Q. I understand that the FDA recently approved a new silicone gel-filled breast implant by a company called Sientra. What is a gel-filled implant and how is it used?A. On March 9, 2012, the U.S. Food and Drug Administration (FDA) approved a silicone gel-filled breast implant manufactured by Sientra, Inc. (based in Santa Barbara, CA) to increase breast size (augmentation) in women at least 22 years old and to rebuild breast tissue (reconstruction) in women of any age. As a condition of approval, Sientra is required to conduct post-approval studies that will assess long-term safety and effectiveness outcomes as well as the risks of rare disease outcomes. The FDA based its Sientra approval on three years of clinical data from 1,788 participants.
Silicone gel-filled breast implants are medical devices implanted under the breast tissue or under the chest muscle for breast augmentation or reconstruction. These implants have a silicone outer shell that is filled with silicone gel. They come in different sizes and have either smooth or textured shells.
Breast reconstruction includes primary reconstruction to replace breast tissue that has been removed due to cancer or trauma or that has failed to develop properly due to a severe breast abnormality. Breast reconstruction also includes revision surgery to correct or improve the result of a primary breast reconstruction surgery.
Breast augmentation includes primary breast augmentation to increase the breast size, as well as revision surgery to correct or improve the result of a primary breast augmentation surgery. With this recent new approval, there are now three FDA-approved silicone gel-filled breast implants in the U.S. manufactured by Allergan, Mentor and most recently, Sientra.
In our practice, we begin with a private, complimentary consultation that serves to determine desired results for breast augmentation. There are multiple options when it comes to breast implants and we encourage all patients who are seeking this procedure to discuss all alternatives thoroughly with their physician. We see an increase in inquiries this time of year as women prepare for the upcoming summer swimsuit season. Spring is an opportune time for this procedure as patients are usually able to return to work within a week of breast augmentation, and can resume all other normal activities after two to four weeks. Scars will begin to fade after a few months. Our patients find that shopping for clothes and participating in summer activities are far more pleasurable, and usually report an increased sense of self-confidence.
John Smoot, MD, is Chief of Plastic Surgery at Scripps Memorial Hospital-La Jolla and Wendell Smoot, MD, has been voted by his peers as Top Doctor in San Diego for five consecutive years. Carol Hollan, MD, is San Diego’s first female board-certified plastic surgeon while Reza Sadrian, MD, is one of very few plastic surgeons dually certified in plastic and reconstructive surgery as well as oral and maxillofacial surgery. The practice has over 20 years of tenure in the industry and each is individually board certified by the American Board of Plastic Surgery. Any of the physicians can provide consultations on plastic surgery procedures and/or laser and skincare treatments at their Laser and Skincare Center and can be reached at their offices on the campus of Scripps Memorial Hospital-La Jolla in the Ximed Medical Building by calling (858) 587-9850 or via the web at sandiegoplastiscurgeryclinic.com.
By Wendell Smoot, MD, Reza Sadrian, MD, Carol Hollan, MD and John Smoot, MD