22 février, 2005 05:42
Dear Friends,
The FDA has finally announced what we already knew: their advisory panel will meet on April 11-13 to consider whether to approve silicone gel breast implants.
The important news is that the "Open Public Comment Period" is on the first day, Monday, April 11.
We will hold a free workshop at the same location on the day before, to help women prepare to testify. The workshop will provide useful information explaining the FDA advisory panel process, and help you target your testimony to make it effective.
The announcement is below. PLEASE contact Dr. David Krause asap to sign up to testify if there is any chance that you will be able to come to testify. You can always cancel later, but you can't always sign up -- the spaces get filled.
IN ADDITION to signing up with Dr Krause, let us know NOW if you might be interested in testifying. Please email me or Michelle Nawar from our staff immediately, even if you have already done so.
Testimony is limited to silicone gel breast implants, not saline. However, it is OK to testify if you have had both, as long as you testify about your experience with silicone. Support group leaders can also testify about their members, even if they themselves had saline implants.
We especially need testimony from women who had silicone implants since the mid-1980's made by Mentor or McGhan (Inamed)
We hope to hear from you soon!
Diana Zuckerman, Ph.D.
President
National Research Center for Women & Families
1901 Pennsylvania Ave, NW, Suite 901
Washington, DC 20006
202 223-4000
Here's the info::
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee
April 11, 2005 8 a.m. - 5:30 p.m.
April 12, 2005 8 a.m. - 6 p.m.
April 13, 2005 8 a.m. - 6 p.m.
Hilton Washington DC North
Grand Ballroom
620 Perry Pkwy.
Gaithersburg, MD
Agenda:
On April 11, 2005, the committee will hear oral presentations from the public.
On April 12 and 13, 2005, the committee will discuss, make recommendations,
and vote on two premarket approval applications for Silicone Gel-Filled
Breast Prostheses.
Background material and meeting information will become available no later
than one business day before each meeting day (Simply select the appropriate
committee link).
Procedure:
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 by March 28, 2005. Oral presentations from the
public will be scheduled on April 11, 2005, between approximately 8 a.m. and
5:30 p.m., and on April 12 and 13, 2005, between approximately 2:45 p.m. and
3:45 p.m. Time allotted for each presentation may be limited. Those desiring
to make formal oral presentations should notify the contact person before
March 28, 2005, 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. Persons attending FDA's advisory committee
meetings are advised that the agency is not responsible for providing access
to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings
and will make every effort to accommodate persons with physical disabilities
or special needs. If you require special accommodations due to a disability,
please contact AnnMarie Williams, Conference Management Staff, at
240-276-0450 at least 7 days in advance of the meeting.
Contact Person:
David Krause, Center for Devices and Radiological Health (HFZ-410), Food and
Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850,
301-594-3090, ext. 141, or FDA Advisory Committee Information Line,
1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512519.
Please call the Information Line for up-to-date information on this meeting.
