Inamed Silicone Breast Implant Core Study Results at 6 Years

Abstract

Study results demonstrate the safety and effectiveness of Inamed silicone-filled breast implants through 6 years, including a low rupture rate and high satisfaction rate.

Acellular Dermal Matrix for Optimizing Outcomes in Implant-Based Breast Reconstruction: Primary and Revisionary Procedures

“…Core clinical studies from device manufacturers have reported a 6-year cumulative incidence of capsular contracture rate of 14%-16% in primary and 25% in revision reconstruction patients (Cunningham & McCue, 2009;Spear et al, 2007). Capsular contracture was also the most common reason for revisionary surgery in these studies.…”

“…Despite these benefits, implant-based reconstruction is not without concerns; it is associated with a high rate of implant-related complications notably capsular contracture, implant malposition, asymmetry, and rippling (Cunningham & McCue, 2009;Handel et al, 2006;Spear et al, 2007). Consequently, rates of revisionary surgery are also high; approximately 34%-52% of reconstruction patients undergo revision surgery within 3-6 years of their primary procedure and 36% of revision reconstruction patients undergo further revisionary surgery (Cunningham & McCue, 2009;Handel et al, 2006;Spear et al, 2007).…”

“…In primary reconstruction patients, a 20% reoperation rate due to implant malposition has been reported over a 6-year period (Spear et al, 2007). A number of factors may cause implant malposition including inadequate or excessive pocket dissection; overzealous release of the IMF, lateral and/or medial release of breast tissues, or lateral and/or medial release of the pectoralis major muscle; placement of excessively large implants; or attenuated capsular tissues (Baxter, 2003).…”

Breast implant design

“…However, these studies compared the third generation silicone implants to saline implants and therefore the current implants may have other outcomes since 4 th generation silicone breast implant safety and long-term outcomes have been described (22,23,25,27,28,41).…”

Cross-Linked Hyaluronic acid can Prevent the Capsular Contracture Formation

“…BBC causes breast firmness, uncomfortableness, pain, a change in the appearance of the breast, and palpability of the silicone implants. In clinical settings, the incidence of symptomatic BCC ranges from 5 to 20% [2,3] and additional surgeries may be required to clean the scar tissue which may involve removal or replacement of the implants [4]. Currently, there is no effective treatment to avoid BCC.…”