Risky Pelvic Mesh Highlights Worries about FDA Process, MSNBC, July 26, 2011
MSNBC reports on Janet Holt, 54, who underwent surgery for pelvic organ prolapse four years ago, and today reports “the medical device that was supposed to fix Holt’s problem has caused a host of new ones, sparking constant pain and requiring seven more operations as other surgeons tried to remove the mesh, which had eroded into her vagina, bit by bit.”
Holt is not alone. With about 200,000 pelvic operations performed every year in the U.S., there are a growing number of reports of surgical mesh-associated complications in women. Because of the controversy, the FDA issued its second warning about synthetic surgical mesh in less than three years.
“Holt has become a poster child for growing concerns about the government process that allows devices such as surgical mesh — made of the same material as Rubbermaid storage containers — to be used with no testing on patients before they’re allowed on the market.”
Read the rest of the story here.