Short-term safety outcomes of mastectomy and immediate implant-based breast reconstruction with and without mesh (iBRA): a multicentre, prospective cohort study

Abstract

SummaryBackgroundUse of biological or synthetic mesh might improve outcomes of immediate implant-based breast reconstruction—breast reconstruction with implants or expanders at the time of mastectomy—but there is a lack of high-quality evidence to support the safety or effectiveness of the technique. We aimed to establish the short-term safety of immediate implant-based breast reconstruction performed with and without mesh, to inform the feasibility of undertaking a future randomised clinical trial comparing different breast reconstruction techniques.MethodsIn this prospective, multicentre cohort study, we consecutively recruited women aged 16 years or older who had any type of immediate implant-based breast reconstruction for malignancy or risk reduction, with any technique, at 81 participating breast and plastic surgical units in the UK. Data about patient demographics and operative, oncological, and complication details were collected before and after surgery. Outcomes of interest were implant loss (defined as unplanned removal of the expander or implant), infection requiring treatment with antibiotics or surgery, unplanned return to theatre, and unplanned re-admission to hospital for complications of reconstructive surgery, up to 3 months after reconstruction and assessed by clinical review or patient self-report. Follow-up is complete. The study is registered with the ISRCTN Registry, number ISRCTN37664281.FindingsBetween Feb 1, 2014, and June 30, 2016, 2108 patients had 2655 mastectomies with immediate implant-based breast reconstruction at 81 units across the UK. 1650 (78%) patients had planned single-stage reconstructions (including 12 patients who had a different technique per breast). 1376 (65%) patients had reconstruction with biological (1133 [54%]) or synthetic (243 [12%]) mesh, 181 (9%) had non-mesh submuscular or subfascial implants, 440 (21%) had dermal sling implants, 42 (2%) had pre-pectoral implants, and 79 (4%) had other or a combination of implants. 3-month outcome data were available for 2081 (99%) patients. Of these patients, 182 (9%, 95% CI 8–10) experienced implant loss, 372 (18%, 16–20) required re-admission to hospital, and 370 (18%, 16–20) required return to theatre for complications within 3 months of their initial surgery. 522 (25%, 95% CI 23–27) patients required treatment for an infection. The rates of all of these complications are higher than those in the National Quality Standards (<5% for re-operation, re-admission, and implant loss, and <10% for infection).InterpretationComplications after immediate implant-based breast reconstruction are higher than recommended by national standards. A randomised clinical trial is needed to establish the optimal approach to immediate implant-based breast reconstruction.FundingNational Institute for Health Research, Association of Breast Surgery, and British Association of Plastic, Reconstructive and Aesthetic Surgeons.

Multicentre study of prepectoral breast reconstruction using acellular dermal matrix

“…Other case series using this product indicated satisfactory short-term clinical and aesthetic outcomes. These results were comparable to national data on implant-based reconstructions in the UK 2,28,29 . A long-term outcome study 17 of ten patients, with a median follow-up of 49⋅2 months, reported no capsular contracture rates and minimal implant rippling in two patients.…”

“…The more recent implant-based breast reconstruction evaluation (iBRA) study 28 included 2108 patients operated on for implant-based reconstruction between February 2014 and June 2016, but only 42 (2⋅0 per cent) who had a prepectoral reconstruction. The first audit 2 covered breast reconstructions performed from January 2008 to March 2009 with an implant-based reconstruction cohort of more than 3000 patients.…”

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

“…A series of 269 reconstructions found seroma rate of 14.1%, skin necrosis rate of 23.4%, and infection rate of 8.9% . The most recent prospective study (iBRA) found a major complication rate of 18%, 25% infection rate, and 9% implant loss . The UK national quality standards define <5% implant loss and <10% infection rates.…”

“…6 The most recent prospective study (iBRA) found a major complication rate of 18%, 25% infection rate, and 9% implant loss. 7 The UK national quality standards define <5% implant loss and <10% infection rates. However, the above-mentioned studies and meta-analysis reflect real-world outcomes.…”

Immediate and delayed autologous abdominal microvascular flap breast reconstruction in patients receiving adjuvant, neoadjuvant or no radiotherapy: a meta-analysis of clinical and quality-of-life outcomes

“…Previous studies evaluating the impact of PMRT on types of immediate BRR showed its potential feasibility in this setting, with lower morbidity rates compared with those of implant‐based procedures. Surprisingly, the rapid adoption of immediate implant‐based reconstruction in about 70 per cent of women, compared with 34 per cent of autologous procedures when PMRT is recommended, may be influenced by surgeon and patient preferences, regardless of current evidence.…”