URGENT: Information on Manufacturer's Silicone Implant Studies

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Note: forwarded message attached.

Kathynye@... wrote: From: Kathynye@...Date: Fri, 22 Apr 2005 12:59:41 EDTSubject: POST:URGENT: Information on Manufacturer's Silicone Implant Studies Kathynye@...I bold and underlined parts.Kathy NyeSubj: 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