1. Men’s Health Seminar 1001183r3 (10/11) Dr. Manuel Perez June 7, 2012

2. Satisfying Solutions Erectile Restoration

3. Erectile Dysfunction (ED) What is it? The inability to maintain an erection firm enough to have sexual intercourse How prevalent is it? 1 in 5 American men 1 Over 30 million American men 2 Over 150 million men worldwide 2 Causes: 90% physical, 10% psychogenic 3 1. Selvin E, Burnett A, Platz E. Prevalence and risk factors for erectile dysfunction in the US. Am Jour of Med 2007(120) 151-157 2. Sun P, Seftel A, Swindle R, Ye W, Pohl G. The costs of caring for erectile dysfunction in a managed care setting: evidence from a large national claims database. J Urol. 2005 Nov;174(5):1948-52 3. Mulligan T, Teitelman, J. Geriatric sexual dysfunction. Va Med Q. 1991 Spring;118(2):97-9

4. Main Physical Causes of ED 4 Vascular Diabetes Medication Pelvic Surgery, Radiation or Trauma Neurological Causes Endocrine Problems Other 4. Goldstein I. Male sexual circuitry. Working Group for the study of central mechanisms in erectile dysfunction. Sci Am., Aug 2000;283(2):70-75 Vascular Diabetes Medication Vascular

5. Degree of ED by Age 5 5. Data on file at AMS; Dymedex Market Research Prevalence of ED by Age and Severity (%) Severe Moderate Mild or Mild/Moderate 100% 80% 60% 40% 20% 0%

6. Nearly every man can be successfully treated. Do you have to live with ED? NO!

7. Treatment Options For Erectile Dysfunction

8. Oral Medications Not effective in approximately 30% of cases 6 Work only in response to sexual stimulation 7,8 Must take at least ½ hour to one hour before anticipated sexual activity 7 Viagra ® can remain effective for up to 4 hours 7, Cialis ® can be effective up to 36 hours 8 High fat meals can affect absorption of Viagra 7 Estimated cost per pill: $15-$30 9A 6. Goldstein I, Lue TF, Padma-Nathan H, Rosen RC, Steers WD, Wicker PF, for the Sildenafil Study Group. Oral sildenafil in the treatment of erectile dysfunction. N Engl J Med. 1998 May 14;338(20):1397-404 7. http://www.pfizer.com/files/products/uspi_viagra.pdf; downloaded 7/21/11 8. http://pi.lilly.com/us/cialis-pi.pdf; downloaded 7/21/11 9A. http://www.buyviagrapillsonline.com/; downloaded 3/3/11 VIAGRA® is a registered trademark of Pfizer Inc. CIALIS® is a registered trademark of Eli Lilly and Company Corporation.

9. Oral Medications Common side effects 7,8 Headache, Facial Flushing, Stuffy Nose, Upset Stomach Some Cautions Cannot take with NITRATES 7,8 Precautions with alpha-blockers; medications for high blood pressure and for prostate problems 7,8 Tell Your Doctor if You: Have ever had any heart problems, stroke or low or high blood pressure 7 Have ever had liver or kidney problems 7 7. http://www.pfizer.com/files/products/uspi_viagra.pdf; downloaded 7/21/11 8. http://pi.lilly.com/us/cialis-pi.pdf; downloaded 7/21/11

10. Vacuum Erection Device Some Advantages 10 Non-invasive Drug free Cost effective 9B. Levine L, Dimitrious R. Vacuum constriction and external erection devices in erectile dysfunction. Urologic Clinics of North America 2001 May (28) No. 2, 335-341 10. Yuan J., et al. Vacuum therapy in erectile dysfunction – science and clinical evidence. International Journal of Impotence Research. 2010; 12: 211-219 11. The Process of Care Consensus Panel. The process of care model for evaluation and treatment of erectile dysfunction. Int J Impot Res. 1999;11:59-70. Position Paper 12. Miner M.M., Kuritzky L. Erectile Dysfunction: A sentinel marker for cardiovascular disease in primary care. Cleveland Clinic Journal of Medicine. 2007 May; 74 (3); 30-37 Some Disadvantages Cumbersome 12 Unnatural erection 12 Erection is not warm to the touch 12 Bruising/burst blood vessels 9B, 11 Penile pain/discomfort 11 Numbness 11 Delayed ejaculation 11

11. Urethral Suppository: MUSE ® MUSE is a trademark of VIVUS, Inc. 13. http://www.muserx.net/res/pack_inserts_PFI_1.3.pdf downloaded 11/12/10 14. http://www.infertility-male.com/erectdys/muse.htm, downloaded 2/15/11 15. Shabsigh R, Lue T.F. A Clinician’s Guide to ED Management. MPR Urologist 2006; 76-77 Some Disadvantages Penile Pain & Burning 13 Inadequate penile ridigity 14 Must be refrigerated 13 Cost is approximately $25 per application 14 Patients with poor manual dexterity/vision or severe obesity may find administration difficult 15 Some Advantages No needles or injections Erection within 10 to 15 minutes 13

