Header graphic for print
Dangerous Drugs & Medical Devices News & Commentary on Prescription Drug & Medical Device Lawsuits

1983 – Study Shows: 12% of penile implants require revision surgery

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.

A penile prosthesis and other similar types of treatment are forms of treatment for men with erectile dysfunction.  The prostheses used are bendable or inflatable.  Some basic types of prosthesis consist of a pair of bendable rod like structures that can be surgically implanted within the erection chambers of the penis.  The most common types are manufactured by American Medical Systems, and are used for a wide variety of patients.  The use of these implants are usually used when there is a clear medical cause for ED and when the problem is unlikely to resolve or improve naturally or with other medical treatments.  Certain medical conditions may create the need for the use of these penile implants: for example, when scarring has caused an erection to curve, we see prosthesis implanted during surgery to reconstruct the penis; this is called peyronie’s disease.

Many times, these implants require painful secondary penis surgeries and infections are so bad that the implants have to be removed.  Sometimes, reoperation is required and infections are not a rare occurrence.  While the newer penile implant designs are more reliable than their earlier predecessors, there are still cases of implant malfunction.  When this occurs it requires surgery to remove or repair the broken implant.  Internal erosion or adhesion is a serious problem that may lead to a serious infection.  An implant might stick to the skin or rub away the skin of the penis from the inside and could break through the skin.  In 1983, medical researcher CC. Carson, wrote a report titled “Inflatable Penile Prosthesis:  Experience with 100 patients”, where he reviewed the experience and complications that men had with their penile prosthesis implants.  An inflatable penile prosthesis was implanted for the treatment of chronic erectile dysfunction over a two year period.

Carson states “Each patient was thoroughly evaluated by history, physical examination psychologic investigation, and appropriate laboratory testing. Of these patients, the most common indication for prosthesis implantation was diabetes mellitus of adult onset, followed by vascular disease and radical pelvic surgery.”  Mechanical complications and malfunction occurred in 12 of 100 patients and these complications were surgically corrected in secondary operations.  Diabetes raises the risk factors associated with these procedures and the study found that one diabetic patient had an infection that required the removal of the implant.

Due to the high rate of complications associated with penile prostheses, a number of penile prosthesis lawsuits have been filed.

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