FDA Never Tested the Surgical Mesh Implanted in Your Body for POP Repair

Our medical device lawyers here at Denena & Points are pleased that the FDA has finally recognized officially the risks of transvaginal surgical mesh repairs for pelvic organ prolapse (POP). We applaud Public Citizen's petition for rigorous approval and testing processes on these medical devices. A careful review and approval process of any medical device before surgeons place it in your body could only be beneficial. The surgical mesh, which had been used fairly successfully for years to repair hernias, just doesn't seem to be suitable to the more challenging task of POP repair.

Transvaginal surgical mesh repairs of POP have caused thousands of women severe pain and trouble as the mesh eroded or extruded through the vagina. But undoing a surgical mesh repair presents a daunting task. The surgical mesh designs encourage the growth of the patient's own tissues through and around the surgical mesh. In a successful operation, this tissue growth could help anchor the mesh in place. In an unsuccessful operation, it makes it virtually impossible to extract the surgical mesh without substantial invasion of and trauma to the patient's already weakened tissues.

And, guess what? This surgical mesh that has caused so many women so much pain didn't even require testing and approval before it went out on the market and into their bodies. Indeed, this surgical mesh was implanted transvaginally into hundreds of thousands of women over the years with far less safety testing than your car's airbag received.

That just seems wrong. The inequity derives from the method that the FDA uses to classify medical devices. Only a small percentage of medical devices, those thought to pose the highest risk (like some implanted cardiac devices) have to undergo any testing or approval at all. Even some cardiac medical devices go to market without testing.

But people are beginning to ask questions. More and more individuals and organizations are calling for more rigorous approval and testing of the medical devices that end up inside our bodies. Let's hope these questions bring about the desired changes. As I age, I'm sure I'll have need of various medical devices. When the doctors put these devices inside my body, I'll want to feel secure that they've been carefully tested and found to be safe.