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

Inclusion Criteria:

1. Genetically female ≥22 and ≤66 years of age;

2. Breast augmentation subject with capsular contracture (Baker grade III or IV);

3. Desired a new implant with no more than a 25% increase in implant size (not toexceed a volume increase greater than 150cc compared to the existing implant);

4. Planned revision approach via inframammary fold (IMF) incision;

5. Willing and able to comply with the study procedures including the 2-year follow-upvisit;

6. Lives within 3 hours driving distance from the investigator site; and,

7. 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. Had ≥2 capsular contracture revisions on the breast(s) intended for treatment

4. Has an extra-capsular rupture (breast implant silicone gel or saline has leakedoutside of the capsule) in breast(s) intended for treatment

5. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended fortreatment.

6. Abnormal findings on diagnostic imaging within 1-year of study enrollment (mammogramfor patients ≥35 years old; MRI for patients <35 years old or breast ultrasound ifMRI is contraindicated)

7. Has symptoms consistent with Breast Implant Illness (BII)Systemic SymptomsAssociated with Breast Implants (SSBI)

8. Infection present in the breast (day of surgery exclusions are noted in Section 5.3)

9. Current or recent breast feeding (within 3-months or enrollment) or history ofmastitis within the 6-months prior to enrollment

10. Prior or current diagnosis of breast cancer

11. Has a mass that was palpated and has not been determined benign via acceptableimaging (MRI) or biopsy results

12. Has undergone prior chest radiation treatment

13. Has received chemotherapy within the last 12 months

14. Current or recent (within 1-year of enrollment) alcohol/substance abuse

15. Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes,vaping, patches, gum, etc.)

16. History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) orBreast Implant Associated Squamous Cell Carcinoma (BIA-SCC)

17. Planned use of another type of matrix (such as ADM) in addition to GalaFLEX LITE™

18. Current or planned use of medical (e.g. Singulair), physical (e.g. massage), ordevice-assisted (e.g. mechanical/thermal ultrasound) tools to manage the breastcapsule(s)

19. Any medical condition that, in the opinion of the investigator, may be associatedwith unduly high risk of intra- or post-operative complications (e.g.,insulin-dependent diabetes, autoimmune disease, connective tissue disorder, chroniclung or severe cardiovascular disease)

20. Concurrent or planned (within the 2-year follow-up time period) elective cosmeticbreast operation to the treated breast (e.g., autologous fat transfer, mastopexy, orimplant size changes)

21. Currently enrolled or has plans to enroll in another clinical study that wouldinterfere with this study, unless it is a retrospective or observational study

22. Is pregnant or plans to become pregnant during the study period

23. Known allergy to tetracycline hydrochloride and kanamycin sulfate

24. Any condition that, in the Investigator's opinion, would preclude the use of thestudy 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 plastic surgeryprocedures 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 lupuserythematosus, Sjorgren's syndrome, scleroderma, polymyositis, or any connectivetissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis,spondyloarthropathies, any other inflammatory arthritis, fibromyalgia, or chronicfatigue syndrome

28. Has, in the investigator's opinion, a mental illness or disability that wouldpreclude their participation in the study

29. Subject has an implant that was never commercially available in the United States (had their breast augmentation in another country)

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 inelevated risk of significant postoperative complications

32. Works for Sponsor or any of their subsidiaries, the study surgeon, or is helping toconduct the study or are directly related to anyone that works for BD or any oftheir subsidiaries or the study surgeons. -