Breast Implant Study Results Reflect Funding

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Breast Implant Study Results Reflect Funding

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Independent Studies Raise Serious Safety Concerns for Implant

Recipients

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. 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

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

Web Site: http://www.center4research.org

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www.BreastImplantAwareness.org