Medical-device safety warnings stopped at national borders

ICIJ and partners collected millions of records and interviewed patients across countries to examine implant approvals, adverse-event reporting, and recalls. They found cases in which a device was withdrawn in one market while remaining available elsewhere.

The records require careful interpretation. An adverse-event report indicates suspected involvement, not proof that a device caused the injury or death. The investigation also acknowledged the substantial benefits of medical devices, while challenging gaps in testing and follow-up.

A practical obstacle was identifying the same product across different naming systems. ICIJ built a cross-country database of recalls and safety notices to reconnect that information. The historical report asks how a global industry can operate when patients and clinicians cannot easily discover what another regulator already knows.