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Johnson & Johnson Seeks Withdrawal of Transvaginal Mesh from U.S. Market

June 5, 2012 — Ethicon, Inc., a subsidiary company of Johnson & Johnson, announced that it is withdrawing four different types of transvaginal mesh products from its commercial market. The devices have been the source of thousands of severe injuries. The companies are facing approximately 600 lawsuits in a Multidistrict Litigation (MDL) in U.S. District Court, from women who allege that the defective devices have caused severe infection, scarring, chronic pain, organ damage, and more.

In the announcement from Johnson & Johnson, company officials said that they have asked the FDA for permission to stop “commercializing” the products in the future. The company also plans to advice healthcare providers to use alternative treatments for their patients. This does not mean that the company is recalling devices that are already implanted in women.

Although the FDA has not get given Johnson & Johnson permission to stop selling the product, the company is already planning on halting sales of the device by the beginning of 2013.

The following devices will be withdrawn:

  • Gynecare Prolift
  • Prolift+ M
  • TVT Secur
  • Prosima

Much of the controversy surrounds Ethicon’s Gynecare Prolift, a transvaginal mesh device that was introduced in 2005 and then sold for three years without FDA approval. The company claimed that their actions were justified because the Gynecare Prolift was “substantially similar” to mesh products that had already been approved by the FDA.

Unfortunately, many people are angry because the “substantially similar” device was Boston Scientific’s ProteGen, which was recalled for safety issues more than a decade ago.

During a recent Congressional overhaul of the FDA’s user fee and approval process, public advocates sought to close this loophole and outlaw the fast-tracked approval of “similar” devices, when the devices were based on products recalled for safety issues. The clause was removed from the final legislation.

The transvaginal mesh devices are designed to support sagging pelvic muscles, which can cause stress urinary incontinence and pelvic organ prolapse. Unfortunately, the device itself has been associated with severe side effects, including erosion of the mesh into the vagina, perforation of internal organs, severe scarring, chronic pain, infection, decreased quality of life, and more.

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