Breast Implants and the FDA

Buttock and Breast Augmentation (NYC), Park Plaza Plastic Surgery New York (NY)

Currently, both saline and silicone breast implants have been approved by the U.S. Food and Drug Administration (FDA) for use in breast augmentation and reconstruction. Only three companies manufacture FDA-approved breast implants in the United States: Allergan, Mentor, and Sientra. Saline breast implants have been in use longer than silicone in the United States, but as of June 2013, five different types of silicone breast implants have been approved.

Even though silicone breast implants have been the standard for decades in other countries, they were taken off the market in the United States in 1992 due to the lack of adequate data from manufacturers on their safety and effectiveness. The FDA requested new studies to re-evaluate the safety of silicone breast implants.

In 2006, the FDA finally concluded that there were no significant safety concerns stemming from the use of silicone breast implants, and re-approved them for breast augmentation. However, for 14 years, Americans had only one breast implant choice: saline. As a result, some women who underwent breast augmentation between 1992 and 2006 now seek out revision breast augmentation to take advantage of the superior naturalistic look and feel of silicone gel implants. However, saline breast implants are still a popular choice among many women. Dr. Lefkovits can discuss the benefits and drawbacks of each option with you during an initial breast augmentation consultation.

If you are considering breast augmentation in New York and would like to learn more about your breast implant options, please contact Park Plaza Plastic Surgery today or call (212) 750-9494 to schedule your consultation with New York City board-certified plastic surgeon Dr. George Lefkovits.