The first order is to reclassify the medical devices from class II (moderate-risk) to class III (high-risk). The second order requires manufacturers to submit a premarket approval application to support the safety and efficacy of surgical mesh for transvaginal repair of POP.
The FDA had noted an increase in adverse events following use of surgical mesh for transvaginal POP repair. In 2011, an expert advisory panel recommended that more data was needed to establish the safety of the device. Since then, the FDA has issued various safety communications to warn doctors and consumers about the increase in adverse events. Orders were also issued to manufacturers to conduct post-market surveillance studies to address the safety and efficacy concerns.
Under the new orders manufacturers will be required to address safety concerns such as severe pelvic pain and organ perforation, through a strict premarket approval pathway to demonstrate safety and efficacy. They will have 30 months to submit a premarket approval application for devices that are already being marketed and an application must be submitted for new devices before they can be cleared for marketing.
The final orders apply to mesh devices marketed for transvaginal repair of POP and not surgical mesh for other indications, such as stress urinary incontinence (SUI) or abdominal repair of POP. Currently, there are 5 manufacturers who market this product.
For more information visit FDA.gov.