Restrictions on Silicone Breast Implants

BIRMINGHAM, Ala., Sept. 18 /PRNewswire/ -- The government may sue certain breast implant manufacturers for millions of dollars in health expenses for breast implant injuries, a federal appeals court ruled earlier this week. The ruling opened Bristol Myers Squibb Co., 3M Corp. up to liability for monies Medicare spent treating women injured by silicone gel breast implants (Centers for Medicare and Medicaid Services of the Department of Health and Human Services, formerly the Health Care Financing Administration). The 11th U.S. Circuit Court of Appeals reversed a trial court's dismissal of the government's claims in a decision made public Tuesday.

This decision came even as the U.S. Food and Drug Administration prepares for a hearing October 14 & 15 to consider lifting restrictions on the sale of silicone gel breast implants. However, members of the U.S. Congress have raised concerns about the data and poor follow-up of these trials, and consumer organizations have vowed to oppose the manufacturers attempt to allow unrestricted sales of silicone breast implants.

"It is absurd that the FDA would consider making it easier to get implants when Medicare is suing for millions of dollars of medical expenses because of implant injuries," said Sybil Niden Goldrich, founder of the Command Trust Network, an information clearinghouse. Goldrich's story about her problems with implants led to the original restrictions on their sale.

Last September, several federal government agencies were awarded $10 million as part of the Dow Corning bankruptcy settlement. The government also received $100,000 from Inamed -- the same implant maker currently requesting that the FDA lift restrictions on the sale of the devices. It appears the government settled for a low amount due to the then precarious financial condition of Inamed. In those proceedings, the U.S. government sought reimbursement on behalf of the U.S. Department of Defense, Veteran Affairs, Health and Human Services, the Indian Health Service and the Centers for Medicare and Medicaid Services (formerly the Health Care Financing Administration).

Due to a regulatory loophole, the FDA has never approved silicone breast implants, nor have they ever been proven safe. However, in 1992 the FDA declared a partial moratorium on their sale due to health complaints. Until the first augmentation-only clinical trial was approved by the FDA in 1998, implants were only available to breast cancer survivors and women replacing the devices, provided they participated in a manufacturer-sponsored study.

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.