Medical Devices

Compression Socks in False Disguise Sneak into Stores

CE marking is affixed to products within the EU as a safeguard protecting consumers. It indicates that a product complies with regulations and is suitable for use. Even so, compression socks marked with this label but failing to fulfil its requirements have been available on the Slovenian market since 2016. The Agency for Medicinal Products and Medical Devices of the Republic of Slovenia commenced an inspection.

Breast Implants Inferno

No one knows how many adverse events with breast implants occur in Slovenia. Doctors often report about them to breast implant manufacturers but not to the competent national authority as they are obliged to by law. Mary paid the price of loosely regulated medical devices. More than once.

Essure, a Luxury Foreign Body

The gynaecologist confirmed: the procedure was a success. Mirjana Rajh was done in ten minutes. It was actually not painful, and she really was up and running in no time. Just like she was told. She did not expect any issues.

Data on Orthopaedic Implants Kept in Notebooks

In a month, on 1 January 2019, the National Arthroplasty Registry – which contains  data on all artificial hips, knees, shoulders, and other joints implanted in Slovenian patients – will be up and running. But it will not contain any data. Most Slovenian hospitals keep it on paper.

A Serious Flaw in the Slovenian Health Care System

Medical devices concern everyone, yet no one really cares about them. Certainly not as much as about medicines. In the framework of a global investigation project by the International Consortium of Journalists and its media partners, the Implant Files, we found that the regulation of medical devices in Europe – and in Slovenia – is largely inadequate and full of loopholes. And the patients are completely at the mercy of this system. A system that is ruled by manufacturers and their business secrets, one that treats the public merely as a fly in the ointment of development.