Public Citizen, a non profit advocacy group founded by Ralph Nader, recently turned up the scrutiny of synthetic surgical mesh products used to treat a condition known as pelvic organ prolapse by urging the Food and Drug Administration to recall the devices.
In a petition filed last Thursday, August 25, 2011, Public Citizen asked the FDA to order a recall of all non-absorbable surgical mesh products marketed for transvaginal repair of pelvic organ prolapse (POP).
The product is used to treat pelvic organ prolapse, which occurs when internal organ support structures become so weak or stretched that organs, like the uterus, bladder or bowels, sag from their normal position and bulge or prolapse into the vagina.
The condition isn’t life-threatening, but generally results in discomfort and disruption of sexual, urinary and defecatory functions. The mesh is used to reinforce the repair and correct the anatomy.
In 2010, Public Citizen said nearly 300,000 women in the U.S. had surgery to correct pelvic organ prolapse, which occurs when connective tissues and muscles around the bladder, rectum or uterus weaken, causing the organs to slip into the vagina.
Of those, nearly 67,500 women had the mesh product implanted transvaginally, according to Public Citizen. Some of those patients — federal regulators have received 1,503 official reports — suffered from complications, including injuries to their pelvic organs or painful erosion of the mesh implant.
The synthetic mesh implant, which are made from a material similar to Rubbermaid storage containers — is an examples of a device approved through the FDA’s controversial 510(k) program. Unlike prescription drugs, which undergo years of testing to prove they are safe, the mesh implants weren’t required to be studied in patients before they were allowed to go onto the market.
“Surgical mesh needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life,’’ said Michael Carome, deputy director of Public Citizen’s Health Research Group. “Even the FDA seriously questions the safety and effectiveness of these products, so they should be removed from the market immediately.’’
The FDA issued its own safety warning about the devices last month. “There are clear risks associated with the transvaginal placement of mesh to treat pelvic organ prolapse,’’ William Maisel, deputy director of the FDA’s Center for Devices and Radiological Health, said in a statement issued by the agency last month.
“The FDA,’’ Maisel said, “is asking surgeons to carefully consider all other treatment options.’’
Patients with pelvic organ prolapse can opt to have their anatomy corrected surgically through the abdomen or through the vagina, using either stitches or the controversial surgical mesh implants. The FDA has said its reviews of scientific literature suggest that many patients who undergo transvaginal repairs with mesh are exposed to greater risks compared to patients whose repairs are made with stitches alone.
In its petition, Public Citizen echoed the concerns of the FDA, noting that the mesh implants offer no clinically significant benefit and have high rates of serious complications which may or may not be corrected with additional surgery.
The petition also addressed the lack of testing required before the mesh implants are put on the market. The group is urging the FDA to require any future versions of the implants to be reclassified so they are subject to more stringent approval requirements.
The group said the requirements should include mandatory testing in humans to assess whether the devices are safe and effective before they are permitted to be widely marketed.