Women Caught in Middle of Breast-Implant Debate : Health: Research indicating that the silicone-gel devices are mostly safe comes out at same time as a tentative settlement for those who say they were harmed.
While lawyers were busy over the past year hammering out a billion-dollar legal settlement for women with health problems possibly due to silicone-gel breast implants, doctors were gathering evidence indicating the implants may be safe for most women.
Left in the gap between the two warring professions are women who have, or want to get, the implants but are unsure whom to believe.
The settlement comes at a time when most doctors are vehement that the implants are generally safe. In the past year, more than a dozen studies have appeared, seeming to absolve the implants of the most serious charge: silicone leaching from the implant can migrate throughout a woman’s body and cause a wide range of autoimmune disorders, such as lupus, scleroderma or rheumatoid arthritis.
In the studies, comparing women with implants to similar-age women without implants, the rate of autoimmune illnesses was equal.
The evidence is impressive because it was gathered from large independent studies, says Dr. Jack C. Fisher, president of the California Society of Plastic Surgeons.
And in a heavy-handed statement published in December, leaders of the American Medical Assn. said the group strongly supports continued use of the implants.
The public anxiety over the safety of the implants “is not warranted based on current scientific evidence,” wrote the AMA’s Council on Scientific Affairs in the Journal of the American Medical Assn.
But others contend that the recent tentative agreement on a nationwide class-action lawsuit--which creates a $4.75-billion fund to compensate thousands of women who claim they were harmed by the implants--gives the impression that the manufacturers are admitting liability. Manufacturers say the settlement is not an admission of guilt but simply puts a divisive issue to rest.
“A woman would have to be a fool to get silicone breast implants knowing that the manufacturers have agreed to put together this pot of money to pay sick women,” says Marie Walsh of the Breast Implant Information Foundation, Laguna Hills.
While the most recent scientific studies indicate that the implants are safe for most women, the settlement may carry a stronger message--”a message of guilt to the public,” says Fisher. “The average person will conclude that silicone is bad for your health.”
The mixed bag of news has left confused a great many of the 1 million to 2 million U.S. women with the implants, which were removed from the market except as part of clinical studies in a 1992 moratorium issued by the Food and Drug Administration.
Breast-cancer survivors who desire breast reconstruction are typically baffled by the issue, says Sharon Green, executive director of the national nonprofit breast cancer support group Y-ME.
“We originally took a stance to keep them on the market,” Green says. “We felt there were problems, but we felt each individual had to determine what their risks were. But these studies, both international and national, are coming in and they are not showing definite (problems). Now that there is a settlement on the table what does that mean? I don’t know what to tell anyone anymore.”
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Silicone-gel breast implants have been implicated in several problems, including breakage, painful hardening of the breast and--the most grave charge--causing a range of autoimmune disorders.
While manufacturers acknowledge the problems of hardening and rupture, the link to autoimmune diseases is unproven, although hundreds of women with the implants now claim to have developed one or more of the disorders. But the new studies tend to refute any link.
A Mayo Clinic study found no higher incidence of the disorders among 824 women with silicone implants compared to 1,634 women who did not have implants.
In another study at Houston’s M.D. Anderson Cancer Center, the incidence of autoimmune disease among 250 breast cancer patients who received implants was compared with 353 cancer patients who had breast reconstruction using their own tissue. There was no difference in disease rates between the two groups.
And, in another strong study, a range of laboratory tests, such as blood tests, were performed on 200 women with implants and 100 women of the same age who did not have implants. University of Toronto researchers concluded that there was no evidence that silicone-gel implants were related to autoimmune disease.
The studies have been trumpeted by implant manufacturers.
“There is a growing body of valid scientific evidence that shows no link between implants and connective tissue or autoimmune disease,” says Dr. Ralph Cook, Dow Corning’s director of epidemiology.
Cook notes that none of these studies was funded by Dow Corning, the largest implant manufacturer. But Walsh isn’t convinced because the studies haven’t been conducted over a long enough time period.
