FDA Meeting / Medical Implants / Sept. 19 & 20

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MM Comments:

I honestly think many of us need to attend this meeting. Especially since this evenings news stated that 'silicone BIs' are now back on the 'legal market', although you are supposed to be in a research group to receive them!

Public Meeting onMedical Implant Information, Performance, and Policies Symposium

What:

Medical Implant Information, Performance, and Policies Symposium - The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) will hold a public meeting to discuss some of the recommendations of the 2000 Technology Assessment Conference regarding patient education and information.

When:

September 19 and 20, 2002: Thursday from 8:00 a.m. to 4:00 p.m.; Friday from 8:00 a.m. to 12:00 p.m.

Where:

University of land Shady Grove Campus. Directions can be found at http://www.shadygrove.umd.edu/about/directions.php

Why:

The goals of the Symposium are three-fold:

Define the role that the federal government can play in encouraging the use of explanted medical devices for research Design of a possible structure for federal programs supporting gathering and dissemination of information derived from medical implant retrieval Design of a federal program to promote implant retrieval for use in research intended to promote safer health care.

Agenda:

On September 19, invited speakers will provide their perspective to address the challenges and opportunities in educating patients about implants and the importance of implant retrieval. The presentations are intended to lead to audience participation and discussion during breakout sessions.

After the breakout session, the chair of each session will prepare a summary of the session, which will include an implementation plan. The summary will be presented to the general audience on the morning of September 20.

Procedure:

Interested persons may join the discussion during the breakout sessions. To obtain additional information, or to register for this symposium, visit the website at http://www.nibib.nih.gov/events/BMIS2002.htm.

Who Should Attend:

Medical device manufacturers, distributors, and vendors involved with implanted medical devices, consumer organizations, caregivers, and government agencies.

Registration:

There is no charge for registration. If you plan to attend, a registration form is available to download. Please submit this form electronically to bmis@..., or by fax to 301-480-4973.

If you require special accommodations due to a disability, please contact MasiMax Resources, Inc., 1375 Piccard Drive, Suite 175, Rockville, MD 20850, Tel: (240) 632-5635, Fax: (240) 631-8150, or e-mail: dogunshakin@... at least 7 days in advance of the meeting.

Questions:

If you have questions about the meeting, send an e-mail to aac@..., or to dogunshakin@...

Updated 8/30/2002

Martha Murdock, DirectorNational Silicone Implant Foundation | Dallas Headquarters"Supporting Survivors of Medical Implant Devices"4416 Willow LaneDallas, TX 75244-7537