Deliberate Blindness: How Swissmedic Rubber-Stamped Fatal Heart Experiments

When a state oversight body exists primarily to shield the public from harm, one might expect at least a minimum threshold of curiosity. In Switzerland, however, regulatory authorities prefer a gentler touch. An investigation by public broadcaster SRF into Swissmedic’s handling of experimental heart implants at University Hospital Zurich paints a devastating picture of institutional passivity, administrative naivety, and a refusal to enforce basic accountability.

Between 2016 and 2020, the hospital's cardiac clinic, then led by surgeon Francesco Maisano, recorded over 70 unexpected deaths. An administrative report later identified severe deficiencies, highlighting 13 cases where the use of innovative medical devices was entirely inappropriate. The hospital board eventually referred 11 unexpected deaths and those 13 device cases to the Zurich public prosecutor. Central to the controversy was the Cardioband, a device designed to repair leaking heart valves. Maisano had co-developed the product and held stock options in its manufacturer.

When the uncertified device was first implanted into a patient's right heart valve in 2016, the wire snapped during the procedure, leaving the valve unsealed. Instead of demanding answers, Swissmedic issued repeated special exemptions for subsequent procedures without asking a single safety question. Internal emails expose the agency's mindset: inspectors explicitly agreed to avoid being intrusive after severe complications occurred, refraining from requesting incident reports from the manufacturer. When a third patient died 18 days after surgery due to a damaged coronary artery, the regulator simply accepted the hospital's internal assessment without conducting an independent inquiry.

The official stance remains predictably defensive. The applications were examined by Swissmedic with the necessary care and urgency in accordance with the legal bases applicable at the time, stated executive board member Karoline Mathys, adding that Swissmedic takes the safety of patients very seriously. Regarding the patient fatality, she maintained that the documents showed that there was no direct connection between the product and the event.

The ultimate irony lies in the political response. In 2021, the Federal Council abolished the permit requirement for uncertified medical devices entirely, citing the rationale that assessing such applications was very difficult for Swissmedic. Rather than sharpening its supervisory teeth, the state simply erased the standard it failed to uphold. Patients are left with less oversight today than when the scandal began, proving once again that when bureaucracy faces its own shortcomings, its preferred remedy is self-exemption.

Written by Thorben Thiede thorben.thiede@alpineweekly.com