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Lawsuits and Recalls

Transvaginal Mesh Injury: Recalls and Lawsuits

Introduced as a means to support the bladder, the FDA approved the first ever transvaginal mesh product in 1996 - the ProteGen® sling by Boston Scientific.  The mesh sling was intended to treat stress urinary incontinence, but after hundreds of complaints it was recalled in 1999.

Many manufacturers, following Boston Scientific’s lead, introduced their own version of the transvaginal mesh implant.  These mesh implants were introduced as a means of treatment for two common conditions: pelvic organ prolapsed (POP) and stress urinary incontinence (SUI).

  • Pelvic organ prolapsed (POP) – results from weak or damaged vaginal walls that allow the organs to fall through the pelvic floor and drop into the vaginal cavity
  • Stress urinary incontinence (SUI) – loss of urinary control when pressure on the bladder results from dropping into the vaginal cavity or pressing into other organs

The mesh implants have caused grievous injuries when they eroded through vaginal walls and organs – often within weeks of the original surgery.  The erosion can cause pain and infection, urinary problems, organ perforation, bleeding, vaginal scarring and shrinkage among other things.  This erosion often requires multiple surgeries to remove the pieces of mesh, and in far too many cases there is no way to remove all of the mesh and undo the harm that has been caused.  Complications may be lifelong and debilitating.

Recalls

After thousands of complaints, only a handful of mesh implants have been recalled by the Food and Drug Administration (FDA).  These devices include:

  • 1999 - Boston Scientific
    • ProteGen
  • 2012 – C.R. Bard
    • Avaulta Plus
  • 2012 - Ethicon (Johnson & Johnson)
    • Gynecare Prolift Kit
    • Gynecare Prolift + M Kit
    • Gynecare TVT Secure
    • Gynecare Prosima Pelvic Floor Repair System Kit

Lawsuits

Many experts maintain that the mesh implants are not safe for transvaginal placement, the products were not properly tested before entering the market, and the manufacturers had a duty to thoroughly test the transvaginal mesh implants prior to marketing them for transvaginal placement.  The failure to test prior to marketing has resulted in many manufacturers having lawsuits filed against them.  In fact, more than 18,600 lawsuits have been consolidated into five class action lawsuits assigned to Chief Judge Joseph R. Goodwin, in the U.S. District Court for the Southern District of West Virginia.

  • 6,028 cases filed
    • IN RE: American Medical Systems, Pelvic Repair System Products Liability Litigation (MDL – 2325)
  • 3,557 cases filed
    • IN RE: Boston Scientific Corporation Pelvic Repair System Products Liability Litigation (MDL – 2326)
  • 320 cases filed
    • IN RE: Coloplast Corporation Pelvic Support Systems Products Liability Litigation (MDL – 2387)
  • 2,938 cases filed
    • IN RE: C.R. Bard, Inc., Pelvic Repair System Products Liability Litigation (MDL – 2187)
  • 5,763 cases filed
    • IN RE: Ethicon, Inc., ( a division of Johnson & Johnson) Pelvic Repair System Products Liability Litigation (MDL – 2327)

In addition to the class action lawsuits, many more have been brought on an individual basis against Boston Scientific, Ethicon, AMS and C.R. Bard.  Listed below are the totals as of May 2012:

  • 529 cases filed against American Medical Systems
  • 313 cases filed against Boston Scientific
  • 740 cases filed against C.R. Bard
  • 457 cases filed against Ethicon (Johnson & Johnson)

If You Have You Been Injured

If you have been a victim of the dangerous side effects of these transvaginal mesh implant devices, the attorneys at Zinda Law Group want to help you.  Contact us today to learn how we can help you.  Call (800) 863-5312 for a free no-fee consultation and let us help you today.