FDA Panel Calls for Tougher Approvals for Vaginal Mesh
Emma Hitt, PhD
September 9, 2011 — The US Food and Drug Administration's (FDA's) Obstetrics & Gynecology Devices Advisory Committee appeared to be in favor of requiring more stringent premarket testing of vaginal mesh products and also supports reclassifying these products as Class III devices.
Currently, pelvic organ prolapse (POP) surgical mesh products are considered Class II medical devices in the FDA's 510(k) approval process; therefore, manufacturers are required to show only that the device is "substantially equivalent" to an existing device on the market, without requiring preclinical testing.
The 15-member panel, led by Tommaso Falcone, MD, professor of surgery and chair of obstetrics and gynecology at the Cleveland Clinic Foundation in Ohio, convened in Gaithersburg, Maryland, yesterday and today to discuss the use of surgical mesh for treatment of POP and stress urinary incontinence.
The panel considered the risks and benefits of surgical mesh used for POP repair given the available data from the FDA's Manufacturer and User Device Experience (MAUDE) database.
According to background information from the FDA, vaginal mesh used for POP repair is associated with perioperative risks, including organ perforation and bleeding. Long-term risks include mesh exposure into the vagina, bladder, or rectum, with clinical sequelae that include pelvic pain, infection, dyspareunia (painful sex for patient or partner), and the need for additional corrective surgeries.
Other risks that can occur without mesh erosion may include urinary problems, vaginal scarring or shrinkage, recurrent prolapse, and neuromuscular problems.
Since 2008, the FDA has received 2874 adverse event reports of complications following surgery, with 1503 adverse event reports associated with transvaginal implants used in POP repair and 1371 associated with stress urinary incontinence repair.
Although there was no formal vote, the panel members expressed support for the FDA's plans to conduct "section 522" postmarketing studies on vaginal mesh products. Despite pleas from consumer advocates to remove vaginal mesh products from the market completely, however, the panel made no call for this action.
Some committee members noted a paucity of data regarding vaginal mesh products currently on the market. Postmarketing "studies are ongoing but…until [the data] are there, they don't exist," Dr. Falcone said.
"It's possible that the ongoing studies are already available to address the need [for postmarketing studies]," said George Flesh, MD, from Harvard Medical School in Boston, Massachusetts. However, any studies "need to be randomized, controlled studies or cohort studies and need to go on for at least 3 years," he said.
The other panelists largely concurred with the need for more studies, with some variations in the duration and types of studies that should be conducted.
Dr. Flesh also recommended that the FDA should not penalize manufacturers by requiring them to perform additional studies on a product that had merely been tweaked or improved.
In a letter dated August 30, 2011, Cook Biotech Inc., a manufacturer of non-crosslinked biologic graft products, urged the FDA to consider different types of transvaginal mesh materials when making decisions about these products.
"There are significantly different types of mesh products and grafts used, i.e., synthetics (both absorbable and non-absorbable) vs. biologics," the company wrote. And while the FDA raises legitimate concerns about these products, the agency "only briefly acknowledges that there are significantly different types of mesh products and grafts used, i.e., synthetics (both absorbable and non-absorbable) vs. biologics."
The FDA does not always follow the recommendations of its advisory committees, but it often does.
According to Lisa Spitzer MSW for the Vaginal Mesh Helpline " I listen to horror stories on a daily basis." "The Fda is failingin its protection of women by not having stronger controls, warnings and even pulling the product from the market" "The horrors of the vaginal mesh are endless" "Womens lives are being ruined"