USFDA Issues New Rules for Using Transvaginal Devices to Repair Pelvic Organ Prolapse

Doctors have been commonly using surgical mesh to repair Pelvic Organ Prolapse (POP) transvaginally for many years. Now the U.S. Food and Drug Administration has announced two new rules for manufactures to strengthen the data requirements of surgical mesh.

Women with POP are implanted with a surgical mesh using a minimally invasive transvaginal technique. But, recently FDA has received thousands of reports of surgical mesh complications like severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.

‘The U.S. Food and Drug Administration has issued two final orders for manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally.’

Therefore, an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. Now, the FDA has issued two rules for manufactures namely,

• Reclassify these medical devices from class II (moderate-risk devices) to Class III (high-risk devices).
• Submit a premarket approval (PMA) application.

"These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse. We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures," said William Maisel, deputy director of science and chief scientist for the FDA's Center for Devices and Radiological Health.

Source: Medindia