Medical devices are an important part of today’s health care reality.  In the same way that prescription medications need to undergo extensive testing before earning the Food and Drug Administration’s (FDA) approval, medical devices, including breast implants, also need to pass similarly stringent requirements to demonstrate safety and efficacy.

What New Breast Implant Was Approved?

The implant, filled with silicone gel, is very similar in composition to those already on the market.  The main difference between this implant and its predecessors is Sientra, the manufacturer, which was not previously producing this medical device. Like its silicone-filled predecessors, this implant is only an option for women older than 22, with the exception of women who need breast reconstruction; the latter group may elect to receive this implant at any age.

What Breast Implants Existed Before This Newcomer?

Saline and silicone gel breast implants have been an option for use in breast reconstruction or augmentation surgeries for many years.  Before Sientra, the two FDA-approved breast implant producers were Allergan and Mentor.  Other implant manufacturers in different parts of the world have recently received negative media attention because of potentially dangerous implants that women received in France, the United Kingdom, and other European countries.  Mentor, Sientra, and Allergan produce the silicone implants that are approved for these surgeries specifically in the United States.