No Way Breast Implants Should Be Considered Safe


THE public controversy over silicone-gel breast implants simply won't go away. And neither, apparently, will the implants themselves.

Recent data suggest that growing numbers of women are once again choosing breast implants of all types, lulled, perhaps, by a spate of recent news articles implying that the safety of these devices has finally been established.

As a physician who treats many women suffering serious medical consequences associated with silicone-gel implants, I find this new trend very disturbing.

Much has been made in the news media of a recent report issued by a National Science Panel at the direction of U.S. District Court Judge Sam C. Pointer. However, this report does not exonerate silicone-gel breast implants.

Indeed, a vast literature of medical studies of "in vitro" immunoassays, human cell cultures and experimental animal research published in leading medical journals all document a host of complex immune system effects linked with silicone exposure.

But perhaps more important, what's being lost in this highly charged public debate is the human suffering that doctors like myself confront on a daily basis.

Dozens of women have come to my office seeking help. By now the similarities in their medical histories are familiar. They were told the devices involved little or no risk. Later their bodies began to exhibit alarming symptoms -- extreme pain centered in the joints and muscles, debilitating fatigue, scary and unsettling memory lapses, dry eyes, night sweats, chronic inflammations and other ailments signaling that something clearly is wrong.

The consistent appearance of these diverse health problems in implanted women suggests an underlying problem.

Dr. Louise Brinton, the National Cancer Institute's chief environmental epidemiologist, along with other top researchers, has suggested that women with implants may be suffering from a "silicone-related" disease. Based on my own examinations, and on those of my colleagues, women with implants do appear to have a higher than average likelihood of being afflicted by this unusual set of symptoms.

Very little of the research (epidemiology in particular) has focused on the "atypical" symptoms of women with implants, an inadequacy that a panel convened by the National Institutes of Health said needs to be addressed.

Dr. Brinton herself is conducting a large epidemiological study with some clinical review. With the results due out later this year, it is hoped her data will shed much-needed light on the subject.

On one point, however, there is no doubt -- the implants themselves fall apart in the body. A number of safety studies, including one by researchers at the U.S. Food and Drug Administration, report that the envelope encasing the silicone gel, itself made of silicone, deteriorates as the devices age.

After 10 years, more than half of implants begin to break apart; after 20 years, nearly all have fallen apart .

Furthermore, there is no doubt that implants cause painful and debilitating complications. A Mayo Clinic study shows one in four women require additional surgery within five years due to medical complications with their implants. These include deformity, burning rashes, rotting breast tissue and migration of the implant away from the breast area. Hardly a safe product.

Studies have shown that silicone leaking from implants may travel throughout a woman's body. Using animal models, researchers have found that the silicone leaking from implants collects at the highest concentrations in the brain, uterus, ovaries and lungs. What happens when silicone invades these vital organs? There is evidence of a systemic autoimmune response to silicone in some women.

Recently, researchers at Baylor College of Medicine reported that an injection of silicone compounds like those used in implants induced, in some cases, fatal liver and lung damage in mice. They write, "Our findings indicate that these compounds (silicones) are highly toxic and produce extensive tissue injury and death in these mice."

As a treating physician, my job is to alleviate the suffering of my patients and protect the health of others. On behalf of my patients suffering debilitating complications from silicone-gel breast implants, and on behalf of those still contemplating implants, I anxiously await complete and independent scientific research that gets to the truth behind these illnesses and these faulty products.

We still do not have the results of such research available. In the meantime, I appeal to the public -- and especially the news media -- to defer judgment and to view the safety of these devices with suspicion.

Walker is a neurologist who practices in Dallas. He has a long-standing interest in autoimmune diseases and the management of chronic pain.