As of last year, more than 8,000 women have filed lawsuits against various manufacturers of transvaginal mesh implants.

Today, the U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP).

If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

Doctors try to repair this condition with a surgical mesh, which is a medical device that is used to provide additional support when repairing weakened or damaged tissue.

“The FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health. “If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”

Vaginal mesh implants have been linked to numerous serious complications including:

  • erosion of the vaginal tissue
  • serious infection
  • bleeding
  • vaginal pain
  • urinary problems such as incontinence
  • pain during sexual intercourse (dyspareunia)
  • organ perforation (puncturing)
  • organ prolapse

If you or someone you love have suffered as the result of a defective surgical transvaginal mesh device, please call us right away.