FDA has approved four breast implants for marketing in the U.S.:

• In May 2000, Mentor and Allergan (formerly Inamed) received approval for saline-filled breast implants. These implants were approved for breast augmentation in women 18 years or older and for breast reconstruction in women of any age.

• In November 2006, Allergan and Mentor received approval for their silicone gel-filled breast implants. These implants were approved for breast augmentation in women 22 years or older and for breast reconstruction in women of any age.

All breast implants other than these four approved devices are considered investigational devices, including the more-cohesive (“gummy bear”) implants. For a woman to receive an investigational breast implant in the U.S., she must enroll in a clinical study.

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