Breast Implant Study Results Reflect Funding

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Breast Implant Study Results Reflect Funding

Wednesday April 19, 12:41 pm ET

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