The Food and Drug Administration (FDA) has ordered Boston Scientific and Coloplast, the producers of surgical mesh, to stop selling and distributing its products made for treating pelvic organ prolapse (POP) immediately. This decision was reached after thousands of patients filed suit against the companies, blaming the product for painful and often permanent complications, many requiring further surgery. They include bowel obstruction, bowel perforation, bleeding, and late abscess.
The order follows recent expert hearings before the FDA. Surgical mesh lawsuits have ranked as one of the largest mass tort cases in United States history, with producers having to pay nearly $8 billion to resolve over 100,000 claims. The FDA has since classified the mesh as “high risk,” and required producers to provide evidence that the product was safe and beneficial to patients.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair pelvic organ prolapse,” said Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health. “We couldn’t assure women that these devices were safe and effective long term.”
Vaginal mesh has been available in the United States since 1996. Many women required a second surgery to treat complications, often requiring the surgical mesh to be removed.
“For years, women have suffered complications from surgical mesh,” said Berman & Simmons attorney Susan Faunce. “This decision by the FDA is going to help thousands of women in the future and is one step in holding manufacturers accountable.”