Bovine Pericardium
in Breast Reconstruction

What Is Bovine Pericardium?

The bovine pericardium is the fibrous sac that encloses the heart of cattle (Bos taurus). Rich in Type I and Type III collagen, elastin fibres, and structural glycoproteins, it forms one of the most mechanically robust and biochemically stable biological tissues available for medical use. Once harvested, cleaned, and processed through standardised decellularisation protocols, it becomes an acellular bovine pericardium matrix (ABPM) — a scaffold that is free of cellular antigens yet retains its three-dimensional collagen architecture.

In reconstructive surgery, this matrix functions as a temporary biological scaffold: host fibroblasts, vascular endothelial cells, and immune-regulatory cells gradually infiltrate and remodel it, replacing the exogenous collagen with native tissue over a period of weeks to months. The result is a biological integration process that, when successful, produces a strong, vascularised neo-tissue layer indistinguishable from the patient's own fascial structures.^[6]

History of Bovine Pericardium in Breast Reconstruction

Biological matrices entered breast reconstruction in the early 2000s, initially dominated by acellular dermal matrices (ADMs) derived from cadaveric human skin or porcine dermis. These products demonstrated that a biological scaffold could support the lower pole of a breast implant, enable prepectoral placement, and reduce rates of capsular contracture — transforming the standard of care in implant-based reconstruction.

Bovine pericardium emerged as an alternative xenograft in the mid-2000s, first reported in cardiovascular and neurosurgical indications before being adapted for breast reconstruction. Its appeal was clear: unlike cadaveric ADMs, it is available in consistent supply without ethical constraints; unlike porcine products, it carries a distinct tissue architecture that many surgeons found advantageous for mechanical handling and suturing.

The first documented use of acellular bovine pericardium in implant-based breast reconstruction dates to the late 2000s, with published case series appearing in the European plastic surgery literature through the 2010s.^[5] By 2020, multiple prospective studies had confirmed its viability,^[3] and CE-marked devices specifically designed for breast reconstruction — including the ExaShape line by Advanced Biomedical Concept — had entered clinical practice with dedicated anatomical configurations.

How Bovine Pericardium Works: The Biological Mechanism

Unlike synthetic meshes — which remain permanently in the body as foreign material — an acellular bovine pericardium matrix undergoes biological remodelling. The timeline and mechanism proceed in three overlapping phases:

1. Inflammatory phase (Days 1–14): Host macrophages and neutrophils infiltrate the matrix. Macrophage polarisation towards an M2 (pro-regenerative) phenotype is critical. High-quality decellularisation, which removes MHC antigens and residual DNA, minimises the M1 inflammatory response that would otherwise trigger excessive fibrosis.
2. Proliferative phase (Weeks 2–8): Fibroblasts migrate into the collagen scaffold via micro-channels left by the decellularisation process. Neovascularisation begins — new capillaries penetrate the matrix, bringing oxygen and nutrients. Host collagen synthesis progressively replaces the bovine collagen.
3. Remodelling phase (Months 2–12): Matrix metalloproteinases (MMPs) degrade residual bovine collagen while host fibroblasts deposit organised, mechanically functional neo-tissue. The scaffold gradually integrates, and the distinction between implant and native tissue effectively disappears.

Clinical Applications in Breast Reconstruction

Prepectoral Breast Reconstruction

The most significant shift in implant-based breast reconstruction over the past decade has been the move from subpectoral (under the pectoralis major muscle) to prepectoral (above the muscle) implant placement. Prepectoral reconstruction eliminates animation deformity, reduces pain, and preserves muscle function — but it requires a robust biological scaffold to support the implant in the subcutaneous plane and provide the soft-tissue coverage that the muscle previously supplied.

Acellular bovine pericardium is ideally suited to this role. Applied as a wrap, pocket, or sling around the implant, it provides immediate mechanical support while its biological remodelling creates a durable, vascularised envelope over the following months.

Direct-to-Implant (DTI) Reconstruction

In direct-to-implant (DTI) reconstruction — a single-stage procedure performed immediately at the time of mastectomy — the biological matrix must fulfil the dual function of supporting the implant and integrating rapidly with the mastectomy skin flap above. The vascularity of bovine pericardium matrices, combined with their collagen architecture, makes them particularly well-adapted to DTI scenarios where the quality of skin perfusion and biological support are critical determinants of outcome.

Staged (Two-Stage) Reconstruction

In two-stage reconstruction, bovine pericardium can be used to wrap a tissue expander during the expansion phase, providing biological support throughout the expansion period before the exchange procedure for a definitive implant.

Choosing the Right Bovine Pericardium Device

Not all bovine pericardium matrices are identical. Key variables that affect clinical performance include source animal age, decellularisation protocol, membrane thickness, available configurations (flat, meshed, pre-formed pocket, 3D pocket), and regulatory status. When evaluating devices for breast reconstruction, surgeons should consider:

• Regulatory clearance: CE mark under EU MDR 2017/745 is the European standard; confirm the device's risk classification (Class IIb or III).
• Source material age: Younger animals (under 24 months) produce thinner, more uniform collagen architecture, which may translate to more consistent remodelling outcomes.
• Configuration: Flat sheets offer intraoperative flexibility; pre-formed pockets (such as BioShield Pocket variants) reduce operative time and technique variability; 3D configurations optimise anatomical conformity.
• Mesh vs. solid: Meshed membranes (e.g. PREPEC) promote faster vascularisation and may reduce seroma risk; solid membranes provide maximum mechanical barrier function.
• Clinical evidence: Prefer devices supported by peer-reviewed published series, not only bench testing.

