Penile Implant FDA Device Recalls

About 1 in 8 men will be diagnosed with prostate cancer in their lives. It mainly affects older men. Often, it is not surgically treated, but some tumors require removal of part or all of the prostate. An unwanted side effect of this surgery can be erectile dysfunction (ED). One option for addressing ED is a medical device known as a “penile implant.” These devices are regulated by the Food and Drug Administration (FDA) in the United States. According to a 2015 report, 7.4% of these implants require a reoperation (“revision”) surgery. Elevated risks of revision following implantation of a medical device, from a knee replacement prosthesis to a penile prosthesis, can be caused by design or manufacturing issues. The FDA has a process for identifying medical device problems and issuing product recall notices. 

The purpose of this post is to notify readers that I will be posting short informational pieces under “updates and news” when I find a penile prosthesis implant recall on the FDA website.