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

2006 – 1 in 5 AMS Penile Implants Mechanically Unsuccessful

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.

Penile prostheses
have been invented to treat a number of ailments of the penis.  These ailments may range from physical malformations to functional conditions.  One common condition that penile prostheses have been used to treat is erectile dysfunction.  Implantation of a prosthetic penis to treat erectile dysfunction is typically only performed when natural remedies and medications have failed.  The preferred prosthetic type is an inflatable prosthetic, allowing for a more natural look and function.  Several models have been developed, including the AMS 700CX and 700 CXM models. Implantation of penile prosthetics is generally not a dangerous procedure, but has at times required corrective surgery after complications.

One study evaluating the long-term effectiveness of penile prostheses was conducted by NB Dhar et al. within the Glickman Urological Institute of the Cleveland Clinic Foundation.  The study is titled “Long-term mechanical reliability of AMS 700CX/CMX inflatable penile prosthesis” and was published in the Journal of Urology in 2006.  The study was conducted to determine “the long-term mechanical reliability of the AMS 700CX/CXM inflatable penile prosthesis in men with organic erectile dysfunction.”  In this case, organic erectile dysfunction refers to issues due to a physical condition in the penis, rather than erectile dysfunction due to psychological issues.

The study included 455 patients who underwent implantation of an AMS 700CX/CXM inflatable penile prosthesis.  Follow ups were conducted using telephone interviews and mailed questionnaires with 380 of the 455 patients.  Data were collected based on 2 primary criteria including overall failure and mechanical failure caused by a malfunctioning component.

The data showed 74.9% of implantations were overall successful, while 81.3% were mechanically successful.  Follow-up in this study was up to 231 months after implantation, which is the longest follow-up, conducted of penile prosthesis implantation showing overall and mechanical survival.  This means that nearly 20% of penile implants failed mechanically.

Research such as that summarized above demonstrates clearly that American Medical Systems (the manufacturer of the AMS 700CX/CXM implant) knew, or should have known, the risks associated with their products.  And because so many men have used penile prostheses unaware of the rate of failure associated with these devices, complication, and the rate at which reoperation is required, many 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.