The US Food and Drug Administration (FDA) has issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP).
Following the years of reports of pain, bleeding and infection among women who have received the implants, the FDA says that plastic mesh used to repair pelvic collapse should be reclassified from a moderate-risk device (class II) to a high-risk device (class III).
If finalized, the manufacturers are required to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.
POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina.
While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.
FDA’s Center for Devices and Radiological Health deputy director of science and chief scientist Dr William Maisel said the FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products.
"If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair," Maisel added.
The FDA will take comments on the proposed plan for 90 days.