12. Penile Injection Therapy Some Advantages Effective 17 On-set of erection within 5-20 minutes 16 Some Disadvantages Risk of erection lasting 4 hours or more (priapism) 16 Possible bleeding at injection site 16 Possible pain at injection site 16 Requires training 16 Cavernosal fibrosis 16 Poor long-term tolerability 17 Fear of sticking needle in penis 17 16. http://labeling.pfizer.com/ShowLabeling.aspx?id=589; downloaded 7/21/11 17. Rajpurkar A, Dhabuwala CB. Comparison of satisfaction rates and erectile function in patients treated with sildenafil, intracavernous prostaglandin E1 and penile implant surgery for erectile dysfunction in urology practice. J Urol Jul 2003 v.170(1)p.159-63

13. Penile Implants Ideal for men who have tried other treatments without success On the market for over 30 years Over 300,000 implants to date 18 High patient and partner satisfaction 19,20 18. "Penile Prosthesis." The Sexual Medicine Web Site. 2008. European Society for Sexual Medicine. 23 Jan 2009 http://www.essm.org/patient-area/penileprosthesis.asp; downloaded 1/8/09 19. Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and safety of, and patient satisfaction with the Ambicor inflatable penile prosthesis: results of a 2 center study. J Urol. 2001 Sep;166(3):932-7 20. Montorsi F et al. AMS three-piece inflatable implants for erectile dysfunction; a long-term multi- institution study in 200 consecutive patients. Eur Urol. 2000; 37:50-55

14. Penile Implant Versus Other Treatment Options 17. Rajpurkar A, Dhabuwala CB. Comparison of satisfaction rates and erectile function in patients treated with sildenafil, intracavernous prostaglandin E1 and penile implant surgery for erectile dysfunction in urology practice. J Urol Jul 2003 v.170(1)p.159-63 Overall Patient Satisfaction with ED Treatments 17 Percentage Satisfied n=22 n=31 n=32

15. Three-Piece Inflatable Penile Implant Some Advantages Totally concealed in body Device is inflated to provide rigidity and deflated for concealment Erection longevity is controllable When deflated, the cylinders are soft and flaccid Expands in girth (all AMS 700 ® cylinders) and length (AMS 700 LGX ® and Ultrex ® cylinders) AMS 700 with InhibiZone ® is the only inflatable penile prosthesis with clinical evidence showing a significant reduction in the rate of revision due to infection

16. Implants are Highly Recommended 19 19. Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and safety of, and patient satisfaction with the Ambicor inflatable penile prosthesis; results of a 2 center study. J Urol. 2001 Sep; 166 (3) :932-7 These recommendations pertain to the AMS Two-piece inflatable prosthesis

17. Offers a long-term solution to ED Provides the ability to have an erection anytime you choose Allows for greater spontaneity – have sex when the mood strikes Enables you to maintain an erection as long as you desire Eliminates the need for costly pills or shots Feels natural during intercourse 19 Does not interfere with ejaculation or orgasm Benefits 19. Levine LA, Estrada CR, Morgentaler A. Mechanical reliability and safety of, and patient satisfaction with the Ambicor inflatable penile prosthesis; results of a 2 center study. J Urol. 2001 Sep; 166 (3) :932-7

18. Possible Risks Will make latent natural or spontaneous erections as well as other interventional treatment options impossible If an infection occurs, the prosthesis may have to be removed May cause the penis to become shorter, curved or scarred There may be mechanical failures of the prosthesis Pain (typically associated with healing process)

19. As with any medical procedure, there are risks involved and not all patients are candidates for a penile implant. Discuss the risks and benefits of this procedure in more detail with your doctor.

20. Insurance Coverage Is a penile implant covered by insurance or Medicare?

21. Summary ED is a common problem Nearly every man can be successfully treated for ED Penile implants offer a long-term solution Talk to your partner, talk to your Prosthetic Urologist

22. Brief Summary – AMS 700 and Ambicor The AMS 700 ® Series Inflatable Penile Prosthesis and the AMS Ambicor ® Penile Prosthesis are intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence). These devices are contraindicated in patients who have active urogenital infections or active skin infections in the region of surgery or (for the AMS 700 with InhibiZone®) have a known sensitivity or allergy to rifampin, minocycline, or other tetracyclines. Implantation will make latent natural or spontaneous erections, as well as other interventional treatment options, impossible. Men with diabetes, spinal cord injuries or open sores may have an increased risk of infection. Failure to evaluate and treat device erosion may result in infection and loss of tissue. Implantation may result in penile shortening, curvature, or scarring. Possible adverse events include, but are not limited to, urogenital pain (usually associated with healing), urogenital edema, urogenital ecchymosis, urogenital erythema, reservoir encapsulation, patient dissatisfaction, auto- inflation, mechanical malfunction, impaired urination, penile curvature, or sensation change. Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events. Rx Only

23. Questions on ED?