On March 9th, 2012 the Food and Drug Administration (FDA) approved the use of a new type of silicone gel filled implants manufactured by Sientra, Inc. The silicone implants will be available for use in aesthetic breast augmentation patients over 22 years of age as well as in breast reconstruction patients of all ages. These implants will provide a 3rd alternative to the silicone gel filled implants currently on the market from Allergan and Mentor.
Sientra presented data collected on almost 1800 patients over a 3 year course, which, similarly to previous data on other silicone gel filled breast implants, demonstrated the “reasonable safety and effectiveness” of the devices, as per Dr. William Maisel, deputy director of science of the FDA’s Center for Device and Radiological Health. The approval is contingent upon follow up studies to monitor the risks and complications of these breast implants over a 10 year course. Issues such as capsular contracture, infection, rupture and implant removal will be studied and reported. Data will also be collected regarding other diseases such as connective tissues and neurological disease, rheumatoid arthritis and certain cancers.
Additional information as provided by the American Society of Plastic Surgery (ASPS) is available here.
Dr. Olivia Hutchinson, a board certified female plastic surgeon in NYC, performs breast augmentation using both saline and silicone filled breast implants. Breast implants may be used in breast enhancement procedures alone or in combination with breast lift (mastopexy), liposuction or as part of a mommy makeover. Please call us at (212) 452-14oo or contact us to schedule a consultation with Dr. Hutchinson.
Posted in: Breast Implants