Boston Scientific Investigated by FDA for Alleged Counterfeit Raw Materials in Vaginal Mesh ImplantsApr 5, 2016
The U.S. Food and Drug Administration (FDA) is examining allegations that Boston Scientific Corp. used counterfeit raw materials smuggled from China to use in vaginal mesh implants. The mesh implants are used to treat urinary incontinence and various pelvic organ problems in women. The FDA did not recommend removal of the implants, but advised disclosure of the investigation to both health care professionals and patients, the Boston Globe reports.
The technical term for the implant is urogynecologic surgical mesh and, according to the FDA, Boston Scientific will be conducting new tests in the next few months. The FDA website states that "additional tests include chemical characterizations and toxicological risk assessment of the raw material alleged to be counterfeit." Boston Scientific, based in Marlborough, Massachusetts, said, it "does not use 'counterfeit' or 'adulterated' materials" in its medical devices.
Boston Scientific, along with other companies that market vaginal mesh implants, has been hit with thousands of lawsuits over the past decades from women suffering the gynecologic condition known as pelvic organ prolapse. Painful intercourse, infections, bleeding, urinary problems and overall discomfort are some of the women's complaints, reports the Boston Globe. In their safety alert, the FDA said, it "is not currently aware that the alleged counterfeit raw material contributes to adverse events associated with these products."
A RICO (Racketeering and Corrupt Organizations Act) action was filed in District Court in the Southern District of West Virginia before Judge Joseph Goodwin. The RICO suit was filed as a class action on behalf of women who have been harmed by the Boston Scientific mesh.