Boston Scientific, one of several manufacturers under fire for its transvaginal mesh products, now is facing more scrutiny as the marketing of these products is investigated.
In the company’s recent filing with the U.S. Securities and Exchange Commission (SEC), it revealed that California Attorney General Kamala Harris and “several other state attorneys general offices intend to initiate a civil investigation into our sales of transvaginal surgical mesh products.” No details have been made public about the allegations.
However, in August 2012, another division of the company was served with a federal complaint that marketing of its spinal cord stimulator violated states’ False Claims Acts. Boston Scientific is accused of submitting fraudulent bills for implanted devices, off-label promotions, and under-reporting of certain adverse events related to the device.
Women’s Health Business Drops 11 Percent
Despite worldwide growth in its Urology/Women’s Health division, Boston Scientific reported to the SEC an 11 percent decline in its Women’s Health business “primarily due to continued pressures on elective procedures and lower sales levels following the FDA release of a Public Health Notice update in July 2011 regarding complications related to the use of urogynecologic surgical mesh for pelvic organ prolapse (POP).”
That U.S. Food and Drug Administration alert stated that complications from transvaginal mesh used in POP surgeries are not rare, which was a change from its previous warning. Furthermore, the agency clarified that such procedures are not necessarily more effective than traditional non-mesh repair, and they may expose patients to greater risk.
With transvaginal mesh surgeries, a synthetic material is placed through the vagina into the pelvic cavity to support organs that have dropped or protruded because of pelvic organ prolapse. POP largely occurs in older women after pregnancy and childbirth have weakened pelvic muscles. Mesh also can be used to correct incontinence. Unfortunately, many of the brands of mesh, including Boston Scientific’s versions, have been linked to life-altering complications.
Erosion of the material into nearby tissues and organs and extrusion of the mesh from the vagina can cause severe and constant pain, according to reports from patients. These conditions can require women to undergo multiple corrective surgeries to try to remove the pieces of mesh, which may be difficult or impossible to remove.
Other complications of transvaginal mesh include organ perforation, incontinence issues, painful sexual intercourse and infection.
Boston Scientific Faces 2,500 Mesh Lawsuits
In the same SEC filing, Boston Scientific stated that it faces more than 2,500 product liability cases in U.S. federal and state courts over its transvaginal mesh products. “Generally, the plaintiffs allege design and manufacturing claims, failure to warn, breach of warranty, fraud, violations of state consumer protection laws and loss of consortium claims,” the company reports.
Many of the state cases have been assigned to one Massachusetts judge, and the federal lawsuits have been consolidated in a multidistrict litigation (MDL) in the U.S. District Court for the Southern District of West Virginia.