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

Penile Implant Failure Rate 10% at 5 years

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
implantation can help men with their erectile dysfunction, however this surgery comes with many possible complications that can include infection and mechanical failure.  Sadly, reoperation may be the only to correct complications that can arise.  In 2013, a team of medical researchers led by E. Chung from the Department of Urology at Princess Alexandra Hospital in Brisbane, Australia, published a study titled “Penile Prosthesis Implantation for the Treatment for Male Erectile Dysfunction:  Clinical Outcomes and Lessons Learnt After 955 Procedures,” wherein the main aim was to determine how well penile prosthesis worked over long term use.  The Ultrex cylinder implant was used 54 percent of the time to correct the patient’s erectile dysfunction that was organic in nature.

The study used men around the age of 53.2 years old and looked at 955 penile prostheses between 1981 and 2010.  One way the study tracked how well the penile prostheses held up over the years was to conduct a follow up survey and have the patients answer questions about their experience.  This survey/follow up happened from 12-355 months after implantation of the penile prosthesis.

Results from the study showed that revision surgery and complications during the operations occurred.  Infection of the prosthesis was seen 0.8 percent of the time and occurrence rate of these infections were the same for pelvic trauma patients and diabetics.  In all, 75 percent of the causes for mechanical failure were from fluid loss.  Chung states “The average time to prosthetic revision was 102 (30-210) months. Kaplan-Meier estimates of overall penile prosthesis survival at 5 and 10 years were around 90.8 and 85.0 %.”

This research demonstrating that in the long term, penile implants fail between 9.1 and 15 percent of the time, it may be used in a penile implant lawsuit to demonstrate to court that the manufacturers of these devices knew, or should have known, the risks associated with their products.

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