1. Female Sterilization Robert D. Auerbach, M.D. FACOG
Senior Vice President & Chief Medical Officer
CooperSurgical, Inc.
Associate Clinical Professor
Yale University School of Medicine

2. Objectives Female Sterilization Overview
Methods of Female Sterilization
Studies and Findings:
Sterilization failure rate
Ectopic pregnancy rate with failure
Other Considerations
Summary of Female Sterilization
Male Sterilization

3. Female Sterilization Overview
Sterilization is the most widely used means of permanent contraception in the United States
Over 700,000 sterilizations are performed annually in the United States
#1 method of birth control for women ages 35 to 44
Younger women (ages 20-29) are more likely to undergo postpartum sterilization procedures
Approximately 50% of the tubal ligations performed annually are postpartum
Most postpartum procedures are performed within 24 hours
Older women (ages 35-49) are more likely to undergo interval procedures
Data quoted: Grimes, DA. Update on female sterilization: Failure rates, counseling issues, and post sterilization regret. The Contraception Report (3): 4-11
Quoted Data from: Grimes DA. Update on female sterilization: Failure rates, counseling issues, and post sterilization regret. The Contraception Report. 1996; 7(3):4-11

4. Female Sterilization Overview
The History of Female Sterilization
1823 – First proposed by James Brundell in London
1880 – First published report of procedure by Lungren in Toledo, Ohio
1930 – First publication of the Pomeroy Technique, Pomeroy, New York State Journal of Medicine
1936 – Bosch performed the first laparoscopic tubal occlusion in Switzerland

5. Female Sterilization Overview
Sterilization as a method of contraception
Prior to 1960, sterilization of females was performed primarily as a result of medical indications
Increased interest in family planning coupled with safer and more effective methods allowed sterilization to become a viable method of contraception during the 1960s
Widespread acceptance of laparoscopy led to the development of several methods
Electrocautery (mono-polar and bi-polar)
Clips (Hulka and Filshie)
Bands (Yoon Band, Falope Ring)
Data Quoted From: Hulka J and Stepian A. Laparoscopic sterilization. In: Gordon AG, Hulka JF, Walker DM, and Campana A, eds. Practical Training and Research in Gynecologic Endoscopy
Sklar AJ. Tubal Sterilization. eMedicine. November 15, Available at

6. Female Sterilization Overview
Anatomy
Ampulla
Isthmus
Infundibulum
Fimbria

7. Methods of Female Sterilization
Interval
Laparoscopic
Electrocoagulation (Mono and Bi -Polar)
Falope Ring
Hulka Clip
Filshie Tubal Ligation System
Hysteroscopy
Essure
Adiana
Post Partum/ Labor & Delivery
Pomeroy
Parkland
Irving
Uchida
Filshie Tubal Ligation System

8. Methods of Female Sterilization1
Procedure
Timing
Technique
Minilaparotomy
Post Partum
Post Abortion
Interval
Mechanical Devices (Clips, Rings)
Tubal Ligation or Excision
Laparoscopy
Interval Only
Electrocoagulation (Unipolar, Bipolar)
Mechanical Devices (Clips, Rings)
Laparotomy
In conjunction with other surgery (Cesarean section, salpingectomy, ovarian cystectomy, etc.)
1 Female Sterilization In: Landry E, ed. Contraceptive Sterilization: Global Issues and Trends. New York: Engender Health; 2002:
Since 2002, hysteroscopic methods are available and can be performed interval-only (Essure and Adiana).

9. Methods of Female Sterilization
Monopolar Coagulation
Laparoscopic
Proposed in 1937 by Anderson
Complications
Bowel Burn
Bleeding
Longer portion of tube is damaged
Failures and ectopic pregnancy
Transection is frequent
Failure Rate: 7.5/1000 ( %)1
1 Peterson LS Contraceptive use in the United States: Advance Data: From Vital Health Statistics February 1995;

