After years of patient complaints about injuries and tens of thousands of lawsuits, the federal Food and Drug Administration yanked from the market a surgical mesh widely used to repair pelvic conditions in women.
The agency has been slow to act on transvaginal mesh, which has been in use since the 1970s, with surgeons increasing its use in the 1990s. That in turn created an avalanche of complaints from safety advocates and women patients, who said the implant and procedure caused pain, bleeding, and scarring. This was not the surgical innovation, they said, that was supposed to remedy the pelvic tissue collapse that can cause the bladder or reproductive organs to slip out of place, causing pain, constipation and urinary leakage.
The FDA issued a series of increasing warnings about mesh, finally reclassifying it in 2016 as high-risk and ordering its makers to produce medical-scientific evidence about the device’s long-term safety.