New scar-wrap to treat painful tightness after breast implants
Part of Cancer, Women’s health & pregnancy clinical trials.
This trial tests a medical mesh/scaffold (GalaFLEX LITE™) used during revision surgery to help treat capsular contracture, where scar tissue tightens around a breast implant. It may improve comfort and the appearance of the breast after implant augmentation problems.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You were assigned female at birth, and you’re between 22 and 70 years old
- You have capsular contracture with Baker grade 3 or 4 (the tightness is considered severe)
- You want new silicone implants with no more than about a 150cc change in size
- You plan to have the revision done through an incision under the breast fold (IMF)
- You can come to study visits for 2 years and use an electronic diary with smart technology
- You’re able to sign informed consent after reviewing the implant decision checklist
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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