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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.
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).
The 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.
Within 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.
The 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.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
2,108 enrolled.
182 patients, 95 percent confidence interval 8 to 10
Source522 patients, 95 percent confidence interval 23 to 27
Source370 patients, 95 percent confidence interval 16 to 20
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Implant loss within 3 monthsprimary | Immediate implant-based reconstruction, all techniques | 2,081 | 9% | - | - | link |
| Infection needing antibiotics or surgery within 3 months | Immediate implant-based reconstruction, all techniques | 2,081 | 25% | - | - | link |
| Unplanned return to theatre within 3 months | Immediate implant-based reconstruction, all techniques | 2,081 | 18% | - | - | link |
Shares Mastectomy Reconstruction Outcomes Consortium (MROC), Pre-BRA (pre-pectoral breast reconstruction evaluation), Oncoplastic breast surgery, Breast reconstruction.
Shares Oncoplastic breast surgery, Breast reconstruction, Mastectomy, HER2-positive breast cancer.
Shares Oncoplastic breast surgery, Mastectomy, HER2-positive breast cancer, Breast cancer (all types).
Shares Breast reconstruction, Mastectomy, HER2-positive breast cancer, Breast cancer (all types).
Shares Breast reconstruction, Mastectomy, HER2-positive breast cancer, Breast cancer (all types).
Shares Mastectomy, HER2-positive breast cancer, Breast cancer (all types), Triple-negative breast cancer (TNBC).
Shares Mastectomy, HER2-positive breast cancer, Breast cancer (all types), Triple-negative breast cancer (TNBC).
Shares Mastectomy, HER2-positive breast cancer, Breast cancer (all types), Triple-negative breast cancer (TNBC).