Los Angeles Plastic Surgeon Reports on 5-Year Follow-Up Data for Sientra Breast Implants
Study Published in Plastic and Reconstructive Surgery in November.
Marina Del Rey, California (October 2012) – Principal investigator W. Grant Stevens, MD, FACS, reported results of a 5-year follow-up study of Sientra breast implants in the November issue of Plastic and Reconstructive Surgery. Titled "5-Year Follow-Up Data from the U.S. Clinical Trial for Sientra's U.S. Food and Drug Administration–Approved Silimed® Brand Round and Shaped Implants with High-Strength Silicone Gel," the study concluded that 5 years of study continue to provide a comprehensive safety and effectiveness profile of Sientra's portfolio of Silimed brand shaped and round implants.
"In March of 2012, the FDA approved Sientra's application for premarket approval of its Silimed brand silicone gel implants based on data from the largest silicone gel breast implant study to date. This was the first approval for shaped silicone gel breast implants," said Dr. Stevens, a board-certified Los Angeles plastic surgeon. "This was the largest pivotal breast implant clinical trial of its kind, which helped achieve approval of the first, and currently only, form-stable anatomical gel breast implant along with the high-strength cohesive silicone gel round implants." He added that this study which included data from 1,800 subjects implanted with 3,506 Sientra silicone gel breast implants is a critical step in furthering the science and safety of breast implants, as well as evidence of a high satisfaction rate among women for all implantation indications.
The round and shaped breast implants, which have been available on all continents and in over 70 countries for almost 15 years, are now available in the United States for primary and revision breast augmentation in women at least 22 years old and for primary and revision breast reconstruction in women of any age.
Dr. Stevens said, "Complication rates remained low over the 5 year period. Subjects reported that the implants looked natural and soft." He added that while the complication rate was relatively low, there were reports of capsular contracture and asymmetry. "The rate of contracture was more than 3 times lower for textured implants versus smooth, which needs further study. We noted that the rate of occurrence suggests that some complications may be the result of surgical technique (e.g., incision size and implant placement) rather than the implant itself."
The study will continue through 10 years after implantation to examine the long term safety and effectiveness of Sientra's implants. For a copy of the abstract click here.
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