Fw: COMMENTARY: Breast Implants: The Controversy Continues

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----- Original Message ----- From: ilena rose

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Sent: Friday, September 05, 2003 9:01 AM

Subject: COMMENTARY: Breast Implants: The Controversy Continues

COMMENTARY: Breast Implants: The Controversy Continues

After over eight long, profitable and acquisition filled years, silicone giant, Dow Corning, remains in bankruptcy “protection” while hundreds of thousands of their former customers are still uncompensated for their silicone breast implant related illnesses and injuries.

Concurrently, the largest and most aggressive silicone maker, Inamed, out of Santa Barbara, CA, is pushing both the FDA and Health Canada for safety approval on their latest version of “new and improved” gel implants. They want the FDA to consider extremely short term data for these medical de vices, implanted for the duration of a woman’s life.

This is analogous to the tobacco industry offering up just two years of data on smokers’ health, and claiming that cigarettes are “safe.”

Most egregious in their massive public relations campaign, is ignoring the vast amount of damning scientific data now available.

By early 2001, 234,187 women had filed severe adverse complication reports with the FDA. This included over 65,000 complaints for silicone implants filled with salt water, best known as “saline.” Yet in mid- 2000 for the first time ever and despite extremely high complication rates (infections and painful hardening etc.) saline implants were deemed to be "safe enough" and received a cautious FDA approval.

In 2000, the FDA released indisputable, objective evidence of enormously high rupture rates. In 2001, the National Cancer Institute (NCI) revealed more bad news.

These studies showed an increased risk of death from brain cancer, lung cancer, and other respiratory diseases, as well as high suicide rates for breast implant patients. The NCI also reported a 21% increased risk of cancer generally, compared to other women the same age. Another FDA study reported that women with ruptured and leaking silicone gel implants were more likely to suffer from fibromyalgia and other painful and debilitating diseases.

Plastic Surgeons and silicone companies also fund websites that promote implants and minimize the risks. One goes so far as to promote a dangerous procedure known as TUBA (trans umbilical breast augmentation). The FDA specifically recommends against this method of inserting the implant through the belly button for several reasons.

Insurers are now frequently denying coverage to any woman with breast implants for any reason.

The National Organization for Women is being viciously attacked for their cautionary stand, requesting longer clinical trials with far longer and comprehensive data. It is not a matter of “choice” as is being claimed, rather a matter of long term information on devices whose complications may take years or even decades to manifest.

Recent examples of “new and improved” implants, included a massive “recall” of 10,000 of British women whose failed experiment with soybean oil implants left them with no good options. In the early 90’s polyurethane was “the” “new and improved” silicone gel covered implant which ultimately also proved to be a health disaster for more than a hundred thousand women.

PR teams for the implant makers claim that “silicone gel implants are back.” In fact, they never left. The moratorium from 1992, after lobbying from manufacturers and cancer groups, specifically allows the sale of gel implants to women post mastectomy. This despite high rates of additional surgeries, infections, and other serious complications for these women.

Do women deserve a “choice”? Of course, they do.

But those life changing, irreversible decisions must be made on long term scientific safety evidence -- and two years of data is simply not long enough.

Ilena Rosenthal is the Director of the Humantics Foundation for Women and heads a large, international support group for women with breast implants. She can be reached via ilena2000@....

For more information:

http://www.BreastImplantAwareness.org

http://www.center4policy.org/

http://www.fda.gov/cdrh/breastimplants/ FDA website on breast implants

http://www.now.org NOW organization link to July, 2003 Statement on breast implants