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Surgeon-Controlled Study and Meta-Analysis Comparing FlexHD and AlloDerm in Immediate Breast Reconstruction Outcomes

Sobti, Nikhil; Liao, Eric C. M.D., Ph.D.

Plastic and Reconstructive Surgery: November 2016 - Volume 138 - Issue 5 - p 959–967
doi: 10.1097/PRS.0000000000002616
Breast: Original Articles
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Background: The use of acellular dermal matrix has facilitated immediate prosthesis-based breast reconstruction. However, few studies directly compare surgical outcomes following acellular dermal matrix–based reconstruction with two of the most commonly available materials, AlloDerm and FlexHD. Those studies that are available often do not adequately control for the surgeon as a variable. The authors hypothesize that complication rates will not differ significantly between AlloDerm and FlexHD when practice and surgeon variables are properly controlled.

Methods: Retrospective review was conducted to identify consecutive implant-based reconstruction procedures performed at a tertiary academic medical institution by a single plastic surgeon over 6 years. Univariate and binomial regression analyses were conducted to compare patient characteristics and clinical endpoints across acellular dermal matrix groups (AlloDerm/AlloDerm ready-to-use versus FlexHD Pliable/Perforated).

Results: Of the 233 patients that underwent matrix-based breast reconstruction, 11 (4.7 percent) developed surgical-site infection. The infection rate was not statistically different between patients who received FlexHD [n = 5 (5.0 percent)] versus AlloDerm [n = 6 (4.6 percent)] on either univariate (p = 0.89) or binomial regression analysis (p = 0.56). Likewise, there were no statistical differences in rates of seroma, hematoma, explantation, or delayed wound healing.

Conclusions: Clinical endpoints of interest were all equivalent between acellular dermal matrix types. This study uniquely reports a single-surgeon case series comparing outcomes between different acellular dermal matrix types. Instead of focusing on acellular dermal matrix as a predictor of outcome, other patient and surgeon factors should be addressed to improve results and innovate better alternatives.


Boston, Mass.

From the Division of Plastic and Reconstructive Surgery, Massachusetts General Hospital.

Received for publication March 5, 2015; accepted June 3, 2016.

Disclosure: Dr. Liao serves as a consultant and principal investigator on a research study funded by Musculoskeletal Transplant Foundation and serves as a consultant for LifeCell Inc., manufacturers of FlexHD and AlloDerm, respectively. No funds were received for this clinical study.

Eric C. Liao, M.D., Ph.D., 15 Parkman Street, WACC 435, Boston, Mass. 02114,

©2016American Society of Plastic Surgeons