Re: Breast-Implant-Related Illness Studies from New England Journal, Mayo Clinic.

For your information, I have attached a copy of the New England Journal of Medicine article of June 22, 1995. The study found no increased risk of connective tissue disease among women with breast implants. We object to the study on the grounds that it looks for a connection between implants and the wrong diseases, was controlled by Dow Corning, and did not use a large enough sample of women:

1. The study was done in 1992 by sending questionnaires to nurses who had been participating in a large study since 1976. It was retrospective. When the symptoms were recorded no one knew what symptoms could be attributed to silicone implants, so many symptoms may have been overlooked.

2. The researchers identified definite connective tissue disease according to accepted diagnostic criteria. They did not consider atypical connective tissue disease. They did not consider symptoms such as fatigue, insomnia, sore throat, cognitive deficits, dizziness, arthralgias, lymphadenopathy, or diseases such as fibromyalgia.

3. Three of the studies authors, Dr. Jorge Sanchez-Guerrero, Dr. Graham Colditz, and Dr. Matthew Liang, were being paid by the breast implant manufacturers consultants to the implant manufacturers while the study was being conducted. They failed to disclose this conflict of interest. Dow Corning did not directly fund the study but did contribute $7 million to Brigham & Woman's Hospital, the institution conducting the study, while the study was in progress. Dow Corning was sent the questionnaire before it was sent to the nurses.

4. Approximately 1,100 women were involved in the study and six were found to have connective tissue disease. Six out of 1,100 is within the normal incidence of connective tissue disease.

A study of 1,100 people is not statistically significant when the occurrence of the disease is a very small percentage.

To be statistically significant there would have to be a study of over 20,000 women. The numbers in the current study would not have found a connection between smoking and lung cancer.

In the American Class Action (MDL), approximately 90,000 women have submitted physician's reports indicating that they suffer from Atypical Connective Tissue Disease. If the total number of women with breast implants is two million then about 4.5% have Atypical Connective Tissue Disease.

The latest speculation is that the two million number may be exaggerated and the actual number of women with implants may be closer to one million. If this is the case, then about 9% have Atypical Connective Tissue Disease.

These percentages are expected to increase as many women have not yet been diagnosed by a physician. As well, many women were implanted in the late 1980's. As most women don't develop symptoms for about 8 years, these women are not yet sick.

The Mayo Clinic study was the largest United States survey of its kind: Researchers reviewed the medical charts of 749 women with breast implants and 1,498 without. Yet the authors agree it would take a much bigger sample - 62,000 of the estimated 800,000 to 1 million U.S. women with implants compared to 124,000 without - to detect diseases as rare as scleroderma and systemic sclerosis.

"Our results," they wrote, "cannot be considered definitive proof of the absence of an association between breast implants and connective-tissue disease."

These two studies are being held in high esteem by The Medical Community. On close scrutiny they are found invalid. None of this troubling speculation will be settled until those larger studies - on women and their children - are undertaken.

Sincerely,

Adella Matthew

President

The New England Journal Of Medicine

March 6, 1997

In this documentation, the complications leading to surgery after breast implantations are recorded on a total of 749 women in the USA

The documentation did not deal with any autoimmune diseases; swelling and/or joint pain or arthritis-like pain; general aching; unusual hair loss; unexplained or unusual loss of energy; greater chances of getting colds, viruses, or flu; swollen glands or lymph nodes; rash; memory problems; headaches; muscle weakness or burning; nausea; vomiting; or irritable bowel syndrome.

What was determined from the entire research study (that excluded all disease except for the mention of cancer) was that 24% of the implanted breasts of the 749 women all required surgery for complications.

24% With Implants Need Surgery

Article in the Province newspaper 7 March 1997 reprinted from a Boston newspaper: One in four women with silicone breast implants will suffer from breast-deforming scarring, Implant rupture, or other complications requiring surgery within five years, says Mayo Clinic researchers.

Their study found that 178 women - or 24 percent - needed surgery for at least one local complication. It was based on a review of medical records of 749 women who received breast implants between January 1969 and December 1991. Scarring severe enough to cause breast deformities was the most common problem, followed by implant rupture, bruising, and infections.

Complication rates were higher - more than 30 percent - among women who had the implants for breast reconstruction after mastectomy to treat or prevent breast cancer. Only twelve percent of healthy women who had implants for purely cosmetic reasons developed problems, the researchers report in yesterday's New England Journal Of Medicine.

Researchers estimate that one million to two million women in the U.S.have had implants.

I hope this will be of help to you. If you have any further questions please do not hesitate to give us a phone call.

Sincerely,

Adella Matthew

President