Health Canada Notifies Hospitals of Complaints Alleged in Vaginal Mesh Lawsuit Filings

Published on May 15, 2014 by Sandy Liebhard

Hospitals in Canada have been warned by the country’s regulators about complaints that have been filed by women who allege chronic pain, organ damage and other serious injuries in vaginal mesh lawsuit filings.

Health Canada alerted the public on May 13th that mesh erosion and contraction, infection, muscle damage and dyspareunia (pain during sexual intercourse) are among the side effects reported by women who received transvaginal mesh. Following these complaints, the federal agency has vowed to review labeling on pelvic mesh devices to be sure they adequately relay the risk for these complications. If they are determined to be inadequate, Health Canada will request manufacturers to adjust them, according to its Notice to Hospitals.Transvaginal mesh devices are designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women.

Aside from Health Canada’s most recent warning, regulators in the U.S. have already filed several alerts about the possible dangers of transavaginal mesh. The U.S. Food and Drug Administration (FDA) issued its first warning in 2008 that categorized the risk for side effects as ‘rare.’ After seeing a significant increase in the number of mesh-related claims filed in its adverse event report database, the FDA reclassified this risk as ‘not rare.’

50,000 Vaginal Mesh Lawsuits Now Filed in the U.S.

Following an influx of transvaginal mesh complaints, the number of lawsuits filed in the U.S. has continued to increase. Court records indicate that over 50,000 federal claims are now pending in courts throughout the country on behalf of women who similarly accuse pelvic implant manufacturers of failing to provide adequate warning about side effects that may follow use of their products. Such companies as Johnson & Johnson’s Ethicon, C.R. Bard Inc., American Medical Systems and Boston Scientific have been named defendant in these lawsuits; many of which are now pending in separate litigations established in the U.S. District Court, Southern District of West Virginia.

Additionally, hundreds of claims have been filed at the state court level in a pair of proceedings located in New Jersey’s Atlantic County Superior Court.