New review clears silicone gel breast implants of serious health risks (10/27/2007)

Women who receive silicone gel-filled breast implants do not have a higher risk of breast cancer or other cancers and do not experience lower survival rates after breast cancer diagnosis, according to a new report published in the November issue of Annals of Plastic Surgery. This is the first exhaustive review in almost a decade of the health effects of cosmetic breast implants.

The review was led by Joseph McLaughlin, professor of medicine at Vanderbilt-Ingram Cancer Center and a member of the International Epidemiology Institute (IEI), Rockville, Md., and Loren Lipworth, associate professor of medicine at Vanderbilt-Ingram and member of IEI. The two cancer epidemiologists surveyed the epidemiological evidence on the safety of breast implants, including numerous large cohort studies with long-term follow-up.

The in-depth review also addressed various non-cancer outcomes and found no causal association between silicone breast implants and health issues such as connective tissue disease, neurologic disease or birth defects in children born to women with implants.

"Few implantable medical devices have been investigated for safety hazards more extensively than silicone gel-filled breast implants," said McLaughlin. "For almost three decades researchers around the world have been conducting in-depth studies on the health of women with implants to determine if there are significant health risks. The evidence is clear that implants are not linked to serious disease."

Dozens of health risk studies were launched after the Food and Drug Administration (FDA) in effect banned the use of silicone breast implants in 1992, citing a lack of evidence that the devices were safe. One fear of safety advocates is that the implants interfere with mammography to screen for breast cancer. However McLaughlin, Lipworth and their colleagues reviewed several large studies, which used control groups to provide comparison data, and found that while the sensitivity of mammography may be reduced somewhat by the implants, women with implants in fact do not present with more advanced cases of breast cancer or suffer from lower survival rates after diagnosis with breast cancer, both of which would indicate interference by implants. And there is no evidence that the implants caused higher rates of cancer, regardless of anatomic site.

The only cancer risk cited in any of the incidence studies was a significant increase in lung cancer in a large group of Swedish women with breast implants. However an earlier survey of these same women found that they were 2.8 times more likely to be current smokers than the general female population. Smoking is the primary risk factor for lung cancer.

"We also looked at the risk for brain cancer because of an isolated mortality elevation reported in one study," said Lipworth. "Further research, based on a number of large-scale incidence surveys with complete follow-up, consistently failed to demonstrate any excess of brain cancer among women with cosmetic breast implants."

The weight of this evidence and that for non-cancer outcomes are among the reasons the FDA lifted its ban on silicone gel-filled breast implants in 2006.

"This long-needed review by Joe McLaughlin, Loren Lipworth and their colleagues reinforces the clinical evidence gathered by surgeons for decades," said Dr. Bruce Shack, chairman of the Department of Plastic Surgery at Vanderbilt University Medical Center, who performs both cosmetic and reconstructive breast surgery. "More than 300,000 women are choosing to have breast implants every year in the United States and these studies document the safety of the implants and the techniques utilized by plastic surgeons."

While the researchers found no increased cancer risk or link to autoimmune diseases or birth defects, there is a clear statistical correlation with later suicide risk. Five large epidemiologic mortality studies, including a 2007 study of Swedish women by McLaughlin and Lipworth, found an increase in the suicide rate among women who had undergone breast implant surgery during the period of the 1960s through the early 1990s.

"While there is a clear statistical association with suicide, there was also a general association between prior psychiatric illness and suicide," explained McLaughlin. "It is unlikely that the subsequent suicides are related to implants per se, rather the suicide excess reflects either underlying problems prior to the plastic surgery or the development of disorders years later. We believe further studies are needed to determine whether a history of psychiatric illness or other factors prior to or after breast augmentation surgery may place some women at high risk of suicide later in lif

Note: This story has been adapted from a news release issued by Vanderbilt University

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