URGENT: Information on Manufacturer's Silicone Implant Studies

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URGENT: Information on Manufacturer's Silicone Implant Studies

Date: 4/22/2005 12:31:52 PM Eastern Standard Time

From: em@...

We have been informed by the FDA that women who are currently

enrolled in either Inamed's Core or Adjunct Study or Mentor's Core or

Adjunct Study and have complaints specifically relating to the study

should contact Special Investigations, within the Division of

Biomedical Research Monitoring at the FDA. Please note that this is

to complain about a specific aspect of the studies, for example, if

you are not receiving follow-up care by your plastic surgeon. It is

not to complain about the implants, silicone-related health problems

or FDA policies.

The phone number for this Division is (240) 276-0125 and the e-mail

address is BIMO@.... Please note this information is

different from what was provided at the Advisory Panel meeting on

April 13. The phone number and contact person provided at the

meeting were inaccurate and should not be called. If you have

complaints regarding a silicone breast implant study being conducted

by either Inamed or Mentor please contact the Division immediately.

It is crucial that the FDA get this information. Also, we would like

to know about any problems you are having in these studies. Please

contact McKinney at em@....

If you know of other women who may be in either of these studies

please forward this information to them.

Thank you.

McKinney