Recent communication from the U.S. Food and Drug Administration (FDA) over the potential for injury caused by transvaginal mesh products has sparked a “sea change” in ongoing litigation over these products, which promises to be a significant mass tort, said Bryan Aylstock of Aylstock Witkin Kreis & Overholtz, P.L.C. speaking at the Transvaginal Mesh Litigation Conference, sponsored by HB Litigation Conferences, on Oct. 4 in Amelia Island, Fla.
The FDA advisory letter, released on July 13, 2011, stated, “The FDA is issuing this update to inform you that serious complications associated with surgical mesh for transvaginal repair of POP are not rare. This is a change from what the FDA previously reported on Oct. 20, 2008. Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
“The FDA finally recognized what a lot of doctors knew for a while which is, for most of these women, there is no medical reason why they need this mesh. There are traditional methods … that doctors have been using for a long time that help to alleviate pelvic organ prolapse [POP], stress urinary incontinence [SUI], which don’t use the polypropylene mesh and do not expose the patients to the associated risks,” said Aylstock.
“These patients may need some additional surgery if those traditional methods fail but you’re not going to have a lifetime of pain. You’re not going to have mesh eroding into the pelvic organs [and] they’re not going to have a devastation like our clients are seeing,” he continued.
2008 FDA Advisory
The current transvaginal mesh litigation was spawned in part by a 2008 FDA advisory that warned doctors of the possibility of rare complications due to the products. “There was certainly some litigation over it, but it didn’t have the national front-page news implications in 2008. Unless you were in the litigation you probably weren’t aware of it,” said Aylstock.
He pointed to data released by the FDA indicating that, in 2010 alone, 300,000 women were diagnosed with POP, and 75,000 of those women received treatment with transvaginal mesh. Ten percent of the women experienced adverse events due to the transvaginal mesh, said Aylstock.
“Women have been suffering in silence for years because nobody wants to talk about it. They see an ad or they hear it from their doctor, or they saw the FDA alert. They say, ‘That’s me. I have erosion. I didn’t want to talk about it, I certainly didn’t want to air it out in public,’” he said.
Mesh Products Approved
Vance Andrus of Andrus Hood & Wagstaff PC, said doctors began using surgical mesh inserted transvaginally to treat both POP and SUI in the 1990s.
“In order to do that the surgeons were required to take mesh, which came in sheets, and cut it and fit it to the particular use that they thought was necessary to insert and attach it,” he explained. Soon thereafter, several medical supply companies began to make transvaginal surgical mesh kits. “These kits not only had the mesh pre-cut, pre-measured and pre-sized, but had various types of insertion tools and various types of anchoring devices, in which you could either treat SUI or POP,” Andrus said.
“By 1996, the FDA had cleared the first surgical mesh products specifically for use in SUI. It’s important to note here that this original product was called Protogen. It’s now been withdrawn from the market as being unsafe,” he said.
Manufacturers continued to create various types of “fixation tools, internal insertion tools, anchors, surgical techniques, and absorbable and various biological materials” for the treatment of SUI, Andrus noted. “However, it’s important for you to note is that all surgical transvaginal mesh products today are 510 (k) [of the Food Drug and Cosmetic Act] applications built upon prior applications … all of which are traced back to a product that’s no longer on the market because it’s unsafe,” said Andrus.
Chemically vs. Biologically Inert
“One of the things that the surgical mesh people have touted is that their polyproplylene surgical mesh is inert and common, and therefore safe. While it may be chemically inert, the question is whether or not it’s biologically inert,” he pointed out.
Andrus said that the major manufacturers of these products include American Medical Systems (AMS) J&J Ethicon, CR Bard, Boston Scientific and Tyco Healthcare. “This is a huge number of very substantial and well-funded defendants and there are a large number of products. But at its basis, there is only one product and it is causing one type of serious problem and we need to focus on that,” said Andrus.
“So, the question is, is this material safe and effective?” said Andrus. “And if it is not, we have serious problems.”