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

2007 Study Finds 11.9% of Penile Implants Result in Mechanical Failure

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.

There are many reasons why a man would undergo the implantation of a penile prosthesis.  When the pharmacological route does not adequately manage erectile dysfunction, a penile prosthesis might be the best option.  Penile implants are also used to correct penile malformation.  The surgery required for a penile prosthesis is complex and complications can occur.  Infection of the implant, protrusion of the implant through the skin, and mechanical malfunctions are all possible complications that can lead to serious medical conditions.  Many times, the only way to correct these problems are through painful reoperations.

Author Xuan XJ., from the Division of Urology, the First Affiliated Hospital, Sun Yat-sen University, China, conducted a study titled “Outcome of Implanting Penile Prosthesis for Treating Erectile Dysfunction:  Experience with 42 Cases”.  The aim of this study was to determine the short term results of a three-piece inflatable penile prosthesis implantation.  The Medical Instrumentation Company of Muping made the implanted prostheses.  Author XJ Xuan, states “Three-piece IPPs were implanted in 42 Chinese patients with ED refractory to systemic treatment between May 2002 and May 2004.”  Causes for erectile dysfunction in these patients were paraplegia (impaired motor functions in the lower extremities), fibrosis of corpus cavernosum (scar tissue in the erectile tissue or hardening of the erectile tissue), and Klinefelter’s syndrome (men born with an extra x chromosome which can lead to decreased testicular hormone function).

The study followed up with these patients were given follow ups that occurred from 24 to 57 months.  Xuan further states “Implantation procedures were successfully performed upon all 42 patients.”  The implants ranged from 13 cm to 18 cm, with a diameter of 1 cm.  Five patients experienced mechanical complications and one patient experienced an infection of the implant.  In all, 41 of the patients reported they were able to have normal sex after the surgery.  The study found that despite the possibility of complications, the three- piece implant was safe for the treatment of erectile dysfunction.

This study, showing that 11.9% of patients experienced mechanical complications with the implanted penile prosthetic, could have been used in a penile implant lawsuit to demonstrate to court that the manufacturers of these devices knew, or should have known, the rate of complications associated with their products, but failed to act.

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