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Free & Goss Attorneys

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Johnson and Johnson’s Ethicon unit announced they will stop selling four of their transvaginal mesh kits, three for treating pelvic organ prolapse, and one for treating stress urinary incontinence.  The announcement came yesterday in a letter from J&J to U.S. District Court Judge Joseph Goodwin, the Federal Judge in West Virginia overseeing the consolidated litigation.  The halted sales will take place worldwide.

The recall comes on the heels of an FDA statement slamming J&J for selling its Prolift device for three years without FDA clearance, a recent demand by the FDA for J&J to conduct postmarketing study on organ damage and other serious injuries, and the threat of dealing with tens of thousands of lawsuits related to the product.

Though not certain, there remains a strong possibility the catalyst for the recall was the FDA demand for safety and effectiveness data, and the assumption that none of the recalled devices would prove to be safe or effective enough to remain on the market after FDA review.  Unfortunately, this is just another example of too little too late, as the safety review should have been conducted at market entry.

J&J has asked the FDA for 120 days to end sales in order to “notify its customers and provide those hospitals and surgeons with sufficient time to select alternative treatment options for their patients.”  In addition J&J “will also discontinue or revise as appropriate, all marketing materials during this time.”

Recalled devices include:

  • Gynecare TVT Secur System
  • Gynecare Prosima Pelvic Floor Repair System
  • Gynecare Prolift Pelvic Floor Repair System
  • Gynecare Prolift+M Pelvic Floor Repair System