{"entity":{"id":"pre-bra","kind":"trial","name":"Pre-BRA (pre-pectoral breast reconstruction evaluation)","aka":["Pre-BRA study"],"tldr":"Putting the implant in front of the chest muscle rather than behind it was adopted across Britain on the argument that it hurts less and looks better. This study followed the first 347 women and found the implant was lost about as often as with the older technique, and that physical and sexual wellbeing were worse than before surgery at both three and eighteen months.","summary":"Pre-BRA is a prospective cohort at the second and third stages of the IDEAL framework for surgical innovation, designed to establish whether pre-pectoral reconstruction was safe and stable enough to justify a randomised trial. 347 women had 424 immediate implant-based reconstructions at 40 United Kingdom centres between July 2019 and December 2020, most of them single-stage direct-to-implant (357, 84.2 percent) and mesh-assisted (341, 80.4 percent). Four patients (0.9 percent) had to be converted to a sub-pectoral reconstruction during the operation because the skin flap was too poor.\n\nAt three months, 144 of the 343 women who had pre-pectoral reconstruction (42.0 percent) had at least one complication: 28 (8.2 percent) lost the implant, 67 (19.5 percent) had an infection, 60 (17.5 percent) were readmitted and 55 (16.0 percent) needed a reoperation. Implant loss is comparable to the sub-pectoral mesh-assisted technique measured by iBRA.\n\nThe patient-reported analysis, published in 2025 and covering 338 of 343 women (98.5 percent), is the part worth reading before consenting. Against their own scores before surgery, women reported statistically significant and clinically meaningful falls in both physical and sexual wellbeing at three and at eighteen months. Two-thirds (167 of 251) rated the result excellent or very good; major complications, implant loss and dissatisfaction with visible wrinkling or rippling were what reduced satisfaction.\n\nThe authors' conclusion is a statement about consent rather than about technique: these findings should be discussed with patients so that expectations are realistic.","status":"completed","asOf":"2026-09-25","links":[{"label":"ISRCTN11898000","url":"https://www.isrctn.com/ISRCTN11898000"},{"label":"Pre-BRA three-month safety (British Journal of Surgery 2022)","url":"https://doi.org/10.1093/bjs/znac077"},{"label":"Pre-BRA patient-reported outcomes at 3 and 18 months (British Journal of Surgery 2025)","url":"https://doi.org/10.1093/bjs/znaf032"}],"tags":[],"related":[],"cancers":["breast-cancer","breast-hr-positive","breast-her2-positive","tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":["breast-reconstruction","mastectomy","body-image-after-breast-surgery"],"trials":["ibra-study","best-bra"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"ISRCTN11898000","phase":"observational","setting":"Immediate pre-pectoral implant-based breast reconstruction after mastectomy for cancer or risk reduction at 40 United Kingdom centres: implant loss at three months, and patient-reported outcomes on the BREAST-Q at three and eighteen months","sponsor":"University of Bristol, with the Association of Breast Surgery","result":"Implant loss 8.2 percent at three months and a complication in 42.0 percent; physical and sexual wellbeing fell significantly against baseline at three and eighteen months, and two-thirds rated the outcome excellent or very good.","yearReported":2025,"enrolled":347,"enrolledBasis":"registry","outcomes":[{"endpoint":"Implant loss within 3 months","primary":true,"unit":"%","arms":[{"name":"Immediate pre-pectoral implant-based reconstruction","n":343,"value":8.2,"note":"28 women"}],"source":"https://doi.org/10.1093/bjs/znac077"},{"endpoint":"Any complication within 3 months","unit":"%","arms":[{"name":"Immediate pre-pectoral implant-based reconstruction","n":343,"value":42,"note":"144 women"}],"source":"https://doi.org/10.1093/bjs/znac077"}],"replication":"iBRA measured the same short-term endpoints across all implant techniques in 2,081 patients and found implant loss of 9 percent."},"route":"/trials/pre-bra/","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":"body-image-after-breast-surgery","kind":"term","name":"Body image after breast surgery and reconstruction","route":"/terms/body-image-after-breast-surgery/"},{"id":"breast-reconstruction","kind":"term","name":"Breast reconstruction","route":"/terms/breast-reconstruction/"},{"id":"mastectomy","kind":"term","name":"Mastectomy","route":"/terms/mastectomy/"}],"trial":[{"id":"best-bra","kind":"trial","name":"Best-BRA","route":"/trials/best-bra/"},{"id":"ibra-study","kind":"trial","name":"iBRA (implant Breast Reconstruction evAluation)","route":"/trials/ibra-study/"},{"id":"mroc","kind":"trial","name":"Mastectomy Reconstruction Outcomes Consortium (MROC)","route":"/trials/mroc/"}]}}