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

Penile Prosthesis Lawsuit Information

“Exploratory surgery” required in 10% of penile prostheses by American Medical Systems

Recent medical research has shown that use of penile prostheses (penile implants) by American Medical Systems, Inc. can result in complications requiring further operations on the penis at a rate of 2-6% (about 1 in every 25 implants).

Sometimes, penile prostheses result in infections, and sometimes the infections are so bad the prosthetic must be removed.  One study that reviewed the safety of penile implants in 185 men, (published by an Italian research team in a 2000 edition of the medical journal European Urology) found that among men who used penile prostheses by American Medical Systems (AMS), “Complications requiring surgical exploration included infection in 12 patients (6%) and mechanical failure in 8 patients (4%).” (emphasis added)

In August 2013, the FDA reported a man required hospitalization after an infection associated with a penile implant by AMS, and while the FDA has published a number of adverse events associated with AMS penile implants, more and more are sold every day.

Penile Prostheses Complications

According to Mayo Clinic, penile implants “are typically recommended after other treatments for [erectile dysfunction] fail,” and “there are two main types of penile implants, semirigid [(two-piece or three-piece)] and inflatable.  Each type of penile implant works differently and has various pros and cons.”  (hyperlinks added)

Because these devices are implanted surgically, malfunction of the implant or complications associated with the penile prosthetic often require “revision surgery,” which can be very painful.

In the past few decades, a number of peer-reviewed medical research studies have been published that show the risks associated with different penile implants, and many of those papers show similar results: between three and five percent of penile implants require additional surgery, and though some research has shown a rate of complications associated with penile prostheses as high as 25% , the publication of so much research demonstrating the frequency with which secondary operations are required illuminates that the manufacturers of penile implants (particularly American Medical Systems) knew, or should have known, the risks associated with their products.

Penile Prosthesis Lawsuits

The rates of failure and complications that require additional surgery are unacceptably high, and many patients enter surgery unaware of the risks associated with penile prostheses.  As a result, many men injured by penile prostheses have been filing penile prosthesis lawsuits since the 1990s, securing significant financial compensation from the manufacturer the defective penile implant they used.  Many of these penile implant lawsuits are filed against American Medical Systems, the manufacturer of AMS 700™ Series—3-Piece Inflatable Penile Implant, AMS Ambicor® 2-Piece Inflatable Penile Implant, AMS non-inflatable penile implants, and others.

In 1993, the LA Times, reported that a “Los Angeles Superior Court jury awarded a Chatsworth bank executive $300,000 in damages Monday from the manufacturer of a penile inflation device that failed, causing him permanent sexual problems”, and while that article continued, stating that “The U. S. Food and Drug Administration announced [in 1993] that makers of inflatable implants–the most popular type–would be required to submit scientific evidence that their products are safe and effective”,  ten years later, penile implants by American Medical Systems continue to cause undue injury to thousands of men every year.

 

Also, every post we’ve written about Penile Implants is available here.