Comparison of sterile versus nonsterile acellular dermal matrices for breast reconstruction.

BACKGROUND: Acellular dermal matrix (ADM) has been associated with an increased incidence of complications after implant-based breast reconstruction. Recently, sterile ADM has been introduced in an attempt to minimize these complications. To analyze the impact of this product on patient outcomes, we created a database of patients undergoing implant-based breast reconstruction.
METHODS: Patients undergoing implant-based breast reconstruction at the University of Kentucky Medical Center from January 1, 2011, to December 31, 2011 were identified. A database of patient characteristics and outcomes was created. Outcomes investigated included mastectomy flap necrosis, dehiscence, infection, red breast, capsular contracture, hematoma, and seroma. Statistical analysis was performed.
RESULTS: Fifty-eight patients underwent breast reconstruction with implants or tissue expanders. Of the 58 patients, 9 had the sterile form of ADM placed, 25 had the original aseptic but not sterile ADM, and 24 were not reconstructed with ADM. The most frequent complication noted was seroma, occurring in 6/9 patients with sterile ADM as compared to 2/25 with the aseptic ADM. This was statistically significant (P = 0.003).
CONCLUSIONS: The use of sterile ADM is associated with a statistically significant increase in seroma formation. The etiology of this increased incidence remains unknown, but it correlates with the introduction of the sterile form of ADM at our institution. A different preparation or sterilization process, or some other variable as yet unknown, may be responsible. Further studies comparing the different forms of ADM in an animal model may serve to clarify this issue.