BellaGel breast implant: 6-Year results of a prospective cohort study

Background This is the first clinical study conducted among Asian women using breast implants manufactured by an Asian company. Four-year data regarding the safety and efficacy of BellaGel breast implants have already been published, and we now report 6-year data.Methods This study was designed to take place over 10 years. It included 103 patients who underwent breast reconstruction or augmentation using BellaGel breast implants. The rates of implant rupture and capsular contracture were measured and analyzed to evaluate the effectiveness of the breast implant.Results At patients’ 6-year postoperative visits, the implant rupture and capsular contracture rates were 1.15% and 2.30%, respectively. The implant rupture rate was 3.77% among reconstruction cases and 0% among augmentation cases. The capsular contracture rate was 5.66% among reconstruction cases and 0.83% among augmentation cases.Conclusions The 6-year data from this planned 10-year study suggest that the BellaGel cohesive silicone gel-filled breast implant is an effective and safe medical device that can be used in breast reconstruction and augmentation.

Correlation between the Used Polymeric Biomaterials, Implant Design and Clinical Performance of the Mammary Implants

Based on different statistics, we could consider that the most frequent operation in plastic surgery is breast surgery with the support of mammary implants. Some women have from the beginning those aesthetic features to seduce the audience but others need some improvements by using artificial implants and surgical techniques to obtain similar results. In the last time, specialists from medicine and engineering try to find out technical solutions to obtain good quality mammary implants using advanced polymeric biomaterials or surface modifying techniques, in order to assure more time lasting for these implants and less reactivity from the human body. Today, the mammary implants are manufactured currently by a silicone elastomer shell filled with cohesive silicone gel or with saline liquid. In this paper we present aspects from our experience in which we operated more than 500 patients who need aesthetic improvements with mammary implants for different clinical situation like breast augmentation, breast reconstruction after oncologic surgery and breast asymmetry.