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.