Bovine Acellular Dermal Matrix in Immediate Breast Reconstruction: A Retrospective, Observational Study with SurgiMend.

BACKGROUND

Acellular dermal matrices can be combined with implant-based breast reconstruction to help optimize outcomes. SurgiMend PRS is a fetal bovine dermis-derived acellular dermal matrix composed of type I collagen and approximately 30 percent type III collagen, sharing many of the properties of human cadaveric acellular dermal matrix.

METHODS

This was a retrospective, single-center analysis of 111 adult patients (147 breasts) undergoing one-stage (83.7 percent) or two-stage (16.3 percent) immediate breast reconstruction after mastectomy. The aims were to characterize the safety profile of SurgiMend and investigate associations between risk factors and complications.

RESULTS

The mean age of the patients was 47.9 years and the mean body mass index was 24.7 kg/m. After a median follow-up of 24.3 months, the overall rates of minor and major complications were 25.2 percent (n = 37 of 147) and 12.9 percent (n = 19 of 147), respectively. The most common major complications were seroma [n = 12 (8.2 percent)] and necrosis [n = 9 (6.1 percent)]. All occurred within 3 months after surgery. The rate of capsular contracture was 2.7 percent (n = 4). A total of 2.7 percent of implanted breasts (n = 4) required explantation. In a univariate analysis, smokers had a greater risk of major complications (p = 0.013), and postoperative radiation therapy and obesity were associated with an increased risk of capsular contracture (p = 0.006) and explantation (p = 0.006), respectively. In a multivariate analysis, several factors were associated with complications or explantation, including obesity (p < 0.05), preoperative chemotherapy (p < 0.001), and mastectomy weight (p < 0.05). These associations align with other studies of implant-based reconstruction and do not appear to be specific to this acellular dermal matrix.

CONCLUSION

The results are consistent with previous analyses of SurgiMend, and support its value in implant-based breast reconstruction.

CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.