Thousands of women who allegedly suffer from serious and painful vaginal mesh complications following procedures to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) are now seeking legal recourse via vaginal mesh lawsuits. These women allege the devices are defective and put recipients at increased risk for serious injuries. Yet despite mounting legal claims and reports of significant injuries associated with the mesh, most device manufacturers have yet to implement a vaginal mesh recall.
Vaginal Mesh Complications
Vaginal mesh is implanted beneath the skin to strengthen weakened vaginal walls or support the urethra or bladder. Research has shown that younger women, women who underwent a hysterectomy, and women diagnosed with less severe forms of POP are more likely to experience severe complications from these devices. In 2011, the U.S. Food and Drug Administration (FDA) reported a five-fold increase in the number of serious complication reports associated with vaginal mesh used in POP repairs and warned that such complications were not rare, a change from its original position. The agency said that it was unable to conclude if mesh is more effective than nonmesh in POP repair and warned that use of vaginal mesh in these procedures could present greater risks to patients. The FDA also said it received 1,371 reports of serious complications in women implanted with vaginal mesh to treat SUI from 2008 through 2010.
Meanwhile, the devices remain on the market and the FDA has not announced any vaginal mesh recalls, but has ordered the manufacturers of transvaginal mesh used in POP to conduct post-market safety studies of their products as part of its review.
Vaginal Mesh Lawsuits
In the face of mounting injury reports, vaginal mesh lawsuits continue to be filed around the country, and juries have already found in favor of some women who alleged serious, debilitating injuries:
- Several centralized litigations have been established in U.S. District Court, Southern District of West Virginia for claims involving products manufactured Boston Scientific, American Medical Systems, C.R. Bard, and Johnson & Johnson’s Ethicon unit. The first trial of a C.R. Bard lawsuit is expected to begin this summer in the federal vaginal mesh litigation.
- According to court documents, the plaintiff in a New Jersey state lawsuit was forced to undergo at least 18 surgical procedures to correct vaginal mesh complications caused by the Ethicon Prolift vaginal mesh product. In March 2013, the jury hearing her case ordered the device maker to pay the plaintiff $3.35 million in compensatory and $ 7.76 in punitive damages.
- A prior vaginal mesh trial brought over C.R. Bard’s Avaulta mesh led to a California Superior Court awarding the plaintiff $5.5 million for injuries she claimed to have sustained.
All of the pelvic mesh litigations are being closely watched by attorneys and plaintiffs alike, as their outcomes could provide valuable clues into how juries might weigh similar claims.
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