Implant scandal He allegedly let his patients down - but Bernese star surgeon remains silent

Instead of answers, there was only one sentence on Friday: "I'm not making a statement." The accused Bernese star surgeon is not breaking his silence in the major trial about defective intervertebral disc implants.

It is one of the biggest trials against a doctor in Swiss judicial history: a renowned surgeon is accused of allegedly inserting immature intervertebral disc implants into seven of his patients and then abandoning them.

The public prosecutor is accusing him of grievous bodily harm and violating the Therapeutic Products Act.

In the trial at the Bern-Mittelland Regional Court, which has been ongoing since Monday, former patients reported a lack of transparency, information and aftercare. The surgeon's former assistant doctor and various experts and expert witnesses also gave evidence.

The questioning of the accused doctor was now on the trial agenda on Friday. However, the last day of the mega-trial ended without any new findings - the surgeon answered all of the presiding judge's questions on the advice of his lawyer: "I won't make a statement."

In the past, the surgeon denied the allegations. His lawyer told the Tamedia newspapers that her client had "behaved correctly both legally and in terms of professional ethics". The presumption of innocence applies until any final conviction.

Allegedly groundbreaking "Cadisc-L" prosthesis

At the center of the allegations is the "Cadisc-L" intervertebral disc prosthesis - a plastic implant designed to replace damaged intervertebral discs. In comparison with other prostheses, "Cadisc-L" was supposed to retain more flexibility in the spine.

The surgeon had inserted the prosthesis into seven patients at the Salem Hospital in Bern between 2011 and 2013. The implant failed in all of them, causing physical damage to the spine, the public prosecutor's office writes in the indictment.

During the trial, one patient described how she still suffers from severe restrictions and pain to this day and "has to motivate myself every day". One man, on the other hand, has come to terms with the fact that he still has the implant in his back. However, he is worried that it could get worse one day.

Another patient who still has the prosthesis in his back said: "I'm constantly thinking that there's a ticking time bomb inside me." And for two women, the implant in their back has shattered into several pieces.

"Implant Files" get the case rolling

In 2018, an international research team brought the case to public attention as part of the so-called "Implant Files".

Explosive: the surgeon is said to have been involved in the development of "Cadisc-L" himself. He chaired the scientific advisory board of the British manufacturing company Ranier, which has since gone bankrupt. The accused was compensated for his mandate.

The accused did not inform the patients about his involvement, the victims said in court. One patient commented: "If I had known that he himself was involved, a second opinion would have been important for me."

Patient concerned: "I would have needed this knowledge"

The indictment reveals that animal experiments with the prosthesis are said to have already shown defects. Long-term studies on its effectiveness were also lacking.

Nevertheless, the product was launched on the market in 2010. Dozens of patients across Europe are said to have suffered serious complications as a result. The implant was recalled in 2014.

According to patients, the controversial history of the prosthesis was not mentioned during consultations. Although the surgeon explained the normal surgical risks before the procedure, he did not explain the specific risks of the prosthesis or the inadequate results of animal experiments.

"I would have needed this knowledge to decide whether I wanted to take the risk or not," said one patient.

How detailed does a doctor have to explain the risks?

The surgeon's former assistant doctor, who was involved in two "Cadisc-L" operations in 2012 and 2013, partially contradicted these statements in court.

Although she was unable to provide information about the individual procedures or details about the prosthesis, her former boss had "taken a lot of time to get to know the patients". He also listed the risks: "As far as I could tell, he did a thorough job."

These are big questions that the three regional judges have to deal with: How much detail must a doctor provide about possible risks? When are follow-up checks mandatory? Does a doctor have to disclose their own financial interests? The ruling will set an important precedent in this regard.

First, however, the pleadings of the prosecution and defense are scheduled for the end of January. The verdict is scheduled to be delivered on February 9.