On February 12th, FDA’s Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee held a hearing to review the status of mesh devices for pelvic organ prolapse, taking a fresh look at a device type that has been the source of intense patient pushback over the past few years. The advisory committee offered several non-binding recommendations, primarily focused on postmarket surveillance data used to support premarket applications for pelvic mesh products.
According to the FDA’s 24-hour summary of the hearing, the Society of Gynecological Surgeons said the data suggest the rate of mesh erosion may be as low as 1.4 percent and as high as 19 percent. Another medical society recommended that uses of mesh be restricted to those at high surgical risk, including those with recurrent prolapse and/or comorbidities, while a third indicated a preference for up to ten years of data on safety and effectiveness.
That last message was not lost on the advisory panel, which said that a reasonable expectation regarding device durability is ten years. The panel also suggested that premarket studies of meshes for pelvic organ prolapse (reclassified by the FDA as Class III devices in 2016, although meshes for other uses remain Class II) should run as long as 24 months, with an additional five years of postmarket surveillance. Surgeon experience and patient selection were also considerations for the advisory committee, and it seems likely that companies in this space will have substantially more work ahead of them.