FDA: PMA Requirements for Surgical Mesh Devices Possible
The US Food and Drug Administration appears likely to require premarket assessments rather than premarket notifications for surgical mesh devices used to treat pelvic organ prolapse (POP) but not for stress urinary incontinence (SUI) in women.
According to a recently posted FDA executive summary, the agency’s Obstetrics & Gynecology Devices Advisory Committee will meet September 8th and 9th to reconsider surgical mesh products’ current Class II classification based on clinical literature and adverse event data culled from the Manufacturer and User Device Experience (MAUDE) database.
Regarding surgical mesh products used in vaginal POP procedures, the agency recommends reclassification of these devices to Class III and requiring PMAs due to safety and effectiveness concerns stemming from literature and medical device report reviews. In addition, the FDA believes post-market surveillance of these products should be required going forward.
For surgical mesh products used to treat SUI, the FDA came to a different conclusion. Reclassification of these products to Class III is not warranted, according to the agency, and clinical trials are not necessary for first-generation devices used in minimally invasive SUI treatments. Second-generation products, however, require both premarket performance data as well as post-market surveillance data according to FDA findings. All mesh products used in SUI procedures, however, can be properly monitored according to Special Controls provisions of the 510(k) process.
According to The Wall Street Journal, roughly nine manufacturers including Boston Scientific and Johnson & Johnson would be affected by a potential reclassification of surgical mesh devices.