Link Between Implants, Immune Disease Is Seen
Dr. Steven R. Weiner was at UCLA in 1982 when he saw the first patient, the one who stood out “like a bright red light.”
The 32-year-old woman had had silicone gel implants placed in her breasts in 1976. Now, she had a painful, swollen left elbow, and a large lymph node in her left armpit appeared to contain silicone. Her muscle and joint pains did not respond to anti-inflammation medications and steroid injections. The whole case could not be explained by any known rheumatic disease.
Finally, Weiner, a rheumatologist, and other UCLA physicians recommended that the woman’s implants be removed. For the first time in years, her elbow returned to normal size and no longer hurt. Her other muscle and joint pains went away.
Over the last decade, Weiner, a UCLA associate clinical professor of medicine, has seen more than 500 patients with both silicone gel breast implants and possible rheumatic ailments.
In about 125 cases, Weiner concluded that the patient’s problems “clearly were related” to their implants. These included about 50 “clean” cases with no other plausible explanation, he said. Of the women whose implants were removed, one-half to two-thirds have significantly improved, he said.
“I don’t even think there is a shadow of a doubt that things are going on,” Weiner said last week. These cases “stood out long before anybody was out there talking about the evils of implants” and “before anyone ever told me that a plastic surgeon would get mad at me if I suggested they did stand out.”
On Jan. 6, the U. S. Food and Drug Administration called for a voluntary moratorium on the sale and use of silicone gel breast implants while it reviews safety data.
The FDA will decide this year whether the known problems and suspected hazards associated with the implants are severe enough to ban the devices or to restrict their use. The FDA could restrict use of silicone implants to women with severe breast deformities and woman who have had cancerous breasts removed.
Dr. David A. Kessler, FDA commissioner, said the growing number of autoimmune disorders, including various forms of arthritis, in patients with implants increased his concern about the safety of the devices. In an autoimmune disease, the body’s immune system, which normally defends against infections, turns against the body, causing disease.
Manufacturers of implants and many plastic surgeons have challenged the reports of autoimmune diseases and vociferously championed the overall safety record of the implants, which were first used in humans in 1962.
Yet a review of scientific articles and interviews with researchers found considerable evidence to support a link between the implants and serious rheumatic ailments in a small percentage of implant patients.
Researchers, including Weiner, acknowledge that the implants’ link to autoimmune diseases has not been established absolutely. This would require a large-scale comparison of women with implants to woman without implants. Implant manufacturers are beginning such a study with University of Michigan researchers. It will take several years to complete.
Little in medicine is known with absolute confidence. Medical ethicists note that the physician’s obligation to patients, particularly when uncertainty exists, is embodied in the Latin maxim primum non nocere , or “first do no harm.”
Interviews and the review of medical journal articles also made clear that silicone gel breast implants can have other adverse reactions and complications. There is no good data, however, on how often many of these problems occur.
* The implants can wear out and rupture, and must be removed and replaced. Dr. Donna de Camara, a plastic surgeon at the University of Illinois Medical School in Champaign, has studied 51 implants removed from 31 woman between 1987 and 1991. She found that 27 implants were ruptured and seven were leaking, according to her presentation at a meeting of plastic surgeons in 1991. Ruptures were more common the longer the implants had been in place.
When implants rupture, silicone gel can ooze into surrounding body tissues, causing inflammation, tenderness, swelling and lumps, according to a 1991 patient information booklet prepared by Dow Corning Wright of Arlington, Tenn., the largest manufacturer of the implants.
* A hard capsule of scar tissue can form around the implant, creating discomfort and pain. Such scar tissue normally forms around any foreign material placed in the body. When the capsule of scar tissue contracts around the implant--a frequent problem--repeat surgery may be required. The problem can recur.
* Even intact implants can ooze small amounts of silicone fluid into the body, although this problem is believed to be less common with newer implants. This is known as “gel bleed.” Silicone can move into the scar tissue surrounding the implant, nearby breast tissue and muscle, or the lymph nodes in the armpit.
