Ongoing Safety and Efficacy of Sientra Silicone Gel Breast Implants Supported by Nine Years of Follow-up Data

Study by Dr. Grant Stevens, Et Al. Reported in Aesthetic Surgery
Journal

MARINA DEL REY, Calif.–(BUSINESS WIRE)–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. Read the full text of the article here http://bit.ly/1SLjncO.

“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,” Dr. Stevens said.
“Data presented in this article further provide guidance to patients and
board-certified plastic surgeons in making an informed decision
regarding breast implant options.”

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 Marina
Plastic Surgery; Facebook;
and follow on Twitter @DrGrantStevens.

Contacts

for Marina Plastic Surgery
Susan Tellem, 310-313-3444 x1
APR,
RN, BSN
Susan@tellemgrodypr.com