WASHINGTON – Makers of trouble-prone implants used to surgically repair women’s pelvic problems would be subject to stricter safety requirements under a federal proposal issued Tuesday.
The Food and Drug Administration says plastic mesh used to repair pelvic collapse should be reclassified as a “high-risk” medical device, following years of reports of pain, bleeding and infection among women who have received the implants. If adopted, the change would require manufacturers to submit studies demonstrating that their products are safe and effective before they can be sold.
Plastic mesh has been used since the late 1990s to strengthen the pelvic wall in cases of pelvic organ prolapse, in which the bladder or other reproductive organs slip down into the vagina. The condition is common among older women and those who’ve had children. The most common technique for implanting the mesh involves a surgical insertion through the vagina.
The FDA’s proposal comes nearly three years after the agency first concluded that women getting the mesh have more complications than women who undergo traditional surgery with stitches. An agency analysis found that 10 percent of women experienced mesh erosion within 12 months, meaning their mesh had worn its way through the vaginal wall into the surrounding tissue or organs. More than half of these women required follow-up surgery to remove the mesh – sometimes two or more procedures.
Mesh products were initially pitched to doctors as a high-tech improvement over surgery, but the FDA found no evidence that they improve safety outcomes.