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

1996 – Study shows 1 in 30 penile implants cause serious 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.

The use of penile implants to correct erectile dysfunction has become a popular method for many men suffering from ED.  The origins of a man’s erectile dysfunction can arise naturally or from an external factor, such as trauma to the organ.  Complications that are commonly seen with the implantation of these devices include device failure and infections that often require corrective surgery.

Author BB Garber, from the Division of Urology, at Graduate Hospital in Philadelphia, worked on a study titled “Inflatable Penile Prosthesis:  Results of 150 Cases”.  The purpose of this study was to determine how safe and effective implanted inflatable penile prosthesis are when used for men who are organically impotent.

Garber writes, “A consecutive series of 150 men (mean age 60 years, range 25-90) were followed for a mean of 19 months (range 0-65) after implantation of the Mentor Alpha 1 penile prosthesis.”  Researchers interviewed the patients by telephone to gather medical information they needed for the study.

Complications were only seen in five patients and they included two peri-prosthetic infections, two intra-operative, and one post-operative cylinder aneurysm (145 of the patients reported having no complications and have fully functioning prostheses).  While none of the patients reported leaking of the penile implant, reoperation needed to correct the first surgery was done in three cases.  Garber concludes with “These results suggest that for men with organic impotence, a Mentor Alpha 1 implant is an effective treatment option with acceptable morbidity and good mechanical reliability.”  However, this shows that about 1 in 30 men suffered serious complications related to their penile prosthesis.

Due to the fact that the manufacturers of many penile prostheses do not adequately warn users of the rates at which infections or complications occur, or the rates at which reoperation is required, a number of penile prosthesis lawsuits are currently being filed.

 

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