Date: Fri, 21 Apr 2000 16:35:54 -0700

I wrote a letter (posted here) to Dr. Henney expressing my

concern about the PMAs for saline implants. This is the

response I received.

Maybe someone could explain this better than I did! I don't think they understood me!

Rogene

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April 18, 2000

Dear Mrs.

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has received your letter and the attachment of web postings dated March 29, 2000 regarding saline-filled breast implants.

As you are aware, on March 1-3, 2000, there was a General and Plastic Surgery Devices Panel meeting. The panel consisted of experts in different fields, such as bioengineering, plastic surgery, toxicology, pediatrics, the bioethics, who passed the conflict of interest screening required by FDA. In addition to these outside experts, the agency invited a practicing mammographer, Dr. Wendie Berf, to present information on the potential for breast implants to interfere with mammography. There was also considerable time on all three days devoted to open public presentations on saline-filled breast implants and patient informed decision making, and many took the opportunity to address the Panel.

The Panel recommended that Mentor Corporation and McGhan Medicalís premarket approval (PMA) applications be found approvable with conditions and recommended that Poly Implants Prosthesesí PMA be found not approvable. FDA is continuing the review of each of these PMAs., taking into consideration the Panelís input and specific recommended conditions of approval. FDA is determining the appropriate manner in which to present the safety data so that (1) we can make a risk:benefit assessment for each indication and (2) the patient can clearly understand the clinical results in order to make an informed decision. Additionally, FDA will address long-term issues because one of the conditions of approval that the Panel recommended was that patient follow-up continue so that long-term follow-up data can be collected and reported to the agency ad added to the device and patient labeling.

FDA acknowledges your frustration with the website

in terms of how the risk information is presented to women. However, that website, as well as physicians, are not under the purview of the FDA. FDA continues to improve its dissemination of information (e.g., FDA website, consumer handbook) and to work with sponsors to improve patient labeling and the dissemination of that patient labeling.

If you have any questions, please call Ms. Samie Allen, Breast Implant Team Leader, at 301-594-3090, ext. 139.

Sincerely yours,

Diana R Lichner

For Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices

Office of Device Evaluation

Center for Device and Radiological Health