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FDA May Reclassify Transvaginal Mesh as “High Risk” Class III Medical Device

January 6, 2012 — The U.S. Food and Drug Administration announced that it will consider reclassifying transvaginal mesh and surgical mesh as “high-risk” medical devices, elevating them from Class II to Class III. The FDA has also ordered manufacturers to complete post-market surveillance studies to investigate the potential risk of complications.

Because Class III devices are considered “high-risk,” manufacturers must get approval from the FDA before they can be sold in the United States. In addition, manufacturers must provide the FDA with ongoing information about the safety and effectiveness of the product.

The FDA is concerned because of a growing number of adverse events. They have ordered 88 post-market study orders to 33 manufacturers of surgical mesh. They have also ordered 11 post-market study orders to seven manufacturers of single-incision mini-slings.

Currently, most surgical mesh is exempt from pre-market and post-market safety studies under the FDA’s 501(k) program, so long as new products are “substantially equivalent” to products that are already on the market. Surgical mesh has been around since the 1950s to repair hernias, but has recently been adapted to treat stress urinary incontinence and pelvic organ prolapse.

The FDA will base their decision on whether to reclassify the surgical mesh as Class III, high-risk medical device based on the following information:

  • Adverse events reported to the FDA
  • Collaborations with professional societies to better understand the safety and effectiveness of these devices.
  • Evaluating the post-market safety data that the manufacturers will conduct and provide to the FDA

Transvaginal mesh and surgical mesh are medical devices that are implanted in women to treat female incontinence. When a woman has “pelvic organ prolapse” (POP) the muscles in the lower abdomen weaken and allow organs to protrude into the vagina. Surgical mesh treats this condition by permanently implanting a “sling” that may be synthetic or biologic, which reinforces the weakened muscles.

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