Mothers Raise Implant Doubts : * Health: Women worry about how their implants might affect their breast-fed children. So far, little research has been done on the subject.
Susan Rodriguez thought nothing about feeding mother’s milk to her three children, despite having breast implants.
“I breast-fed my children for a long time, thinking it was the best thing I could do for them,” says Rodriguez, of Rancho Cucamonga, whose children are all under 6. “Now I don’t know what the outcome of it will be.”
Rodriguez, 37, who has undergone surgery twice in the past year--once to remove her unruptured implants and again to remove pools of silicone that had “bled” through the implants--is among a group of women concerned not only about the effects of implants on themselves, but also about what implants might mean for their breast-fed children.
“I receive many calls from women who are concerned about this issue,” says Rodriguez, a volunteer for the Breast Implant Information Foundation of Southern California, a support group. “I am unsure what to tell them--or myself.”
Unfortunately, the experts don’t have many answers either, in part because so little research has been done on implants and lactating women. Even at last week’s meeting of a Food and Drug Administration advisory committee deliberating the fate of silicone implants, the issue was mentioned only in passing.
Dow Corning Wright, the largest manufacturer of silicone implants, has performed one limited study on humans and none on animals. Milk taken from four women--two with implants--showed no significant difference, says Gene Jakubczak, Dow director of professional relations, noting the research was “very limited.”
Scientists and doctors, however, maintain the study is of little or no value because of its size and are calling for more research.
“It is one of the most important studies that I think needs to be done,” says Marc Lappe, a professor of health policy and ethics at the College of Medicine at the University of Illinois, Chicago.
At the center of the debate is the transmission--if any--of components from breast implants into milk glands. And if that occurs, is it harmful to infants?
FDA spokeswoman Susan Cruzan said agency scientists are concerned that there has been “only one case report” on the issue. Meanwhile, the FDA issued in August a pamphlet stating that risks to breast-fed children cannot be assessed because of little data, and noted that additional studies are planned.
Plastic surgeons and implant manufacturers have long held that augmentation does not interfere with a woman’s ability to breast-feed.
“Certainly, it is safe to breast-feed with implants,” says Nancy Kobus, a spokeswoman for the American Society for Aesthetic Plastic Surgery, which is composed of board-certified plastic surgeons.
However, last December, the American Society of Plastic and Reconstructive Surgeons stopped distributing a patient brochure that said, “. . . current studies suggest that you do not have to worry about silicone seeping into your milk glands. . . . Even if silicone was found in breast milk, it is considered so safe that it is added to many non-prescription medicines recommended for infants.” The group now distributes the FDA pamphlet.
Lappe says newborns or young children are sometimes fed simethicone or other silicone derivatives to treat gas. But this “smoke screen . . . misses the point entirely,” he says.
“The catalysts that are present in a breast implant have never been tested for their safety in oral administration, so those are areas for concern.”
Pierre Blais, who worked for 14 years as a senior scientist for the Canadian agency that regulates implants, said he has looked for, but has not found, silicone in breast milk.
“But, when you look at all the debris, impurities and chemicals that are put into breast prostheses, you find a lot of compounds that on basic scientific principles you would not want to have for breakfast,” says Blais, an Ottowa specialist in medical product design and failure analysis.
Dr. Jane Todaro, a Seattle pediatrician, cautions against concluding that children are in danger. But, she notes, “The infant bowel isn’t fully developed, and the younger the infant the more vulnerable they are to substances passing through.”
Another concern is whether autoimmune diseases can be transmitted to the infant through breast milk. Leaking silicone implants have been suspected by some mothers and physicians of causing cancer and immune system disorders such as arthritis, lupus and scleroderma--although the link has not been established scientifically. (The FDA advisory committee says there is not enough data to establish a cause-effect relationship.)
The body can normally identify an intruder such as a virus or a foreign tissue and send the immune system to attack. However, for reasons that scientists do not fully understand, the body occasionally attacks itself.
