The largest series to date on prepectoral reconstruction assisted by an acellular bovine pericardium pocket. Here is what it recorded.
Material science makes a promise. Real-world clinical data tells you whether the promise holds once the matrix is in a patient and the follow-up clock is running. For ExaShape, the most substantial answer to date comes from a 2024 multicentric study led by De Vita and colleagues, the largest clinical series so far on prepectoral breast reconstruction assisted by an ABPM pocket.
The design is straightforward and the numbers are worth sitting with.
The cohort
De Vita and colleagues followed 65 reconstructions with a mean follow-up of 21.3 months (De Vita R, et al. Clinical Breast Cancer. 2024). This is not a benchtop model or a short-window snapshot. It is a real-world patient cohort tracked across nearly two years, which is the horizon where capsular and remodelling questions actually surface.
What the data recorded
No significant capsular contracture. Across the series, there were no significant cases of Baker III to IV capsular contracture. In implant-based reconstruction, contracture is the complication that most often undoes an otherwise good result, so its absence across this follow-up window is the headline figure.
A 4.3% major complication rate. In a real-world cohort, a major complication rate of 4.3% describes a predictable safety profile rather than an idealised one.
A mean surgical time of 1.42 hours. Time in the operating room is a patient-safety variable, not only a scheduling one. A mean surgical time of 1.42 hours reflects a workflow that does not depend on prolonged intraoperative shaping of the matrix.
Where the outcome is felt
Safety data answers the surgeon’s question. Patient-reported outcomes answer the patient’s. Using BREAST-Q, the same body of work recorded high mean scores for breast shape (4.18 out of 5) and symmetry (4.15 out of 5), alongside meaningful gains in psychosocial well-being (De Vita R, et al. 2024; Mazzocchi M, et al. PRRS 2022).
That pairing matters. A matrix can produce a clean safety table and still leave patients dissatisfied with the aesthetic result. Here the two move together: a predictable safety profile and outcomes patients rate highly.
Reading the numbers honestly
Real-world clinical data is most useful when it is read for what it is. This is a defined cohort, followed for a defined window, reporting defined endpoints. It does not settle every question, and it is not offered as a comparison against any other device. What it does establish is a documented, reproducible picture of prepectoral reconstruction assisted by an ExaShape pocket across nearly two years of follow-up.
For a surgeon weighing a biological matrix, that is the useful kind of evidence: specific, sourced, and long enough to matter.
65 reconstructions. 21.3 months. A safety profile and a satisfaction profile that hold together.
Explore the full dataset and supporting studies in the ExaShape Evidence Library, or model your own case mix with the Decision Simulator.
Scientific references
- De Vita R, et al. A Pericardium Bovine Matrix Pocket in DTI Prepectoral Breast Reconstruction. Clinical Breast Cancer. 2024.
- Mazzocchi M, et al. PRRS 2022.
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