FDA Approves New Brand of Breast Implants

This past Friday, March 9th, the Food and Drug Administration approved a new brand of gel-filled breast implants; those manufactured by Santa Barbara, CA-based firm, Sientra.


As part of its efforts to garner FDA approval, Sientra provided three years of clinical data gathered from 1,788 women who received Sientra's implants. The clinical results were in line with those provided previously by Mentor and Allergan, the other two breast implant manufacturers here in the US. As a condition of approval, however, Sientra must conduct post-approval studies to assess the implants' long-term safety and effectiveness.


Who qualifies for these new implants? Like the gel-filled implants manufactured by Mentor and Allergan, these new breast implants are available to women aged 22 years and older, as well as for women of any age in need of implants for breast reconstruction due to trauma or breast cancer, and/or women with abnormal breast development, such as those with one breast very different in size from the other.

Why another implant? The supposed benefits of the Sientra implants are additional shapes and a better price than implants available through Mentor and/or Allergan.

Will our practice offer these implants? Before using them in my Atlanta plastic surgery practice, I want to be certain that (A) they're as safe as the brand I've been using; (B)they offer a real difference in terms of shape and (C) they will save my patients money.

To your health and beauty, 

Carmen Kavali, MD