Acellular Dermal Matrices in Breast Reconstruction: CARE Trial 5-Year Outcomes Data for More Than 9500 Patients

Background: Few studies have assessed long-term complications in women undergoing implant-based breast reconstruction with use of an acellular dermal matrix(ADM). This study compared outcomes over 5 years in women undergoing breast reconstruction procedures with and without ADM. Methods: Complications data in patients enrolled in the prospective Continued Access Reconstruction/Revision Expansion trial were segregated by use of ADM versus no ADM in patients undergoing primary breast reconstruction or revision reconstruction.Continued Access Reconstruction/Revision Expansion trial evaluated long-term safety and effectiveness of shaped, textured, silicone implants. Results: Of the 9502 women, 257 had primary (n = 160) or revision-reconstruction(n = 97) with ADMs; 9245 had primary (n = 6977) or revision-reconstruction (n = 2268)without ADMs. Capsular contracture rates in primary reconstruction were lower with ADM than without at year 5 (3.2% versus 7.4%); rates were similar at year 1 (=2.4%). Capsular contracture rates in revision-reconstruction were lower with ADM than without at year 5 (1.4% versus 8.9%); rates were similar at year 1 (=2.5%). Seroma rates were low and sustained for all cohorts throughout the 5 years (=2.9%). Reoperation rates increased over time in all cohorts, with similar rates between groups (2.4%47.3%from week 4 to year 5 across cohorts). Other trends over time included lower rates for asymmetry and implant malposition with ADM than without. Conclusion: These long-term data suggest that the use of ADM in breast reconstruction procedures may provide a benefit in reducing complications, such as capsular contracture, and may sustain low rates of seroma.

Automated summary

This study compared complications in breast reconstruction patients using acellular dermal matrix (ADM) versus those not using ADM over a 5-year period. The results showed that patients using ADM had lower rates of capsular contracture and seroma, and the procedure was more successful overall.