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

1989: Research Shows 6% AMS Penile Implants Result in Severe Complications

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 were been invented to treat a variety of ailments of the penis.  The nature of these ailments may range from functionality issues such as erectile dysfunction to physical malformations such as severe curvature.  Prostheses have even been used to replace amputated penises.  Implantation of these prosthetics have sometimes had complications that required followed up corrective surgery.

Many reports have been written on cases of penile prosthesis implantation.  One report of implantations was conducted in Japan, in the Department of Urology in the Toho University School of Medicine.  The report is titled “A Clinical Evaluation of AMS 700 Penile Prosthesis in the Treatment of Impotence,” conducted by M Shirai et al. and was published in the Japanese journal Hinyokika Kiyo, or Acta Urologica Japonica.

The report analyzes the outcomes of 34 implantations of the AMS 700TM and 700 CXTM.  The patients receiving the implantations ranged from ages 32 to 70, with the average age at 57.2 years.  Follow ups were conducted 12 weeks after implantation to evaluate the prosthesis in terms of patient satisfaction with sexual intercourse and postoperative complications.  The results of the follow up showed that 8.8% of the patients were dissatisfied and 2.9% reported a worsened condition after the procedure was conducted.  Furthermore, severe complication occurred in 2 of the 34 cases (5.9%), in both instances complications were a result of infection and required removal of the prosthesis.

The authors state that overall the prosthetic is generally both effective and safe, however it may be subject to complications requiring corrective follow up surgery.  This article, demonstrating such a high rate of reoperation, may be used in a penile implant lawsuit to illustrate to a court that American Medical Systems knew, or should have known, at least since 1989 the rate of complications associated with their products.  Because American Medical Systems knew and failed to act, penile implant lawsuits are currently being filed across the country.

 

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