Autoimmune disease may not develop until many years after a woman has received implants, Walsh says. But Fisher, of the California Society of Plastic Surgeons, notes that the epidemiological studies will continue.
“The very best epidemiological inquiry is the Mayo study. It shows absolutely no difference. But it has to be followed for awhile. It’s going to take a lot more time--10 or 15 years,” he says.
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Studies showing no evidence of autoimmune disorders may have come too late to save silicone implants from the medical devices graveyard.
The lawsuits and the FDA’s moratorium on implants, for example, were motivated as much by the other problems, such as breakage and hardening, as by the possible link to autoimmune disease, says Jeffrey Steinberger, a Beverly Hills attorney representing 2,300 women with implants.
“If someone has had seven surgeries, who cares if (the link to autoimmune disease) has been proven?” he says. “Autoimmune disease isn’t the whole issue. There are a myriad of other problems.”
Indeed, some observers suggest that women will never have all the answers regarding safety.
When the FDA announced its moratorium, the agency said it would allow women to get the implants as part of studies to prove safety. But, it was left up to manufacturers to undertake the studies and submit data to the FDA.
“The FDA’s decision was to allow the manufacturers to do the studies to prove their safety and effectiveness--as long as there are manufacturers that want to do that,” says FDA spokeswoman Susan Cruzan.
Silicone-gel implants are now manufactured by only one company, Mentor Corp. of Santa Barbara, which has agreed to stop making the implants as of April, 1995, as part of its own legal settlement. Mentor’s implants are only available to mastectomy patients as part of the safety studies. Company officials said that enough women will have received the implants by next year’s deadline in order to produce a valid study.
In the meantime, saline-filled implants are still available to women for breast augmentation and reconstruction after mastectomy. And, researchers are actively testing peanut-oil-filled implants as a possible safe alternative.
But while silicone-gel implants may slink out of existence with little fanfare, safety studies will continue to be of great interest to women with implants, particularly those who are having no problems but wonder whether they should have the implants removed to prevent trouble from developing.
Each new report of a potential problem sends shivers through many women. In one of the most alarming studies yet regarding implants, researchers from Schneider Children’s Hospital in New Hyde Park, N.Y., suggested that women with silicone-gel implants who breast feed may pass autoimmune problems to their offspring.
The controversial paper, published in January in the Journal of the American Medical Assn., examined 11 children born to women with silicone breast implants. Of the eight who were breast fed, six developed a rare disorder in the lower esophagus that usually only arises from scleroderma, an illness that some women with implants have reported to suffer.
While there have been numerous anecdotal reports of children of women with implants also having autoimmune disorders, the study was blasted by many doctors.
“The most important question it raises is why the editorial board of that journal would publish a study about 11 children,” says Fisher. “We don’t know if there was any silicone in the breast milk itself. At least you have to start out with evidence that the children were exposed to silicone.”
Breast Implants: a Chronology
* 1962: Breast implants become available.
* 1976: Congress gives the U.S. Food and Drug Administration the authority to regulate medical devices; devices already on the market are “grandfathered” onto the acceptable list without safety tests.
* August, 1991: FDA warns physicians and the public of potential problems with implants due to a high number of consumer complaints.
* Jan. 6, 1992: FDA commissioner David Kessler requests voluntary moratorium on further use of silicone implants until FDA panel can meet to discuss safety.
* Spring, 1992: Several manufacturers, including Dow Corning--the largest manufacturer--voluntarily withdraw implants from the market.
* April 16, 1992: FDA states that proof of safety and effectiveness for silicone-gel implants has not been established by manufacturers and requires new testing. Makes implants available only through controlled safety studies.
* Feb. 14, 1994: Facing a class-action lawsuit, manufacturers agree to pay $4.75 billion to compensate women allegedly harmed by implants.
* April, 1995: Mentor Corp. will cease manufacturing silicone-gel implants, the last manufacturer to do so.
