Mesh Implant Recall Lawsuit

The second federal trial related to a C.R. Bard transvaginal mesh lawsuit came to an early conclusion last week after the parties were able to reach an undisclosed settlement. According to a report from the Charleston Daily Gazette, lawyers in the case were just about to begin their opening statements when the settlement was announced.
It would have been the second trial in a federal multidistrict litigation established for C.R. Bard vaginal mesh lawsuits in the U.S. District Court, Southern District of West Virginia. In the litigation’s first trial, a week prior, the Plaintiff was awarded $2 million in compensatory and punitive damages for vaginal mesh complications she sustained due to C.R. Bard’s Avaulta Plus pelvic mesh device.
These lawsuits are among thousands that have been filed across the country by women who allegedly suffered horrific complications following implantation of pelvic mesh during uro-gynecological surgeries to treat pelvic organ prolapse and stress urinary incontinence.
Numerous medical device makers, including American Medical Systems, C.R. Bard, Boston Scientific, and Johnson & Johnson’s Ethicon unit all have been named in mesh implant lawsuits.
To date, plaintiffs have prevailed in every transvaginal mesh lawsuit that has gone to trial. In addition to last week’s loss in court, a California trial last year involving the same Avaulta Plus mesh device led to a $3 million judgement against C.R. Bard. The first Ethicon mesh lawsuit to go to trial ended in March in New Jersey Superior Court, with the jury awarded awarding more than $11 million in compensatory and punitive damages to woman who was injured by the company’s Gynecare Prolift device.
Synthetic mesh has been popular with surgeons and been used to shore up the vaginal wall in cases of pelvic organ prolapse – a weakening of the muscles and ligaments that support organs like the bladder and uterus. The condition causes extreme discomfort and is potentially dangerous. Symptoms caused by mesh erosion include:

  • Bleeding
  • Urinary problems
  • Vaginal scarring
  • Infections
  • Pain during sex
  • Discomfort
  • Bowel, bladder, and blood vessel perforation

Use of transvaginal mesh to repair pelvic organ prolapse had grown in popularity, in spite of early reports of problems caused by the mesh. In 2008, the Food & Drug Administration issued a warning that the use of vaginal mesh was associated with complications but said at the time that such problems were rare. However, according to Dr. William Maisel, the chief scientist of the F.D.A. division that oversees medical devices, from 2008 to 2010 there was a fivefold increase in adverse event reports related to the use of vaginal mesh to treat pelvic organ prolapse.
A research study released in 2010 in the journal Obstetrics and Gynecology reported 15 percent of the women treated with vaginal mesh experienced potential complications. The study also concluded that mesh did not provide greater benefits than the traditional surgical treatment in which a patient’s own ligaments are used to strengthen the vaginal wall.
In July 2011, the F.D.A. warned that it had received an increasing number of adverse event reports associated with the use of such products and since then litigation for mesh implant lawsuits has built steadily.
In lawsuits involving transvaginal mesh devices it has been alleged that these products were defectively manufactured and inadequately tested. It has also further been alleged that transvaginal mesh implant manufacturers failed to provide adequate warnings about their dangers.
The makers of transvaginal mesh continue to deny responsibility for the horrible problems experienced by women who have received the device. However, justice has yet to be on their side as litigation continues to favor plaintiffs. The question remains, are the manufacturers more concerned about their profits, or the patients they serve?