Transvaginal mesh is used to treat both pelvic organ prolapse (POP) and stress urinary incontinence (SUI). With POP, a woman’s pelvic organs descend and protrude through the vagina. With SUI, a woman experiences involuntary urine leaking. Transvaginal mesh was originally made to treat protruding hernias. It’s primarily made from a synthetic plastic-like material, but it’s also made from stainless steel and biological materials. In hernia surgery, it’s sewn in below the skin and patches the hole in the abdomen, stopping tissue from protruding.
Because treatment for hernias with mesh was successful, surgeons began using it to treat POP, but rather than implanting the mesh abdominally, doctors have been inserting it vaginally. As a result of the vaginal implantation, many women have experienced organ perforation and erosion or disintegration of the mesh. Many have undergone unsuccessful multiple surgeries in attempts to remedy these complications.
The FDA and transvaginal mesh
Nearly 4,000 reports of complications from use of transvaginal mesh were reported to the U.S. Food and Drug Administration (FDA) between 2005 and 2010. The most common complications were an erosion of the mesh and shrinkage, resulting bleeding, swelling, sexual difficulties, infection and overwhelming pain. On October 20, 2008, the FDA issued a notification regarding adverse events and surgical mesh devices. On July 13, 2011, the FDA issued an update on transvaginal mesh use for POP that was directed to both health care providers and patients, advising that surgical mesh complications for POP and SUI are not rare. It went on to advise that it wasn’t clear that POP repair with mesh is any more effective than-than traditional non-mesh repair, and may even expose patients to greater risks. On January 4, 2012, in an update, the FDA announced that it was considering reclassifying transvaginal mesh as a high-risk device. On April 29, 2014, the FDA issued proposed orders reclassifying transvaginal mesh accordingly. About 70,000 transvaginal mesh federal lawsuits have now been filed.
Of the nearly 70,000 federal transvaginal mesh lawsuits, certain claims are common to all of them. Those charges accuse manufacturers of intentionally misleading the FDA, health care providers and the public about both the safety and efficacy of the product, while also failing to warn adequately of the dangers involved in implanting transvaginal mesh. Other allegations accuse manufacturers of rushing their product to the market to maximize profits while making the products from inferior materials. Particularly noteworthy were allegations that once implanted, there was no way of removing the transvaginal mesh.
Likelihood of success
Women injured as a result of transvaginal mesh are experiencing a high rate of success in the courts. Because juries have rendered favorable verdicts, manufacturers now realize their immense exposure. On that basis, rather than running the risk of trial, there has been a trend toward more cases settling. In November of 2014, a Florida jury awarded four women $26.7 million in transvaginal mesh cases against Boston Scientific, and a West Virginia jury awarded four women $18.5 million, including $4 million in punitive damages. Endo Pharmaceutical’s American Medical Systems recently announced a global settlement of about $830 million to resolve all pending claims against it. Given the high rate of success of plaintiff’s in actual trials, other manufacturers are expected to follow suit shortly.
Sources: FDA 7-13-11 Public Safety Update
FDA 1-3-12 Update
FDA 4-29-14 Proposed Orders