Date: Mon, 21 Jun 1999 11:43:29 -0500

Organization: TDN

WASHINGTON (AP) -- Silicone breast implants do not cause life-threatening illnesses, though they can cause problems in some women, a federal advisory panel reports Monday.

The implants have generated controversy in recent years with some women contending that they can break open and lead to such diseases as cancer and nerve and immune disorders.

But the new report from the Institute of Medicine, an arm of the National Academy of Sciences, concludes that women with silicone breast implants are no more likely than the rest of the population to develop serious illnesses.

"Although studies do not show a risk of life-threatening illness from silicone breast implants, it is clear that they can cause serious problems," said the committee chairman, Stuart Bondurant, professor of medicine at the University of North Carolina, Chapel Hill. "It is essential that women fully understand these risks before they decide to undergo this surgery."

As many as 2 million women in the United States and Canada have received the implants either as part of reconstructive surgery or for cosmetic reasons. But in 1992, the Food and Drug Administration banned the use of silicone breast implants except in clinical studies of women receiving them after a mastectomy. Saline-filled implants are still approved for use in cosmetic or reconstructive surgery.

Manufacturers insist the devices are safe, but thousands of women who had sued approved a $3.2 billion plan earlier this month to settle with implant maker Dow Corning Corp. A federal judge next week must decide whether to approve the plan, which would give claimants who want their silicone implants removed $5,000 for the surgery, or $20,000 if their implants have ruptured.

The institute report said the rate of complications varies considerably depending on the type and age of the implant, but the chance that a woman will experience a problem increases with time.

Many women with breast implants have complained that they were not given sufficient information before receiving the implants.

The report urged that researchers monitor women for extended periods to determine the incidence of health problems with implants. The report said the most serious problems associated with implants arise when the tissue around them contracts, when the implant ruptures, or when infection occurs. As a result, many women experience substantial pain and discomfort and many undergo surgery to replace or remove the implants.

While much previous information on implants has been anecdotal, the report said new studies led to several conclusions:

-- There is no evidence to suggest that the silicones used in implants are toxic to humans.

-- There is no established link between implants and a unique disease syndrome. Problems ascribed to implants generally involve symptoms that are nonspecific and common in the general population.

-- There is no evidence that conclusively links silicone to harmful effects on the immune system. Follow-up analyses have failed to uncover associations with specific immunological diseases or other conditions.

-- Although evidence is lacking for any relationship between breast implants and cancer, the presence of implants may make it more difficult to detect cancer through mammography. Despite this, breast cancer mortality is not higher in women who have implants.

-- There is no evidence that mothers with implants pass silicone on to infants when breast-feeding. Much higher levels of silicon -- the element on which the silicone family of organic compounds is based -- have been found in cows' milk and commercially available infant formula than in the milk of nursing mothers with implants.

Of the women who have received implants, about 70 percent obtained them for cosmetic reasons and 30 percent for breast reconstruction after surgery for cancer or other conditions.

The report notes that in developed countries, people are commonly exposed to the kinds of materials used in implants through foods, cosmetics, lubricants for machinery, hypodermic syringes, insulators and other products. About 10 million people in the United States have some type of implant in their bodies, such as an artificial joint or pacemaker, and many of these implants are made at least in part from silicone.