Breast Implant Study Results Reflect Funding

Independent Studies Raise Serious Safety Concerns for Implant Recipients



Apr 19, 2006, 01:00 ET from National Research Center for Women & Families

    WASHINGTON, April 19 /PRNewswire/ -- As the FDA considers whether to
 approve silicone gel breast implants for the first time, three newly
 published peer-reviewed studies provide information that makes the decision
 more difficult for the FDA.
     "The FDA needs more independent research to find out what is causing
 the higher rates of suicide, and to examine other potentially serious
 health risks for women with implants," says Dr. Diana Zuckerman, President
 of the National Research Center for Women and Families and an associate at
 the Center for Bioethics at the University of Pennsylvania.
     A study published today in the Journal of the National Cancer Institute
 (Dow Study), was funded by Dow Corning, a major manufacturer of silicone.
 At one time, Dow was the major manufacturer of breast implants. The company
 has funded almost four dozen research articles in the last decade, all of
 which conclude that breast implants are safe. However, studies funded by
 scientists who do not have ties to implant manufacturers have consistently
 found implant problems that the Dow-funded studies have not.
     The new Dow-funded study, conducted in Sweden, found that Swedish women
 with breast implants were more than twice as likely to have lung cancer as
 women in the general Swedish population, but concluded that this was
 "expected due to the high prevalence of smoking." However, the researchers
 did not statistically control for smoking to determine if smoking was in
 fact the likely cause of lung cancer among these women, and the researchers
 did not mention that almost one-third of women with lung cancer never
 smoked. The Dow-funded study also found a 30% increase in brain cancer
 among women with implants, but since that risk was not statistically
 significant the authors conclude there is no problem.
     "The conclusions of the Dow-funded study need to be viewed in the
 context of independent research that is not funded by any implant
 companies," explains Dr. Zuckerman. "They accurately report the results,
 but their conclusions go beyond the data."
     A new study by scientists at the National Cancer Institute (NCI Study)
 is larger, longer, and better-designed than the Dow-funded study, with
 findings that are strikingly similar, but different conclusions. Published
 in the peer-reviewed journal Epidemiology, the NCI study found a 60%
 increase in deaths from respiratory cancers among women with breast
 implants compared to other plastic surgery patients. NCI scientists did not
 attribute this to smoking, since implant patients have similar smoking
 habits to other plastic surgery patients. The NCI study also found a
 doubling of deaths from brain cancer among women with implants, as well as
 an increase in non-cancerous brain neoplasms. "The NCI authors are
 appropriately cautious about the meaning of these findings, clearly
 indicating that they are not sure if implants are causing cancer deaths,"
 says Judy Norsigian, Executive Director of the nonprofit organization Our
 Bodies, Ourselves and editor of internationally-respected book by that
 title. "In contrast, the Dow-funded researchers are concluding that the
 implants are safe."
     The most worrisome finding in the NCI study was the significant
 increase - - more than double -- in suicides among women with breast
 implants compared to other plastic surgery patients. Three Dow-funded
 studies have also found significant increases in suicides among women with
 implants, all of them comparing implant patients to the general population.
 The controversy is whether women who want breast implants are more prone to
 suicide (which would suggest that women are getting plastic surgery when
 what they need is mental health treatment) or whether breast implants are
 causing pain, complications, or financial stresses (from repeated surgeries
 and implant replacements) that are increasing the risk of suicide.
     "The goal of breast implants is to help women feel better about
 themselves. So, the NCI findings of almost a tripling of suicides should be
 shocking to plastic surgeons and the public," points out Cynthia Pearson,
 Executive Director of the National Women's Health Network, a nonprofit
 health advocacy organization.
     A new study in a peer-reviewed chemistry journal, Analytical Chemistry,
 adds to the FDA's problems and to patients' worries. The study, to be
 published in May but already available online, found very high and
 potentially toxic levels of platinum in the breast milk, urine, hair, and
 nails of women with silicone gel breast implants. Platinum is used in the
 manufacture of silicone elastomer, the rubber balloon-like material that
 the implant shell is made of. Urine samples of women who had silicone gel
 breast implants for an average of 14 years had between 60 and 1700 times
 the amount of platinum when compared to women with no platinum exposure.
 Even more disturbing, women who had breast implants had 100 times the
 levels of platinum in their breast milk.
     "Our hotline hears from women every day, desperately trying to get
 their leaking silicone implants removed, and finding it difficult to afford
 ($5,000- $10,000) or to find a plastic surgeon who wants to remove leaking
 silicone implants without replacing them with new implants. They feel
 trapped with a leaking implant in their body that they don't have the
 resources to remove," Dr. Zuckerman concluded.
     The National Research Center for Women & Families (NRC) is a
 nonpartisan, nonprofit research and education organization that works to
 improve policies and programs that affect the health and safety of women,
 children, and families. http://www.center4research.org
 
