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