubes on a thread with a knot to anchor to the fundus Reduced risk of expulsion, pain & heavy bleeding Progestogen device in development

Female Barrier Contraception- Diaphragms and Caps
Rubber barriers placed into the vagina to cover the cervix prior to sex Sperm remain in vagina where acid conditions kill the sperm in a few hours- need to remain inside for 6 hours. Use of spermicide is controversial Failure rates anything from 5-20%-rates lower in older women and experienced users Need to be individually fitted Last approximately 2 years Size needs to be checked if weight gain, failure, or pregnancy Affected by oil based vaginal lubricants and treatments eg Antifungal creams and pessaries

Barriers-The Female Condom
Lubricated, loose fitting polyurethane sheath with 2 flexible rings - one size fits all Lines the vagina and covers some of the vulva Effectiveness: 85-95%

The Female Condom Advantages Disadvantages
Contraception and STI protection Can be used with oil based products Better heat transmission Stronger than latex Less “constriction” for partner Does not need erection before use May provide better protection against herpes and HPV Disadvantages Harder to dispose of than male condom Requires careful insertion and practise Not yet widely available

Latex male condoms Cornerstone of safer sex-must be used every time to provide maximal protection Can be used with other methods of contraception- “Double Dutch” Affected by oil based lubricants and vaginal medications like antifungals

Polyurethane Male Condom
Stronger and thinner than latex condoms Better heat transmission Can safely be used with oil-based lubricants Can be used by those with latex allergies

Permanent Contraception-
Inner wire/outer coil with synthetic fibre between Inserted into uterine ends of Fallopian tubes through hysteroscope under LA Growth of fibroblasts causes scarring and permanent closure of the tubes -irreversible

Sterilization: Tubal Ligation Methods
Methods for accessing the fallopian tubes Laparotomy Mini-laparotomy Vaginal posterior colpotomy Laparoscopy Hysteroscopy Talking Points Minilaparotomy—“minilap”—the most common technique, involves abdominal 5 cm incision--generally used in postpartum procedures Laparoscopy Laparotomy either for purposes of tubal ligation or at the time of cesarean section - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

Tubal Sterilization: FDA-Approved Methods
The most widely used occlusion methods are typically performed on the isthmic portion of the fallopian tube: Partial salpingectomy Clips Silicone rings Electrocoagulation Micro-insert Talking Points In a partial salpingectomy the fallopian tubes are cut and tied with suture material. The Pomeroy technique, a widely used version of partial salpingectomy, involves tying a suture around the base of a small loop of the tube and cutting off the top segment of the loop. As the tube heals, the suture is absorbed and the two ends separate. This technique requires no special equipment; it can be performed with only scissors and suture. Any obstetrician/gynecologist, family practitioner, or surgeon with operating privileges can perform this procedure, as can physician assistants in some states. With clips, the fallopian tubes are blocked by clamping down and cutting off the blood supply, causing a small amount of scarring or fibrosis that prevents fertilization from occurring. The two most common clips are the Filshie clip, made of titanium, and the Hulka clip, made of plastic. Clips are easy to use, but each type requires a special applicator. They have the highest rates of tubal reversal because they destroy the smallest amount of Fallopian tube. Silicone rings, like clips, also block the tubes mechanically. A small loop of the fallopian tube (much like the Pomeroy procedure) is created, and the stretched ring is advanced over the loop to the base. When the ring is released, it stops the blood supply to that small loop, with resultant scarring that blocks passage of the sperm or egg. The most common of these is the Falope Ring, although the Yoon ring is also popular. Electrocoagulation uses electric current to coagulate or burn a small portion of each fallopian tube. Unipolar coagulation passes current through the forceps applied on the tubes, and the current leaves a woman’s body through an electrode placed under her thigh. Because it was associated with sparking, this approach is no longer recommended. In bipolar coagulation, current passes only between the two ends of the forceps. Bipolar coagulation is safer than the unipolar technique, but it is associated with higher ectopic pregnancy rates than the Pomeroy procedure. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

Hysteroscopic Sterilization Techniques
Electrocoagulation Uterotubal Junction Device Hossenian, 1976 Intra-tubal Device Hamou, 1982 Talking Points: Electrocoagulation is one type of hysteroscopic sterilization technique - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

Hysteroscopic Sterilization Techniques (continued)
Chemical P-Block Device Brundin, 1981 OvaPlug 1981 - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

Transcervical Sterilization Methods
Endoscope Efficiency Continuous Flow Technology Advanced Cardiology Talking Points: Endoscope efficiency: Rod lens, fiberscopes with improved light transmission with high resolution Continuous-flow technology: Low viscosity, physiologic solutions Advanced cardiology technology: Overwire catheters with hydrophilic coating Improved tracking of narrow, tortuous lumen Stent and coil technology - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

Transcervical Sterilization: Advantages to the Provider
Outpatient procedure No general or regional anesthesia Women with certain medical conditions may be eligible Talking Points: Transcervical sterilization is done on an outpatient basis There is no need for general or regional anesthesia - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

