In response to a significant increase in the number of reported adverse events such as organ perforation, infection, and bleeding that have been associated with the use of surgical mesh for transvaginal pelvic organ prolapse (POP) repair, the FDA has issued two Final rules intended to strengthen manufacturer data reporting requirements for the devices. The Final rules, which are effective as of January 5, 2016, reclassify surgical mesh used for transvaginal POP repair as Class III, high-risk devices (81 FR 354), and require manufacturers to submit premarket approval applications (PMAs) to demonstrate their safety and effectiveness (81 FR 364).
POP. Women can experience POP after the muscles and tissues of the pelvic floor are weakened and can no longer support organs such as the bladder, bowel, or uterus. As a result, the organs can drop and bulge or prolapse into the vagina, which can cause low back pain, pelvic pressure, painful intercourse, constipation, and urinary problems. Doctors can perform minimally invasive transvaginal surgery to address significant POP symptoms, during which surgical mesh can be permanently implanted to strengthen weak pelvic floor muscles.
Adverse events. In 2002, the first mesh device marketed for transvaginal repair of POP was approved as a Class II moderate-risk device. The FDA has since seen a “significant increase” in the number of reported adverse events associated with the use of the devices. The agency has received thousands of reports of complications, such as severe pelvic pain, infection, bleeding, organ perforation, painful intercourse, and urinary problems caused by mesh eroding into surrounding tissue.
In 2011, an expert advisory panel determined that more data is needed to establish the safety of the devices. The FDA subsequently took action to warn doctors and patients about the use of the devices and proposed rules seeking to reclassify the devices and require PMAs from manufacturers (see Premarket approval applications required for transvaginal surgical mesh in event of reclassification, May 1, 2014).
PMA. Manufacturers will now have 30 months in which to submit PMAs for devices that are already on the market and will be required to submit PMAs for any new devices. The FDA states that the PMA process will force manufacturers to address such safety concerns associated with the devices. However, the PMA requirement does not apply to surgical mesh that is used for other indications such as stress urinary incontinence (SUI) or abdominal repair of POP.
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