“In March of 2012, the FDA approved Sientra’s application for premarket approval for 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. “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 five 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 over three 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. Click here for a copy of the abstract http://www.ncbi.nlm.nih.gov/pubmed/23096598.
About Dr. Stevens: Grant Stevens, MD, FACS, serves as the medical director of Marina Plastic Surgery Associates MarinaPlasticSurgery/a> in Marina del Rey, CA, and is an expert in breast implants having served as the lead investigator of many studies and clinical trials. He is a Clinical Professor of Surgery and the Director of the University of Southern California Aesthetic Surgery Fellowship and the Aesthetic Surgery Division. He is a Board Certified Diplomate of the American Board of Plastic Surgery and a Fellow of the American College of Surgeons. Dr. Stevens is on the editorial board of the Aesthetic Surgery Journal and on the board of directors of the American Society of Aesthetic Plastic Surgery. He has been elected by his peers into the "The Guide to Top Doctors" and Castle Connolly's "Top Doctor Guide" recognizing him as one of the best plastic surgeons in America. Dr. Stevens has authored more than 50 articles and book chapters and is an ASAPS Traveling Professor. He has performed surgery on patients from all 50 states and 63 foreign countries. He is past chairman of the California Medical Association Advisory Panel on Plastic Surgery. He has received the Special Congressional Certificate of Recognition and the Distinguished Service Citation from the Medical Board of California.
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