The FDA met last week to determine whether surgical mesh inserted surgically inserted into the vagina, also known as transvaginal mesh or pelvic mesh, needs tighter regulation by the FDA. The mesh is used to treat a painful condition called pelvic-organ prolapse. As the result of close to 3000 reports of adverse events, including seven deaths, the manufacturer – Johnson & Johnson now faces several lawsuits across the country.
Transvaginal mesh – like many other defective medical products – was allowed on the market as the result of an expedited regulatory process. The pelvic mesh is currently considered a Class II medical device and was allowed a quick entry into the market without preclinical testing if manufacturers were able to show that the devices is “substantially equivalent” to an existing device on the market.
The FDA is evaluating whether to change the classification of the transvaginal mesh to Class III – high risk. If the FDA changes the rating, the pelvic mesh would require additional testing and be subject to a longer approval period.
Based on initial reports of the transvaginal mesh hearings, it appears that the advisory committee is in favor of stricter testing requirements. A number of risks are associated with the mesh, including organ perforation and bleeding, long-term mesh exposure to the bladder, vagina and rectum, pain and infection, urinary problems, as well as the need for additional revision surgeries. Several reports also indicated that the use of the mesh exposes patients to “unnecessary risk without a benefit above safer options.”