10. Methods of Female Sterilization
Bipolar Coagulation
Laparoscopic
Introduced in 1973 by Jacques Rioux
Benefits
Most common method of laparoscopic sterilization
Burn several locations along the tube
Complications
Formation of uteroperitoneal fistulas
High rate of ectopic pregnancy
Potential for bowel burns
Reversals are potentially more difficult due to the extent of tube damage
Failure Rate: 24.8/10001 (.2-2.5%)
1 Peterson HB, et al. The risk of pregnancy after tubal sterilization: Findings from the U.S. Collaborative Review of Sterilization. Am J obstet. Gynecol ; 174 (4):

11. Methods of Female Sterilization
Destruction of the Entire Fallopian Tube: “Three Burn” Technique

12. Methods of Female Sterilization
Falope Ring (Yoon band)
Laparoscopic
Mechanical occlusion invented in 1974
Tubal occlusion accomplished by placing a silicone band around the tube in a similar fashion to Pomeroy-technique
Thicker tubes may be problematic
May not be suited for postpartum
Complications
Increased patient discomfort during recovery – large area of necrosis
Failure Rate: 17.7/10001 (1.8%)
1 Peterson HB. Et al. The risk of Pregnancy after tubal sterilization: Findings from the U.S. Collaborative Review of Sterilization. Am Journal of Obstetrics and Gynecology ; 174(4):

13. Methods of Female Sterilization
Falope Ring/Yoon Band

14. Methods of Female Sterilization
Hulka Clip
Laparoscopic
Tubal occlusion is accomplished by placing a spring clip (plastic and gold plate) across the fallopian tube
Hulka clip has limited tubal capacity
Not magnetically inert
Potential patient allergy due to gold plate
Failure rates 36.5/1000 (3.7%) (Ectopic 8.5/1000)1
1 Pregnancy After Tubal Sterilization with Bi-Polar Electrocoagulation. Obstetrics and GYN. August 1999 Volume 94. Herbert B Petterson et al for the CREST Working Group

15. Methods of Female Sterilization
Hulka Clip

16. Methods of Female Sterilization
Hulka Clip

17. Methods of Female Sterilization
Filshie® Tubal Ligation System
Laparoscopic and Minilapararotomy
FDA approved in 1996 (post CREST study)
Tubal occlusion accomplished by placing a titanium hinge clip lined with silicone rubber across the fallopian tube
Large tubal capacity
Magnetically inert (okay for MRI)
Minimal post operative pain
Designed for use interval and post partum (post vaginal birth and at the time of C-section)
Clip migration rare but possible
Failure rate of 2.7/1,000 (.27%)1,2
1 A Penfield, MD. The Filshie Clip for Female Sterilization: A Review of World Experience. American Journal of Obstetrics and Gynecology, March 2000
2 Failure Rates from Family Health International, used in the initial FDA PMA Submission for the Filshie Clip

18. Methods of Female Sterilization
Filshie® Clip – Laparoscopy

19. Methods of Female Sterilization
Filshie® Clip – Laparoscopy

20. Methods of Female Sterilization
Essure®
Hysteroscopic (Hospital and Office-based procedure)
Approved in 2002
Micro-insert placed into each tube, PET fibers stimulate in-growth over several weeks
86% Success Rate for 1st time placements of micro-inserts
3 months of alternative contraception until HSG procedure confirms occlusion
Not suitable for patients with known allergies to contrast media or hypersensitivity to nickel
Irreversible
May limit a patients ability to have in vitro fertilization, should patient change her mind
May limit the ability to perform endometrial ablation in the future
ACOG does not recommend concomitant endometrial ablation
Failure rate .26%1
(5 year rate)
FDA. Essure System: Summary of Safety and Effectiveness. November 4, 2002 available at 1UpToDate – Hysteroscopic Sterilization; Jan 2010

21. Methods of Female Sterilization
Adiana®
Hysteroscopic (Hospital and Office-based procedure)
Approved in 2009
Catheter delivers low RF energy for one minute then a 3.5 mm non-absorbable silicone elastomer matrix is placed in each tubal lumen
3 months of alternative contraception until HSG procedure confirms occlusion
Failure rate 1.8%1
(2 year rate)
Photograph from Adiana website
1Adiana Transcervical Sterilization System PMA P Draft Panel Discussion Questions, p.2, December 14, 2007.

