No one knows how many adverse events with breast implants occur in Slovenia. Mary paid the price of loosely regulated medical devices. More than once.
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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.
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The baclofen pump implanted under Blaž’s skin stopped working twice in five years, both times due to corrosion. Both times, the staff at the University Rehabilitation Institute Soča managed to save his life. SynchroMed II pumps have been the subject of numerous recalls, adverse events, court orders, and lawsuits. They also already killed.
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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.
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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 the Implant Files, we found that the regulation of medical devices in Europe – and in Slovenia – is largely inadequate and full of loopholes.
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