While there are numerous complications that occur from having breast implants, most patients never think of one that has been around for decades…capsular contracture. This is the development of abnormal amounts of scarring around an implant. While normally significant scarring around a medical implant may be irrelevant or even advantageous, it is not so around a device that is designed to make a soft and supple feeling and looking breast.
Capsular contracture has been extensively studied and it is still not completely understood why it happens in some patient’s breast implants and in most others it does not. Biofilms are now cited as a causative factor outside of hematomas and documented infections. Prevention of capsular contracture has historically focused on the implant’s properties including submuscular implant placement and textured implant surfaces.
Textured breast implant surfaces have been used in elective breast augmentation and breast reconstruction to both help long-term implant positioning and prevent capsular contracture. In the November 2013 issue of the journal Plastic and Reconstructive Surgery, an article appeared entitled ‘Risk Factor Analysis for Capsular Contracture in Silimed-Brand Round Smooth and TRUE Texture Implants’. This clinical study evaluated over 2,500 patients (over 5,000 implants) over five years to assess the capsular contracture rates. The found that there is a statistically significant reduction in the occurrence of capsular contracture with the TRUE texture implants compared to smooth implants.
With these findings, Sientra announced a new warranty program known as C3, the first of its kind for first-time breast augmentation patients who choose Sientra-brand textured implants. The C3 program provides a free replacement implant if the patient requires revisional breast surgery for a Baker Grade III or IV capsular contracture within the first two years after the original implantation surgery. This is in addition to the current implant deflation warranty. No additional registration forms or fees will be required.
This is the first-of-its kind of protection program for women undergoing primary breast augmentation. With this program, women will finally have the comfort of knowing there is assistance in the event they ever 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.
Dr. Barry Eppley
Indianapolis, Indiana