WASHINGTON, Oct. 4 /PRNewswire/ -- A new research summary by the National Cancer Institute (NCI) reveals its concerns about the health risks of silicone and saline breast implants, finding that "implant patients were three times more likely to die from respiratory tract cancer, two to three times more likely to die from brain cancer, and four to five times more likely to die from suicide" compared to other plastic surgery patients of the same age.(1) NCI researchers also found an increased risk of certain connective tissue diseases, such as a doubling in rheumatoid arthritis, and even greater increases in lupus and Sjogren's Syndrome.(2) However, increases in connective tissue diseases were not conclusive because of methodological issues, including the difficulty of studying increases in rare diseases and the lack of medical exams to confirm the accuracy of the diagnoses. "This very cautious summary provides essential information for women considering implants, and the almost two million American women who already have them," noted Dr. Diana Zuckerman, President of the National Research Center for Women & Families, a Washington-based nonprofit research and policy organization. "This is the latest of several red flags, warning women that the risks of breast implants have not been adequately studied. Women in the NCI studies had implants for at least 8 years -- longer than any other studies. But, women getting implants want them to be safe for the rest of their lives, and we still need research to find out what is happening to all the women who already have had breast implants for 20 years or more." In addition to finding a higher risk of death from certain cancers and suicide, this study crystallizes the difficulties researchers face in studying the health risks of breast implants: * More long-term data is needed on women with breast implants; * Large samples sizes are necessary to detect rare but debilitating diseases, such as scleroderma; * Safety studies need to be based on medical exams by independent doctors; * Studies are needed to evaluate the health of women with leaking silicone breast implants. Most epidemiological research on implants has not satisfied these criteria. The studies by NCI and the Food and Drug Administration (FDA) are the best studies thus far, because patients in their studies had implants for a minimum of six years. Most epidemiological studies that have been widely quoted, including those in the Institute of Medicine report on implants, included women who had breast implants for only a month or more. "This report confirms how difficult it is to measure disease risks when studying breast implants, because many diseases take at least 10-15 years to develop. After years in the human body, breast implants change dramatically, and even the sturdiest silicone implants tend to break and leak. The FDA should consider these long-term risks when they consider manufacturers' applications to sell silicone breast implants without restrictions," added Dr. Zuckerman, who served on the NCI scientific advisory panel for their studies on breast implants. This is the first time NCI has summarized all their research data in one report. The review includes findings from four published studies. These studies were ordered by Congress in the early 1990s, after a federal investigation revealed that a regulatory loophole had enabled manufacturers to sell their products for nearly forty years without conducting safety studies. The increase in diseases and suicide among women with implants are expected to be considered by the FDA as it reviews new data recently provided by implant manufacturers. In January 2004, the FDA announced its intention to keep restrictions on the sale of silicone breast implants due to safety concerns and the lack of long-term safety data. According to the FDA, and the manufacturers' own data, nearly all implants fail, many women require corrective surgery within a few years, and patients report an increase in joint and muscle pain and chronic fatigue.(3) In addition, breast implants interfere with the detection of breast cancer. According to a recent study published in the Journal of the American Medical Association, mammograms missed 55% of breast cancers in women with breast implants, compared to 33% in women without implants.(4) Concerns have mounted recently, after a study presented at the American Chemical Society's August 2004 meeting found higher than normal concentrations of platinum, which is highly toxic, in women with silicone breast implants, and in the children they breast-fed after getting implants.(5) The National Research Center for Women & Families, formerly known as the National Center for Policy Research for Women & Families, provides consumer- friendly research-based information on a wide range of health issues affecting women, children, and families. See http://www.center4research.org and http://www.breastimplantinfo.org for more information. (1) http://www.nci.nih.gov/newscenter/siliconefactsheet (2) Brinton, LA et al (2004). Risk of Connective Tissue Disorders among Breast Implant Patients, American Journal of Epidemiology, 160: 619-627. (3) www.fda.gov/ohrms/dockets/ac/cdrh03.html#GeneralandPlasticSurgery (4) Miglioretti DL, Rutter CM, Geller BM, et al. (2004). Effects of breast augmentation on the accuracy of mammography and cancer characteristics. Journal of the American Medical Association, 291: 442-50. (5) "Platinum found in women with implants.'' The Associated Press, August 26, 2004.
SOURCE National Research Center for Women & Families