“The follow-up data from the ongoing Core Study of the Sientra portfolio of HSC and HSC+ silicone gel breast implants reaffirm the strong safety profile as well as continued patient satisfaction,” says lead author W. Grant Stevens, MD, FACS, founder and director of Marina Plastic Surgery in Marina del Rey, Calif, in a media release.
“Data presented in this article further provide guidance to patients and board-certified plastic surgeons in making an informed decision regarding breast implant options,” he adds.
The prospective, multicenter clinical study designed to assess the safety and effectiveness of Sientra silicone gel breast implants began in 2002 and is currently in its 10th and final year of clinical follow-up.
The study enrolled 1,788 patients and 3,506 implants in four indications: 1,116 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, the release explains.
[Source(s): Marina Plastic Surgery, Business Wire]