Sientra Launches Industry's First-Ever Patient-Centric Capsular Contracture Care Program
- The innovative patient-care program, named CapCon Care or C3, was introduced and received enthusiastically, at the recent annual meeting of the American Society of Plastic Surgeons.
- C3 is supported by capsular contracture analysis results from Sientra's 5-year clinical studies that enrolled 2,560 patients (5,109 implants), published in the November 2013 issue of the prestigious peer-reviewed Plastic and Reconstructive Surgery (PRS) journal.
SANTA BARBARA, Calif.--(October 22, 2013)--Sientra, a privately-held medical device company focused on plastic surgery and aesthetic medicine, announced the launch of its Capsular Contracture Care program, or C3, a first-of-its-kind protection program for women seeking primary breast augmentation.
With this program, women will finally have the comfort of knowing there is assistance in the event they experience capsular contracture, a tightening of the scar tissue around the breast implant that can occasionally cause the breast to feel too firm. Women who receive any shape, size or style of Sientra's textured breast implants featuring TRUE Texture™ will be eligible for a free-of-charge product replacement if they develop capsular contracture of the breast requiring revision surgery within two years of implantation.
"For years, concerns about capsular contracture have existed," said Hani Zeini, Founder and CEO of Sientra. "Sientra is proud, once again, to take a leadership position in the U.S. by advancing patient care through offering valuable and innovative solutions for both patients and physicians. The C3 program is the embodiment of the forward-thinking and disruptive innovation Sientra has become known for."
Additionally, in the November 2013 edition of Plastic and Reconstructive Surgery (PRS), an article titled "Risk Factor Analysis for Capsular Contracture in Sientra's Silimed-Brand Round Smooth and TRUE Texture Implants" by Stevens et al., looks at a variety of factors affecting capsular contracture rates in Sientra's U.S. clinical studies. This analysis covers 2,560 patients (5,109 implants) at 34 clinical sites through 5-years, making it the largest study of its kind, to-date, providing a robust dataset that allows for statistically significant findings.
Importantly, the article concludes that there is a statistically significant reduction in capsular contracture with TRUE Texture implants, which are unique to the Sientra portfolio, when compared to smooth implants. This article is the most thorough multivariate analysis to-date comparing the results of textured and smooth implants in regards to capsular contracture. Armed with this data and analysis, Sientra offers the ground-breaking and unprecedented C3 program to its customers, and their patients. The Sientra C3 program is characterized by its remarkable simplicity and protection.