With over 500 transvaginal mesh claims (225 of which are Bard's Avaulta TVM) from 37 different states—so far—Garrrad is hopeful that attorneys can make a difference through litigation. And he is seeing a large influx of women interested in filing transvaginal mesh claims.
"Irrespective of the FDA warning (July 2011) and committee hearings, experts confirm in many respects what we have been saying: Transvaginal mesh has not been well-researched and lots of women have been injured by these products," says Garrard, explaining that the root of the problem is that [the manufacturers] haven't considered natural characteristics in terms of anatomy and functions in the pelvis.
These mesh products were put on the market without testing them to see that they actually mate or work in the pelvis. Several motions in the pelvic region, such as motion in the digestive system and motion in the vagina if a woman is sexually active, relate to the mesh, which is generally a synthetic material made with a knitted or woven polypropylene. This kind of mesh doesn't have the elasticity to accommodate that motion. "As a consequence, you get a significant fibrotic reaction, a hyper-inflammatory reaction that leads to pain, shrinkage of mesh and significant changes in the vaginal structure," Garrard says, and that the "system has failed both women and the medical profession."
The 510(k) process is one of two ways that the FDA allows materials to be marketed. Drugs go through a pre-market approval process but the mesh went through the "short version," i.e., the 510(k), which is a process whereby a company approaches the FDA for product approval and says that this product is similar to a product already on the market. "The company fills out the forms, the FDA looks at it and clears it to be marketed," says Garrard. "The FDA is not looking at safety and doesn't believe the product needs to stand on its own; consequently there is no approval of the product. So the FDA is abiding by the regulations that have been put into place.
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Currently Pelvic Organ Prolapse (POP) cases involving transvaginal mesh are in the discovery phase. Garrard says he is collecting lots of documents and evidence and talking to experts. "There will probably be a trial sometime in 2012, and we will likely see a lot of claims," he says, adding that his goal is to help women and to make a difference. "I will probably end my career as a women's health care lawyer."