On November 15, the House Energy and Commerce Subcommittee on Health held a hearing to examine issues surrounding the safety of breast implants and access to treatment for breast and cervical cancer for women receiving services through the Indian Health Service. Specifically, the subcommittee discussed two legislative proposals (H.R. 1961 and H.R. 1383).
Sponsored by Rep. Roy Blunt (R-MO), the Breast Implant Research and Information Act (H.R. 1961) would direct the National Institutes of Health (NIH) to report to Congress on the status of existing breast implant studies. The bill also would require the NIH to appoint a breast implant research coordinator to coordinate and expand research on the health implications of saline and silicone breast implants. Additionally, the measure would direct the Food and Drug Administration (FDA) to expand and intensify its activities regarding silicone breast implants by expediting a current criminal investigation of a manufacturer, providing up-to-date information about problems with implants to consumers through a toll-free hotline, and requiring that manufacturers update package inserts and informed consent documents to accurately reflect problems with implants.
Diana Zuckerman of the National Center for Policy Research for Women and Families detailed the history of breast implants and current research on their safety. Noting that “breast implants have been sold in this country for almost 40 years,” Ms. Zuckerman stated, “We still know very little about their long-term health risks.”
She told the subcommittee that two recent studies have shown that “women who have breast implants are at significant risk for several debilitating and fatal diseases.” One study by the National Cancer Institute (NCI) at the NIH found that “women with implants were more likely to die from brain cancer, lung cancer, other respiratory diseases, and suicide compared to other plastic surgery patients.” Another study by the NCI found that “women with breast implants are more likely to develop cancer compared to other women their age.” A third study by the FDA found that “women with leaking silicone gel breast implants are more likely to have several painful and potentially fatal autoimmune diseases.”
Ms. Zuckerman also criticized the FDA for failing to adequately protect consumers. “The FDA had ignored the concerns of its own scientists by allowing the sale of breast implants without requiring that the manufacturers prove that implants were safe,” she said.
Kim Hoffman, a recipient of breast implants who suffered from side effects as a result of the implants, testified before the subcommittee about her experience. She told the subcommittee about her repeated attempts to document her complaints with her surgeon, a clinical trial in which she was participating, and the FDA. “There was no apparent action,” she said, adding, “As the watchdog of public safety for food, drugs and medical devices, the FDA has failed specifically in its duties, by allowing a medical device with high complication rates to be marketed to American women by companies with dubious manufacturing practices.”
Pamela Noonan-Saraceni, a breast cancer survivor who received an implant as part of her reconstructive surgery, also testified about her experience. “I was never advised of any of the health risks associated with the implants,” she said. She urged Congress to consider ways to improve the informed consent process, saying, “The informed consent agreement drawn up by the breast implant manufacturers is the only required information women receive about the implants and the study prior to surgery. This document contains inaccurate data on rupture and contracture rates, the efficacy of the implants, the risks and complications, and the need for future reoperations.”
When asked how the FDA should have responded, Ms. Zuckerman stated that the approval should not have been made based on data over a three-year period. “These are devices that are implanted for a lifetime. It is dangerous to make an approval on three years of data,” she said. She also noted that the FDA ignored recommendations made by its advisory group on what should be done in regard to breast implants.
A representative of the FDA did not testify before the subcommittee.
Subcommittee Chair Michael Bilirakis (R-FL) and Ranking Member Sherrod Brown (D-OH) expressed support for H.R. 1961. “This bill would recommend further studies into the risks of breast implants, providing women with more complete and accurate information,” stated Rep. Brown, adding, “This bill would require the study of a population not included in any past studies, breast cancer survivors who are seeking reconstructive surgery.”
Rep. Bilirakis agreed, “Many women have received breast implants and unfortunately suffered debilitating diseases that may have been linked to the procedures.”
Jacqueline Johnson of the National Congress of American Indians spoke about the need for Congress to act on H.R. 1383, the Native American Breast and Cervical Cancer Treatment Technical Amendment Act. Sponsored by Rep. Tom Udall (D-NM), the bill would make a technical correction to last year’s Breast and Cervical Cancer Prevention and Treatment Act (P.L. 106-354) to allow Native American women access to optional Medicaid treatment for breast or cervical cancer.
Calling the bill a “corrective action,” Ms. Johnson said that the 1996 Health Insurance Portability and Accountability Act (P.L. 104-191) contains a provision that includes health care provided through the Indian Health Service as credible health care coverage. By doing so, the law was intended to benefit American Indians by ensuring that they would not be subject to pre-existing condition exclusions and lengthy waiting periods when seeking health care coverage.
“Rather than benefiting American Indian women, it works to penalize them from receiving coverage under the Breast and Cervical Cancer Prevention and Treatment Act,” stated Ms. Johnson. “Many Indian women who rely on Indian Health Service programs for their basic health care are excluded from treatment.”
Rep. Bilirakis told Ms. Johnson, “It certainly was an oversight. It was not intended.” Rep. Brown agreed, “We need to move this to a floor vote. These women should not have been excluded last year.”