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CC BY-NC-ND 4.0 · Arch Plast Surg 2022; 49(06): 716-723
DOI: 10.1055/s-0042-1758638
Breast/Trunk
Original Article

A Nationwide Analysis Evaluating the Safety of Using Acellular Dermal Matrix with Tissue Expander-Based Breast Reconstruction

Jessica Luo 
1   Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, Utah
,
Whitney D. Moss 
1   Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, Utah
,
Giovanna R. Pires 
1   Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, Utah
,
Irfan A. Rhemtulla
1   Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, Utah
,
Megan Rosales
2   Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah
,
Gregory J. Stoddard 
2   Division of Epidemiology, Department of Internal Medicine, University of Utah School of Medicine, Salt Lake City, Utah
,
Jayant P. Agarwal 
1   Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, Utah
,
Alvin C. Kwok 
1   Division of Plastic and Reconstructive Surgery, Department of Surgery, University of Utah School of Medicine, Salt Lake City, Utah
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Abstract

Background In March 2021, the United States Food and Drug Administration (FDA) safety communication cautioned against the use of acellular dermal matrix (ADM) products in breast reconstruction and reiterated that the FDA does not approve ADM use in breast surgery. This study aims to assess the safety of ADM use in breast reconstruction.

Methods Women who underwent ADM and non-ADM assisted tissue expander (TE)-based breast reconstruction were identified using the National Surgical Quality Improvement Program database (2012–2019). Trends of ADM use over time, and 30-day outcomes of surgical site infection (SSI), dehiscence, and unplanned reoperation were assessed.

Results Of the 49,049 TE-based breast reconstructive cases, 42.4% were ADM assisted and 57.6% non-ADM assisted. From 2012 to 2019, the use of ADM increased from 26.1 to 55.6% (relative risk [RR] =1.10; p < 0.01). Higher rates of SSI (3.9 vs. 3.4%; p = 0.003) and reoperation (7.4 vs. 6.0%; p < 0.001) were seen in the ADM cohort. There was no significant difference seen in dehiscence rates (0.7 vs. 0.7%; p = 0.73). The most common reoperation within 30 days for the ADM group (17.6%) was removal of TE without insertion of implant (current procedural terminology: 11,971). ADM-assisted breast reconstruction was associated with increased relative risk of SSI by 10% (RR = 1.10, confidence interval [CI]: 1.01–1.21; p = 0.03) and reoperation by 15% (RR = 1.15, CI: 1.08–1.23; p < 0.001).

Conclusions ADM-assisted breast reconstruction more than doubled from 2012 to 2019. There are statistically higher complication rates of SSI (0.5%) and reoperation (1.4%) with ADM use in TE-based breast reconstruction, suggesting that reconstruction without ADM is safe when comparing immediate postoperative outcomes.

Keywords

tissue expander - breast reconstruction - outcomes - acellular dermal matrix

Patient Consent

The patients provided written informed consent for the publication and the use of their images.


Ethical Approval

This study was provided an exemption from the University of Utah IRB.


Authors' Contributions

The conceptualization of the goals/aims of the article were driven by Alvin Kwok, Jayant Agarwal, Jessica Luo, Megan Rosales, Gregory Stoddard, and Irfan Rhemtulla. Whitney Moss and Giovanna Pires were involved in drafting, revising, and approving the final version for submission.


Financial Disclosure Statement

Dr. Jayant Agarwal is a consultant for DonJoy Orthopedics, which is unrelated to this article. The remainder of the authors have nothing to disclose.




Publication History

Received: 04 November 2021

Accepted: 08 July 2022

Article published online:
13 December 2022

© 2022. The Korean Society of Plastic and Reconstructive Surgeons. This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/)

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