The U.S. Food and Drug Administration (FDA) approved a new silicone gel–filled breast implant made by Sientra, offering a third option in breast implant options for women in the United States. As with the other two breast implant products, women who choose to have these new implants should be monitored for any possible problems.
Despite the need for monitoring, the FDA deemed the new Sientra implant and those from Allergan and Mentor as safe. “Data on these and other approved silicone gel–filled breast implants continue to demonstrate a reasonable assurance of safety and effectiveness,” said William Maisel, MD, deputy director for science in the FDA’s Center for Devices and Radiological Health, in a press release.“It’s important to remember that breast implants are not lifetime devices,” said Dr. Maisel. “Women should fully understand risks associated with breast implants before considering augmentation or reconstruction surgery and recognize that long-term monitoring is essential.”
Sientra’s new implants can be used for breast reconstruction for women at any age and to increase a women’s breast size in women aged 22 years and older.
For more information on breast implants go to:
- How Long do Breast Implants Last?
- When do Breast Implants Need to be Replaced?
- Is a Screening MRI for Women with Breast Implants Necessary?
More information on the FDA decision is available on the agency’s Web site.
- Source: U.S. Food and Drug Administration & MedScape
- Copyright: Karol A. Gutowski, M.D., Chicago, IL, 2012