FDA announces panel meeting on surgical mesh placed transvaginally to treat pelvic organ prolapse
On February 12, 2019, the U.S. Food and Drug Administration (FDA) will hold a public meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee to discuss urogynecologic surgical mesh
placed transvaginally in the anterior vaginal compartment to treat pelvic organ prolapse. This meeting will provide the public, including patients, an opportunity to comment.
This meeting is part of ongoing FDA efforts to identify benefit-risk concerns related to some of these devices, and strengthen the FDA’s regulatory oversight to protect patients, while enabling those who need these devices to benefit from them. Providing patients with access to the safest possible medical devices on the market to meet their health care needs remains a top FDA priority.
Meeting Location: Hilton Washington, DC North/Gaithersburg Time: 8:30am ET to 6:30pm
Meeting Topic The
FDA is seeking expert opinion from the Committee on the evaluation of the risks and benefits of these surgical mesh devices. The Committee will be asked to provide scientific and clinical input on assessing the effectiveness, safety, and benefits and risks of urogynecologic mesh placed transvaginally in the anterior vaginal compartment, as well as feedback on identifying the appropriate patient population and physician training needed for these devices.
Submit Comments on the Docket
The FDA has established docket number FDA-2018-N-4395 to allow the public to submit comments for this meeting. Electronic or written comments can be submitted to the docket through February 11, 2019.
For more information on this meeting, please contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health (CDRH) at 1-800-638-2014, 301-796-7100 or DICE@fda.hhs.gov.