22. Methods of Female Sterilization
Postpartum
Pomeroy
Parkland
Irving
Uchida
Filshie® Tubal Ligation System

23. Methods of Female Sterilization
Pomeroy Technique
Developed in 1930 by Ralph Hayword Pomeroy
Incision – suprapubic and subumbilical (PP)
Isthmic portion is ligated twice with 0 or 2-0 plain catgut suture
Segment is then excised
Inspect for hemostasis and the presence of the tubal lumen
Benefits
Easy technique
Highly effective
Relatively inexpensive (excluding lab costs for pathology)
Complications
Infection and bleeding
Potential ectopic pregnancy
Tied
Cut
Final result
Failure Rate: 7.5/1000
1 Pregnancy After Tubal Sterilization with Bi-Polar Electrocoagulation. Obstetrics and GYN. August 1999 Volume 94. Herbert B Petterson et al for the CREST Working Group

24. Methods of Female Sterilization
Parkland Technique
Introduced in the 1900s
Isthmic portion of tube is segmented and ligated at two points
An avascular area in the mesosalpinx is opened
0 or 2-0 plain catgut passed through the opening
Proximal and distal ligated and segment excised
Failure rate not reported1

25. Methods of Female Sterilization
Parkland Technique (continued)
Benefits
Designed to reduces natural tube re-attachment
Good success rates
Few complications
Inexpensive to perform (if no pathology)
Complications
Ectopic pregnancies, infection, bleeding
Time required to perform procedure properly
Failure rate not reported1

26. Methods of Female Sterilization
Irving Technique
Method published in 1924
Was developed for sterilization at C/S
Bury the proximal tubal stump within the myometrium
Original description – distal tube buried in the broad ligament
Benefits
Used in conjunction with cesarean delivery
Complications
Moderate level of difficulty to perform
Pomeroy and Parkland are quicker
Failure rate: 1/10001
1 Up to Date – Sept 2010, Stovall T. et al. Surgical Sterilization of Women
1. Sterilization. The University of Kentucky Department of OB-GYN Women’s Health Curriculum.

27. Methods of Female Sterilization
Uchida Technique
Introduced by Hajime Uchida in the 1940s
Most complex method
Inject saline into the subserosal layer 2 cm distal to the cornua
Incise serosa to free a 2 to 3 cm segment
Ligate proximal and distal end of freed tube
Proximal tube “dunked,” distal is “exteriorized” and serosa is then closed
Benefits
Can be performed immediately postpartum
Complications
Moderate level of difficulty to perform
Pomeroy and Parkland are quicker
Failure rate: more than 20,000 cases performed by Uchida personally without a failure 1
1 Sklar AJ. Tubal Sterilization. eMedicine. November Available at

28. Methods of Female Sterilization
Filshie® Tubal Ligation System
At the time of C-section or minilaparotomy Post Vaginal Birth
FDA approved in 1996 (post CREST study)
Tubal occlusion accomplished by placing a titanium hinge clip lined with silicone rubber across the fallopian tube
Large tubal capacity
Minimal post operative pain
* Olgibo N. Pomeroy technique or Filshie clips for postpartum sterilisation? Retrospective study on comparison between Pomeroy procedure and Filshie clips for a tubal occlusion at the time of Caesarean Section. Arch Gynecol Obstet, 11 Dec 2009
* Yan J.S., Hsu J. and Yin C.S. Comparative study of Filshi e clip and Pmeroy method for postpartum sterilization. Int. J. Gynecol. Obstet., 1990, 33:
Failure rate range: % *

29. Methods of Female Sterilization
Filshie® Clip: Postpartum Sterilization (Mini-laparotomy)

30. Methods of Female Sterilization
Filshie® Clip: Postpartum Sterilization (Cesarean)

31. Methods of Female Sterilization
Postpartum: Filshie® in place

32. Methods of Female Sterilization
Filshie® Tubal Ligation System and Pomeroy Postpartum
Randomized Trial to compare perioperative outcomes of Filshie clip vs. Pomeroy technique for postpartum and intraoperative Cesarean tubal sterilization: a pilot study. Kaunitz et al
32 Randomized Patients were sterilized by Filshie Clip or Pomeroy
Filshie mean duration 7 min faster (p=0.08)
Filshie rated as easier by the operator (p=0.03)
70% of surgeons preferred the Filshie clip