 

SOURCE National Research Center for Women & Families
    WASHINGTON, April 19 /PRNewswire/ -- As the FDA considers whether to
 approve silicone gel breast implants for the first time, three newly
 published peer-reviewed studies provide information that makes the decision
 more difficult for the FDA.
     "The FDA needs more independent research to find out what is causing
 the higher rates of suicide, and to examine other potentially serious
 health risks for women with implants," says Dr. Diana Zuckerman, President
 of the National Research Center for Women and Families and an associate at
 the Center for Bioethics at the University of Pennsylvania.
     A study published today in the Journal of the National Cancer Institute
 (Dow Study), was funded by Dow Corning, a major manufacturer of silicone.
 At one time, Dow was the major manufacturer of breast implants. The company
 has funded almost four dozen research articles in the last decade, all of
 which conclude that breast implants are safe. However, studies funded by
 scientists who do not have ties to implant manufacturers have consistently
 found implant problems that the Dow-funded studies have not.
     The new Dow-funded study, conducted in Sweden, found that Swedish women
 with breast implants were more than twice as likely to have lung cancer as
 women in the general Swedish population, but concluded that this was
 "expected due to the high prevalence of smoking." However, the researchers
 did not statistically control for smoking to determine if smoking was in
 fact the likely cause of lung cancer among these women, and the researchers
 did not mention that almost one-third of women with lung cancer never
 smoked. The Dow-funded study also found a 30% increase in brain cancer
 among women with implants, but since that risk was not statistically
 significant the authors conclude there is no problem.
     "The conclusions of the Dow-funded study need to be viewed in the
 context of independent research that is not funded by any implant
 companies," explains Dr. Zuckerman. "They accurately report the results,
 but their conclusions go beyond the data."
     A new study by scientists at the National Cancer Institute (NCI Study)
 is larger, longer, and better-designed than the Dow-funded study, with
 findings that are strikingly similar, but different conclusions. Published
 in the peer-reviewed journal Epidemiology, the NCI study found a 60%
 increase in deaths from respiratory cancers among women with breast
 implants compared to other plastic surgery patients. NCI scientists did not
 attribute this to smoking, since implant patients have similar smoking
 habits to other plastic surgery patients. The NCI study also found a
 doubling of deaths from brain cancer among women with implants, as well as
 an increase in non-cancerous brain neoplasms. "The NCI authors are
 appropriately cautious about the meaning of these findings, clearly
 indicating that they are not sure if implants are causing cancer deaths,"
 says Judy Norsigian, Executive Director of the nonprofit organization Our
 Bodies, Ourselves and editor of internationally-respected book by that
 title. "In contrast, the Dow-funded researchers are concluding that the
 implants are safe."
     The most worrisome finding in the NCI study was the significant
 increase - - more than double -- in suicides among women with breast
 implants compared to other plastic surgery patients. Three Dow-funded
 studies have also found significant increases in suicides among women with
 implants, all of them comparing implant patients to the general population.
 The controversy is whether women who want breast implants are more prone to
 suicide (which would suggest that women are getting plastic surgery when
 what they need is mental health treatment) or whether breast implants are
 causing pain, complications, or financial stresses (from repeated surgeries
 and implant replacements) that are increasing the risk of suicide.
     "The goal of breast implants is to help women feel better about
 themselves. So, the NCI findings of almost a tripling of suicides should be
 shocking to plastic surgeons and the public," points out Cynthia Pearson,
 Executive Director of the National Women's Health Network, a nonprofit
 health advocacy organization.
     A new study in a peer-reviewed chemistry journal, Analytical Chemistry,
 adds to the FDA's problems and to patients' worries. The study, to be
 published in May but already available online, found very high and
 potentially toxic levels of platinum in the breast milk, urine, hair, and
 nails of women with silicone gel breast implants. Platinum is used in the
 manufacture of silicone elastomer, the rubber balloon-like material that
 the implant shell is made of. Urine samples of women who had silicone gel
 breast implants for an average of 14 years had between 60 and 1700 times
 the amount of platinum when compared to women with no platinum exposure.
 Even more disturbing, women who had breast implants had 100 times the
 levels of platinum in their breast milk.
     "Our hotline hears from women every day, desperately trying to get
 their leaking silicone implants removed, and finding it difficult to afford
 ($5,000- $10,000) or to find a plastic surgeon who wants to remove leaking
 silicone implants without replacing them with new implants. They feel
 trapped with a leaking implant in their body that they don't have the
 resources to remove," Dr. Zuckerman concluded.
     The National Research Center for Women & Families (NRC) is a
 nonpartisan, nonprofit research and education organization that works to
 improve policies and programs that affect the health and safety of women,
 children, and families. http://www.center4research.org
 
 SOURCE National Research Center for Women & Families