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

AMS Antibiotic-Coated Penile Prostheses No Safer than Traditional AMS Implants

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 prosthesis implantation surgery is a serious operation, but can help with erectile dysfunction and other ailments.  Even when the operation is being done by a skilled surgeon, it is not uncommon for serious complications to arise.  In many cases, the only way to correct the problems that come with these surgeries are reoperations that can be painful.  Complications range from protrusion of the implant through the skin to serious infections and mechanical failure.

Author I. Moncada, from the Departments of Urology and Andrology at Hospital La Zarzuela in Madrid, Spain, worked on a study titled “Inflatable Penile Prosthesis Implantation Without Corporeal Dilation:  A Cavernous Tissue Sparing Technique”, where the purpose was to determine if dilation of the corpora cavernosa before implanting the penile prosthesis results in more favorable outcomes.  (The corpora cavernosa is a spongy part of erectile tissue that fills with blood during a penile erection.)

The study included patients who used an AMS 700CX or an antibiotic coated 700CX InhibiZone 3-piece prosthesis.  Moncada states “They were randomized to penile implantation without (group 1) or with (group 2) penile dilation. Postoperative pain was measured on the day after surgery and at day 7 postoperatively.”  Pain and postoperative complications were similar across both groups.  In all, 100 patients were used in this study, and they were asked to help with the follow-ups by recording penile length and girth during sexual stimulation.  Complications seen were problems during the operations and pain after the operation.

Further, “Immediately postoperatively, and at 3 and 6 months penile length was significantly greater in group 1 than in group 2” and “Mean International Index of Erectile Function scores were higher in group 1 (12, range 10 to 14 vs 7, range 6 to 8).”  As such, the researchers did not conclude that penile dilation was necessary.

Due to the fact that a number of men have entered into penile prosthesis surgery unaware of the risks associated with the use of these devices and their implantation, a number of penile implant lawsuits have been filed around the world.

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