New FDA Regulations for Transvaginal Mesh

Austin, TXBecause more than 50,000 transvaginal mesh lawsuits have been filed against a number of mesh manufacturers, the FDA has finally backtracked on its “fast-track” 501k process.

The FDA approved the transvaginal mesh product to treat urinary incontinence or pelvic organ prolapse because it was deemed “low to moderate” risk and there was a similar device already on the market. “TVM manufacturers got a green light from the FDA and their product was fast-tracked. And guess what? The whole idea was flawed to begin with - these mesh devices fall through the safety crack.”

Because the FDA gave the mesh this rating, it was approved without a requirement to conduct human clinical trials. Instead, so many women have said they have been “guinea pigs” for these mesh manufacturers.

Malik says that mesh degrades and breaks down over time and the vagina is not a sterile environment so it is prone to infection and in turn it causes mesh to erode through the vaginal canal. And then the problem that mesh was supposed to treat in the first place “comes back with a vengeance.”

Now the FDA has reclassified TVM products as high risk, which means that a manufacturer must conduct clinical trials before it intends to market its product and current mesh makers must conduct safety studies if they wish to keep their products in the marketplace.

Of course this move by the FDA is far too late for at least 50,000 women. But the agency can only do so much. “The FDA is at the mercy of Congress and they are also overwhelmed by so many products entering the marketplace,” says Malik.

“I think that there are too many of these complex devices that have made it to market without clinical testing.” Dr. Greg Curfman, executive editor of the New England Journal of Medicine, told PBS in its Need to Know program (March 22, 2013). The show included an interview with Linda Gross, a former nurse who was awarded $11.1 million in compensatory and punitive damages by a New Jersey jury. She had endured 22 surgeries in attempts to remove the mesh, but she is still in pain.