FDA Seeks Stricter Rules following Pelvic Mesh Lawsuits

A slew of pelvic mesh lawsuits have prompted the U.S. Food and Drug Administration (FDA) to seek stricter rules for makers of the problematic implants.

Pelvic mesh, also known as transvaginal mesh (TVM), has been used for more than 15 years to repair womens’ pelvic walls in cases of pelvic organ prolapse, a condition where organs slip through the pelvic wall into the vagina. This condition can occur post-childbirth and in older women and can lead to “embarrassing bladder leaks,” reports The Associated Press.

The FDA has authority to regulate all medical devices, including pelvic mesh. When approving a medical device for use in the U.S., the FDA classifies the device based on its potential risks and uses. The three classes are:

  • Class I (low-risk),
  • Class II  (moderate-risk), and
  • Class III (high-risk).

According to the FDA, Class III devices require a showing of safety and effectiveness before they can be marketed. Pelvic mesh used to be classified as a Class II device, but the multitude of mesh-related lawsuits has convinced the FDA otherwise.

In a recent press release, the FDA announced it would seek to classify transvaginal mesh as a Class II device and propose requiring its manufacturers to submit to premarket approval for safety and effectiveness. Like other FDA proposals, the changes will be available for public comment for 90 days before they become effective and final.

One large surgical mesh manufacturer, C.R. Bard, has seen millions of dollars in losses due to transvaginal mesh suits and there are many women who may still suffer from pelvic mesh injuries.

This liability is not only felt by the big medical companies, but doctors who improperly implant the mesh or fail to disclose the risks may also face lawsuits for medical malpractice or medical battery.

Until the FDA rules go into effect, transvaginal mesh may still be sold by its manufacturers and are still available for physicians to use in treatment of pelvic organ prolapse, despite the possibility of litigation over its use.

If you or a loved one suffered serious side effects following TVM implant, you may be entitled to compensation. For more information, contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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