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

Exploring GalaFLEX LITE™ for breast implant contracture treatment.

Recruiting
22-66 years
Female
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is exploring a new method to reduce a problem called capsular contracture after breast implant surgery. Capsular contracture happens when scar tissue forms tightly around a breast implant, making it feel hard or look different. The study tests the GalaFLEX LITE™ Scaffold, a supportive mesh, to see if it helps avoid contracture better than usual methods. Participants will be randomly chosen to either get this scaffold or not during their revision surgery. This research will involve between 250 and 530 breasts.

  • Study Length: Participants must agree to follow-up visits for 2 years.
  • Eligibility: Only women aged 22-66 with specific breast conditions can join.
  • Risks: Includes potential infections and need for additional surgeries.

Participants must live within 3 hours of the study location and be willing to attend follow-ups. Some people will not qualify, such as those with certain health conditions or those who have had multiple previous surgeries for capsular contracture.

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Study details
    Capsular Contracture Associated With Breast Implant
    Capsular Contracture Grade III
    Capsular Contracture Grade IV

NCT05945329

C. R. Bard

7 March 2026

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