In a recent crackdown on the medical device companies, the FDA has classified transvaginal mesh devices to a high risk – class 3 category. [1] Further, the FDA also requires the medical device makers to submit a premarket approval application (PMA) to prove the safety and effectiveness of these devices. Transvaginal mesh devices are used in the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI). With more than 300,000 women undergoing transvaginal surgeries each year since 2010, the market for these devices has grown considerably, inviting more companies to enter the lucrative market.