Transcervical Sterilization: Disadvantages to the Provider
Special equipment and training needed for insertion Some women may not be candidates Uncertainty still exists about long-term effectiveness and insurance coverage Talking Points: Special equipment (5 mm hysteroscope with 5 FR operating channel) needed for insertion Special training in technique is required Women with distorted tubes or uterine cavities may not be candidates Uncertainty still exists about long-term effectiveness and whether insurance companies will cover these procedures - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

Transcervical Sterilization: Advantages to the Patient
No incision Absence of a scar preserves privacy Less invasive Less discomfort Faster recovery Efficacy Talking Points: For women with medical conditions such as heart disease and obesity procedure may be safer, partly because of routine use of local anesthesia, particularly. Some of these women are ineligible for conventional tubal sterilization. Because no incision is necessary, it's less invasive, women have less discomfort and recover faster, and the absence of a scar preserves their privacy. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

Transcervical Sterilization: Disadvantages to the Patient
Another contraceptive method is required for three months after insertion Non-reversible; some women may experience regret Talking Points: The need for backup birth control and possibility of experiencing regret are two patient disadvantages to transcervical sterilization - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

New Tubal Occlusion Method: Micro-Insert Tubal Occlusion (Essure®)
FDA approval in November 2002 Only FDA approved hysteroscopic method of tubal sterilization available Placement of micro-inserts into proximal fallopian tubes Talking Points: The device is 4 cm long and is both soft and flexible. It is composed of a narrow inner coil and a larger diameter outer coil. Laced along the length of the inner coil is a weave of PET fibers. At full expansion the outer coil can achieve a diameter as great as 2 mm. The leading edge of the device has a small ball tip swelling which facilitates the forward advancement and proper placement of the device into the proximal fallopian tube. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007.

Micro-Insert: Design Micro-Insert length = 4 cm Fiber Material: PET
Inner Coil Material: Stainless Steel Fiber Material: PET Dynamic Expanding Superelastic Outer Coil Material: Nitinol Talking Points: Device is soft and flexible. Composed of a narrow inner coil made out of Stainless steel and a larger diameter outer coil in Nitinol (50% nickel 50% titanium). Laced along the length of the inner coil is a weave of PET (Polyethylene terephthalate) fibers. These fibers will promote a rapid tissue in-growth during the first 3 months in the Fallopian tube. Full length of the Micro-Insert is 4cm and the super-elastic outer coil expands from a wound-down diameter of 0.8mm to a fully opened diameter of up to 2mm. Leading edge of the device has a small ball tip swelling which facilitates the forward advancement and proper placement of the device into the proximal fallopian tube. All materials are extensively documented as implantable materials and widely used in cardio-vascular applications. Source ARHP. Clinical Update on Transcervical Sterilization April. - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007. Micro-Insert length = 4 cm ARHP. Clinical Proceedings. May 2002.

Micro-Insert: Mechanism of Action
Expansion of outer coil for acute anchoring Space filling/mechanical blockage of tubal lumen Tubal occlusion by tissue in-growth into and around the micro-insert Long-term nature of tissue response not known beyond 24 months Talking Points: There is a three fold explanation for the Essure device’s mechanism of action: First the expandable outer coil is responsible for acute device anchoring; second the device provides both space filling and mechanical blockage of the tubal lumen; and finally occlusion is achieved as a result of a tissue in-growth from the tubal mucosa into and around the Micro-Insert. Source: Essure® Prescribing Information - - - Original content for this slide submitted by the ARHP Clinical Advisory Committee for New Developments in Contraception: Permanent Options for Women in October Original funding received from Conceptus, Inc. through an unrestricted educational grant. Last reviewed/updated by Chris Knutson, RN-C, MN, ANP, Anne Moore, MSN, RNC, FAANP, and Anita L. Nelson, MD in February 2007. Essure® Prescribing Information

Male Hormonal Contraception
Recent trials at Andrology Clinic, Concord Hospital Depo Provera plus testosterone implants 3 monthly Very low sperm count (less than 1 million per ml) in all men on trial - 80% had no sperm Few side-effects Similar regime using an oral progestogen and testosterone implants being trialed in UK Implants and testosterone also being trialed

The Introduction of a New Contraceptive Method to the Market
New contraceptive methods usually considered newsworthy Consumers increasingly well informed around options and their rights to informed choice The growing number of options available makes it increasingly difficult for health practitioners to do justice to the pros and cons of each method in the available time.

Contraceptive Counselling
The trend to an increase in available contraceptive options seems likely to continue along with an acceptance that the consumer has a right to accurate, comprehensive and balanced information from their health provider Any clinician attempting to counsel a patient around contraceptive choice will need to put this counselling within the broader context of the person’s past experiences, cultural background and belief systems A person will rarely persist with a contraceptive method they do not feel is right for them - they will simply feel their practitioner has not heard them In the area of contraception the clinician is often the adviser, sometimes the supplier, but, if they have any sense at all, never the decider.

Contraception Updates

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