Prepectoral direct-to-implant breast reconstruction using a novel acellular dermal matrix: framework for a cohort study
Tanas Y., Swed S., Spiegel A.
Retrospective Study, published in Int J Surg Protoc (2025) — summary generated from the PubMed abstract.
Early human evidence such as case series or small samples is exploring possible benefits.
- Level A · Stronger Clinical Evidence
- Level B · Emerging clinical evidence with positive signals
- Level C · Early human research exploring benefits
- Level D · Scientific groundwork from lab and animal studies
- Emerging · Emerging topic under active research
This page is generated from the PubMed record. The Thai description is an automated summary of bibliographic fields and the abstract, not a full translation, and is not medical advice.
- Study type
- Retrospective Study
- Journal
- Int J Surg Protoc (2025)
- Reported sample size
- —
- Source database
- Europe PMC
- PMID
- 41334424
- PMCID
- PMC12668585
- DOI
- 10.1097/sp9.0000000000000059
- Citations
- 1
Abstract (original English)
Background Capsular contracture remains a significant complication in implant-based breast reconstruction, particularly in the context of prepectoral direct-to-implant (DTI) techniques. The advent of acellular dermal matrices (ADMs) has enabled broader adoption of prepectoral reconstruction by enhancing implant support and tissue integration. FlexHD Pliable PRE is a novel ADM designed specifically for prepectoral breast reconstruction, featuring fenestrations and conformable architecture to optimize pocket support and aesthetic outcomes. However, clinical data evaluating capsular contracture rates and associated risk factors with this product remain limited. Objective To determine the incidence of capsular contracture and identify associated risk factors in patients undergoing prepectoral DTI breast reconstruction using FlexHD Pliable PRE. Methods This retrospective cohort study includes all consecutive patients who underwent prepectoral DTI breast reconstruction with FlexHD Pliable PRE between February 2017 and June 2024. Exclusion criteria include subpectoral placement, autologous reconstruction, and follow-up under 12 months. Patient demographics, procedural details, and postoperative outcomes (including capsular contracture, implant malposition, infection, implant loss, and other potential complications) will be collected. Capsular contracture will be defined as Baker grade
What this study does not prove
- • This study does not prove SVF is an approved treatment or a replacement for standard care.
- • Without an adequate control group, treatment effects cannot be separated from other factors.
Evidence level
Early human evidence such as case series or small samples is exploring possible benefits.
How we grade evidenceBrowse all related research
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