M Keeling keeling.m@worldnet.att.net

March 25, 2005

David Krause

CDRH (HFZ-410)

Food and Drug Administration

9200 Corporate Blvd.

Rockville, MD 20850

Dear Mr. Krause and Advisory Panel Members,

I am submitting the following information in writing before the April 11-13 advisory meeting on silicone gel-filled breast implants:

1. Citizen petition filed by CANDO on November 18, 2003
2. German research published in 2003 "Determination of Siloxanes, Silicon, and Platinum in Tissues of Women with Silicone Gel-filled Implants".
3. Letter to Scripps Institutional Review Board written by CANDO on behalf of patient Shannon Scott. I filed a complaint with the FDA in September 2004 regarding fraud in clinical trials by under-reporting of complications. Delores E. Bernato FDA/CDRH/OC/DBM is investigating this allegation. Mrs. Bernato can be contacted at 240/276-0265.
4. Dow Corning’s letter to EPA "Notification of Substantial Risk to Platinum 3-8015 Intermediate (Platinum #2)."
5. The Center for Disease Control (CDC) data on urine platinum testing in the general U.S. Population found that no one of the 1,007 or 2,466 tested had over the level of detection of 0.04 ug/L. CANDO’s research with three independent labs is finding significant amounts of platinum in the urine of breast implanted women and their children born after implantation.

Mentor’s most resent FDA approved product insert makes the following statement "Toxicity studies are currently in progress by various research facilities, universities, government agencies, the medical community and the medical device industry. Some of these studies are conducted in animal models to determine potential immunotoxicty and autoimmune issues related to silicone materials. There is a potential that in the animal models being studied, immunotoxicity may result." Please ask to have copies of any preliminary or published results from these studies before making a decision on the safety of gel-filled breast implants. Ionized platinum is on the list of suspected metals as being an immunotoxicant, neurotoxicant, respitory toxicant, and sense organ toxicant.

Mentor’s product insert states "Manufacturers are sponsoring large-scale scientific studies to explore whether a possible link exists between silicone breast implants and connective tissue disorders." Please ask for the preliminary or published results from these studies before making a decision on the safety of gel-filled breast implants. Participants in the adjunct study report they are being admitted fraudulently, they are not being tracked by the surgeons, and their symptoms and diagnoses are not being reported in their medical histories when they are examined in follow-up visits after implantation.

Mentor’s product insert states "The medical literature suggests that in vivo degradation and particle shedding of silicone elastomers may occur in the fibrous capsule and draining lymph nodes. Further research is being undertaken to determine the effects of enzymatic degradation and the possibility of extract toxicity." Please ask for the preliminary or published results from these studies before making a decision on the safety of gel-filled breast implants. The pro-implant lobby has been brilliant in their buying and designing of research studies, convincing the medical community that silicone is safe, and convincing potential consumers that putting devices in their bodies that leak and bleed chemicals is harmless. They have been brilliant in the same way Enron was brilliant for a time with their accounting. Remember the tobacco companies testifying before Congress that nicotine was non-addictive.

Mentor’s product insert states "Further scientific studies are necessary to show an association in humans between silicone implants and birth defects." Please verify second-generation health effect research has begun. Consumers can make a choice when they believe they understand the amount of risk they are willing to take, children born to implanted women cannot.

Since 1992 women have only been allowed to get gel-filled breast implants if they enrolled in a study. This advisory committee should now have thirteen years of data on failure rates alone. The pro-implant lobby has been brilliant in convincing the FDA that platinum in implants is harmless and only two or three years of data is sufficient to determine safety. Surgeons without ethics are able to convince young women that breast implants are harmless with statements like "My wife has had implants for years and breast-fed all of our children without any problems."

I have worked as a volunteer for the last eleven years on learning the truth about breast implants and to insure that women understand the risks of chemicals in medical devices. Thank you for your consideration.

Sincerely,

Marlene Keeling, President

Chemically Associated Neurological Disorders

P.O. Box 682633

Houston, Texas 77268-2633