How to Read This Page
⚠ Important — different studies, not a head-to-head trial
The figures below come from separate published studies with different patient cohorts, complication definitions, follow-up periods and surgical settings. They are presented together to give indicative context — not as a controlled head-to-head comparison. A lower number in one study does not, on its own, prove one material or technique is superior to another.
Each bar is labelled with its own source. Where a figure is a device-specific ABC-related series it is marked as such. Always read outcomes in the context of the full publication and your own clinical judgement.
This page gathers the published outcome data that appears across ABC's clinical guides into one visual reference. It is intended for surgeons and informed readers who want the numbers and their sources in one place. Full narrative context lives in the prepectoral breast reconstruction and biological matrix pillar guides, and a structured material comparison lives in biological matrix vs. ADM.
Overall Complication Rates
Reported overall or major-complication rates in implant-based reconstruction series. Ranges reflect pooled meta-analyses; single values reflect individual cohorts.
Scale 0–35%. Definitions of "complication" differ between studies.
Read with care: the ADM figure is a pooled range across 2,667 patients; the bovine-pericardium figure is a single 65-patient prepectoral DTI cohort. Cohort size and case mix differ substantially.
Implant Loss / Explantation
Implant loss (device removal) is one of the most consistently reported and clinically meaningful endpoints in reconstruction outcomes.
Scale 0–10%.
Read with care: the ExaShape figure is a single loss in a small 21-patient early series — a wide confidence interval. The iBAG figure is a large real-world registry. Small denominators make single-patient events swing the percentage sharply.
Capsular Contracture
Capsular contracture (Baker grade III–IV, unless noted) is a longer-term outcome; reported rates depend heavily on follow-up length and grading.
Scale 0–15%. Grading systems and follow-up differ.
Read with care: capsular contracture accrues over years, so rates in shorter-follow-up series read lower. Prepectoral placement in general has been associated with low contracture rates in the literature[5], but grading and follow-up are not standardised across these studies.
Size of the Evidence Base
How many patients sit behind each source. Larger denominators generally give more stable, generalisable estimates — a key reason registry and meta-analytic data carry weight even when device-specific series are smaller.
Scale 0–2,800 patients.
Why this matters: bovine-pericardium biological matrix is a newer material, so its device-specific evidence base is smaller and growing. Larger ADM datasets reflect a longer market history — not necessarily a better outcome. Interpreting small series requires caution around confidence intervals.
Evidence Timeline
Key publications that shaped the modern prepectoral, biological-matrix and fat-grafting approach — the studies cited throughout ABC's guides.
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2007Coleman & Saboeiro revisit fat grafting to the breast, establishing safety and technique that underpin lipofilling in reconstruction.[7]
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2016Gschwantler-Kaulich randomised ADM against synthetic mesh, reporting comparably high complication rates (~31%) in both arms.[6]
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2017Vidya, Masià et al. publish foundational prepectoral implant-based reconstruction series, helping establish above-the-muscle technique.[5]
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2020The iBAG multicentre study (Masià et al.) reports real-world prepectoral ADM outcomes across 1,450 procedures and 30 centres.[3]
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2022Mazzocchi et al. report an early ExaShape bovine-pericardium series (n=21) with a single implant loss.[8]
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2023Zhu & Liu publish an ADM meta-analysis pooling 2,667 patients — a large reference dataset for complication benchmarking.[2]
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2024De Vita et al. report a prepectoral direct-to-implant bovine-pericardium series (n=65) with 9.2% major complications.[1]
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2025Casella et al. (STEP) add device-specific bovine-pericardium safety data in prepectoral reconstruction.[4]
Interpreting the Data Responsibly
Three principles apply to every figure on this page. First, denominators matter: a 4.8% loss rate from a 21-patient series carries a much wider confidence interval than a 6.5% rate from 1,450 procedures. Second, definitions vary: "complication" and capsular-contracture grading are not standardised across studies, so identical labels can measure different things. Third, time matters: outcomes like capsular contracture accrue over years, so shorter-follow-up series naturally read lower.
Bovine-pericardium biological matrix is a newer material with a smaller but growing device-specific evidence base. The available series are encouraging, but they are early and small relative to the large ADM datasets accumulated over a longer market history. The honest reading is that the data is indicative and promising, not yet definitive — and that is exactly how it should be presented to patients and colleagues. For the full narrative and material-by-material discussion, see the biological matrix vs. ADM comparison and the prepectoral reconstruction pillar.
ExaShape and PREPEC bovine-pericardium biological matrix and the EXAFAT fat-grafting system are supported by a growing body of peer-reviewed evidence. Explore the full clinical library, device IFUs and surgical technique resources.
Frequently Asked Questions
Can I compare these numbers directly to choose a material?
Why is the bovine-pericardium evidence base smaller?
Why does a small series show a higher implant-loss percentage?
Are these figures a claim about ABC device performance?
Where can I read the full context behind these numbers?
References
- De Vita R, et al. "Prepectoral direct-to-implant breast reconstruction with acellular bovine pericardium matrix." Clin Breast Cancer. 2024. DOI: 10.1016/j.clbc.2024.06.004. (Prepectoral DTI series, n=65 — 9.2% major complications)
- Zhu L, Liu P. "Acellular dermal matrix in implant-based breast reconstruction: a meta-analysis." Aesthetic Plast Surg. 2023. DOI: 10.1007/s00266-023-03296-0. (ADM meta-analysis, n=2,667)
- Masià J, et al. "The iBAG multicentre study of prepectoral ADM reconstruction." J Surg Oncol. 2020. DOI: 10.1002/jso.26073. (Real-world registry, 1,450 procedures / 30 centres)
- Casella D, et al. "STEP: bovine pericardium in prepectoral reconstruction." J Clin Med. 2025. DOI: 10.3390/jcm14176296. (Device-specific safety series)
- Vidya R, Masià J, Berna G, et al. "Prepectoral implant-based reconstruction — foundational series." Breast J. 2017. DOI: 10.1111/tbj.12810. (Foundational prepectoral technique)
- Gschwantler-Kaulich D, et al. "ADM vs synthetic mesh: a randomised comparison." Eur J Surg Oncol. 2016. DOI: 10.1016/j.ejso.2016.02.007. (Randomised ADM vs mesh, ~31% both arms)
- Coleman SR, Saboeiro AP. "Fat grafting to the breast revisited: safety and efficacy." Plast Reconstr Surg. 2007;119(3):775–785. DOI: 10.1097/01.prs.0000252001.59152.8a. (Foundational fat grafting technique)
- Mazzocchi M, et al. "Bovine pericardium acellular matrix (ExaShape) in implant-based breast reconstruction." Plast Reconstr Regen Surg (PRRS). 2022. DOI: 10.57604/PRRS-064. (Early ExaShape series, n=21 — 1 implant loss)