An immediate 1-stage implant-based breast reconstruction (IBBR) with use of acellular dermal matrices (ADMs) after mastectomy may carry a higher risk for complications compared to 2-stage IBBR, according to a study published in The Lancet Oncology.1

Researchers conducted an open-label, randomized, controlled trial of 142 women across 8 hospitals to compare the safety between 1-stage IBBR with ADM and 2-stage IBBR.

Participants were eligible if they intended to undergo skin-sparing mastectomy as well as immediate IBBR and had a breast carcinoma or a gene mutation that was linked with breast cancer. Each was then randomized to either treatment option.

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In total, 59 women, which included 91 breasts, underwent 1-stage IBBR with ADM, while 62 women, which included 92 breasts, underwent 2-stage IBBR.

Treatment with 1-stage IBBR with ADM was associated with a “significantly higher risk per breast” of surgical complications, reoperation, as well as removal of the implant, the ADM, or both, compared to treatment with 2-stage IBBR.

Twenty-six out of the 91 breasts (29%) in the group treated with 1-stage IBBR with ADM developed severe grade 3 adverse events compared to 5 of the 92 breasts (5%) in the 2-stage IBBR group. Mild to moderate adverse events had a similar frequency in the 2 groups.

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“Understanding of selection of patients, risk factors, and surgical and post-surgical procedures needs to be improved,” the authors concluded.


  1. Dikmans REG, Negenborn VL, Bouman M, et al. Two-stage implant-based breast reconstruction compared with immediate one-stage implant-based breast reconstruction augmented with an acellular dermal matrix: an open-label, phase 4, multicentre, randomised, controlled trial. Lancet Oncol. 2016 Dec 21. doi: 10.1016/S1470-2045(16)30668-4 [Epub ahead of print]