FDA Reclassifies Transvaginal Mesh Devices as “High Risk,” Regulators Announce

FDA Reclassifies Transvaginal Mesh Devices as “High Risk,” Regulators Announce

FDA Reclassifies Transvaginal Mesh Devices as “High Risk,” Regulators Announce

FDA Reclassifies Transvaginal Mesh Devices as “High Risk,” Regulators Announce

Transvaginal mesh devices – also known as bladder mesh and vaginal slings – have recently been reclassified by regulators at the U.S. Food and Drug Administration (FDA). Once classified as class II, moderate-risk devices, transvaginal mesh is now a class III, high-risk device, according to regulators.

The main reason, official say, that they have elevated the risk classification for transvaginal mesh devices is that they have “seen a significant increase in the number of reported adverse events associated with the use of surgical mesh.”

Background on the Risks Associated with Transvaginal Mesh

Used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), transvaginal mesh has been linked to some serious, potentially irreversible complications, the worst of which generally include:

  • Mesh erosion through the vaginal lining
  • Puncturing of the tissues and/or organs surround the mesh implant
  • Recurring POP or SUI
  • Vaginal scarring
  • Pain during intercourse.

Over the years, researchers have discovered that about 1 in every 10 women with a transvaginal mesh implant require at least one complicated surgery to remove these devices within a year of implantation. Such findings ultimately prompted the FDA to warn, in July 2011, that:

Serious complications associated with surgical mesh for transvaginal repair of POP are not rare… Furthermore, it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.

FDA Also Orders Safety Reports on Bladder Slings to Verify “Effectiveness”

At the same time the FDA reclassified transvaginal mesh devices as high risk, regulators issued another order, mandating that manufacturers – like Boston Scientific, Ethicon, and C.R. Bard – submit “a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for transvaginal repair.”

According to the FDA, these manufacturers will have 30 months to submit their PMA for devices currently on the market. For any new devices, a PMA will have to be submitted as part of the requirements for FDA approval.

Commenting on the FDA’s actions, William Maisel, M.D., M.P.H., chief scientist for the FDA’s Center for Devices and Radiological Health, has stated:

These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse… We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.

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