FDA Increases Regulatory Requirements for Transvaginal Mesh
Posted 04 January 2016 | By
The US Food and Drug Administration (FDA) announced Monday that it is increasing regulatory oversight of transvaginal mesh after receiving thousands of reports of injuries, including pelvic pain and bleeding, caused by the devices.
Various types of surgical meshes have been in use since the 1950s, and in 1992, FDA cleared the first transvaginal mesh to repair pelvic organ prolapse (POP) as an alternative to native-tissue repair.
Under two final orders that take effect Tuesday, FDA is reclassifying transvaginal mesh used to repair POP from Class II to the more stringent Class III, and will require manufacturers to submit a premarket approval (PMA) application for the devices by 5 July 2018.
The orders come a year and a half after FDA first proposed reclassifying the devices to Class III, and do not apply to surgical mesh used for other indications, including stress urinary incontinence or hernia repair.
In 2008, FDA issued a safety communication alerting the public to what it said were rare complications associated with the device.
However, in 2011, FDA updated its communication to state that complications caused by the device are not rare, citing a dramatic increase in the number of adverse events reported between 2008 and 2010.
That year, FDA convened its Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to review the safety and effectiveness of transvaginal mesh. The panel found that the safety of the device was "not well established" and "may not be more effective than traditional 'native-tissue' repair without mesh."
Then in 2012, FDA ordered transvaginal mesh manufacturers to conduct postmarket surveillance studies on the devices to help the agency develop a better picture of the devices' safety and effectiveness. By February 2013, the agency had issued 95 study orders to a total of 34 manufacturers for the devices.
Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair
Obstetrical and Gynecological Devices; Reclassification of Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair