Can breast implants cause birth defects?

That is one of the questions the FDA has ordered implant manufacturers to investigate.

So far, there is no scientific proof to demonstrate a link. It is not clear whether silicone, even if it does leak from an implant, crosses the placenta that nourishes a developing fetus or whether it can be transmitted in breast milk. Also unknown is whether silicone is harmful in either case.

The only report of possible transmission from mother to baby, according to the FDA, is the discovery of a trace amount of a chemical called TDA, 2 toluene-diamene, which can cause cancer in laboratory animals, in one of three samples of breast milk taken from a woman who had polyurethane implants. Polyurethane implants are no longer sold in the United States. They were withdrawn from the market by the manufacturer in April 1991 because of concerns about their safety.

While scientific evidence is lacking, there are scattered anecdotal reports that implants may have harmed some children who were breast-fed after their mothers received implants. A few of the approximately 10,000 lawsuits filed on behalf of women who claim they were injured by implants involve allegations of birth defects.

"It's really hard to know if there are second-generation effects from implants because for 30 years no one's bothered to look," said Esther Rome of the Boston Women's Health Book Collective and a member of an FDA advisory panel on implants. Breast implants were first introduced in 1962 at a time when the FDA had no power to regulate medical devices.

That power was granted by Congress in 1976, and implants were grandfathered in under the law. The FDA did not begin the cumbersome process of requesting safety data until 1988.

Many doctors discount any link between implants and birth defects, but Pierre Blais, a specialist in plastics and a member of the Laval University biomaterials group in Toronto, is not so sure. He has accumulated data on 1,000 implant patients, among whom are 10 women who have given birth to 35 children. Some of the infants were born before their mothers received implants, others afterward.

"The post-implant children have more health problems" than do their siblings, Blais said. "You'd put a label on these children as sickly." The health problems, according to Blais, include joint pain, digestive disorders and swollen lymph nodes.

Jama Russano, 35, of Northport, N.Y., said she believes that her sons, ages 5 and 9, have implant-related illnesses. Russano, who breast-fed both, has had a silicone gel implant in one breast since she was 14, when a tumor was removed along with her breast.

Russano said that her younger son's symptoms are "a lot like mine": burning in the knees, chest pain and digestive problems. Her 9-year-old, she said, has swollen joints.

"I've heard from 50 women whose kids have problems," said Russano, who is forming a support group for mothers who believe their children are suffering from implant-related disorders.

Karen Koskoff, co-chair of the breast implant litigation group for the American Trial Lawyers Association, is representing a woman who claims her 11-month-old daughter's health problems were caused by polyurethane implants.

The infant was breast-fed for the first two weeks of her life and, according to Koskoff, has subsequently suffered from frequent respiratory infections and intermittent fevers of 105 and 106 degrees. Treatment with a potent antibiotic appears to have controlled the infection but has destroyed the baby's permanent teeth, said Koskoff, who practices in Bridgeport, Conn.

Doctors discovered the baby had a fungal infection caused by an organism normally found in amphibians, not in people, Koskoff said. The fungus has been cultured from polyurethane implants, she added.

Francine Gingras, a spokeswoman for Bristol-Myers Squibb, which manufactured polyurethane implants, declined to be interviewed. "As a matter of policy, we don't comment on litigation," she said.