33. Studies and Findings
The U.S. Collaborative Review of Sterilization (CREST )
MATERIALS AND METHODS
10,685 WOMEN STERILIZED ( )
MEDIAN AGE: 30 years old
FOLLOW-UP: 8-14 years
METHODS OF STERILIZATION:
Yoon band 31.2 %
Bipolar 21.2 %
Postpartum 15.3 %
Hulka clip 14.9 %
Unipolar 13.4 %

34. Studies and Findings Findings from CREST RESULTS: Failure Rates
34 Luteal phase pregnancies
143/10,685 True failures (1.34%)
15% Spontaneous abortion
18% Induced abortion
29% Deliveries
3% Ongoing pregnancy at time of study
33% Ectopic pregnancy
2% Status unknown

35. Studies and Findings Sterilization: A Review of World Experience1
3.65%
1,595
Hulka Clip
2.01%
425
Interval Partial Salpingectomy
1.77%
3,329
Yoon Band
0.75%
1,432
Unipolar Coagulation
2.48%
2,267
Bipolar Coagulation
Failure
Rate
Patients
(No.)
Method
Modified from Peterson et al 2
1 A. Jefferson Penfield, MD The Filshie Clip for Female Sterilization: A Review of World Experience. American Journal of Obstetrics and Gynecology. March 2000
2 Pregnancy After Tubal Sterilization with Bi-Polar Electrocoagulation. Obstetrics and GYN. August 1999 Volume 94. Herbert B Petterson et al for the CREST Working Group

36. Studies and Findings
The Filshie® Clip for Female Sterilization: A Review of World Experience1
Investigator
0.4 % 3 7
796
Puraviappan
et al
0.22% 5
6-15
2,194
Totals*
0.00 % 10
497
Yuzpe
(Rioux et al)
0.21% 1
467
Heslip
0.23%
434
Filshie
Failure
Rate
Failures
(No.)
Follow up
(years)
Patients
* Extrapolated Data
1 A. Jefferson Penfield, MD. The Filshie Clip for Female Sterilization: A Review of World Experience. American Journal of Obstetrics and Gynecology, March 2000

37. Studies and Findings 0/30,000** procedures 0.22%** Filshie® Clip
Most Common Methods Failure Rates and Ectopic Pregnancy
0/30,000** procedures
0.22%**
Filshie® Clip
17.1/1000* procedures
2.4%*
Bipolar Cautery
1.5/1000* procedures
0.75%*
Pomeroy (PP)
Ectopic Preg
Failure rate
Method
* The Risk of ectopic Pregnancy after tubal sterilization, Peterson H. NEJM March 13, 1997
** Kovacs et al. Female Sterilization with Filshie clips: What is the risk of failure? A retrospective survey of 30,000 applications. J. of Family Planning and Reproductive Health Care. 2002: 28(1): 34-35

38. Studies and Findings Major Studies
CREST – 10,685 women followed for 8-14 years
Devices
RF – monopolar and bipolar
Banding – Falope Ring
Clip – Hulka Spring Clip
Partial Salpingectomy – interval and postpartum
Failure Rates – 1.38%
IUP
Ectopic*
“Although tubal sterilization is highly effective, the risk of sterilization failure is higher than generally reported.”
* Pregnancy After Tubal Sterilization with Bi-Polar Electrocoagulation. Obstetrics and GYN. August 1999 Volume 94. Herbert B Petterson et al for the CREST Working Group

39. Studies and Findings Major Studies Filshie® Tubal Ligation System
Approved after the CREST study
Studies: FDA PMA – 1996
Interval sterilization
Paraviappan
Yuzpe
Heslip
Filshie
Postpartum
Yan – 1989
de Villiea – 1987
Filshie – 1987
Kohaut – 2003
Olgibo

40. Studies and Findings Major Studies Essure
Approved after the CREST study
Studies
Palmer – 2009
Levy – 2007
Kerin – 2003
FDA PMA – 2005
Adiana
FDA PMA
Images from Product websites

