National Cancer Institute Spells Out Risks of Breast Implants

Data Show Increased Risks Of Death From Cancers and Suicide



Oct 04, 2004, 01:00 ET from National Research Center for Women & Families

    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
    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