The FDA has warned women about the risks of transvaginal mesh for years. Now, the agency is finally taking direct action to limit the use of this popular but potentially dangerous product.
In a press release on Monday, the FDA announced that the surgical mesh, used to treat pelvic organ prolapse (POP), will be reclassified as a class III or high-risk medical device. In addition, manufacturers will have to receive premarket approval (PMA) for safety and effectiveness to keep selling the product.
“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said Dr. William Maisel, deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”
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POP is a common condition in which weakened pelvic floor muscles—whether caused by aging, childbirth, a hysterectomy, or another risk factor—allow pelvic organs like the bladder, bowels, or uterus to descend into the vagina, causing pelvic pain, problems with intercourse, and urinary issues. Estimates of its prevalence vary but a 2002 study in the American Journal of Obstetrics and Gynecology found POP in over 40 percent of women over 60 who had not had a hysterectomy.
In 2002, surgical mesh was cleared by the FDA as a class II or moderate-risk treatment for reinforcing the pelvic floor muscles and permanently repairing POP. That was before the agency received “thousands of reports” about adverse events associated with the product.
Those risks, which the agency first cautioned patients about in 2008, include but are not limited to severe pelvic pain, infection, bleeding, organ perforation, urinary problems, and vaginal scarring. That year, the FDA reported that they had received “over 1,000” reports of these adverse events.
By 2011, when the FDA issued a second warning, they had received nearly 2,000 more reports. In bold print in that year’s safety communication, the agency noted that these serious complications are “not rare”—a change from their 2008 reporting. The most common complication, they noted, was the erosion of mesh through the vagina, which can require multiple surgeries to resolve, if it can be resolved at all. Providers and patients alike were warned to “be aware of the risks” before pursuing mesh-based treatments.
“Recognize that in most cases, POP can be treated successfully without mesh thus avoiding the risk of mesh-related complications,” the FDA told health-care providers.
As transvaginal mesh manufacturers were hit with thousands of lawsuits, the FDA placed them under further scrutiny as well, initiating the postmarket surveillance that would eventually lead to the agency’s most recent orders. By mid-2014, there were nearly 60,000 pending transvaginal mesh lawsuits.
Now, if manufacturers want to keep making this mesh, they have a 30-month deadline to submit their PMA. It is, at last, a bold move to limit a treatment that was becoming increasingly popular even as the FDA warned of the serious risks associated with it.
A June 2015 study published in the BMJ examining POP-related surgeries in New York found that mesh use actually increased by 44.7 percent from 2008 to 2011.
“Despite multiple warnings released by the FDA since 2008, use of mesh in pelvic organ prolapse surgery continues to grow,” the authors concluded, adding that this increase was taking place “even three to four years after regulatory alerts.”
POP-related surgeries are big business. In the United States, there are over 300,000 such surgeries annually, costing over $1 billion. But although mesh became widely perceived as a “quick fix” treatment option for POP after its introduction in the 1990s, it is far from the only way to manage this common condition, even in the operating room.
As the American Academy of Family Physicians (AAFP) notes, some of the symptoms of POP, such as urinary problems, can be counteracted with Kegel exercises. Even severe instances of POP can be treated with a pessary, a removable and washable rubber device inserted into the vagina that keeps pelvic organs in place.
A pessary, as a 2010 study in the AAFP’s journal noted, “can be used in almost all circumstances when a nonsurgical option is desired,” even though it has traditionally been seen as a short-term solution. Pessaries aside, there are non-mesh surgical options that may carry less risk while being just as effective. The 2015 BMJ study found that non-mesh surgeries were associated with less risk of reintervention within a year in patients under 65.
And in 2012, Dr. Diane Mitchell, assistant director for science at the FDA’s Center for Devices and Radiological Health, said in a Medscape broadcast, “Postmarketing data indicate that repair of POP with surgical mesh is no more effective than POP repair with sutures alone, particularly for certain types of prolapse.” “Patients who undergo POP repair with mesh are often subject to complications not experienced by patients who undergo surgery without mesh,” she emphasized, noting that these complications can be “permanent and life-altering.”
Unless the five manufacturers currently making transvaginal mesh can document its safety, the product will be gone in 2019 and listed as high risk by the FDA until then. This could be the death knell for one of the most litigated medical products still in use today.
