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

2003: Study Shows 8.5% Penile Implants Require Surgical Removal Due to Device 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.

Penile prosthesis implants require delicate surgeries, and complications that lead to serious medical conditions may occur, including infection, protrusion of the implant through the skin, and mechanical failure of the device.  In many cases, the only way to correct problems that arise from complications are secondary, revision surgeries.  Author KH Ferguson from the Department of Urology (MCSU) at Wilford Hall Medical Center at Lackland Air Force Base in Texas, conducted a study titled “Prospective Long-Term Results and Quality-of-Life Assessment After Dura-II Penile Prosthesis Placement”, where the objective was to study the long term reliability of the Dura-II malleable penile prosthesis.  The study also looked at how satisfied the patients were with the results of their implants.

Ferguson states that “Between 1992 and 1996, 94 patients underwent Dura-II implantation for erectile dysfunction. Patients were prospectively examined and completed standardized questionnaires regarding sexual activity, prosthesis function, intercourse satisfaction, and overall quality of life.”  In order to eliminate possible bias of interpretation of the results, the study hired an outside statistician, apart from the original study team.  On average, the patient age for this study was 63 years old and they got a follow up after 5.7 years.  Eighty-five patients were included in the follow up to begin, but sadly 14 patients passed away during the course of the follow-up evaluation.

It was found that eight prostheses (of 94) had to be removed due to complications after implantation.  No mechanical failures were reported and 87 percent of the patients reported they were happy with the rigidity of the implant and felt the operation improved their quality of life.  Ease of concealing these implants is important and overall, it was reported that this was not a problem.  Author Ferguson concludes that most of the patients used in this study would undergo the surgery again after knowing what it includes, and states “The Dura-II malleable penile prosthesis provides good rigidity, ability to conceal the device, and mechanical reliability, as demonstrated by the results of this long-term study.”

Due to the fact that many men enter into penile prosthesis surgery unaware of the fact that between about 4 and 12 percent of the time penile implants require revision surgery, a number of penile implant lawsuits were filed.

 

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