National Institutes of Health Publishes Report on Safety of Silicone Breast Implants
Santa Barbara, Calif., May 8, 2003 – Inamed Corporation (Nasdaq: IMDC), a global healthcare company, announced today that the National Institutes of Health (NIH) has published a report on the status of its research on the long-term health effects of silicone breast implants. Included in the NIH report are key results from a long-term retrospective National Cancer Institute (NCI) study of women who elected to have breast augmentation surgery. The NCI researchers found:
“No significant increase in breast cancer incidence or mortality among women with implants compared to controls. In fact, a slight decrease in breast cancer risk was found during the initial ten-year follow-up period, perhaps due to medical screening prior to surgery. “
“Patients in the study group experienced lower rates for nearly every cancer and for total mortality when compared to other plastic surgery patients, except for an elevation in the risk of lung and brain cancers, and suicide. While the reasons for the excesses were unclear (to the researchers), it is possible that the higher risks observed were due to either chance or to factors common to women who choose to have implants, such as smoking in relation to the lung cancer excess.”
“The lower overall mortality rates of the implant population support previous findings that people who undergo elective surgery are generally healthier than their peers.” “The methodology behind the NCI study is particularly meaningful due to the long duration and the large cohort of patients studied,” commented Nick Teti, Chairman, President and Chief Executive Officer of Inamed. “We believe in the strength of the growing body of scientific evidence supporting silicone breast implants and in the science-based process that will be used to evaluate the safety of these products.”
The National Cancer Institute study is one of the longest and largest studies to date on the health effects of breast implants. It involved 13,500 women who elected to have breast augmentation surgery prior to 1989, and compared them to 4,000 control subjects. The study was part of the fiscal year 1992 Senate Appropriations Report which asked the NCI to develop a strategy for conducting longitudinal studies of women with various types of silicone breast implants. As part of the 2002 Medical Device User Fee and Modernization Act, Congress required that the NIH publish a report on the status of the ir research. The URL link to the NIH report is listed below:
In addition, the NIH report described a study that is currently in progress at the Mayo Clinic that will collect clinical information on reconstructive surgery, breast implants and complications in women with hereditary breast cancer risk who undergo prophylactic mastectomy. The NIH reported that the additional data about reconstructive surgery and implant use may provide information about long-term outcomes and effects of breast implants in the highly select group of women studied.
About Inamed Corporation
Inamed (Nasdaq: IMDC) is a global healthcare company with over 25 years of experience developing, manufacturing and marketing innovative, high-quality, science-based products. Current products include breast implants for aesthetic augmentation and for reconstructive surgery; a range of dermal products to treat facial wrinkles; and minimally invasive devices for obesity intervention, including the LAP-BAND System for morbid obesity. The Company’s website is www.inamed.com.
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