3rd May 11:06
The Silicone Wars (cancer mastectomy fibromyalgia)
The Silicone Wars
In the courtrooms, the Food and Drug Administration (FDA), Health
Canada, internet newsgroups, and every other medium … the silicone
wars are raging again.
Powerful women, who previously loved and cherished their breast
implants, are now speaking out about their personal silicone implant
horror stories. These include Miss America 1993, Leanza Cornett;
Golden Globe Award winning actress, Minister, and activist, Sally
Kirkland; actress and author, Mariel Hemingway; former Walton's star,
Mary McDonough, and Leigh Taylor-Young, from "Dallas" and "Soylent
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
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 devices, implanted for the duration of a woman's life.
Decisions will be made on the basis of Inamed's reporting.
This is ****ogous to the tobacco industry offering up just two years
of data on smokers' health, and claiming that cigarettes are "safe."
It's not science.
In 2000, The Securities and Exchange Commission settled a financial
fraud case against Inamed's former CEO, Don McGhan for multiple
violations. There is so much at stake for millions of women's health
if safety approval is granted that will be based on the basis of the
integrity of Inamed's reporting.
Even more 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
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 are all over the media falsely
claiming that the Institute of Medicine gave silicone implants a
"clean bill of health." They also sponsor websites that promote
implants and minimize the risks. One goes so far as encourage 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.
More health insurers are refusing to insure women with any history of
The National Organization for Women is being viciously attacked for
their cautionary stand, requesting clinical trials with longer
duration and more 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
Recent examples of "new and improved" implants, included a massive
"recall" of 10,000 British women. That failed experiment with soybean
oil implants left them with no good options. In the early 90's
polyurethane covered was "the" "new and improved" silicone gel 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
intense lobbying by the manufacturers, 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. These women, even without safety approval from the FDA,
may continue to get silicone gel implants.
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
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 email@example.com, (858)
For more information:
http://www.fda.gov/cdrh/breastimplants/ FDA website on breast implants
statement from July, 2003