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clinical evidence

A grid of seven questions. One, what was the design: randomised, prospective cohort or retrospective series. Two, which plane: prepectoral, subpectoral or dual plane. Three, one stage or two: direct-to-implant or expander. Four, who was included: flap thickness, smoking, BMI, radiotherapy, prior surgery. Five, how long was follow-up, since late complications such as capsular contracture need years. Six, how were complications defined and counted: per patient or per breast, minor and major, and whether rippling counts. Seven, who did it and who paid: learning curve, number of surgeons, and conflicts of interest. A closing line states that two numbers are only comparable if the answers match.
Clinical Insights — 03 October 2026

How to Compare Mesh Studies in Breast Reconstruction (and Why 9% and 38% Can Both Be Right)

Headline complication rates for the same material range from under 10% to nearly 40%. Seven questions explain why, and show how to…

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The conformity assessment route for a high-risk implantable device under EU Regulation 2017/745. A manufacturer holds a quality management system and a technical file, assembles clinical evidence into a clinical evaluation report, and submits both to a notified body, which is an independent organisation designated by a member state rather than a government agency. The notified body audits the system and examines the file and, for this class, the design dossier. A certificate allows the CE mark and market access. After launch the obligations continue: post-market surveillance, a periodic safety update report, post-market clinical follow-up feeding back into the clinical evaluation, and vigilance reporting of serious incidents. The device carries a unique device identifier and its data are registered in the European database, EUDAMED. The loop is drawn as continuing rather than ending at approval.
Clinical Insights — 19 September 2026

What the CE Mark Tells You, and the Six Questions It Does Not Answer

The CE mark answers whether a device meets the regulation for its intended purpose. It does not answer whether it is the…

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A four-row evidence table comparing breast-conserving surgery with mastectomy. Row one, NSABP B-06, a randomised trial of 1,851 women: no survival difference at twenty years, hazard ratio for death 0.97 for lumpectomy with radiotherapy against mastectomy. Row two, the Milan trial, randomised, 701 women: all-cause death 41.7 percent against 41.2 percent at twenty years. Row three, the EBCTCG meta-analysis of 10,801 women: radiotherapy after conservation halves recurrence and reduces breast cancer death. Row four, a Dutch registry of 37,207 women: conservation with radiotherapy associated with better ten-year overall survival, with confounding by severity possible. A closing line notes that no study shows mastectomy improving survival for a woman eligible for both.
Clinical Insights — 18 September 2026

When Mastectomy Is Chosen: What the Evidence Says, and What Reconstruction Owes the Patient

Fifty years of trials say conservation is at least as safe as mastectomy for eligible women. When mastectomy is the plan, the…

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CLINICAL EVIDENCE — 22 July 2026

Prepectoral, mesh-supported reconstruction: fewer reoperations, better long-term value

A 2026 multicenter cohort followed 501 immediate direct-to-implant reconstructions after nipple-sparing mastectomy for up to 10 years — comparing prepectoral placement with…

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Clinical Insights — 11 July 2026

The Clinical Evidence for Biological Matrices in Breast Reconstruction

Which outcomes matter, the limits of the current literature, and a framework for critically appraising biological matrix evidence in implant-based reconstruction.

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EXAFAT_device_on_surgical_surface
Article — 06 July 2026

The Retention Problem: Why Fat Grafting still falls short – and what changes When you fix the Process

A thought leadership article for the plastic and reconstructive surgery community | Advanced Biomedical Concept | June 2026 Ask any experienced breast…

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Article — 01 July 2026

From Membrane to Living Tissue: A 12-Month Timeline

Follow a single ExaShape matrix from the moment it is placed to the moment it becomes patient-specific collagen. A biological matrix is…

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Article — 01 July 2026

Twenty-One Months of Real-World Clinical Data

The largest series to date on prepectoral reconstruction assisted by an acellular bovine pericardium pocket. Here is what it recorded. Material science…

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Exashape
Article — 01 July 2026

The Bilayer, Explained

One surface protects the implant. The other invites the body in. ExaShape does not ask you to choose. Ask a biological matrix…

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Article — 01 July 2026

Not All Matrices Share a Biography

Two biological matrices can look identical on the back table and behave nothing alike. The reason is written into the tissue they…

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Advanced Biomedical Concept

Innovators in breast reconstruction surgery. CE-marked biological membranes and surgical support devices. Founded 2020, Rome, Italy.

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