The Next Medical Device Controversy: Vaginal Mesh
Marci Sutin Levin says U.S. regulators failed her by not requiring extensive testing before allowing Johnson & Johnson to sell the type of surgical mesh implanted in her in 2007 to hold her pelvic organs in place. Now the 65-year-old New York marketing executive says she can’t work, sleep through the night, or have sex with her husband due to endless pain worse than that of natural childbirth. “The pain of childbirth was finite, and you’re delivering a child,” Levin says. “This was very, very different. It’s relentless, and it’s untenable. And it doesn’t lead to anything.”
Levin has filed one of about 270 lawsuits pending against J&J. In all, about 600 suits have been filed against it and other mesh makers, including C.R. Bard, Boston Scientific, and American Medical Systems, acquired in June by Endo Pharmaceuticals Holdings.
The U.S. Food and Drug Administration warned on July 13 of a fivefold increase in women suffering pain and injuries after surgeons inserted mesh through vaginal incisions. Last week an advisory panel agreed with FDA staff that the agency should reclassify mesh from moderate risk to high risk of harming patients if it fails, and require more studies to determine if it’s safe and effective.
Personal injury lawyers say they expect a surge in lawsuits by women responding to ads about the dangers of transvaginal mesh for “pelvic organ prolapse.” This refers to a condition in which organs like the bladder bulge, or prolapse, into the vagina. “We’re getting an amazing number of calls,” says attorney Bryan F. Aylstock of Aylstock, Witkin, Kreis & Overholtz in Pensacola, Fla. “The FDA notification brought it to the attention of a lot of lawyers who were doing other things and to women who had been suffering in silence.”
So far, none of the cases have gone to trial, and women must prove their claims that mesh makers knew of safety risks and failed to disclose them and that the products were defective. An industry group whose members include J&J, Boston Scientific, Bard, and American Medical Systems told the FDA advisory panel last week that using mesh in transvaginal procedures is safe and effective and serious injuries are rare. J&J spokesman Matthew Johnson says it’s too early to comment on the potential impact of mesh lawsuits, but that the company is willing to conduct studies of the devices to ensure doctors and patients have “informed access to treatment options.” Boston Scientific and Bard in statements defended mesh as a valuable option for women. American Medical Systems didn’t return a call for comment.
About 300,000 women in the U.S. had pelvic organ prolapse surgeries last year, including more than 70,000 who received vaginal meshes. Between 2008 and 2010, the FDA received 1,503 reports of injuries or malfunction, a fivefold increase from 2005 to 2007.
Concern over mesh safety is slowing the pace of implants, says Mike Matson, an analyst at Mizuho Securities USA. Bard, which estimated the global prolapse mesh market at $175 million, saw its own pelvic prolapse business fall about 30 percent in 2010 due to what it called “regulatory delays” on product approvals. Matson says J&J is the global leader in prolapse mesh, followed by American Medical Systems, Boston Scientific, and Bard. He figures mesh products represent no more than 2 percent of any of the makers’ sales, limiting financial risk. Still, the suits are another high-profile controversy pushing the FDA toward toughening its approval process for devices, Matson says. As moderate-risk devices, vaginal meshes currently need only show that they are “substantially equivalent” to existing products. A change to a high-risk status would require tests to show efficacy and safety.