Fw: Capitol Hill Press Conference on Breast Implant Bill

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Martha Murdock, DirectorNational Silicone Implant FoundationDallas, Texas Headquarters

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Sent: Saturday, May 26, 2001 5:10 PM

Subject: Capitol Hill Press Conference on Breast Implant Bill

Dear Friends, For those who haven't seen it, here are two stories about the new legislation that would require federally-funded research on breast implants, including for breast cancer patients. The press conference was held in front of the Capitol on Thursday. The event starred a Republican and Democratic Member of Congress, who were introducing a new bill requiring long-term research on the safety of breast implants. Best wishes, Zuckerman, Ph.D. National Center for Policy Research for Women and Families http://www.cpr4womenandfamilies.org/ http://womenshealth.medscape.com/reuters/prof/2001/05/05.25/20010524legi004.ht ml New Bill Calls for More Breast Implant Research WASHINGTON (Reuters Health) May 24 - New legislation introduced Thursday on Capitol Hill calls on the Food and Drug Administration and the National Institutes of Health to step up research into the possible negative health effects of breast implants. In a 1999 study, the Institute of Medicine found no reliable evidence linking silicone breast implants to systemic autoimmune diseases. The report said that local pain, scarring, and other nonsystemic complications are the primary concerns with the implants. But supporters of the new legislation said that the IOM report focused on women who had had implants for too short a time to tell if they really suffered negative health effects. They pointed to three new epidemiologic studies, one of which found an increased incidence of lung and other cancers in 13,000 women who had either silicone or saline implants. "We can't draw conclusions from these studies, but they are a wake-up call," Dr. Zuckerman, the president of the National Center for Policy Research for Women and Families, said in an interview with Reuters Health. An estimated 2 to 3 million women have received the implants, including some 300,000 last year, Dr. Zuckerman said. The bill orders the National Institutes of Health to intensify research into the health implications of implants, and mandates that the Food and Drug Administration step up its efforts to disseminate accurate information about implants to consumers. It also bolsters FDA's postmarket review of saline implants currently on the market. "These implants have never been proven safe and effective," said Rep. Gene Green (D-Tex.), a sponsor of the legislation. The bill offers no new money to NIH or FDA for fulfilling the mandates. Supporters said that record funding levels expected from Congress for NIH this year would allow for the changes with no increase in dollars. "I think the NIH budget can easily accommodate this," said co-sponsor Rep. Roy Blunt (R-Mo.), the House Deputy Minority Whip. ------------------------------------------------------- Lawmakers Concerned About Breast Implants Seek More Research, Oversight By LIBBY QUAID WASHINGTON (AP) Kim Hoffman was wearing a hospital gown, about to have breast implant surgery, when a consent form was thrust into her hands. Hoffman didn't know that the Food and Drug Administration had banned her silicone-gel implants, except for a few women receiving them in strictly controlled clinical trials, she said. She was told the consent form was just more red tape, Hoffman said. ``I didn't understand that I was part of an experiment,'' the Marshfield, Mo., woman said during a Capitol news conference Thursday. Eight months later, she had the implants removed after suffering a range of complications, including debilitating muscle weakness and tremors that cost Hoffman her job running two preschools. Her story and others like it have prompted legislation that would require stricter FDA regulations, more extensive government-funded research and more information about potential health risks from implants. The measure is especially timely because of new research suggesting that, counter to earlier studies, women with breast implants may face higher risks of lung and brain cancers as well as the painful condition fibromyalgia, said Zuckerman, director of the National Center for Policy Research for Women and Families. She said research to date is lacking, especially on patients who received implants for reconstruction after undergoing mastectomies. ``Do implants create health risks, and do women with implants die at a younger age?'' Zuckerman asked. ``Those are still questions we need to answer.'' She mentioned a study by researchers >from FDA and the National Institutes of Health linking ruptured silicone gel breast implants to fibromyalgia. However, another study to which she referred has also been interpreted as generally reassuring. National Cancer Institute researchers said a study they released in April found that while women with implants do face slightly increased risks of developing lung and brain of cancers, they do not face such risks for most cancers, including cancers of the mouth, stomach, large intestine, breast, cervix, uterus, ovary, bladder, thyroid, connective tissues and immune system. Rep. Roy Blunt, R-Mo., said he and other sponsors of the legislation want sound science and thorough FDA oversight, ``so women who have suffered the trauma of a mastectomy won't become a victim again because of reconstructive surgery.'' Blunt became involved in the issue because Hoffman is a constituent. Women have a right to know whether their symptoms were triggered by implants, said Rep. Gene Green, D-Texas. ``The government should support research that will independently and comprehensively answer questions surrounding these products,'' said Green, a sponsor who has pushed a similar measure for the past few years. Introduced Thursday, the measure would require the National Institutes of Health to intensify research into potential health problems caused by breast implants, along with expanding FDA's efforts to distribute accurate and current implant data. Lawmakers also seek to force the FDA to complete its ongoing criminal investigation of an implant manufacturer accused of data manipulation in its trials of breast implants. In addition, the FDA would perform tougher evaluations on saline implants already on the market under the bill. Between 1.5 and 2 million women have received breast implants since 1962, about 80 percent for cosmetic reasons and the rest as breast reconstruction after cancer.