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Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

2008 – High rate of complications, secondary surgeries seen with penile implants from American Medical Systems

Posted in Penile Implants

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.

Erectile dysfunction is a medical condition that plagues millions of men in the united states alone.  When the pharmacologic route doesn’t adequately solve the problems seen with erectile dysfunction, men may turn a penile prosthesis implant for the solution.  There are several different types of implants available on the market today, but the most commonly used penile prostheses are those manufactured by American Medical Systems (AMS).  The surgery required for these implants are delicate by nature and are often accompanied with serious complications such as infections and painful reoperations.

Author A. Natali from the Uro-Andrological Unit within The Department of Urology at University of Florence, in Florence, Italy, conducted a study called “Penile Implantation in Europe:  Successes and Complications with 253 Implants in Italy and Germany”, where the goal of the study was assess complications and patient satisfaction with AMS penile implants.  The study consisted of 253 consecutive patients who had clinically diagnosed erectile dysfunction.  Natali A. states “Pre, intra- and postoperative data were obtained from chart review, with a mean follow-up of 60 months; 200 patients were available for evaluation. Patient satisfaction data were collected using the Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) questionnaire.”  Major postoperative complications were seen in 20 percent of the patients.  In all, 9 men experience prosthesis infections, 18 had mechanical failure, and 13 men experienced erosion of the prosthesis.  Natali A. further states “ Partner satisfaction with the AMS 700CX, AMS Ambicor, and AMS 600-650 was 91%, 91%, and 75%, respectively; dissatisfaction was 0%, 5%, and 6%, respectively.”  The study noted that patients claimed they had more natural erections than before the operation, but hardness was the same as before.  The use of standardized assessment tools for patient satisfaction will allow future comparison of data between different centers performing similar penile prosthesis implants.

Due to the fact that many men have used AMS penile implants that required reoperation, unaware of the risk for infection or complications, a number of AMS penile implant lawsuits have been filed.

Our Penile Prosthesis Lawsuit Information page is a great place to start if you have any questions about penile prostheses.

We are no longer accepting cases regarding these products.  Due to a terrible Supreme Court ruling, consumers injured by this product are no longer permitted to sue the manufacturers of this device.  We wish we could help, but the Supreme Court has taken the rights of citizens away to protect the profits of medical device manufacturers.  For more information, please read the following New York Times article entitled “Medical Device Ruling Redraws Lines on Lawsuits.
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