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J&J Transvaginal Mesh Implants Recalled

J&J Transvaginal Mesh Implants Recalled

Ethicon Recall – Transvaginal Mesh Attorneys

Johnson and Johnson subsidiary, Ethicon Inc., announced that it will stop selling four of its transvaginal mesh implant systems. The announcement came yesterday in a letter from J&J to U.S. District Court Judge Joseph R. Goodwin, the Federal Judge in West Virginia overseeing the consolidated lawsuit.

Johnson and Johnson’s transvaginal mesh recall affects the following products:

  • GYNECARE PROSIMA Pelvic Floor Repair System,
  • GYNECARE PROLIFT Pelvic Floor Repair System, and
  • GYNECARE PROLIFT +M Pelvic Floor Repair System.

The decision comes on the heels of lawsuits filed by nearly 1,000 women who claim the transvaginal mesh products have caused serious, life-altering  injuries. J&J marketed these products  treat stress urinary incontinence (“SUI”) and pelvic organ prolapse (“POP”) in which internal organs slump into the vagina.

Other side effects included infection and recurrence of pelvic organ prolapse or stress urinary incontinence, all of which are medical issues TVM implants are supposed to fix.

According to Bloomberg, many women claim the transvaginal mesh has eroded and shrunk over time, causing pain and injuries after the devices were threaded into place through vaginal incisions.

The FDA released a statement condemning Johnson & Johnson for selling its Prolift device for three years without FDA authorization, and recently ordered the company to conduct post-marketing studies on organ damage and other serious injuries.

Ethicon has asked the FDA for 120 days to end the sales so it can notify customers and provide surgeons and patients adequate time to explore alternative options.

Last year, the FDA issued a statement saying it was uncertain whether prolapse implants provided any benefit over traditional surgery, and that they also noticed a large increase in deaths and injuries.

The Strom Law Firm, LLC is currently reviewing cases on behalf of women who have suffered life altering complications after receiving a transvaginal mesh implant for Stress Urinary Incontinence (SUI) or Pelvic Organ Prolapse (POP).  Contact us today for a free confidential consultation with a female attorney.  803.252.4800.




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