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Majority of Silicone Breast Implants Rupture; Allowing Silicone to Spread Throughout Body, Says Lancet Study

FDA Researchers Find Rates of Rupture 'Higher Than Previously Suspected'

WASHINGTON, Nov. 21 /PRNewswire/ -- The following was released by the Command Trust Network, a national silicone implant information clearinghouse:

Researchers from the Food and Drug Administration (FDA) have confirmed that silicone implants rupture at very high rates. Results show that rupture occurs at a rate of 63 percent for implants in place between one and twenty- five years, according to research by FDA scientist S. Lori Brown, published in Britain's respected medical journal, The Lancet, on Friday.

The study also said after 20 years, 95% of women with silicone breast implants could expect that neither of their implants would still be intact. "There is emerging consensus that both the incidence and prevalence of breast- implant rupture are much higher than previously suspected," said Ms. Brown in The Lancet.

The rupture rates released today are confirmed by the findings of other researchers. They shatter the manufacturers' claims of rupture rates as low as 1%.

The Lancet article further describes the health problems that result when an implant ruptures and allows silicone gel to spread throughout the body. Silicone has been found in breast tissue and even leaking from women's nipples. Silicone has also migrated far beyond the breast region to such sites as the liver, lymph nodes, and arm, noted this study.

Injections of silicone were banned in the 1960's for their dangerous health effects. Today the extent of the health hazards of free silicone in the body are not fully known, but it is widely recognized that silicone is not inert. Silicone causes immune tissue responses and the formation of silicone granulomas (the body's response to fight a foreign substance).

The pain and disfigurement associated with silicone spread is also well documented. The Lancet study cites one case, where a woman with a ruptured implant had the silicone gel migrate down her arm to her hand, causing pain and swelling, ulcers which oozed silicone, numbness, tightening of the skin, and permanent scarring.

The authors also point out that while the mechanism of causation is not yet clear, the development of connective-tissue disease after silicone-oil injections has been reported.

The Lancet study said that epidemiological studies "have not excluded a slightly increased risk for specific connective-tissue diseases, nor the possibility that women with breast implants may develop an atypical syndrome."

"The FDA researchers have issued a resounding message: silicone implants rupture at very high rates, a ruptured implant causes silicone to spread throughout the body, and the effects of silicone in the body are significant," said Sybil Niden Goldrich, co-founder of Command Trust Network.

"Silicone injections were banned for their dangers in the 1960's. Putting the same dangerous silicone in an implant that will rupture is irresponsible," she continued. SOURCE Command Trust Network
 -0- 11/21/97

/CONTACT: Linda Ricci or Karin Wallestad of Fenton Communications, 202-822-5200, for the Command Trust Network/

CO: Command Trust Network ST: District of Columbia IN: HEA CHM SU:

JA -- DCF034 -- 9237 11/21/97 16:08 EST
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Publication:PR Newswire
Date:Nov 21, 1997
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