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Consumer & Women's Health Groups Picket HHS Against Approval Of Silicone Gel
Breast Implants


FDA Poised to Lift Restrictions; Hearings Scheduled Oct 14th & 15th

Women Senators Decry Government Hypocrisy

WASHINGTON, Oct. 8 /PRNewswire/ -- Today, women harmed by silicone breast
implants traveled from all over the country to picket the U.S. Department of
Health and Human Services. They called on HHS Secretary Tommy Thompson to stop
the U.S. Food and Drug Administration from lifting restrictions on the sale of
the devices. Women carried giant photographs of broken breast implants and
posters showing terrible disfigurements caused by the devices and chanted,
"Silicone breast implants hurt women. Tommy Thompson, protect women." For
three hours, women came to the microphone to tell their personal stories of
breast implant problems.

As the women shared their stories in front of HHS, a lawsuit by another of its
agencies, the Centers of Medicare and Medicaid, asking for the reimbursement of
millions of dollars in health care costs due to breast implant injuries was
made public. A letter from women senators calling attention to the suit and
decrying the government hypocrisy was circulated. Senators Barbara Boxer
(D-CA), Dianne Feinstein (D-CA) and Mary Landrieu (D- LA) signed the letter.

The women came to D.C. one week before the FDA convenes an advisory panel to
consider lifting restrictions on silicone gel breast implants. The FDA is only
looking at data from a clinical trial that began three years ago even through
their own researchers have shown that problems with implants increase
dramatically at, on average, seven to ten years after implantation.

"Another generation of women should not suffer because the FDA has bowed to
pressure from manufacturers and plastic surgeons," said Kim Gandy, President of
the National Organization for Women. "How can the FDA approve silicone breast
implants while its parent agency is suing for millions in reimbursement? Tommy
Thompson must protect American women from silicone gel breast implants."

Women may get silicone gel breast implants for health reasons and they are
widely available for cosmetic purposes through clinical trials.

Women at the rally spoke of the unacceptably high complication rates for cancer
survivors. "Everyone is concerned about women who need the devices after
mastectomy. But cancer survivors can already get silicone and saline implants
without restriction. So there is no public health need to approve the
devices," said Sybil Niden Goldrich, who received implants after mastectomy.
"Tommy Thompson and Mark McClellan can not put these things back on the market
until we understand their long-term health effects."

Breast implant sales continue to soar (up over 600 percent between 1992 and
2002). More than 300,000 women received the devices last year -- more than
ever before. All implants fall apart in the body over time; at least one in
four women require additional surgery related to the implants with five years;
and the little long-term health research that's been done has found increased
incidence of cancer and fibromyalgia.

"Tell me I did not suffer in vain," said Mary McDonough, an actress who played
Erin on the Waltons and who founded the LA-based support group In the Know with
other women from the entertainment community. "My breast implants nearly
killed me. I simply cannot believe that after all that I have been through --
and everything hundreds of thousands of women have suffered -- that the FDA
would put these back on the market after looking at only three years of data."

Sponsoring organizations include Breast Cancer Action, In the Know, the
National Organization for Women, Public Citizen, The Feminist Majority
Foundation, The National Council of Women's Organizations, CAN DO, National
Silicone Implant Foundation, Silicone Solutions Outreach of Northern Louisiana,
Toxic Discovery Network and other groups.

SOURCE Breast Cancer Action; In the Know; National Organization for Women;
Public Citizen; Feminist Majority Foundation

CO: Breast Cancer Action; In the Know; National Organization for Women;
Public Citizen; Feminist Majority Foundation; National Council of Women's
Organizations; CAN DO; National Silicone Implant Foundation; Silicone
Solutions Outreach of Northern Louisiana; Toxic Discovery Network

ST: District of Columbia

SU: LEG WOM

http://www.prnewswire.com

10/08/2003 13:00 EDT