July 30, 2014 — Boston Scientific has won the first trial out of more than 12,000 vaginal mesh lawsuits pending against the company, according to Bloomberg.
The plaintiff, Diane Albright, was implanted with Boston Scientific’s Pinnacle mesh implant in August 2010. It was supposed to reinforce weakened pelvic muscles, but instead caused complications including pain, bleeding, and incontinence.
Albright claimed the device was defective because it was made from materials that were biologically incompatible with human tissue. In some patients, these materials could cause pelvic tissue to break down, leading to an immune response in some patients. Treatment may involve surgery to remove or replace the implant.
Albright filed her lawsuit in 2012 in Middlesex County Superior Court, Massachusetts. She accused Boston Scientific of failing to warn women and doctors about these risks.
After a three week trial, jurors deliberated for six hours before rejecting Albright’s claims and clearing Boston Scientific of wrongdoing. A company spokeswoman said they are “pleased” with the outcome. The next trial is scheduled to begin in September in Delaware.
Boston Scientific and other manufacturers are facing more than 60,000 lawsuits involving vaginal mesh products. The cases are centralized before U.S. District Judge Joseph Goodwin in federal court in West Virginia. Thousands of lawsuits are also pending in state courts in Delaware, New Jersey, Massachusetts, Missouri, and California.
Failure to Warn About Risks
Boston Scientific developed the ProteGen, one of the first vaginal mesh implants, in 1996. A year later, the company voluntarily pulled it off the market after receiving 123 complaints about discomfort, pain during sex, and erosion of the vagina.
Despite safety concerns, the FDA continued to approve new devices from Boston Scientific and other manufacturers that could trace their design back to the ProteGen. Not surprisingly, many women were injured by the same types of complications.
In 2011, the FDA warned that serious, potentially permanent complications were “not rare”. Since then, thousands of women have filed lawsuits alleging that device-makers should have known better, conducted new safety tests, or at least warned about the risks.
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