Can Breast implants cause birth defects?

[Guest guest]

Breast Implants and Birth Defects

Can Breast implants cause birth defects?

That is one of the questions the FDA has ordered

implant manufacturer's 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 if 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 They were withdrawn from the market by the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 involved 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 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.

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 spokswoman 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. G.

Goodman