Overview
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.
Description
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.
Eligibility
Inclusion Criteria:
- Genetically female ≥22 and ≤66 years of age;
- Breast augmentation subject with capsular contracture (Baker grade III or IV);
- 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);
- Planned revision approach via inframammary fold (IMF) incision;
- Willing and able to comply with the study procedures including the 2-year follow-up visit;
- Lives within 3 hours driving distance from the investigator site; and,
- Provision of signed and dated informed consent form.
Exclusion Criteria:
- BMI <18 or >35
- Existing and/or replacement implant size > 800 cc
- Had ≥2 capsular contracture revisions on the breast(s) intended for treatment
- Has an extra-capsular rupture (breast implant silicone gel or saline 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.
- 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)
- Has symptoms consistent with Breast Implant Illness (BII)Systemic Symptoms Associated with Breast Implants (SSBI)
- Infection present in the breast (day of surgery exclusions are noted in Section 5.3)
- Current or recent breast feeding (within 3-months or enrollment) or history of mastitis within the 6-months prior to enrollment
- Prior or current diagnosis of breast cancer
- Has a mass that was palpated and has not been determined benign via acceptable imaging (MRI) or biopsy results
- Has undergone prior chest radiation treatment
- Has received chemotherapy within the last 12 months
- Current or recent (within 1-year of enrollment) alcohol/substance abuse
- Current or recent (within 4-weeks of enrollment) nicotine user (includes cigarettes, vaping, patches, gum, etc.)
- History of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) or Breast Implant Associated Squamous Cell Carcinoma (BIA-SCC)
- Planned use of another type of matrix (such as ADM) in addition to GalaFLEX LITE™
- 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)
- 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)
- 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)
- 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
- Is pregnant or plans to become pregnant during the study period
- Known allergy to tetracycline hydrochloride and kanamycin sulfate
- 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
- Subject will not remain under the care of the investigator for all plastic surgery procedures while enrolled in the study
- Actively using immunosuppressants such as oral steroids or biological therapies (inhalers or topical steroids are permitted)
- 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
- Has, in the investigator's opinion, a mental illness or disability that would preclude their participation in the study
- Subject has an implant that was never commercially available in the United States (had their breast augmentation in another country)
- Has been implanted with any silicone implant other than breast implants
- Is taking any drugs that would interfere with blood clotting or might result in elevated risk of significant postoperative complications
- 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. -