Sientra Reports the Long-term Safety and Effectiveness of Silicone Gel Breast Implants with Results from the Largest Core Breast Implant Trial To-Date
Santa Barbara, California – April 2, 2018 – Plastic and Reconstructive Surgery’s recently published annual supplement included data validating Sientra’s growing portfolio of implants and expanders as safe and innovative options for surgeons and patients undergoing aesthetic or reconstructive breast surgery. The four-part supplement, which includes the Company’s finalized 10-year FDA Core Study, provides a comprehensive look at the long-term outcomes, surgical best practices and product differentiation of Sientra’s breast implants and tissue expanders.
Clinical data from all U.S. manufacturers’ FDA-approved 10-year studies, including comparisons of smooth and textured breast implants were reported and showed that Sientra implants performed safely over the long-term. The Sientra 207 highly cohesive breast implants reported high satisfaction with surgeons and patients, with 92% of plastic surgeons and 94% of patients reporting satisfaction with surgical results. This supplement also includes important new data and preventative measures for capsular contracture.
Also captured within the supplement were surgeon’s case studies on Sientra’s breast tissue expander, the AlloX2®, which is the first and only dual port breast tissue expander designed to address post-surgical infection with its novel drainage system. The studies highlighted the product’s effectiveness in treating post-surgical seromas, the most common complication in tissue expander-based breast reconstruction, and the authors noted the product should be considered for non-invasive treatment of other common complications of tissue expander-based breast reconstructions.
“This supplement is an important new resource for surgeons as they evaluate the benefits and risks associated with all breast implant options,” said Dr. Brad Calobrace, the lead editor of the analysis. “Sientra continues to provide surgeons with a wealth of data to help them make educated choices about which breast implants options are right for their patients.”
At the 10-year time point in the study, the overall incidence of cancer and connective tissue disease remained low and no cases of BIA-ALCL reported. Although BIA-ALCL is a rare condition, Sientra is committed to remaining at the forefront of this research and education through collaborations with board-certified plastic surgeons, medical societies and regulatory bodies.
“We are proud of the long-term safety and effectiveness of Sientra’s portfolio of implants and expanders,” said Rosalyn d’Incelli, Sientra Vice President of Clinical and Medical Affairs. “The safest and best outcomes for patients will come from putting the best implants in the hands of highly trained, board-certified plastic surgeons, and Sientra commits to continue to provide superior implant options for both surgeon and patients.”
Headquartered in Santa Barbara, California, Sientra is a medical aesthetics company committed to making a difference in patients’ lives by enhancing their body image, growing their self-esteem and restoring their confidence. The Company was founded to provide greater choice to board-certified plastic surgeons and patients in need of medical aesthetics products. The Company has developed a broad portfolio of products with technologically differentiated characteristics, supported by independent laboratory testing and strong clinical trial outcomes. The Company sells its breast implants and breast tissue expanders exclusively to board-certified and board-admissible plastic surgeons and tailors its customer service offerings to their specific needs. The Company also offers a range of other aesthetic and specialty products including BIOCORNEUM®, the professional choice in scar management, and miraDry®, the only FDA cleared device to reduce underarm sweat, odor and permanently reduce hair of all colors.
For more information about Sientra, visit www.sientra.com.