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After 20 years, FDA finally bans pelvic mesh in the U.S.

When a pharmaceutical drug or medical device is found to be unsafe, most of us would reasonably expect it to be pulled off the market immediately. After all, these products are under the regulatory authority of the Food and Drug Administration. Unfortunately, change almost never occurs so quickly. Dangerous and defective products remain on the market for years after problems are discovered, and most manufacturers will spend enormous amounts of time and money denying that their products are unsafe.

This is the case with a product called transvaginal mesh, used to treat pelvic organ prolapse (POP) in women. The mesh has been on the market for about 20 years, and the FDA has known about the massive number of injuries and health problems associated with the mesh since at least 2011. Yet is was only last month that the FDA finally ordered the remaining manufacturers of transvaginal mesh to remove their products from the U.S. market.

Pelvic organ prolapse is a fairly common condition wherein pelvic organs begin to drop or press into the vagina because the muscles and tissues supporting these organs have become weak. The mesh, which was originally used in abdominal hernia surgery, was repurposed to support and reinforce the weak/loose muscles and tissues.

Surgically implanting the mesh sounds like an easy fix to an inconvenient health problem. But thousands of women have found that their lives were forever altered by having the mesh implanted. Commonly reported injuries include:

  • Severe pain in the pelvis and abdomen
  • Bleeding
  • Infections
  • Pain during sex
  • Perforation of organs
  • Urinary problems

In some cases, the pain is so severe and so constant that women are unable to work or enjoy normal activities. And because the mesh can break down and erode into surrounding tissues, it can be exceedingly difficult to surgically remove.

Manufacturers (and former manufacturers) of transvaginal mesh are currently facing more than 100,000 lawsuits from injured women around the world. The fact that the FDA took so long to act in the face of such overwhelming evidence is simply unacceptable.

If you or someone you love has been seriously injured by dangerous and defective transvaginal mesh, you should know that you have legal options. Please discuss your case with an experienced mass tort attorney in your area.

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