The U.S. Food and Drug Administration has ordered Boston Scientific and Coloplast medical device companies to stop selling trans vaginal mesh, also known as pelvic mesh or bladder sling, products used for the transvaginal repair of pelvic organ prolapse and stress urinary incontinence.
Over the past decades, surgical mesh has been widely used to attempt to fix these conditions, however, in recent years, the FDA has issued a series of health warnings concerning dangerous risks associated with the mesh products and devices after thousands of lawsuits emerged in which women claim the mesh caused them serious internal injury.
After the devices’ reclassification by the FDA in 2016, companies were required to submit applications and receive approval in order to keep selling mesh products in the United States. According to MSN, the Director of the FDA’s Center for Devices and Radiological Health said in a statement that the agency “wanted evidence showing they worked better than surgery without using the mesh to repair pelvic organ prolapse”
“That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” the Director noted.
Read the full article on MSN’s site.
Transvaginal Mesh Injury Attorneys at Lieff Cabraser
If you have suffered serious injuries or complications from a surgery involving transvaginal mesh, you are not alone, and Lieff Cabraser can assist you in evaluating your legal options. We have female attorneys and nurses in our San Francisco, New York, and Nashville offices who represent women across America injured by transvaginal mesh. Learn more about Vaginal Mesh/Bladder Sling complications and lawsuits and your legal rights.