DATA SUPPORTS SIENTRA BREAST IMPLANT SAFETY.
Since approval in March 2012, data on Sientra's silicone gel implants have been updated and published regularly to provide immediate visibility to the continued safety and performance of these devices. The nine-year follow-up data support the previously published data confirming the ongoing safety and efficacy of Sientra breast implants, reports Grant Stevens, MD, FACS, et al., in the Aesthetic Surgery Journal (Vol. 36 (4): 404-416). The authors provide updated nine-year study data for Sientra's round and shaped silicone gel breast implants.
The Sientra Core Study began enrollment in 2002 at institutional review board-approved clinical sites across the United States (the list of the approving institutional review boards is available online at www.aestheticsurgeryjournal.com). The prospective, multicenter clinical study is currently in its 10th and final year of study follow-up. The study was designed to assess the safety and effectiveness of the Sientra silicone gel breast implants. A total of 1788 patients and 3506 implants in four indications were enrolled: 1116 primary augmentation, 363 revision-augmentation, 225 primary reconstruction and 84 revision-reconstruction. Across all four cohorts, the magnetic resonance imaging (MRI) cohort consists of 571 patients who undergo regular MRIs to assess for ruptures. Additionally, as of approval in 2012, all non-MRI cohort patients were provided the opportunity to undergo MRI.
Dr. Stevens is the founder and medical director of Marina Plastic Surgery. He is a board certified Diplomate of the American Board of Plastic Surgery, a Fellow of the American College of Surgeons and the International College of Surgeons. He is Chairman of the USC-Marina Aesthetic Surgery Fellowship, Director of the USC Division of Aesthetic Surgery and a Clinical Professor of Surgery at the USC Keck School of Medicine. Dr. Stevens serves on the Board of Directors as treasurer of the American Society of Aesthetic Plastic Surgery, as well as the third vice president for the International Society of Aesthetic Plastic Surgery where he serves as one of the traveling professors. He has spoken at more than 100 meetings and 300 invited talks nationally and internationally.
For more information, visit www.marinaplasticsurgery.com or call 310/313-3444 x1.
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|Publication:||Biotech Equipment Update|
|Date:||Mar 31, 2016|
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