Prior to the FDA approval on November 17, 2006, silicone gel breast implants were not available for general use and women could only obtain silicone breast implants as part of an FDA-sanctioned study such as the Silicone Adjunct Study which is now closed.
As of November 17, 2006, women aged 22 and over qualify for the silicone gel breast implants manufactured by Mentor Corp. and Inamed. Not all silicone gel breast implants made by these manufacturers have been approved. According to Mentor's website, eligibility is as follows:Mentor MemoryGel Silicone Gel-Filled Breast Implants are indicated for females for the following uses (procedures):• Breast augmentation for women at least 22 years old. Boston breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery.•
Breast reconstruction. Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of aprimary breast reconstruction surgery. (A separate patient brochure is available for and should be read for breast reconstruction.)
Wednesday, March 7, 2007
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