One-stage direct-to-implant breast reconstruction using acellular dermal matrix

In May, 2015, the Dutch Health Care Inspectorate issued a safety alert for ADM, which led to the suspension of surgery for patients who had not yet been operated on; others declined further participation in the trial. [...]this safety concern prompted a preliminary analysis of safety data, and data on surgical complications and reoperation rates were published early (in 2017).4 The high failure rate (26%) associated with one-stage ADM-assisted reconstruction did not reflect the experience of many surgeons and far exceeded a target implant loss rate of less than 5% for oncoplastic breast practice.5 This failure rate probably reflected poor patient selection, highlighting the unforgiving surgical environment of a one-stage procedure and the need for meticulous dissection of skin flaps.6,7 Improved understanding and attention to surgical detail might help to minimise future complications as more experience is accrued. [...]levels of patient satisfaction are not necessarily concordant with aesthetic outcomes judged by health-care professionals. [...]the suggestion that increased numbers of complications with ADM might be acceptable if greater intraoperative fill volumes lead to improved patient satisfaction is not upheld.8 Rates of questionnaire completion were relatively modest and are a limitation of this study; only 80% of patients in the one-stage group and around 70% in the two-stage group completed postoperative questionnaires. Despite the fact that research is ongoing to better define so-called minimal important differences, the inclusion of greater numbers of patients and higher rates of questionnaire completion are unlikely to change the basic conclusions of this study pertaining to the use of ADM for one-stage IBBR. [...]when adjustments were made for the high rate of complications and reoperation in the one-stage group, there were still no statistically significant differences between the two groups for these primary outcome measures.