Consumer advocacy group Public Citizen urged the FDA to recall transvaginal mesh products after the agency released warnings that the device may expose patients to unnecessary risk without offering clinical benefit above safer options.
Public Citizen, founded by Ralph Nader, filed a petition to the FDA today asking the watchdog agency to ban the marketing of all currently available non-absorbable surgical mesh
products indicated specifically for transvaginal repair, order all manufacturers to recall the products and require all future transvaginal mesh devices to be classified as Class III devices and submitted as premarket approval applications.
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.
"Surgical mesh in POP treatment procedures needlessly exposes patients to a wide array of serious risks, many of which can permanently alter women’s quality of life," Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group said in a press release. "Even the FDA seriously questions the safety and effectiveness of these mesh products, so they should be removed from the market immediately."
The most common issues include mesh becoming exposed or protruding out of the vaginal tissue, pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.
"There are clear risks associated with the transvaginal placement of mesh to treat POP," said Dr. William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health, in an agency release last month. "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."
The latest warning updated 2008 communications that addressed concerns about adverse events associated with the transvaginal placement of the mesh. From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007, according to the release.