C. R. Bard
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.
Capsular contracture is the number one complication leading to revision surgery after breast augmentation(2-4) which has been commonly cited as impacting 10 to 20% of all breast augmentation patients.(5-10) A prospective, randomized controlled study of patients presenting with Baker grade III or IV capsular contracture will be undertaken to investigate the ability of P4HB (specifically GalaFLEX LITE™ Scaffold) to reduce the recurrence of clinically significant CC and/or malposition requiring surgical correction. The primary endpoint is a composite of capsular contracture recurrence and/or brea…
Inclusion Criteria: 1. Genetically female ≥22 and ≤70 years of age; 2. Breast augmentation subject with capsular contracture (Baker grade III or IV); 3. Desires a new silicone implant with no more than a ± 150cc volume change in implant size; 4. Planned revision approach via inframammary fold (IMF) incision; 5. Willing and able to comply with the study procedures including the 2-year follow-up visit; 6. Can complete all required study visits as scheduled (i.e., physically attend); 7. Has reviewed and completed an FDA required Breast Implant Patient Decision Checklist (e.g., implant-specific p…
Bioabsorbable surgical mesh manufactured from poly-4-hydroxybutyrate (P4HB) and knitted into a surgical scaffold used to reinforce soft tissue
Surgery performed without the use of a scaffold