Date: Sat, 8 Jan 2000 10:23:29 -0600

Organization: Microsoft Corporation

Toxic Discovery Network, Inc.

1906 Grant Lane Columbia, MO. 65203

Phone: (573) 445-0861 Fax: (573) 445-8539

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According to the Jan 3 Gray Sheet, a publication that focuses on medical devices, the FDA will probably hold it's Advisory Committee review of saline breast implants on March 1-3. The FDA has not officially announced this yet, and the meeting will need to be announced in the Federal Register. So, don't buy nonrefundable airline tickets at this point, but start thinking about whether you want to attend.

The purpose of the meeting is to decide whether saline implants are safe and effective, and should remain on the market. All the studies will be presented by the manufacturers -- that is the format for all FDA hearings of this type. The expert panel members, scientists and doctors who do not work for FDA, will make the recommendation. (There is usually one consumer repand one industry rep on the panel, but neither can vote). It is expected that there will be a public comment period, during which anyone can speak for a few minutes if they have signed up in advance. At the 1991 meeting on silicone gel implants, the public comment period was very important and powerful, with many reconstruction patients flown in by the plastic surgeons to ask that implants remain on the market, and many ill implant patients begging them to take them off the market.

I will sign up to speak, and our Center will help other women who also want to participate either with written or oral statements. If you have had experiences with saline implants made by either McGhan or Mentor, and are interested in participating, please contact me as soon as possible. We can help with testimony and logistics, and may be able to assist with travel costs.

Diana Zuckerman

Diana Zuckerman, Ph.D. Executive Director

National Center for Policy Research for Women and Families

1444 Eye Street, NW Suite 900 Washington, DC 20005 202 216-9507

January 3 Gray Sheet:

Saline-Filled Breast Implant PMA Initial Panel Reviews Slated For March The first premarket approval application submissions required under FDA's Aug. 18 final rule will be reviewed by FDA's General and Plastic Surgery Devices Panel at a scheduled March 1-3 meeting, according to the agency. Among the submissions to be considered by the panel are PMAs filed by Mentor and Inamed's McGhan Medical unit on Nov. 12 and Nov. 16, respectively. Both devices, which are intended for female breast augmentation or reconstruction, consist of a silicone shell inflated with sterile isotonic saline.

The August final rule required manufacturers of saline implants to file either a PMA, a product development protocol or an investigational device exemption, or to remove their products from commercial distribution. The reg, which took effect at the time of publication, granted firms 90 days to comply with submission requirements, or until Nov. 17 ('The Gray Sheet" Aug. 23, p, 8).

The final rule marked the end of a process begun ten years earlier. In June 1988, saline-filled breast implants were placed into Class III, and six months later the agency signaled its intent to require PMA or PDP submissions. A proposed rule was published in 1993.

An Institute of Medicine review of both saline and silicone-filled implants did little to deter FDA. IoM concluded that there is "no definitive evidence linking breast implants to cancer, immunological diseases, neurological problems, or other systemic illness."

The agency notes that while the risks associated with breast implants may not be as great as suggested in the 1993 proposed rule, local complications like rupture, pain, capsular contracture, disfigurement, and serious infection that may lead to medical interventions and repeat surgeries, nonetheless remain health risks that warrant PMA and PDP submissions.

While silicone-filled implants remain available in the U.S., their use has been restricted to clinical trials for breast reconstruction since April 1992, when the agency lifted a four-month distribution moratorium due to safety concerns. Both Mentor and McGhan have been participating in an FDA-sanctioned adjunct study of the silicone devices in reconstruction after mastectomy that began in April 1998.