* Surgery to place the implants can lead to such complications as bleeding, swelling, infection and pain.
* The implants can interfere with mammograms used for early diagnosis of breast cancer. Silicone is opaque to X-rays and can obscure a woman’s breast tissue. Breast cancer develops in about one in every 10 American women.
Dr. Melvin J. Silverstein, a cancer surgeon who practices in Van Nuys, has studied the mammograms of 62 women with silicone gel implants and compared them to the women’s mammograms before they had implants.
Depending on the surgical implant technique and the mammogram technique, Silverstein found a decrease of between 15% and 43% in the amount of breast tissue that could be seen before and after the implants. “State-of-the-art mammography was not possible in most patients,” he concluded.
From another study of 45 breast cancer patients, Silverstein found preliminary evidence that women with silicone gel breast implants who develop cancer may have a worse prognosis than patients without implants. The patients with implants appear more likely to have advanced cancers when their conditions are diagnosed, he said.
Silverstein believes that women should be allowed to evaluate these risks and decide whether to have breast implants.
In the United States, 1 million to 2 million women have had breast implant surgery. The most common device has a silicone gel-filled interior that is covered by a rubber-like silicone envelope. About 80% of the women have implants for cosmetic reasons, the rest for breast reconstruction.
Since the late 1970s, dozens of reports from around the world in medical journals and at medical meetings have remarked on autoimmune diseases in patients with these implants.
Some researchers, such as Dr. Nir Kossovsky, a UCLA pathologist, suspect that some people with implants produce antibodies against a complex of silicone molecules and body proteins that become attached to the silicone.
Such antibodies could trigger the autoimmune reaction that can lead to rheumatic diseases. Certain people may have a genetic predisposition to produce such antibodies, said Dr. Yale Bickel, a Long Beach rheumatologist, who over the last 15 years has seen several dozen patients with both implants and rheumatic ailments. In some cases, “there is a real suggestion about a cause-and-effect relationship,” he said.
Critics of the autoimmune disease theory say that it is just that--a theory. They note that the detailed immunologic studies necessary to prove it have yet to be conducted.
The critics point out that rheumatologists who treat these patients may be seeing the coincidence of relatively uncommon rheumatic conditions in the hundreds of thousands of women with breast implants. They claim that improvements seen in women after their implants are removed may represent a placebo effect.
Weiner and others counter that the patients they have evaluated in detail do not fit known categories of rheumatic ailments.
Weiner has identified two groups of rheumatic disease occurring in women after they get silicone breast implants.
The first is a scleroderma-like illness that differs from scleroderma itself in key respects, he said. Scleroderma is a disease in which the skin hardens and organs deteriorate. The patients Weiner has seen have diffuse, tight skin, but not organ problems. And many patients can get better. “Scleroderma just does not get better,” Weiner said.
The second group of patients has what Weiner calls “chronic silicone arthropathy.” These patients, like the first patient Weiner saw in 1982, become ill with joint, muscle and nerve pains an average of eight to 10 years after receiving their implants. They do not fit standard diagnoses and do not improve with medications.
Many have had implant complications, such as rupture, capsular contraction, or large lymph nodes in their armpits, Weiner said. A number show abnormal “anti-nuclear antibody” blood tests, which is characteristic of some rheumatic diseases. And a substantial number have improved when their implants were removed, he said.
In its June, 1991, product information for physicians, Dow Corning Wright said that “convincing evidence does not exist to support a causal relationship between exposure to silicone materials and the acquisition or exacerbation of a variety of rheumatic and connective tissue disorders.”
Nevertheless, the manufacturer recommended that when a physician suspects such a problem and the problem persists, the implant should be removed, along with the surrounding capsule tissue. “Such patients should not be re-implanted,” Dow Corning Wright said.
