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Comparative Effectiveness Review of Human Acellular Dermal Matrix for Breast Reconstruction

January 28, 2019

Health Problem: In women without adequate local tissue and muscle envelopes following mastectomy, human acellular dermal matrix (HADM) provides an alternative to autologous tissue donation or more extensive dissection and may enable 1-stage breast reconstruction (BR).

Technology Description: Biologic meshes are extracellular collagen matrices derived from human (allograft) or animal (xenograft; porcine or bovine) tissues. Products differ in the tissue source, material size and thickness, and processing (i.e., decellularization, sterilization, and cross-linking). In immediate postmastectomy BR, HADM is used after skin-sparing mastectomy for prosthesis-based BR. HADM is used to cover a temporary tissue expander or permanent implant, particularly the inferolateral border, for which there is commonly insufficient muscle coverage.

Controversy: The use of HADM remains controversial due to a lack of strong comparative evidence demonstrating superiority to conventional autologous methods or animal-derived acellular dermal matrix, despite the greater cost of HADM. HADM products have been brought to market into the United States through pathways that do not require demonstration of their safety and efficacy. Further, previous systematic reviews have reported increased risk of infection and other complications, compared with conventional BR that does not use HADM.

Key Questions:

For immediate postmastectomy 1-stage and 2-stage prosthesis-based BR:

  • How do clinical outcomes of HADM compare with those of BR methods that do not use mesh?
  • How do clinical outcomes of HADM compare with those of other types of mesh (animal-derived and synthetic)?
  • How do clinical outcomes of different HADM products compare?
  • What complications are associated with biologic mesh, and how do they compare with those associated with other types of mesh or BR that do not employ mesh?
  • Have definitive patient selection criteria for BR with HADM been established?