After Removing Transvaginal Mesh Products from the Market, Johnson & Johnson asks FDA to Waive Safety Studies

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After Removing Transvaginal Mesh Products from the Market, Johnson & Johnson asks FDA to Waive Safety StudiesOverview: Last month, Johnson & Johnson told the U.S. Food and Drug Administration (FDA) that it would no longer sell four types of transvaginal mesh implants. But at the same time, the company also asked the agency to waive its previous order of post-market surveillance studies for the products.

 

 

 

 

 

 

 

  • Last month, J&J/ Ethicon said it would no longer sell four types of transvaginal mesh products
  • In pulling the products from the shelves, the company also asked the FDA to waive the post-market studies it had ordered; the devices were never tested before approval
  • The FDA asked manufacturers to conduct studies assessing the safety of transvaginal mesh implants in January after receiving thousands of complaints

Product: Prolift, Prolift + M, TVT Secur, and Prosima transvaginal mesh implants

Manufacturer: Ethicon, Inc./Johnson & Johnson

Side Effects & Complications

  • Mesh erosion
  • Pain during sexual intercourse (dyspareunia)
  • Perforation or puncture of the bladder, bowels, intestines, and blood vessels near the vaginal wall
  • Recurring Pelvic Organ Prolapse (POP)
  • Vaginal bleeding
  • Urinary problems
  • Chronic vaginal drainage, discharge, or infection
  • Vaginal scarring and shortening

 

J&J Tries to Postpone Post-Market Studies

Last month, J&J told the FDA that it’s Ethicon unit would stop selling four types of Gynecare transvaginal mesh implants, including the  Prolift, Prolift + M, TVT Secur and Prosima. The devices are expected to be completely off the market the first quarter of 2013. Johnson & Johnson, who is facing hundreds of lawsuits claiming that the meshes caused serious injuires, said that the decision was not based on safety concerns.

The company also issued to letter to Judge Joseph R. Goodwin, who is overseeing the multidistrict litigation with transvaginal mesh, regarding the decision. In the letter, Ethicon states that is has asked the FDA for 120 days to notify consumers and healthcare professionals. Apparently, it also asked the agency to waive the safety studies it had ordered, requesting “that the FDA’s Office of Surveillance and Biometrics place the existing 522 orders requiring additional studies for these products on hold.” The FDA has mandated these post-market studies in January after receiving thousands of reports citing complications such as mesh erosion and perforation. The agency is expected to respond to these requests by August 4th.

Transvaginal Mesh Issues

Because they were approved through the 510(k) route, transvaginal mesh implants were not clinically tested before being sold and implanted. This places even more weight on the post-market studies, which are intended to assess the devices’ effect on organ damage and other health issues.