Implant Based Breast Reconstruction With Acellular Dermal Matrix

Abstract

Objective: To evaluate clinical outcomes of using acellular dermal matrix (ADM) with implant based breast reconstructions (IBBRs) in a randomized controlled trial. Summary Background Data: The use of ADMs in IBBRs is widespread, but link between ADM and complications remain a controversial topic. In view of reports concerning harm, we present 6-months safety data of ADM-assisted IBBR in the setting of breast cancer treatment. Methods: An open-label, randomized, controlled trial recruiting patients from 4 centers in Sweden and 1 in UK. Eligible were women with breast cancer planned for mastectomy with immediate IBBR. Participants were randomly allocated to IBBR with or without ADM (Strattice, Branchburg, NJ), with stratification by center in blocks of 6. Main primary endpoint was number of unplanned reoperations at 24 months, and safety expressed as the incidence of adverse events with a 6-month follow-up time for all participants. Analysis were done per protocol using Fisher exact test for complications and reoperations. Results: From start of enrolment on April 24, 2014, to close of trial on May 10, 2017, 135 women were enrolled, of whom 64 with ADM and 65 without ADM were included in the final analysis. Four patients (6%) in each group had reconstructive failure with implant loss, but IBBR with ADM exhibited a trend of more overall complications and reoperations (difference 0·16, 95% CI, −0·01 to 0·32, P = 0·070), and with higher risk of wound healing problems (P = 0·013). Conclusions: With 6-months follow-up for all participants, immediate IBBR with ADM carried a risk of implant loss equal to conventional IBBR without ADM, but was associated with more adverse outcomes requiring surgical intervention. Further investigation of risk factors and patient selection in a long-term follow-up is warranted.

ESTRO ACROP consensus guideline for target volume delineation in the setting of postmastectomy radiation therapy after implant-based immediate reconstruction for early stage breast cancer

“…Surgical techniques for breast reconstruction continue to develop with the aim of improving cosmetic outcomes via pre or post-pectoral placement of the implant, or the use of an autologous-flap, lipofilling or synthetic coverage materials in conjunction with the implant [11]. However, little is known about the oncological outcomes associated with these techniques, the impact of RT on cosmetic results, and factors underpinning these outcomes after breast reconstruction and PMRT [2,7,9,12,13].…”

“…In addition, most studies of breast reconstruction and PMRT did not specify the influence of radiation techniques and dose-fractionation schedules used or the long-term oncological outcomes including patterns of recurrence [12][13][14][15].…”

Effect of Immediate Implant-Based Breast Reconstruction After Mastectomy With and Without Acellular Dermal Matrix Among Women With Breast Cancer

“…Safety outcomes have previously been reported. 21 Here, in addition to the primary outcome measure, HRQoL, we report patient-reported cosmetic outcomes. All outcomes were prespecified.…”

“…We have previously published 6-month early safety data on harm and HRQoL. 21,22 Here we present reoperation rates and patient-reported outcomes at the primary trial end point of 24 months.…”

In Vitro Characterization of a Novel Human Acellular Dermal Matrix (BellaCell HD) for Breast Reconstruction

“…A biomaterial requires mechanical strength to uphold integrity until full regeneration of the tissue and has to sustain space for the cell ingrowths and nutrient absorption in vitro, thereby supporting the loadings in vivo [9]. The scaffold should be able to match its characteristics to those of initial tissues to avoid pressure shielding and offer the cell appropriate mechanical cues [10].…”