ASHES

  


Advocating Safety in Healthcare, E-Sisters

FDA announces panel meeting on surgical mesh placed transvaginally 
to treat pelvic organ prolapse

The meeting will be held on February 12, 2019, from 8 a.m. to 6:30 p.m.

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.


Additional Information
Answers to commonly asked questions such as special accommodations due to a disability, visitor parking, and transportation are available on the Common Questions and Answers about FDA Advisory Committee Meetings webpage.


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.



http://app.info.fda.gov/e/es?s=2027422842&e=169584&elqTrackId=78D8A052C380BCBFF284D754BEBE9730&elq=c1f816e9897244bb8829cefcd0128b52&elqaid=6167&elqat=1&fbclid=IwAR2aBPXEkW5j8eYj9ZXRk5fDfMYMMFWGYWP5eel5LIOUnHFaQBawJmiDbTw


FDA is establishing a docket for public comment on this meeting. The docket number is FDA-2018-N-4395. The docket will close on February 11, 2019. Submit either electronic or written comments on this public meeting by February 11, 2019. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before February 11, 2019.

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 5, 2019. Oral presentations from the public will be scheduled on February 12, 2019, between approximately 8:15 a.m. and 9:15 a.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before January 28, 2019. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 29, 2019.

Persons attending FDA's advisory committee meetings are advised that FDA is not responsible for providing access to electrical outlets.


For press inquiries, please contact the Office of Media Affairs at fdaoma@fda.hhs.gov or 301-796-4540.


FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Artair Mallett at artair.mallett@fda.hhs.gov or 301-796-9638, at least 7 days in advance of the meeting.


FOR FURTHER INFORMATION CONTACT: 


Evella Washington, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G640, Silver Spring, MD 20993-0002, Evella.Washington@fda.hhs.gov, 301-796-6683, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572) in the Washington, DC area.