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Recent Silicone Breast Implant News Reports Inaccurate

Devices Still Faulty Even as Manufacturers Push To Lift All Restrictions on Their Sale LOS ANGELES, Dec. 11 /PRNewswire/ -- Recent news reports incorrectly state that

silicone breast implants have no health risks. This information is in direct

contradiction with medical evidence, which shows that silicone implants can

cause painful and potentially deadly problems, from infection to increased

cancer risk. Despite mounting evidence against the devices, manufacturers have

announced plans to seek a lifting of all restrictions on their sale.

"Breast implants lead to a lifetime of repeat surgeries," said Sybil Niden

Goldrich, founder of the Command Trust Network. "The few peer-reviewed studies

on long-term risks show increased rates of fibromyalgia and certain cancers." Goldrich was the first woman to go public with breast implant problems nearly

fifteen years ago. Her activism led to some restrictions on the devices.

Safety Problems Well-Known According to a 1995 New England Journal of Medicine article, one in four women

will need surgery within five years because of problems related to their breast

implants. Another study in which over 8,000 devices were analyzed found that

nearly half of silicone breast implants fall apart in the body within ten years

and three-quarters rupture within 20.

The most common complication is painful tightening and hardening of the breast

that can lead to deformity or movement of the implant away from the breast. Other problems include loss of nipple sensation, painful rashes and numbness. Silicone is also known to move away from the breast to other parts of the body.

Long-Term Health Complications Although it is known that health problems increase markedly ten years after

implantation, very little data are available on long-term health effects. An

FDA team reported in 2001 that women with ruptured silicone breast implants are

significantly more likely to be diagnosed with fibromyalgia and other

illnesses. A National Institutes of Health study showed a 21 percent over-all

increase in cancers and a doubling in stomach, cervical, vulvar and brain

cancers.

Hidden Costs of Implants Implants mean a lifetime of repeat surgeries, usually on a cash basis with no

reimbursement. All implants eventually have to be replaced. Complications

require additional surgery, the cost of which may be the responsibility of the

patient because many insurance companies will increase premiums or drop

coverage for breast implant-related injuries.

Mammography Obscured Breast implants make mammography difficult, potentially delaying the detection

of cancer. Implants may also rupture during mammography because of squeezing.

Breast Implants Never Properly Regulated When Congress first gave the FDA authority to regulate medical devices in 1976,

implants were "grandfathered in" although manufacturers had never submitted

safety data. In 1992 the FDA declared some restrictions on their sale,

limiting them to breast cancer survivors and women replacing the devices. In

1998 the FDA allowed silicone breast implants back on the market for cosmetic

procedures under loosely monitored clinical trials. Ironically, the Government

has been reimbursed millions of dollars by manufacturers for payments related

to breast implant injuries and health problems.

Other Resources for Women The Command Trust Network's free brochure "Are Breast Implants for You" can be

ordered by e-mailing commandtrust@.... Women should also consult the FDA's

"Breast Implant Consumer Handbook," available at 1-888-INFO-FDA or

http://www.fda.gov/cdrh/breastimplants .

About the Command Trust Network The Command Trust Network was founded in 1988 by Sybil Niden Goldrich to ensure

that women would be provided with adequate information before receiving breast

implants. Goldrich received implants after a bilateral mastectomy.

MAKE YOUR OPINION COUNT - Click Here http://tbutton.prnewswire.com/prn/11690X57722644 SOURCE Command Trust Network CO: Command Trust Network; U.S. Food and Drug Administration

ST: California

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