The FDA banned manufacturers of surgical mesh products from selling and distributing their products in the United States immediately. Each year thousands of women undergo transvaginal surgery mesh procedures.
Manufacturers of surgical mesh products must stop selling and distributing their products in the United States immediately, the US Food and Drug Administration ordered Tuesday.
The FDA said it"has determined that the manufacturers, Boston Scientific and Coloplast, have not demonstrated a reasonable assurance of safety and effectiveness for these devices."Each year, thousands of women undergo transvaginal surgery to repair pelvic organ prolapse, a condition where weakened muscles and ligaments cause the pelvic organs to drop lower in the pelvis, creating a bulge or prolapse in the vagina.
"Patients around the world have become unwitting test subjects for new medical technology," the consortium stated."Often following the trusted advice of their doctors, they have been injured, maimed and killed by poorly-tested implants."
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