Bovine Pericardium vs. Synthetic Mesh: Key Differences

Clinical Evidence: What the Data Shows

ExaShape-Specific Clinical Data

The first and, to date, most focused published clinical study specifically evaluating ExaShape BioShield Pocket in prepectoral breast reconstruction is Mazzocchi et al. (2022),^[1] a prospective case series of 21 women undergoing 37 immediate prepectoral reconstructions following nipple-sparing mastectomy. Key findings included:

• Mean implant positioning time of 4 minutes (range 3–9 min) — a direct reflection of the pre-formed BioShield Pocket design eliminating intraoperative membrane cutting and suturing.
• Overall complication rate of 13.5% (5 of 37 cases): 3 wound dehiscences resolved surgically, 1 seroma with dehiscence resolved surgically, and 1 implant loss due to infection.
• No capsular contracture recorded at the time of reporting (7–20 months follow-up).
• BREAST-Q patient-reported outcomes showed statistically significant improvements in overall breast satisfaction, psychosocial well-being, and sexual well-being (all p < 0.05).

The authors concluded that ExaShape "proved to be useful in breast reconstruction, allowing a good aesthetic and functional result," and specifically highlighted its advantages in reducing implant exposure time, bacterial contamination risk, and handling-related injury to the implant.^[1]

Supporting ABPM Evidence with ExaShape Connection

A 2024 multicentre retrospective analysis by De Vita et al.,^[2] published in Clinical Breast Cancer, examined 65 prepectoral DTI breast reconstructions using acellular bovine pericardium matrix (ABPM) pockets, with a mean follow-up of 21.3 months. The lead author (Prof. De Vita) disclosed a consultancy relationship with ExaShape at the time of publication. Key findings:

• Minor complications in 4 breasts; major complications in 2 breasts — a low absolute complication count for a multicentre study.
• No significant capsular contracture recorded at follow-up controls.
• Seven patients required fat grafting at 6 months for mild rippling — consistent with broader prepectoral series.
• Authors concluded ABPM-assisted prepectoral DTI reconstruction is "a reliable, safe and suitable option providing good patient satisfaction outcomes," identifying it as the largest study on this technique at the time of publication.^[2]

Broader Bovine Pericardium Class Evidence

Beyond ExaShape-specific data, the broader class of acellular bovine pericardium matrices has been validated across multiple independent series using different branded products (Exaflex, Tutomesh, Veritas). These studies establish the safety profile of the material class that underpins ExaShape:

• Casella et al. (2025)^[3] — 20 mastectomies with bovine APM wrapping in thin-flap patients; no major post-operative complications.
• Nogueira Sixto et al. (2025)^[4] — 112 mastectomies; seroma 5.4%, capsular contracture 2.67%, implant loss not reported as a primary endpoint.
• Castagnetti et al. (2020)^[5] — 141 breasts at 51-month median follow-up; clinically relevant capsular contracture 12.1% (Grade II), no Grade III/IV.
• Mofid et al. (2012)^[6] — 93 reconstructions; 0% capsular contracture, overall complication rate 21.5% — comparable to ADM benchmarks of the same era.

The ExaShape Product Family

Within the category of bovine pericardium devices, ExaShape by Advanced Biomedical Concept (ABC) represents one of the most comprehensively designed product families available in Europe. The line has been developed from the ground up for breast reconstruction — not adapted from cardiovascular or neurosurgical indications — and is sourced from cattle under 24 months old to ensure optimal collagen architecture.

The ExaShape family addresses every common surgical scenario in modern prepectoral and DTI reconstruction:

• ExaShape Grid: A flat bovine pericardium sheet in a grid pattern, offering maximum intraoperative customisation. Surgeons cut and position the membrane to their preferred configuration for implant coverage.
• PREPEC: A meshed membrane specifically designed for prepectoral placement, with a mesh architecture that accelerates vascularisation and tissue ingrowth.
• BioShield Pocket: A pre-formed implant pocket that wraps the implant in a single step, reducing operative time and standardising technique in routine single-stage prepectoral reconstruction.
• BioShield Pocket PRO: The enhanced pre-formed pocket with optimised geometry for more complex anatomical scenarios and larger implant volumes.
• BioShield Pocket 3D: A three-dimensional bovine pericardium pocket that provides superior anatomical conformity, first used clinically at Guy's and St Thomas' NHS Foundation Trust in London.
• ExaShape Expander: A bovine pericardium wrap for tissue expanders in two-stage reconstruction.
• ExaShape NAC: A dedicated device providing biological support for the nipple-areola complex in nipple-sparing mastectomy.

All ExaShape devices are CE-marked under EU MDR 2017/745 and are distributed in over 23 countries, supported by an international network of trained surgeons and a dedicated e-learning platform offering step-by-step surgical technique guidance.