FDA Proposes Reclassification of Trans Vaginal Mesh as High Risk Device

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.

What is Pelvic Organ Prolapse?

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. Women affected by POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

FDA takes a Stand

According to William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, “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. 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 Litigation

The cases have been centralized before Judge Goodwin for coordinated pretrial proceedings in the U.S. District Court for the Southern District of West Virginia.

Judge Goodwin currently presides over seven different federal multidistrict litigations (MDLs), which have been established for cases filed against different manufacturers of vaginal mesh and bladder sling products. These complaints allege that women face an unreasonable risk of vaginal mesh complications following surgery.

According to an updated court case list released on April 15, Judge Goodwin currently presides over 14,679 Ethicon mesh lawsuits against Johnson & Johnson, as well as 16,515 AMS mesh lawsuits, 9,776 Boston Scientific mesh lawsuits, 7,096 Bard Avaulta mesh lawsuits, 1,267 Coloplast mesh lawsuits, 173 Cook Medical mesh lawsuits and about 25 Neomedic Pelvic mesh lawsuits.

What is Trans Vaginal Mesh?

Surgical mesh is a medical device made from polypropylene plastic that is used to provide additional support when repairing weakened or damaged tissue.

Beginning in January 2012, the FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.

In Sept. 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require PMAs.

In July 2011, the FDA provided an updated safety communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP. At that time, the FDA also released a review of urogynecologic surgical mesh adverse events and peer-reviewed scientific literature that identified serious safety and effectiveness concerns. The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI) in an October 2008 FDA Public Health Notification.