Mentor and Allergan (formerly Inamed) saline-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 18 years or older.
Mentor and Allergan silicone gel-filled breast implants are approved for: (1) reconstruction (primary reconstruction and revision-reconstruction) in women of any age and (2) augmentation (primary augmentation and revision-augmentation) in women 22 years or older.
FDA restricts the marketing of breast implants for augmentation to women of a minium age because young women’s breasts continue to develop through their late teens and early 20s and because there is a concern that young women may not be mature enough to make an informed decision about the potential risks. However, there is there is no age restriction on the marketing of these products for reconstruction, so as to allow young women to have access to breast implants 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.
As for devices that are not approved for marketing, there are various age criteria and other restrictions for women who receive breast implants as part of a clinical study. Contact one of the companies conducting a study for more information. See the company contact information at http://www.fda.gov/cdrh/breastimplants/addsources.html.
Source: U.S Department of Health and Human Services
