The US Food and Drug Administration (FDA) has recently issued final orders strengthening the data requirements for the surgical mesh which is used to repair pelvic organ prolapse (POP) transvaginally.
The orders issued require the manufacturers of the devices to address to the safety concerns, including severe pelvic pain and organ perforation. The manufacturers need to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The presently declared orders are applicable to mesh devices that are marketed for the transvaginal repair of POP. The orders do not apply to surgical mesh that is being used to treat other conditions such as stress urinary incontinence (SUI) or abdominal repair of POP.
William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health, said, “These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapsed”.
As pr reports, surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias. Gynecologists in the 1970s began implanting surgical mesh for the abdominal repair of POP and, in the 1990s the surgical mesh was being used for the transvaginal repair of POP.
The FDA in past few years have noted that there has been a sudden increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair. In 2011, experts suggested that some more data is needed to establish the safety of the device.