I have asked to speak to you briefly today because the issues surrounding the safety of breast implants are confusing to many people. We recognize that, for those women who have implants in place, the confusion can be downright frightening. The U.S. attorney in Minneapolis filed a seizure action against Misti Gold breast implants on behalf of the FDA because the manufacturer of these implants was marketing an unapproved breast implant, and because of unsubstantiated claims about that product. The inappropriate marketing and promotion of these Misti Gold products is illegal. Because the firm was illegally marketing the Misti Gold product, we were left with no alternative but to act.
Unsubstantiated claims mislead the public.
They will not be tolerated by this agency. The many issues involving breast implants are difficult enough for patients to understand, and misleading claims only add to the confusion. It is important for the American public to recognize that our actions against this one breast implant are based on unapproved marketing and misleading claims, and not on any new evidence of risk about these products. Second, let me comment on the purpose of today's meeting. Because of actions earlier this year, these products are no longer being marketed.