New research (2001)

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New Research on the Effect of Silicone Breast Implants on Cancer and Other Illnesses April 27 , 2001

Since breast implants first came on the market in 1962, between 1.5 and 2 million women in the United States have had breast augmentation surgery. About 80 percent of the surgeries were for cosmetic reasons while 20 percent were for breast reconstruction following breast cancer surgery. Whether silicone breast implants negatively affect women's long-term health or increase their risk of dying has been the subject of ongoing debate. The Food and Drug Administration (FDA) banned the use of silicone implants for breast enlargements in 1992 because there was little information on their long-term safety. The FDA now only permits silicone implants to be used in controlled clinical trials of women seeking breast reconstruction. In 1999 the Institute of Medicine (IOM) released a report which concluded that the available evidence did not indicate that connective tissue disease, cancer, neurological diseases, or other systemic complaints or conditions were more common in women who had breast implants then in women who did not. Despite the comprehensive nature of the IOM report, questions about implants remain. To shed additional light on the subject, the National Cancer Institute (NCI) is conducting research on the long-term health effects associated with breast implants. Two new studies from this research were published in the May 2001 issues of the journals Epidemiology and ls of Epidemiology. These studies are based on information collected from 13,500 women who had breast implants prior to 1988. These women's disease and death rates were compared with those of 4,000 women who had other types of plastic surgery. The researchers conducted this comparison because these two groups of women are similar to one another on key health factors, like smoking and alcohol use. The disease and death rates of the women with implants were also compared with those of women in the general population. In order to evaluate breast cancer risk, researchers did not include women who had implants following a breast cancer diagnosis in their analysis. One of the recently published studies looked specifically at cancer rates. When the women with breast implants were compared with the women who had plastic surgery, no differences were seen in the rates of cancers of the mouth, stomach, large intestine, breast, cervix, uterus, bladder, thyroid, connective tissue, and immune system. When the women with breast implants were compared with women in the general population, however, that was not the case. Here, researchers found that the women with implants were two to three times more likely to develop leukemia and cancers of the cervix, vulva, brain, and stomach. Previous studies have also reported an increased risk for cancers of the cervix and vulva in women with implants. This is probably not due to the implants themselves, but to reproductive and lifestyle factors common among the women who choose to have them. These factors could include having multiple sexual partners and not obtaining annual pelvic exams or Pap smear tests. Why the rates would be higher for stomach and brain cancer and leukemia isn't clear. It could be due to factors common among women who get implants or just the result of chance. The second study looked at death rates from an array of diseases, including cancer. In this analysis the researchers found that both the women with implants and the women who had plastic surgery had a lower mortality rate than other women did for nearly every type of death. This probably represents a "healthy patient bias" and substantiates the belief that women who choose to have elective surgery—like plastic surgery or breast augmentation—tend to be healthier than other women are. The study also found, however, that the women with implants had a higher death rate than the women who had plastic surgery. This was because the women with implants were nearly two to three times as likely to die from brain cancer and nearly twice as likely to die from suicide, pneumonia, and emphysema. The higher suicide rate appears linked to characteristics common in women who have implants, marital difficulties, depression, emotional disorders, and low self-esteem. Why the brain cancer rate would be higher isn't clear. Some researchers have suggested that implants affect the neurological pathways, but the research results in this area are inconsistent. The NCI researchers also did not find that the women with implants were more likely to die from the diseases that many believed were caused by silicone implants, like multiple myeloma and connective tissue disorder. NCI researchers are still looking into this question, however, and they will be publishing another paper specifically on connective tissue disorders and implants in the near future. The first analysis from the NCI's research, published in October 2000, looked at breast cancer risk. In that analysis the researchers found no association between breast implants and breast cancer risk or mortality. Although breast tumors tended to be detected at a somewhat later stage in women who had breast implants, this result was not statistically significant. These studies have generated important findings and some new questions. And while these results may contradict what some women have believed about silicone implants, they will clearly be reassuring to others. We still need more studies before we will understand the full picture. Thankfully, this research is now underway.

References:

Brinton L, Lubin J, Burich M, et al. Cancer Risk at Sites Other than the Breast Following Augmentation Mammoplasty. ls of Epidemiology. May 2001;11(4):248-256.

Brinton L, Lubin J, Burich M, et al. Mortality Among Augmentation Mammoplasty Patients. Epidemiology. May 2001;12(3):321-326.

Brinton L, Lubin J, Burich M, et al. Breast Cancer Following Augmentation Mammoplasty (United States). Cancer Causes and Control. 2000; 11(9):819-827.

Bondurant S, Ernster V, Herdman R, editors. Committee on the Safety of Silicone Breast Implants. Safety of Silicone Breast Implants. Institute of Medicine publication. National Academy Press. 1999.

www.nap.edu/books/0309065321/html

Silicone Breast Implants Not Linked to Most Cancers. National Institutes of Health, National Cancer Institute, Press Release. April 24, 2001. www.cancer.gov .

Women With Silicone Breast Implants Have No Increased Risk of Death from Most Causes. National Institutes of Health, National Cancer Institute, Press Release. April 27, 2001. www.cancer.gov.

Questions and Answers for Silicone Breast Implant Study and Breast Cancer Risk, National Institutes of Health, National Cancer Institute, Press Release, October 2, 2000. http://search.nci.nih.gov/search97cgi/s97_cgi