Two NIH Studies and Concerns on Silicone/Saline Implants

NEWS RELEASE National Center for Policy Research for Women & Families

FOR IMMEDIATE RELEASE

FOR MORE INFORMATION Diana Zuckerman, Ph.D. or Salwa Nassar (202) 216-9507 or info@center4policy.org

Breast Implants Linked to Cancer, Lung Diseases, and Suicide Two NIH Studies Raise New Concerns about Silicone and Saline Implants

WASHINGTON, DC - Women who have breast implants are more likely to die from brain tumors, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients, according to a comprehensive new study. Women with implants are also more likely to develop cancer compared to other women their age, according to a second study.

The two federally-funded studies were conducted by scientists from the National Cancer Institute (NCI), Boston University, Abt Associates, and the Food and Drug Administration, with Dr. Louise Brinton from NCI as lead author. They were published in the May issues of two medical journals: Epidemiology and Annals of Epidemiology.

The studies were designed to answer questions of great importance to the almost 2 million U.S. women who have had breast implants: 1) do breast implants increase the risk of cancer and 2) do women with implants die at a younger age than other women?

Mortality The research published in Epidemiology is the first study that has ever examined all causes of death among implant patients. It compares death rates of women with breast implants to death rates of other plastic surgery patients and to women of the same age in the general population. The study is based on medical records and death certificates of almost 8,000 women with breast implants, including silicone gel implants and saline implants, and more than 2,000 other plastic surgery patients. Previous studies of breast implants have focused on breast cancer and autoimmune diseases such as lupus and scleroderma, but not other serious illnesses.

Implant patients were three times as likely to die from lung cancer, emphysema and pneumonia as other plastic surgery patients. Dr. Michael Harbut of the Center for Occupational and Environmental Medicine and Wayne State University points out that previously published medical studies have described lung problems and asthma related to breast implants, and that untreated asthma can develop into emphysema. The greater number of deaths from lung diseases was not explained by smoking, which was comparable among all plastic surgery patients.

Deaths from brain cancer were twice as likely among implant patients. Cognitive problems and memory loss are frequent complaints of women with breast implants, most of whom are in their twenties and thirties, and therefore surprisingly young for these types of problems. PET scans have

-more-

indicated brain abnormalities can decrease when implants are removed. The high rate of suicide could potentially be related to low self-esteem, which has been noted among women who decide to get implants. Breast implant manufacturers claim that implants improve women's self-esteem, but there is no long-term evidence to support that assumption. Psychologists have questioned the wisdom of treating low self-esteem with plastic surgery.

Cancer The second study, published in Annals of Epidemiology, found a 21% overall increased risk of cancer for women with implants, compared to women of the same age in the general population. The number of women with stomach cancer, cervical cancer, vulvar cancer, brain cancer, and leukemia were all at least twice as high among women with implants. Cancer rates for other plastic surgery patients were also higher than the general population, but were lower than for women with breast implants, especially for cervical cancer and lung and other respiratory cancers.

Both studies compared women with implants to women in the general population, and conducted separate comparisons to other plastic surgery patients. Women with implants or other plastic surgery tend to be more affluent than the general population, and also differ from the general population in terms of smoking and several other health-related behaviors. Women with implants and other plastic surgery patients had a lower death rate compared to women in the general population, probably because mortality rates are higher among the poor and because women in poor health do not usually undergo plastic surgery.

"These are groundbreaking studies because they evaluate women who had implants for at least eight years, and study diseases that have never been studied before among implant patients. Most previous studies only focused on a few autoimmune diseases and evaluated women with implants for an average of 6-8 years, including many women who had implants for only a few months or years. Cancer and other life-threatening diseases take many years to develop, so you need to study women who have implants for 10-15 years or more to evaluate long-term risks" explains Diana Zuckerman, Ph.D., President of the National Center for Policy Research (CPR) for Women & Families, and author of numerous articles on women's health, including breast implants.

The well-designed studies contacted all the breast augmentation patients of 18 plastic surgery practices that agreed to participate. The response rate was 71%, which is excellent for a retrospective study that requires patients to complete questionnaires. However, it is unknown whether the plastic surgeons who refused to have their patients participate in the study did so because of concerns that results indicating problems could deter future patients.

"These findings are a wake-up call for the more than 200,000 women and teenagers who plan to get breast implants this year," according to Dr. Zuckerman. "Most important, these studies are a alarming reminder that we still know very little about the long-term dangers of breast implants -- because they have never been studied until now. Rather than speculate about the meaning of these two studies, we need more independently-funded long-term research on the health of women who have already had implants for 15-20 years. Long-term research is long overdue."

CPR for Women & Families is a nonprofit, nonpartisan organization dedicated to improving the lives of women and families by explaining and disseminating objective research information. For additional information about breast implants, see the CPR website at www.center4policy.org.


Are Breast Implants Safe?

MEDSCAPE article by Diana Zuckerman

Part II (with References)
National Research Ctr for Women & Families

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