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Using GalaFLEX LITE™ Scaffold to treat capsular contracture after breast augmentation

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

Not applicable Interventional C. R. Bard · NCT05945329

This study is testing if a new scaffold called GalaFLEX LITE™ can help people who have had breast augmentation and are dealing with capsular contracture to feel better and avoid further problems after surgery.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment250 (estimated)
Ages22 Years to 66 Years
SexFemale
SponsorC. R. Bard Industry-sponsored
Drugs / interventionschemotherapy, radiation
Locations32 sites (Scottsdale, Arizona and 31 other locations)
Trial IDNCT05945329 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the GalaFLEX LITE™ Scaffold in patients undergoing revision surgery for capsular contracture following breast augmentation. Participants will be randomly assigned to receive either the scaffold or standard surgical care without any supportive matrix. The study aims to determine if the scaffold can reduce the recurrence of capsular contracture and related complications compared to conventional methods. The trial will involve between 250 and 530 treated breasts and will follow patients for up to two years post-surgery.

Who should consider this trial

Good fit: Ideal candidates are genetically female individuals aged 22 to 66 with Baker grade III or IV capsular contracture seeking revision surgery.

Not a fit: Patients with a BMI outside the range of 18 to 35 or those who have had multiple previous revisions for capsular contracture may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the recurrence of capsular contracture and improve outcomes for breast augmentation patients.

How similar studies have performed: While the use of scaffolds in surgical procedures is gaining interest, this specific approach with GalaFLEX LITE™ Scaffold is novel and has not been extensively tested in prior studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 to exceed 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-up visit;
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 leaked outside of the capsule) in breast(s) intended for treatment
5. Has prior use of a matrix (synthetic or biologic) in the breast(s) intended for treatment.
6. Abnormal findings on diagnostic imaging within 1-year of study enrollment (mammogram for patients ≥35 years old; MRI for patients \<35 years old or breast ultrasound if MRI is contraindicated)
7. Has symptoms consistent with Breast Implant Illness (BII)Systemic Symptoms Associated 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 of mastitis 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 acceptable imaging (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) or Breast 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), or device-assisted (e.g. mechanical/thermal ultrasound) tools to manage the breast capsule(s)
19. 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)
20. Concurrent or planned (within the 2-year follow-up time period) elective cosmetic breast operation to the treated breast (e.g., autologous fat transfer, mastopexy, or implant size changes)
21. Currently enrolled or has plans to enroll in another clinical study that would interfere 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 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 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 (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 in elevated risk of significant postoperative complications
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. -

Where this trial is running

Scottsdale, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Capsular Contracture Associated With Breast ImplantCapsular Contracture Grade IIICapsular Contracture Grade IV
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.