Boston Scientific Failed To Warn About The Risks Of The Device. The largest transvaginal mesh verdict yet has been handed down to Boston Scientific in a lawsuit alleging the company failed to warn about the risks of the mesh device. Reuters reports that a Delaware jury ordered the company to pay $25 million in compensatory damages and $75 million in punitive damages to a woman who suffered injuries, allegedly due to her Pinnacle and Advantage Fit mesh inserts.
Pelvic mesh devices are approved to treat stress urinary incontinence and pelvic organ prolapse. According to Reuters, the plaintiff was implanted with the transvaginal mesh implants in 2009 to treat these conditions. In 2011, she filed a lawsuit alleging that the mesh caused serious injuries. She alleges that despite two surgeries to correct the complications, parts of the mesh are still in her body and cause constant pain.
Pelvic Mesh Litigation
There have been a total of six verdicts, including this one, in the pelvic mesh litigation against Boston Scientific. This has been the largest issued against the company or any other mesh manufacturer. Last month, Boston Scientific agreed to pay $119 million to settle 2,970 lawsuits. A jury ordered the company to pay $73.4 million to a Texas woman last year. That award was later lowered to $34 million.
Safety concerns over transvaginal mesh implants have prompted numerous lawsuits. According to Reuters, there are an estimated 100,000 cases total against eight manufacturers in state and federal courts. Many of the lawsuits point out that manufacturers did not properly test the devices for safety or efficacy before they were placed on the market. This is because the devices were approved through 510(k), which allows companies to forego such clinical testing if the new devices are shown to be “substantially equivalent” to an older device. This regulatory loophole has since come under intense scrutiny.