FDA Says Surgical Mesh Manufacturers Must Stop Selling Unsafe Devices

On April 16, 2019, The U.S. Food and Drug Administration (FDA) ordered two manufacturers of three different vaginal mesh products to immediately stop selling and distributing their products for not meeting U.S. premarket standards for high risk devices. The FDA also said there was insufficient evidence that the mesh worked better than surgery to repair pelvic organ prolapse (POP).

The three vaginal mesh devices are:

  1. Uphold LITE by Boston Scientific
  2. Xenform by Boston Scientific
  3. Restorelle DirectFix Anterior by Coloplast

These are all of the remaining synthetic mesh products typically provided to thousands of women each year, designed to strengthen weakened pelvic muscles. There are no longer any FDA-approved surgical mesh products for transvaginal repair of prolapse marketed for use in the U.S.

Decision Stemmed From 2016 “High Risk” Reclassification of Products

The FDA announced the ban because the companies “failed to provide reasonable assurance that the products are safe and effective.” The manufacturers were not able to submit evidence that the devices were safe and would benefit patients with the condition since the 2016 reclassification warnings and risks of the mesh products became known.

For years women have reported issues believed to be prompted by their vaginal mesh product such as:

  • Persistent vaginal bleeding or discharge
  • Pelvic or groin pain
  • Exposure of the mesh through the vagina
  • Pain with sex
  • Urinary problems
  • Chronic vaginal infections

“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long term,” said in a statement by Jeffrey Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.

Billions Already Paid to Pelvic Mesh Injury Claim Victims

More than 100,000 people have filed pelvic mesh injury claims in both federal and state courts against seven major manufacturers, including Boston Scientific and Johnson & Johnson. The New York Times reported that the litigation ranks as one of the largest mass tort cases in the nation’s history in terms of claims filed, number of corporate defendants and settlement dollars. Nearly $8 billion has been paid to resolve the claims.

Successful litigation requires detailed medical explanations and an understanding of product liability law. Hiring a personal injury attorney is key in securing fair compensation, as well as educating the public about the dangers of surgical mesh and dangerous medical devices.

Understanding Your Rights as an Injured Consumer

Surgical mesh implants can cause significant physical injuries and mental health complications to women. If you or a loved one has suffered because of a surgical mesh surgery or implant, contact Levin & Perconti for a free consultation.

Call us at 877-374-1417 or 312-332-2872 to speak with a lawyer. You may also contact us online to set up a case evaluation consultation. We work on a contingent fee basis so there are no fees for our services unless we successfully resolve your case.