Methods: The Mastectomy Reconstruction Outcomes Consortium (MROC) Study used a prospective cohort design to evaluate patients undergoing post-mastectomy reconstruction from 11 centers and 57 participating surgeons. The current analysis focused on women receiving immediate tissue expander reconstruction following mastectomies for cancer treatment or prophylaxis. Medical records and PRO data were collected preoperatively and at three months and one year postoperatively. The PRO measures included the BREAST-Q and Numeric Pain Rating Scale (NPRS). Bivariate analyses and mixed effect logistic regression models were used to assess the effects of ADM use on complication rates, time to expander/implant exchange, patient satisfaction with breasts, postoperative pain and other PROs.
Results: A total of 1,107 patients were evaluated, including 546 (49.3%) with ADM and 561 (50.7%) without ADM. Controlling for demographic and clinical covariates, there were no statistically significant differences between the ADM and non-ADM cohorts in overall complication rates (19.9% vs. 18.3%, p=0.40), major wound infections (3.6% vs. 1.9%, p=0.12) or reconstructive failures (2.2% vs 1.0%, p=0.59) at one year following reconstruction. There were also no significant differences between the cohorts in the time to expander/implant exchange (p=0.89) or in one year post-operative PRO scores, including satisfaction with breast (p=0.14), psychosocial well-being (p=0.40), physical well-being (p=0.93) and postoperative pain (p=0.29).
Conclusion: In our multicenter, prospective analysis, we found no significant ADM effects on complications in immediate expander/implant breast reconstruction. Our analyses also noted no statistically significant differences between ADM and non-ADM cohorts for other outcomes, including time to exchange and PROs. The results of this study call into question the utility and value of ADM in immediate expander/implant reconstruction and suggest a need for further critical reassessment of ADM use in this setting.