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

2001 – Study finds 10% failure rate with AMS 700 CXM penile implant

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.

Millions of men today suffer erectile dysfunction.  A penile prosthesis and other similar types of treatment are forms of treatment for men with erectile dysfunction.  The prostheses used are bendable or inflatable.  Some basic types of prostheses consist of a pair of bendable rod like structures that can be surgically implanted within the erection chambers of the penis.

Penile implant surgery is a risky and sensitive procedure, often accompanied with serious infections and painful reoperations.   Many procedures involving these penile prostheses are accompanied with high rates of postoperative complications, and while the newer penile implant designs are more reliable than their earlier predecessors, there are still cases of implant malfunction.  Certain health factors such as diabetes can increase the risk for postoperative complications.  A thorough physical examination from your doctor will ensure you are a suitable patient for a penile prosthesis and can lower the risk factors involved.

Author Y. Deuk Choi from the Department of Urology and Institute of Andrology, at Yonsei University, College of Medicine, in Seoul, worked on a study titled “Mechanical Reliability of the AMS 700 CXM Inflatable Penile Prosthesis for the Treatment of Male Erectile Dysfunction”, where the goal was to review their experience with the AMS 700CXM prosthesis and assess postoperative complications and reliability.  Deuk Choi states “The AMS 700CXM inflatable penile prosthesis with medium controlled expansion cylinders was introduced in 1990 to provide a device with controlled expansion in girth and fitness for Asian men.”  The study was done from January 1991 to April 1999 and included 273 subjects with erectile dysfunction who had primary penile prosthesis implants.  Medical records and telephone interviews were used after the operations to assess function status of the prosthesis.  Age of the patients ranged from 24 to 78 years of age and the mean follow up was 49 months.  28 complications were reported, 8 were non mechanical and 20 were mechanical.  Infection, erosion, surgical complications, and tube kinking were included in the non mechanical complication group.  Mechanical complications that were seen included cylinder tears, pump failure, and reservoir tears.  Deuk Choi Y. further explains “Mechanical reliability of the device was 98.2% after 2, 95.7% after 3 and 90.4% after 5 years.  The AMS 700CXM is suitable for Asian men and its mechanical reliability is excellent. However, more device modifications are needed to guarantee good reliability during long-term followup.”

Because many men have used penile implants by American Medical Systems unaware of the risks associated with these prostheses, a number of penile prosthesis lawsuits have been filed against the company.

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