FDA Warns Surgeons To Avoid Mesh Devices
Law360, New York (July 13, 2011) — The U.S. Food and Drug Administration on Wednesday warned against using surgical mesh in vaginal surgeries to treat a condition in which pelvic organs sag from their normal position, urging surgeons to consider less risky methods.
The agency issued a similar warning in October 2008, but concluded that serious complications arising from the use of surgical mesh were not rare after being flooded with 1,500 more reports of problems associated with the device from 2008 to 2010.
The surgical mesh is permanently implanted in women to correct pelvic organ prolapse, which occurs when structures that support the bladder, uterus and bowel grow weak or stretched — typically after childbirth — causing the organs to drop.
Implanting the mesh through the vagina can fix the problem, but it can also lead to infections, bleeding, pain during sexual intercourse and urinary problems, the FDA said. Moreover, the agency has received reports that surgical tools used to implant the mesh pierced holes in organs.
“The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh,” said William Maisel, deputy director of the agency’s Center for Devices and Radiological Health. “Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
The agency has called on an outside panel of experts in obstetrics and gynecology to meet in September to discuss the safety and effectiveness of surgical mesh in treating pelvic organ prolapse and stress urinary incontinence, a condition involving leakage of urine during physical activity.
In 2010, there were at least 100,000 surgeries to treat pelvic organ prolapse with surgical mesh, with about 75,000 of them involving vaginal, rather than abdominal, surgeries. The FDA said abdominal surgeries pose fewer risks, as do procedures involving stitches alone.
According to the agency, there is no evidence that surgeries involving mesh are more beneficial than nonmesh procedures.
The FDA added that complications associated with using surgical mesh have not been linked to a single brand of mesh.
Representatives for Boston Scientific Corp., a surgical mesh manufacturer, did not immediately respond to a request for comment Wednesday.
American Medical Systems Inc., another surgical mesh maker, is facing a lawsuit from a woman who claims she developed severe vaginal deformities and suffered other serious medical problems after undergoing surgery to implant the company’s Apogee mesh system.
The suit, filed in California federal court in March 2008, alleges that Ellen Ambroff required mesh revision surgery and an operation to remove the device after allegedly suffering a litany of medical problems, including rectal bleeding, chronic hip problems, bowel and bladder incontinence, nerve damage, a blood clot in her rectum, chronic fatigue and heart problems.
–Article By Bibeka Shrestha
–Editing by Chris Giganti.