American Medical Systems, Inc.,   a subsidiary of Endo Health Solutions, Inc., has been named in  5,100 transvaginal mesh lawsuits, most of which have been filed in a federal multidistrict litigation underway in U.S. District Court, Southern District of West Virginia.  During a conference call last week to discuss the  fourth quarter earnings, officials from Endo revealed that the company had taken a charge in the amount of $232 million  that reflects, among other things, a $92 million reserve for product liability claims “essentially” related to vaginal mesh lawsuits pending against American Medical Systems.  According to Endo Health Solution’s fourth quarter earnings statement, a $640 million write-down at American Medical Systems contributed to a net loss of $716.3 million for the quarter.

Transvaginal Mesh Lawsuits Growing in State, Federal Courts

American Medical Systems is just one of several manufacturers facing product liability claims involving vaginal mesh devices used in pelvic organ prolapse repair and stress urinary incontinence.  In addition to American Medical Systems, vaginal mesh lawsuits involving products made by Johnson & Johnson’s Ethicon unit, Boston Scientific and C.R. Bard have also been consolidated in the Southern District of West Virginia.  Bernstein Liebhard LLP Partner, Jeffrey S. Grand, is a member of the Plaintiffs’ Steering Committee in all of these litigations.

Mr. Grand is also serving as Co-Liaison Counsel for thousands of transvaginal mesh lawsuits consolidated in New Jersey Superior Court, Atlantic County.  Just last week, the first trial in the New Jersey Ethicon litigation ended with a $7.76 million punitive damage award for the plaintiff.  The jury had previously awarded the plaintiff $3.35 million in compensatory damages after it  determined that Ethicon failed to provide adequate warnings regarding the risks associated with  one of its  Gynecare mesh products.

Vaginal Mesh Complications

Transvaginal mesh lawsuits began to mount in 2008, after the U.S. Food & Drug Administration (FDA) warned that it had received more than 1,000 reports of complications in women who received pelvic mesh to transvaginally repair pelvic organ prolapse and stress urinary incontinence.   In July 2011, the FDA reported that it had received more than 2,800 reports of additional transvaginal mesh complications.  The FDA also modified its previous position on the frequency of such complications, stating in the alert that vaginal mesh injuries associated with pelvic organ prolapse repair were not rare.  According to the agency, the most frequent vaginal mesh complications reported to the FDA included:

  • Erosion through vaginal tissue
  • Infection
  • Pain
  • Urinary problems
  • Recurrence of prolapse and/or incontinence.
  • Bowel, bladder, and blood vessel perforation
  • Vaginal scarring
  • Pain during sexual intercourse

The FDA has since ordered manufacturers of transvaginal mesh to conduct postmarket safety studies of their products to help it better understand their safety profiles.  The agency is also considering a proposal to reclassify pelvic mesh used in pelvic organ prolapse repair as  a high-risk medical devices, which would make them ineligible for 510(k) clearance.  Most transvaginal mesh products currently on the market were approved through this system, which does not require human clinical trials.

Experienced Vaginal Mesh Complications?  Contact Us Today.

Women who’ve suffered complications from pelvic mesh devices marketed by American Medical Systems and other manufacturers may be entitled to file a transvaginal mesh lawsuit seeking compensation for their pain and suffering.  Bernstein Liebhard LLP offers free legal evaluations to victims of transvaginal mesh complications.  To learn more about filing a vaginal mesh lawsuit, please contact an attorney at 1-877-779-1414.

Published March 4, 2013 by