41. Other Considerations Informed Consent
Discussion with patient must take place and cover the following details:
It must be a voluntary decision
Discussion of other options
Discussion of method of sterilization
Sterilization is permanent
Must be 21 years of age or older
Probability of failure
Discussion about methods of contraception for prevention of STDs
Special consideration for women with mental disabilities
Information taken from the Dept. of Health and Human Services Form:

42. Other Considerations Regret Women may experience regret post-procedure
2-26% of women express regret post-sterilization
1-2% will seek reversal
Sterilization is permanent
Association with age at time of sterilization, change in marital status and future regret
Requests for reversals and/or IVF possible
* Chi, I.C., Jones D.B. Incidence, risk factors, and prevention of poststerilization regret: an updated international review from an epidemiological perspective. Obstet Gynecol Surv 1994;49:722-32
* Van Voorhis BJ. Comparison of tubal ligation reversal procedures. Clin Obstet Gynecol 2000;43:641-9 Curtis, K., Mohllajee, A.P., and Peterson, H.B. Regret Following Female Sterilization at a Young Age: A Systematic Review. Contracep 2006;73:2. P

43. Other Considerations Reversibility
All surgical tubal occlusion procedures are considered to be permanent female sterilization methods.
Changes in lifestyles and life situations among some women has led to instances of regret after sterilization regardless of the method used.
The application of the Filshie® clip in tubal ligation results in an avascular necrotic segment of the fallopian tube of about 4 mm.
The result is complete tubal occlusion with minimal tubal damage.

44. Summary of Female Sterilization
Tubal occlusion is an effective method of female sterilization regardless of method chosen
Failures will occur in some percentage female sterilization procedures regardless of method utilized.
IUP
Ectopic Pregnancy

45. Male Sterilization Vasectomy
Safe and permanent birth control procedure
US: 1 of 5 men over age 35 has had a vasectomy
500,000 vasectomies in the US each year
4 million world wide each year
Cost (US) of procedure $500-$1000

46. Male Sterilization
Vas deferens interrupted

47. Male Sterilization Vasectomy Procedure
Office visit – approximately 1 hour
Local anesthetic to the overlying skin
Clamp the vas through the skin
Incision made
Small segment removed (3 mm)
Cut segments
Tied
Cauterized
Clipped

48. Male Sterilization Post Vasectomy Instructions Complications
Athletic supporter
Decreased activity 1-2 days
Avoid strenuous exercise for 1 week
Complications
Bleeding: %
Infection: %
Sperm granuloma: % (treat with NSAIDs)
Antibodies: 40% (issue after reversal)
Chronic pain: 0-6%

49. Male Sterilization Vasectomy Outcome Post procedure semen analysis
> 20 ejaculations or at least 12 weeks
Many physicians test at 6 or 8 weeks
Efficacy: pregnancy <1%
Reversal1
50-70% who had procedure reversed are fertile
Better success the shorter the interval from procedure to reversal
<3 yrs – 76% successful
>15 yrs – 30% successful
1 Belker, AM, Thomas, AJ Jr, Fuchs, EF, et al. Results of 1,469 microsurgical vasectomy reversals by the Vasectomy Study Group. J Urol 1991; 145:505.

50. Male Sterilization Vasectomy and Cancer?
Concerns of testicular and prostate cancer
Data do not support a risk
2 populations studies – no increased risk of testicular cancer
5 cohort, 10 case-control studies & 1 population-based case-control study showed no increase risk of prostate cancer
* Hewitt, G, Logan, CJ, Curry, RC. Does vasectomy cause testicular cancer? Br J Urol 1993; 71:607
* Moller, H, Knudsen, LB, Lynge, E. Risk of testicular cancer after vasectomy: cohort study of over 73,000 men. BMJ 1994; 309:295.
* Schwingl, PJ, Guess, HA. Safety and effectiveness of vasectomy. Fertil Steril 2000; 73:923.
* Cox, B, Sneyd, MJ, Paul, C, et al. Vasectomy and risk of prostate cancer. JAMA 2002; 287:3110.
* Kronmal, RA, Krieger, JN, Coxon, V, et al. Vasectomy is associated with an increased risk of urolithiasis. Am J Kidney Dis 1997; 29:207.

51. Thank you
for
your
attention