URGENT: Information on Manufacturer's Silicone Implant Studies

[Guest guest]

I may have sent this before, but it bears repeating!

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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