{"entity":{"id":"ibra-study","kind":"trial","name":"iBRA (implant Breast Reconstruction evAluation)","aka":["iBRA study"],"tldr":"The study that counted what actually happens after an implant reconstruction in Britain, rather than what the best units report. One woman in eleven lost the implant, one in four needed treating for infection, and nearly one in five went back to theatre within three months. Every one of those rates is worse than the national standard allows.","summary":"iBRA recruited consecutively between February 2014 and June 2016, taking every woman aged 16 or over having any type of immediate implant-based reconstruction at 81 participating units, which is what makes it a picture of practice rather than of expertise. 2,108 patients had 2,655 mastectomies with immediate implant-based reconstruction, and three-month outcome data were available for 2,081 of them (99 percent).\n\nThe techniques used show how far mesh had spread before the evidence did: 1,376 patients (65 percent) had reconstruction with biological (1,133, 54 percent) or synthetic (243, 12 percent) mesh, 181 (9 percent) had non-mesh submuscular or subfascial implants, 440 (21 percent) had dermal sling implants, 42 (2 percent) had pre-pectoral implants, and 79 (4 percent) had another technique or a combination.\n\nWithin three months, 182 patients (9 percent, 95 percent confidence interval 8 to 10) lost the implant, 372 (18 percent, 16 to 20) were readmitted to hospital, 370 (18 percent, 16 to 20) returned to theatre for a complication, and 522 (25 percent, 23 to 27) needed treatment for an infection. The National Quality Standards ask for under 5 percent for re-operation, readmission and implant loss and under 10 percent for infection, so every one of those rates is above standard.\n\nThe study was designed to test whether a randomised trial of reconstruction techniques was feasible, and concluded that one is needed. Best-BRA is the answer to it. What iBRA cannot do is separate the effect of the mesh from the effect of everything else, because it is a cohort: it establishes that mesh was in majority use without randomised evidence, not that mesh caused the complication rate.","status":"completed","asOf":"2026-09-25","links":[{"label":"ISRCTN37664281","url":"https://www.isrctn.com/ISRCTN37664281"},{"label":"iBRA short-term safety outcomes (Lancet Oncology 2019)","url":"https://doi.org/10.1016/S1470-2045(18)30781-2"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["breast-reconstruction","mastectomy","oncoplastic-breast-surgery","bia-alcl"],"trials":["pre-bra","best-bra","mroc"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN37664281","phase":"observational","setting":"Any immediate implant-based breast reconstruction after mastectomy for cancer or risk reduction, with or without biological or synthetic mesh, at 81 United Kingdom breast and plastic surgical units: implant loss, infection, unplanned return to theatre and unplanned readmission within three months","sponsor":"University of Bristol, funded by the National Institute for Health Research, the Association of Breast Surgery and the British Association of Plastic, Reconstructive and Aesthetic Surgeons","result":"Within three months of immediate implant-based reconstruction: implant loss 9 percent, infection needing treatment 25 percent, return to theatre 18 percent and readmission 18 percent, all above the National Quality Standards.","yearReported":2019,"enrolled":2108,"enrolledBasis":"registry","outcomes":[{"endpoint":"Implant loss within 3 months","primary":true,"unit":"%","arms":[{"name":"Immediate implant-based reconstruction, all techniques","n":2081,"value":9,"note":"182 patients, 95 percent confidence interval 8 to 10"}],"source":"https://doi.org/10.1016/S1470-2045(18)30781-2"},{"endpoint":"Infection needing antibiotics or surgery within 3 months","unit":"%","arms":[{"name":"Immediate implant-based reconstruction, all techniques","n":2081,"value":25,"note":"522 patients, 95 percent confidence interval 23 to 27"}],"source":"https://doi.org/10.1016/S1470-2045(18)30781-2"},{"endpoint":"Unplanned return to theatre within 3 months","unit":"%","arms":[{"name":"Immediate implant-based reconstruction, all techniques","n":2081,"value":18,"note":"370 patients, 95 percent confidence interval 16 to 20"}],"source":"https://doi.org/10.1016/S1470-2045(18)30781-2"}],"replication":"Pre-BRA found the same pattern for pre-pectoral placement specifically, with implant loss of 8.2 percent at three months."},"route":"/trials/ibra-study/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"term":[{"id":"bia-alcl","kind":"term","name":"Breast implant-associated anaplastic large cell lymphoma","route":"/terms/bia-alcl/"},{"id":"breast-reconstruction","kind":"term","name":"Breast reconstruction","route":"/terms/breast-reconstruction/"},{"id":"mastectomy","kind":"term","name":"Mastectomy","route":"/terms/mastectomy/"},{"id":"oncoplastic-breast-surgery","kind":"term","name":"Oncoplastic breast surgery","route":"/terms/oncoplastic-breast-surgery/"}],"trial":[{"id":"best-bra","kind":"trial","name":"Best-BRA","route":"/trials/best-bra/"},{"id":"mroc","kind":"trial","name":"Mastectomy Reconstruction Outcomes Consortium (MROC)","route":"/trials/mroc/"},{"id":"pre-bra","kind":"trial","name":"Pre-BRA (pre-pectoral breast reconstruction evaluation)","route":"/trials/pre-bra/"}]}}