“It is thought that silicone may be working in such a way as to provoke the immune system,” says Lappe. He adds, “I think if a woman has autoimmune disease, whether or not it is due to implants, as a precautionary measure, she should not breast-feed.”
Dr. Ronald Kleinman, chairman of the committee on nutrition of the American Academy of Pediatrics, disagrees. “I can’t answer as to the safety of breast-feeding with breast implants,” he says, adding that he knows of no studies showing that autoimmune diseases can be passed along through breast milk.
This is not reassuring to Jama Russano, a 35-year-old mother of two from North Port, N.Y.
When she was 14, Russano had an implant inserted into an underdeveloped breast. Now she believes she has systemic sclerosis as a result of the implant, and is concerned that her 7-year-old son, whom she breast-fed, may also be developing the disease.
Prior to her pregnancy, Russano began experiencing pain in her muscles and joints, symptoms that she said worsened considerably during the pregnancy. Today, her disease has developed to the point where she has nodules all over her body, chronic fatigue and circulation, muscle and joint problems. Her son, she said, has the same burning feeling in the mid-chest area that signaled the beginning of her own declining health.
“I didn’t really have a problem nursing, but now I wish I had,” says Russano.
Dr. Steven Weiner, an associate clinical professor of medicine at UCLA who suspects a link between silicone breast implants and autoimmune disease, cautions that there is no call for panic. He says established risk factors, such as drugs and alcohol, are a greater concern to the breast-feeding child.
However, Weiner says he advises his patients not to breast-feed if they have foam-coated silicone implants. Most women have silicone implants without foam coating.
Foam-coated implants were manufactured from the mid-1970s until last year by Surgitek, a disbanded division of Bristol-Myers Squibb Co. They were developed in an attempt to reduce the formation of hard, scarred areas that often form around silicone implants. Some 200,000 American women have the foam-coated products. An estimated 1 to 2 million women in the United States have silicone gel implants.
The foam-coated implants were voluntarily pulled from the market by the manufacturer shortly after independent researchers found that the devices could release toluene diamines (TDAs) into the bloodstream. The chemicals have been linked to liver cancer in rats and are suspected of causing illness in humans.
One case of TDAs in human breast milk has been reported by David Black, a toxicologist in Nashville, Tenn. He detected the chemicals in the milk of a woman who came to him for testing. At the time, Black was performing tests for Surgitek and proposed that the company sponsor breast milk research. The company declined, says Black, who is president of Aegis Analytical Corp., a drug testing company.
Francine Gingras, a spokeswoman for Bristol-Myers said, “Because we believe Dr. Black’s methods created TDA artificially, we didn’t go on with any more testing.”
The FDA pamphlet distributed last August mentions Black’s findings, but notes that any risk to the child cannot be assessed from such a limited report. It is unlikely that any silicone that might enter the breast milk could increase the risk of a child developing cancer or autoimmune diseases, the pamphlet states.
It stresses that no link between implants and these diseases has been scientifically established.
Bristol-Myers expects to begin testing soon for the presence of TDAs and their byproducts in the blood and urine of a group of women who have the foam-coated implants. If the substances are detected, then breast milk will be analyzed, Gingras says.
The results may provide some answers to worried women, who have been sitting and waiting. Last week, an FDA advisory panel recommended that silicone-gel breast implants--their use already under voluntary moratorium--be allowed for reconstructive use only. Cosmetic use will be restricted to carefully controlled studies, and both uses will remain under federal monitoring.
“Women have been besieging us (with questions), but there is just nothing documented that we can share with them,” says Betty Crase, spokeswoman for La Leche League International, the breast-feeding advocacy group.
Says Susan Rodriguez: “I think if you were to put silicone gel into baby formula, you would get arrested. We just don’t know the future or what this might cost. I trusted my doctor and now I feel like I’ve been a Guinea pig and didn’t know it.”
