National Institute of Health Warns 'Further Scrutiny' Needed for Breast Implants

September. 15, 2003 - The National Institutes of Health (NIH) has sent a report to lawmakers on Capitol Hill, summarizing what is known and not known about the risks of breast implants. Key concerns include increases in brain cancer, lung cancer, and suicides among implant patients as well as "undesirable immune responses." Meanwhile, Inamed Corporation is asking the Food and Drug Administration (FDA) to approve silicone gel breast implants for the first time, and will present their safety data to the FDA's Advisory panel at a public meeting on October 14-15, 2003.

The newly revised NIH report was sent to several members of Congress two weeks ago but was not made public. It includes research findings on autoimmune diseases that were not included in the April 2003 version of the same report, and expresses concerns about the lack of conclusive research on the risks of breast implants.

"Implants are a public health issue, as this very balanced report makes clear. Let's hope that it will inspire lawmakers and the FDA to carefully examine taxpayer-funded research that raises red flags about the long-term safety of silicone gel implants. The FDA is under tremendous industry pressure to approve silicone breast implants -- creating a real danger that science will get lost along the way," said Dr. Diana Zuckerman, President of the National Center for Policy Research (CPR) for Women & Families, a think tank that scrutinizes research on health and safety issues, including implants.

The NIH report points to National Cancer Institute research finding that women with implants were much more likely to commit suicide or die from lung and brain cancers compared to other plastic surgery patients. The NCI research reveal health risks that "warrant further scrutiny" because the NCI studies are better designed than "previous studies [that] have been too small to evaluate rare diseases" and "have looked at the effects of implants over a shorter time period, typically less than 10 years."

The NCI studies are also superior to previous research because they compared implant patients with other plastic surgery patients. Comparisons of implant patients to the general population can be misleading since plastic surgery patients tend to be more affluent and healthier. The report also states that although breast implants do not apparently cause breast cancer, they "present difficulties for x-ray mammography" because they can obscure cancerous tumors.

The report, prepared by the well-respected Office for Research on Women's Health at NIH, describes new research conducted by scientists at NIH's National Institute of Environmental Health Sciences.

* Research by Dr. Terrance O'Hanlon found "undesirable immune responses" among women with implants and concluded that "further studies are needed to understand if silicone contributes directly or indirectly" to these problems.

* Research by Dr. Frederick Miller, Chief of the Environmental Autoimmunity Group and previously at FDA, focused on debilitating autoimmune diseases that cause long-term muscle weakness and inflammation. Their research suggests that some women develop those diseases because of a genetic tendency, but women who develop these diseases after getting breast implants do not have that genetic predisposition. That would mean that silicone, rather than genes, is causing their disease.

"Fortunately, these important studies are continuing. NIH can help make sure that teens and women with implants and women considering implants will get information based on science, not wishful thinking," concludes Dr. Zuckerman. "The FDA should wait until the ongoing NIH research, and other long-term safety research, is completed before making a decision about silicone gel implants."

CPR is a nonprofit, nonpartisan think tank that focuses on health policy issues for women and families.

Source: National Center for Policy Research for Women & Families

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