Who Makes Defective Vaginal Mesh and How did it Get Approved?

Defective Vaginal Mesh Lawyers

Vaginal mesh, also known as bladder sling or tension free transvaginal tape (TVT), is classified as a medical device. Currently, the majority of medical devices are approved through an expedited process which involves little or no testing. If you have been injured by vaginal mesh, our defective vaginal mesh lawyers can help.

Vaginal Mesh Approved on the Merits of Recalled Device

The U.S. Food and Drug Administration (FDA) currently allows medical devices to go through an expedited approval process called 510(k). The Institutes of Medicine (IOM) conducted a review of the 510(k) process at the request of the FDA and reported that the process should be eliminated. The majority of medical devices recalled due to risk or serious injury or death were cleared through 510(k).

The 510(k) process allows medical devices to be cleared based on the merits of other similar devices. If the original device later turns out to be defective and recalled, the devices which piggybacked on its approval are not affected. In fact, even more devices can be approved based on the existing approved device which later turned out to be so dangerous that the FDA required it be pulled from the market.

This is what happened with vaginal mesh. Boston Scientific’s ProteGen bladder sling was recalled in 1999, but the FDA never stopped approving devices based on their similarity to the defective device.

Clearing medical devices based on existing medical devices is an iffy policy. Clearing them based on devices which have lost their approval status due to defects and safety hazards is just ridiculous.

Transvaginal Mesh Manufacturers

Companies which make vaginal mesh include:

  • American Medical Systems
  • Boston Scientific
  • C.R. Bard
  • Caldera
  • Covidien
  • Ethicon
  • Gynecare
  • Johnson & Johnson
  • Mentor Corporation
  • Scrimmed
  • Sofradim
  • Tyco

If you or a loved one has been injured by defective vaginal mesh, please call our defective vaginal mesh attorneys at 1-877-567-7732 or submit an online questionnaire. Your initial consultation with defective vaginal mesh lawyer is free of charge, and if we agree to handle your case, in most cases we will work on a contingency fee basis, which means we get paid for our services only if there is a monetary recovery of funds. In many cases, a lawsuit must be filed before an applicable expiration date, known as a statute of limitations. Please call right away to ensure that you do not waive your right to possible compensation.