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Journal Article
Observational Study
Bovine Acellular Dermal Matrix in Immediate Breast Reconstruction: A Retrospective, Observational Study with SurgiMend.
Plastic and Reconstructive Surgery 2018 January
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.
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.
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