Prospective, randomized, controlled study to assess the safety and effectiveness of GalaFLEX LITE™ Scaffold in revision surgery for reduction of capsular contracture recurrence and/or malposition in implant-based breast augmentation patients versus patients undergoing conventional revision surgery with no supportive matrix or acellular dermal matrix (ADM). Subjects will be randomized 2:1 to receive either GalaFLEX LITE™ Scaffold or standard care (no ADM or matrix placement). This study is designed using an adaptive approach. The number of the treated breasts will range between 250 and 530.
Genetically female ≥22 and ≤70 years of age;
Breast augmentation subject with capsular contracture (Baker grade III or IV);
Desires a new silicone implant with no more than a ± 150cc volume change in implant size;
Planned revision approach via inframammary fold (IMF) incision;
BMI <18 or >35
Existing and/or replacement implant size > 800 cc
Has an extra-capsular silicone breast implant rupture where silicone gel has leaked outside of the capsule) in breast(s) intended for treatment
Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment
Parallel
GalaFLEX LITE™ Scaffold
DeviceBioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB) and knitted into a surgical scaffold used to reinforce soft tissue
Standard surgery
Other interventionSurgery performed without the use of a scaffold
Effectiveness of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket
Composite of Recurrent Capsular Contracture Baker grade III/IV and/or breast implant malposition
Patient quality of life and satisfaction (12-month)
Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest
Patient quality of life and satisfaction
Select Breast-Q© modules (standardized patient survey) for the treated breast(s): psychosocial wellbeing; sexual wellbeing; satisfaction with breasts; and physical wellbeing - chest
Safety of GalaFLEX LITE™ Scaffold for the stabilization of the implant pocket, reduction of capsular contracture recurrence, and/or malposition
The occurrence of: * Breast fluid collection requiring a drainage procedure at any time, or after drain removal if one is used, within 90 days of surgery * Breast infection requiring oral (PO) or intravenous (IV) antibiotics related to the contracture revision surgery within 90 days of surgery
Device or procedure related adverse events
Select adverse events including: breast infection requiring PO or IV antibiotics related to the revision surgery; breast fluid collection requiring a drainage procedure; breast implant loss; any unscheduled/unanticipated breast reoperation; breast implant malposition recommended for surgery; skin necrosis; wound dehiscence; any seroma within 90 days of surgery; any hematoma within 90 days of surgery; capsular contracture Baker Grade \>1; and red breast syndrome
