Silicone Breast Implant Research and Information Act
This article was originally published in The Gray Sheet
Executive SummaryManufacturers would be required to update package inserts and informed consent documents to reflect accurate information about the rupture rate of the devices under legislation introduced June 10 by Sen. Barbara Boxer (D-Calif.). Firms also would be required to provide informed consent documents at "the initial or earliest possible consultation regarding breast prosthesis, inform women on how to obtain a Medwatch (adverse event reporting) form, and provide potential study participants with the inclusion criteria for the trial and the toll-free consumer information number." In general, the bill authorizes the National Institutes of Health to expand research on the health implications of silicone breast implants, including undertaking a large neurological/immune dysfunction study of women implanted with the devices for at least eight years
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