Date: Sun, 18 Nov 2001 09:32:06 -0800

The following has been sent to us by Kim Hoffman. . .Thank you Kim for sending our way.

Myrl

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Many thanks to all who have helped with educating the National Organization for Women on the breast implant issue. A special thanks goes to Jean Craig, Susan Boone, Diane Griffith, Martha Murdock, and many others.

Yesterday under the leadership of NOW president Kim Gandy the following letter was sent to every member of the House of Representatives in Washington D.C.:

Honorable Member

U.S. Representative

Washington, D. C. 20515

We are very concerned about the lack of oversight that the Food and Drug Administration (FDA) is exercising over the manufacturers of breast implants and the threat that this poses to the health and well-being of the more than 200,000 women who have elective surgery for breast implants each year.

Last year, the FDA approved marketing of saline breast implants notwithstanding data from the manufactures showing, among other findings, that 73% of mastectomy patients reported severe complications within 3 years and despite the hundreds of thousands of women who have reported adverse effects over the past 20 years. New studies by the National Cancer Institute, published in medical journals in May, 2001, found that women who have breast implants are more than twice as likely to die of brain cancer or lung cancer as compared with other plastic surgery patients.

In light of this new evidence, it is obvious that breast implants, both saline-filled and silicone-filled, are potentially hazardous to a woman's health and well-being, and women need to be properly informed of this fact.

We need more independent research on the adverse effects of breast implants and the information needs to be made readily available to women in order to counter the advertising campaigns by the plastic surgery community and the manufacturers, and the social pressure that drives so many women to believe that their bodies should conform to an unrealistic ideal. Neither breast augmentation nor reconstruction surgery is a life-saving procedure, but rather an elective cosmetic surgery to change a woman's appearance, and every woman needs to have unbiased information so that she can decide if the benefits outweigh the risks.

In addition to health risks, there are severe financial risks associated with breast implants. Many women with breast implants have suffered financial ruin as a result of debilitating health problems that have prevented them from working. Many have been turned down for coverage by Supplemental Security Income (SSI) and Medicaid programs because there has not been adequate rigorous, independent scientific research to recognize and define the diseases linked to breast implants. That the U.S. government recognized the financial burden resulting from breast implants is evidenced by the fact that the Department of Justice is seeking reimbursement from the Dow Corning bankruptcy settlement for the SSI funds that the government spent on disabled silicone implant patients. Several major health insurance companies routinely deny coverage to women with breast implants because they know that they have a much higher risk of medical complications. If an insurer does agree to cover an implant recipient, the rates are often much higher and the coverage is restricted to illnesses that are not in the area of the breast. This means that if a woman who has breast implants contracts breast cancer, she may not be covered by her health insurance policy.

We urge you to support H.R. 1961, The Breast Implant Research and Information Act, introduced by Reps. Roy Blunt (R-MO) and Gene Green(D-TX) and 31 co-sponsors in the House; along with Sens. Barbara Boxer(D-CA) and John Edwards (D-NC), who have introduced S. 961, in the Senate. By addressing the need for additional - and unbiased - research and greater FDA oversight, this legislation would give women the critically important information they require to fully understand the impact of breast implants on their health and well-being.

I. Expand National Institute of Health (NIH) Research on Breast Implants. The bill directs NIH to conduct independent, scientifically valid research on both saline and silicone breast implants. The need for such research is clear:

To date, most research on breast implants has been funded by implant manufacturers;

Many studies have been methodologically flawed, combining women with saline and silicone implants, combining mastectomy patients with cosmetic augmentation patients, and including women who have had implants for only a few months;

There has never been a large-scale study focusing exclusively on mastectomy patients, and the long-term effects of implants on their health.

II. Strengthen Post-Market Surveillance Activities Related to Saline Implants at the FDA

The FDA is instructed to conduct post-market evaluations of saline implants, acting on recommendations made by the FDA's General and Plastic Surgery Devices Panel. Strong FDA oversight is especially important given the circumstances surrounding the approval of saline implants:

As noted above, 73% of mastectomy patients reported serious local complications following implantation. Complications included rupture, hardening, infection and chronic pain;

With studies lasting only 3 years, the long-term effect of saline implants is unknown;

At the time of approval, the FDA was conducting a criminal investigation into one of the implant manufacturers related to allegations of data manipulation in its breast implant trials. This investigation remains open.

III. Expand and Intensify FDA Activities Relating to Silicone Breast Implants

The Commissioner of the FDA is directed to take concrete steps to ensure that women, particularly those participating in clinical trials of silicone implants, have accurate, current information about implants. Greater FDA involvement is essential because:

Informed consent agreements and package inserts prepared by manufacturers have been shown to include outdated, inaccurate information; The process of informed consent is as important as what the forms say, and the FDA has not required the physician to provide accurate information in advance of the day of the procedure as they do for other products such as RU-486 (mifepristone); and Women involved in clinical trials have had difficulty in reporting problems with their implants and with the trials themselves.

This legislation is needed because the FDA has not been effective in protecting consumers from these potentially harmful products. In March 2000, the FDA approved saline-filled breast implants made by Mentor and McGhan Corporations for breast augmentation in women (18 years or older) and for breast reconstruction in women of all ages even though there continues to be an ongoing investigation by the FDA's Office of Criminal Investigation of the Mentor Corporation for alleged irregularities in the research and manufacture of these devices (letter from Rep. Tom Bliley (R-VA), chairman of the House Commerce Committee to Dr. Jane Henney, Commissioner of the FDA, in March, 2000, as reported in USA Today).

Studies by the manufacturers have shown that between 73% and 84% of women with saline implants for breast reconstruction had complications within 3 - 4 years, while the complication rates are much lower (13-30% according to McGhan's pamphlet, "Making An Informed Decision") in the first two years.

By allowing pre-market approval after only two years of study, the FDA is ignoring the well-documented high complication rates that occur with the first decade of implantation of both saline- and silicone-filled implants involving pain, infection, hardening of the tissue surrounding the implant, leakage, deflation and surgery to remove the implant. The Institute of Medicine report "Safety of Silicone Breast Implants" (May, 1999) states that "risks accumulate over the lifetime of the implant". The greatest controversy surrounding the health risks of breast implants are for diseases that take many years to develop, such as cancer, fibromyalgia, and other autoimmune diseases. Long-term research is needed to determine these risks.

In addition, more research is needed on the effects of repeated surgeries,implant rupture, and the health effects on children who have been nursed by implanted mothers.

On behalf of all women with breast implants and those considering them, we strongly urge that the FDA give consumers more protection from what we now know are health- and life-threatening hazards associated with these devices. We ask that you pass H.R. 1961 and provide sufficient funding to carry out the legislation's mandates. The time is past due for the federal government to pro-vide more accountability and demand better scientific and medical information on breast implants.

Thank you for the opportunity to comment on this very important bill that has the potential of helping millions of women.

Sincerely,

Kim Gandy, President