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Don’t be fooled by the Pamphlets – Ethicon Pelvic Floor Systems Have Been Pulled from the Market

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Prompted by the prospect of more litigation, Johnson & Johnson’s Ethicon unit told a federal judge in West Virginia it intends to stop marketing four vaginal mesh implant systems as a result of lawsuits filed by women who say the products caused them internal injuries. Those four Gyencare products are:

  • TVT Secur
  • Prosima Pelvic Floor Repair System
  • Prolift Pelvic Floor Repair System
  • Prolift MTM Pelvic Floor Repair System

In a letter to the Judge submitted yesterday, Ethicon notified the court that it will no longer “commercialize” these products but that it has requested 120 days from the FDA to allow stop the marketing. This time frame will be needed in order for Ethicon to warn doctors, change their website (not updated as of 6/5/2012) and to gather all marketing materials such as their pamphlet that guides women to:

Stop Coping. Start Living

As we mentioned in a blog last week, it is important to remember that manufacturers of mesh kits are in the best position to warn the public of complications on a timely basis. While we disagree with the “timeliness” of J&J’s decision to halt sales of their Gynecare products we are nonetheless happy to report that this move will prevent future patients from the life altering injuries we have learned of from many clients.

It is estimated that hundreds of thousands of women reportedly have had these devices implanted and we speak to women everyday that have life changing injuries resulting from these implants. We can’t help but think that some of these women could have been spared their injuries if timely information had been provided to the medical professionals recommending these medical devices.