Silicone Breast Implant Safety

Breast enlargement or augmentation began about 1959. implant-safetySince then about two million women in the United States have undergone breast augmentation. The majority of those augmentations have been performed with silicone filled implants.

Not long after a Connie Chung presented a piece on television about silicone breast implants, the FDA called for a moratorium on the use of silicone-filled breast implants for cosmetic breast augmentation.

However, silicone implants could continue to be used for breast reconstruction. Concern was raised from some women with multiple medical problems about the safety of the silicone used in breast implants. Once their lawyers became involved, the situation rapidly escalated to class action law suits and courtroom proceedings. This was all done without the benefit of true scientific data to either support or refute the safety of these implants.

Many women became scared and worried about their own health and the effects that silicone could have on it. But what is silicone and is it safe?

Silicon is a naturally occurring element which is found in sand, quartz and most rocks. Next to oxygen, silicon is the most common element near the surface of the earth. When silicon is combined with oxygen, carbon and hydrogen it becomes silicone. Silicone comes in a variety of forms including liquids and solids.

Silicone has been a part of manufacturing for many years and is a part of many consumer products. Silicone appears in most hair-sprays, suntan lotions and moisturizing creams. Our contact with silicone is extensive throughout all of our lives and it is widely used in medicine. Silicone is used in artificial joints, pacemakers, heart valves and catheters among others.

Safety issues about silicone have been primarily focused on their use in breast implants and the possible link with breast cancer and autoimmune diseases such as arthritis. Silicone materials have been studied with great interest over the past years. Since so many women already have silicone implants, it has been possible to gather much information about them.

A study published in the New England Journal of Medicine in 1992 studied the potential for breast cancer in over 11,000 women who had received silicone breast implants. This study “did not find an increased risk of cancer among women who had received breast implants, although the length of follow-up, the completeness of follow-up, and the size [of the study group] would have allowed the detection of such a risk.”

There are many similar studies which have been performed by scientists throughout the world.

In fact, most studies using standard mammography have shown no difference in the time to detect breast cancer between women with and without breast implants. There also seems to be no link between arthritis or other connective tissue diseases and silicone.

In an official statement by the American College of Rheumatology, based on several research studies involving over 87,000 women, it was concluded that there is “no reason to discourage women from considering breast [implant surgery] on the basis of acquiring or [worsening] a connective tissue disorder.”

But what about those women who have such terrible medical conditions and have silicone implants?

There is no question that there are women who have connective tissue disorders. Some of these problems can range from mild arthralgias and myalgias (joint and muscle pains) to severely debilitating arthritis, Lupus or other connective tissue disorders. Some of these women may also have silicone breast implants.

Based on research performed, it is not likely that any of these problems are related to silicone. The women who have these problems and who also have silicone breast implants have these problems with the same frequency as other women in the population who have no implants. Further, the overwhelming majority of women with breast implants have no medical problems at all.

According to the FDA, even women who have tested positive for silicone in their body fluids “does not indicate whether a person is sensitive to these substances or is at any risk for any specific disease…”

Four scientific experts in the fields of immunology, epidemiology, toxicology, and rheumatology were appointed by the Honorable Sam C. Pointer, Jr., Coordinating Judge for the Federal Breast Implant Multi-District Litigation, to serve on a National Science Panel. The panel was instructed to review and critique the scientific literature pertaining to the possibility of a causal association between silicone breast implants and connective tissue diseases, related signs and symptoms, and immune system dysfunction. Judge Pointer was recently presented with the final report by this panel. That report can be viewed at http://www.fjc.gov/BREIMLIT/SCIENCE/report.htm.

The conclusions from the science panel were that “The preponderance of data from these studies indicate that silicone implants do not alter incidence or severity of autoimmune disease.” “… there is no evidence that silicone breast implants precipitate novel immune responses or induce systemic inflammation.” “… there are no consistent data to suggest systemic inflammation or systemic induction of anti-silicone or autoreactive responses in women with silicone breast implants.” “… when appropriate comparisons were made, (ill women with implants compared to healthy women with implants, or healthy women with implants compared to healthy women without implants), neither immune system activation nor autoreactivity could be reproducibly demonstrated in women with silicone breast implants.” “The main conclusion that can be drawn from existing studies is that women with silicone breast implants do not display a silicone-induced systemic abnormality in the types or functions of cells of the immune system.”

“No association was evident between breast implants and any of the individual connective tissue diseases, all definite connective diseases combined, or the other autoimmune/rheumatic conditions.” “There was no association between silicone gel-filled implants and any of the definite connective tissue diseases (including Sjögren’s syndrome) or the other autoimmune/rheumatic conditions.” “The one study that specifically addressed undifferentiated connective tissue disease found no association with silicone breast implants.” “Breast implant patients have reported a diversity of symptoms and signs that are also associated with rheumatic or autoimmune diseases.

Furthermore, many of the rheumatologic complaints reported are common in the general population and as presenting complaints in physicians’ offices. No distinctive features relating to silicone breast implants could be identified.”

At the moment it seems that there is no conclusive scientific evidence that silicone materials in breast implants increases the risk of developing breast cancer or connective tissue diseases.

Further information about breast implants can be obtained from the FDA. A simple phone call to the toll free number (800-532-4440), and the FDA will send you a free copy of their “Breast Implant Information Package” The FDA Information for Women Considering Saline-Filled Breast Implants is also available here.

References

  1. Tanne J. Everything You Need to Know About Breast Cancer…But Were Afraid to Ask. New York. October 11, 1993:53-62.
  2. Berkel H, Birdsell DC, et al. Breast Augmentation: A Risk Factor for Breast Cancer? New England Journal of Medicine. 1992;326(25):1649-1653.
  3. Gabriel SE, O’Fallon WM, et al. Risk of Connective-Tissue Diseases and Symptoms. New England Journal of Medicine. 1995;332(25):1666-1670.

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