Acellular Dermal Matrix in Immediate Expander/Implant Breast Reconstruction: A Multicenter Assessment of Risks and Benefits

Abstract

INTRODUCTION Acellular dermal matrix (ADM) has gained widespread acceptance in immediate expander/implant reconstruction due to perceived benefits, including improved expansion dynamics and superior aesthetic results. Although previous investigators have evaluated its risks, few studies have assessed the impact of ADM on other outcomes, including patient-reported measures. METHODS The Mastectomy Reconstruction Outcomes Consortium (MROC) Study used a prospective cohort design to evaluate patients undergoing post-mastectomy reconstruction from 10 centers and 58 participating surgeons between 2012 and 2015. The analysis focused on women receiving immediate tissue expander reconstruction following mastectomies for cancer treatment or prophylaxis. Medical records and PRO data, using the BREAST-Q and Numeric Pain Rating Scale (NPRS) instruments, were reviewed. Bivariate analyses and mixed-effects regression models were applied. RESULTS A total of 1,297 patients were evaluated, including 655 (50.5%) with ADM and 642 (49.5%) without ADM. Controlling for demographic and clinical covariates, no significant differences were seen between ADM and non-ADM cohorts in overall complications (OR=1.21, p=0.263), major complications (OR=1.43, p=0.052), wound infections (OR=1.49, p=0.118), or reconstructive failures (OR=1.55, p=0.089) at two years following reconstruction. There were also no significant differences between the cohorts in the time to expander/implant exchange (p=0.78). No significant differences were observed in PRO scores, including satisfaction with breast, psychosocial well-being, sexual well-being, physical well-being and postoperative pain. CONCLUSION In our multicenter, prospective analysis, we found no significant ADM effects on complications, time to exchange or PRO in immediate expander/implant breast reconstruction. Further studies are needed to develop criteria for more selective use of ADM in these patients.

Does the addition of mesh improve outcomes in implant based breast reconstruction after mastectomy for breast cancer?

“…A recent multicentre prospective North American cohort study18 (1297 women) found no difference in complications and patient reported outcomes between two stage IBBR with and without acellular dermal matrix. Complications were defined as adverse, surgery related, postoperative events requiring additional treatment at two years, including re-operation or readmission to hospital and reconstructive failure (removal of the implant).…”

Perceived barriers to randomised controlled trials in breast reconstruction: obstacle to trial initiation or opportunity to resolve? A qualitative study

“…Despite the widespread adoption of mesh-assisted techniques, there is a paucity of high-quality evidence to support their safety or effectiveness [5][6][7][8]. Multicentre prospective studies have failed to demonstrate any difference in outcomes between single-stage direct-to-implant and two-stage techniques [9,10] or between two-stage reconstructions with and without mesh [11]. However, a recent Dutch multicentre randomised controlled trial (RCT) demonstrated significantly increased numbers of complications when single-stage direct-to-implant procedures were compared with traditional two-stage techniques [12] despite equivalent quality-of-life outcomes [13].…”

Acellular dermal matrices safety in breast reconstruction—Is it truly associated with higher rates of complications? A large single‐surgeon cohort analysis

“…A prospective multicenter study of 1328 reconstructions found a major complication rate of 19.1%, 10.5% infection rate, and 7.4% implant loss . Another multicenter assessment including 655 patients found a major complication rate of 22.4%, 11.3% infection rate, and 9.2% implant loss . A meta‐analysis including 16 studies found a skin flap necrosis rate of 10.9%, with 6.9% seroma‐ and 5.7% infection rate .…”