The Patriot Ledger: Boston Scientific Faces Nearly 300 Mesh Implant Complication LawsuitsMay 29th, 2012 | By Jane Akre | Category: Media Reports
She blames a mid-urethral sling implanted in May 2008 on injuries that followed including debilitating pain and infections which necessitated corrective surgery in 2010.
Natick-based Boston Scientific is facing about 300 such lawsuits filed all over the country. The federal cases have been consolidated in Charleston, West Virginia along with federal cases filed against Ethicon, American Medical Systems and C.R. Bard.
In Middlesex County, Mass. another 100-plus lawsuits have been filed in state court, hoping the wheels of justice will turn quicker there than in federal court where the first bellwether trial is set for February of 2013.
The paper says there are nearly 1,300 federal lawsuits filed so far that all claim complications from synthetic mesh used to treat pelvic organ prolapse and incontinence in women.
It was July 2011 that marked the beginning of the multimillion dollar litigation wave when the U.S. Food and Drug Administration said complications from the transvaginal placement of mesh are not rare and that vaginal mesh may be no more effective than traditional repair using sutures alone. Many women who knew they suffered complications after their implant surgery had somewhere to turn, however, despite the warning, mesh remains on the market and is implanted everyday.
An analyst for Northland Securities tells the reporter it’s taking longer for Boston Scientific and other medical devices to get a medical device cleared for market these days, though there is no expansion on that thought. The rules for approval have not been tightened to make marketing a device any more difficult.
Vaginal mesh represents less than five percent of Boston Scientific’s $7.6 billion in revenue last year, the paper reports.
Boston Scientific Statement on Mesh and FDA Expert Panel Hearing, September 12, 2011
Boston Scientific Hires Former J & J Exec Involved with Defective Recalled Hip Device, Mass Device, CBS News, September 14
MDND – Surgical Mesh Status Conference, May 28, 2012
The Patriot Ledger, “Boston Scientific Faces Nearly 300 lawsuits”