The Food and Drug Administration is warning doctors and patients that using a mesh product in vaginal repair surgery can lead to serious complications. Dr. William Maisel, the FDA’s deputy director and chief scientist in the device division, said there are “clear risks” associated with the mesh. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed about potential complications. The mesh is used to support sagging pelvic organs such as the bladder, uterus, and bowel after they have been lifted back out of the vagina, where they descended.
Mesh-related problems reported to the FDA include painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding, usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it. The FDA said it plans to convene an advisory committee of experts in the fall to determine whether to ban the mesh – manufactured by Natick-based Boston Scientific Corp., Covidien PLC of Mansfield, and several other companies – for this procedure.
Boston Scientific, which has had a string of setbacks stemming from its cardiac devices in recent years, is one of several companies that already face lawsuits over the mesh. Dozens of women who said they endured painful complications after the company’s mesh was implanted filed complaints last year in a California court, and many of the cases are now being transferred to jurisdictions across the country where the plaintiffs live.
“If the product is defective when it’s used in the manner intended by the manufacturer, there’s liability,’’ said Tom Girardi, senior partner at the Girardi Keese law firm in Los Angeles, which represents about 75 patients who used Boston Scientific’s mesh. “It is unfortunate that the FDA doesn’t come to these conclusions before all these people get hurt.
The FDA has decided that it is not necessary to remove the products from the market, Dr. Maisel said “However we think it is important that patients and health care providers have the information we have about the adverse events.
Patient advocates say the FDA has not gone far enough. “The troublesome issue is how is that going to affect what actually happens to patients as long as this product is still on the market and widely available,” said Dr. Diana Zuckerman, president of the National Research Center for Women & Families, which studies women’s health issues.