The key point: According to SRF, Swissmedic allowed a surgeon at Zurich University Hospital to keep fitting the Cardioband implant despite serious complications.
The facts
- Implant: the Cardioband, co-developed by surgeon Francesco Maisano.
- Exemptions: three authorisations in 2016 and 2017, without European certification for this use.
- Oversight: after a patient’s death, no independent investigation by Swissmedic.
The positions
- Swissmedic: says it followed the rules in force at the time.
- Responsibility: according to the authority, it lies with the doctor using an uncertified product.
Key figures
- 3 : exemptions granted in two years.
- About 70: estimated excess deaths in the department.
In short
The Zurich heart surgery scandal now implicates the Swiss therapeutic products regulator.
