Call Today for a FREE Confidential Case Review
Toll-Free 24/7 (866) 920-0753

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.

Do I Have a Transvaginal Mesh Lawsuit?

The Schmidt Firm, PLLC is currently accepting transvaginal mesh induced injury cases in all 50 states. If you or somebody you know was injured by transvaginal mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.

Free Case Evaluation


The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.

No matter what type of case you have, you may contact us with confidence by filling out the email contact form below or calling us directly by dialing toll free 24 hrs/day (866) 920-0753.