# Acellular dermal matrices and meshes in implant reconstruction

Source: https://onco.cc/technologies/acellular-dermal-matrix-breast/  
OnCo record `acellular-dermal-matrix-breast` (Technology). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Sheets of processed animal or human skin, or absorbable synthetic mesh, used by surgeons to cover or support a breast implant or expander. The FDA has warned that complication rates differ between products.

## Summary

Matrices and meshes reach the US market under general surgical mesh codes rather than for breast reconstruction specifically: TEI Biosciences' SurgiMend was cleared as surgical mesh (K083898, 4 February 2009, code FTM) and Tepha's GalaFLEX absorbable mesh as surgical film (K140533, 21 May 2014, code OOD). On 31 March 2021 the FDA issued a safety communication, now archived on its breast implant page, titled "Acellular Dermal Matrix (ADM) Products Used in Implant-Based Breast Reconstruction Differ in Complication Rates". In implant reconstruction the matrix forms a sling at the lower edge of the implant or wraps it completely when the implant sits in front of the chest muscle.

## Fields

- Kind: Technology
- Status: established
- Last checked: 2026-11-04
- Also known as: Acellular dermal matrix; ADM; Biological mesh; SurgiMend; GalaFLEX; AlloDerm
- Tags: devices-gaps-2026-11
- Principle: A decellularised collagen scaffold or bioabsorbable polymer mesh is sutured to the chest wall and muscle to cover and position the implant while the patient's own tissue grows into it.
- Since: 2009
- Strengths: Allows implant placement in front of the muscle; Supports the implant's position
- Limitations: Complication rates differ between products (FDA, 2021); Seroma and infection; adds cost

## Sources

- FDA 510(k) K083898: SurgiMend (4 February 2009): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K083898
- FDA 510(k) K140533: GalaFLEX mesh (21 May 2014): https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K140533
- FDA: breast implants (safety communications and labeling guidance): https://www.fda.gov/medical-devices/implants-and-prosthetics/breast-implants

## Connected records

- cancers: [Breast cancer (all types)](https://onco.cc/cancers/breast-cancer/)
- fronts: [Devices & Physical Therapies](https://onco.cc/fronts/devices/), [Surgery & Interventional](https://onco.cc/fronts/surgery/)
- technologies: [Breast implants for reconstruction (silicone gel, saline and shaped cohesive gel)](https://onco.cc/technologies/breast-implants/), [Breast reconstruction: implant and autologous, immediate and delayed, and what women report afterwards](https://onco.cc/technologies/rejuv-recon-breast/), [Breast tissue expanders (saline and carbon dioxide)](https://onco.cc/technologies/breast-tissue-expanders/)
- terms: [Breast reconstruction](https://onco.cc/terms/breast-reconstruction/)

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