Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation

A Prospective, Randomized, Controlled, Multi-Center Study of GalaFLEX LITE™ Scaffold in Treatment of Capsular Contracture After Breast Implant Augmentation

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 breast implant malposition recommended for surgery OR breast infections requiring oral or IV antibiotic treatment within 90 days of surgery and/or peri-implant fluid collection needing a drainage procedure within 10-90 days of surgery.

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 provided by the manufacturer);
8. Has compatible smart technology that can be used for downloading/using the electronic patient diary; and,
9. Provision of signed and dated informed consent form.

Exclusion Criteria:

1. BMI <18 or >35
2. Existing and/or replacement implant size > 800 cc
3. Has an extra-capsular silicone breast implant rupture where silicone gel has leaked outside of the capsule) in breast(s) intended for treatment
4. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment
5. Abnormal breast findings on imaging within 1-year prior to randomization that have not been determined to be benign
6. Subject reported current, or prior history of, Systemic Symptoms Associated with Breast Implants (SSBI - formerly referred to as BII (Breast Implant Illness))
7. Infection present in the study breast(s) (day of index procedure (surgery) exclusions)
8. Current or recent breastfeeding (within 3-months of enrollment) or history of mastitis within the 6-months prior to enrollment
9. Prior or current diagnosis of breast cancer
10. Has a mass that was palpated and has not been determined benign via acceptable imaging (MRI) or biopsy results
11. Has undergone prior chest radiation treatment
12. Has received chemotherapy within the last 12 months
13. Current or recent (within 1-year of enrollment) alcohol/substance abuse
14. Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes, vaping, patches, gum, etc.)
15. History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIAALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)
16. Planned use of any other matrix (synthetic, biosynthetic, or biological) in the study breast(s) other than the GalaFLEX LITE™ Scaffold used to fully wrap the implant
17. Planned (within the 2-year follow-up time period) use of medical (e.g. montelukast/Singulair; zafirlukast/Accolate), physical (e.g. massage), or device assisted (e.g. mechanical/thermal ultrasound) tools to manage the breast capsule(s)
18. Any medical condition that, in the opinion of the investigator, may be associated with unduly high risk of intra- or post-operative complications (e.g., insulin dependent diabetes, autoimmune disease, connective tissue disorder, chronic lung or severe cardiovascular disease)
19. Concurrent or planned use (within the 2-year follow-up time period) of autologous fat transfer in the study breast(s)
20. Planned (within the 2-year follow-up time period) elective cosmetic surgery on the study breast(s) (e.g., staged mastopexy; revision for implant size change)
21. Currently enrolled or has plans to enroll in another interventional clinical study that would interfere with this study
22. Is pregnant or plans to become pregnant during the study period
23. Known allergy to tetracycline hydrochloride and/or kanamycin sulfate
24. Any condition that, in the Investigator's opinion, would preclude the use of the study device, interfere with the evaluation of the device or breast related outcomes
25. Subject will not remain under the care of the investigator for all breast related plastic surgery procedures while enrolled in the study
26. Actively using immunosuppressants such as oral steroids or biological therapies (inhalers or topical steroids are permitted)
27. Confirmed diagnosis of the following rheumatic diseases or syndromes: systemic lupus erythematosus, Sjorgren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronic fatigue syndrome
28. Has, in the investigator's opinion, a mental illness or disability that would preclude their participation in the study
29. Subject has an implant that was never commercially available in the United States
30. Has been implanted with any silicone implant other than breast implants
31. Is taking any drugs that would interfere with blood clotting or might result in elevated risk of significant postoperative complications (e.g., anticoagulants or antiplatelet medications such as Xarelto, Aspirin, or Eliquis. NSAIDs such as Celebrex, Ibuprofen, Meloxicam are not exclusionary).
32. Works for Sponsor or any of their subsidiaries, the study surgeon, or is helping to conduct the study or are directly related to anyone that works for BD or any of their subsidiaries or the study surgeons
33. Subjects planning to undergo significant weight loss utilizing surgical intervention or prescribed medication(s) (e.g., gastric bypass; gastric sleeve; GLP1 agonists). Subjects with stable weight after previous surgery or current GLP-1 agonists use are not excluded.

Day of Index Procedure (Surgery) Exclusion Criteria

1. Has an extra-capsular rupture (breast implant silicone gel has leaked outside of the capsule) in breast(s) intended for treatment
2. Suspicions of cancer from intraoperative capsule appearance such as capsule masses (based on surgical opinion/visual findings; does not require definitive pathology) inclusive of both BIA-ALCL and BIA-SCC; or,
3. Presence of a systemic infection, infection at the surgical site, or infection anywhere in the body at the time of surgery.