The Swedish police are investigating alleged illegal trachea implants carried out by Italian surgeon Paolo Macchiarini at Karolinska University Hospital in Stockholm, Uppdrag granskning, an investigative news program on SVT, reported yesterday.
Icelandic surgeon Tómas Guðbjartsson took part in one of the operations and Karolinska was under the directorship of Birgir Jakobsson, the current Chief Medical Officer of Iceland, at the time of the operations.
Four out of Macchiarini’s eight patients have died since receiving synthetic tracheas, including his first patient, Andemariam Teklesenbet Beyene from Eritrea, who was a PhD student of geology at the University of Iceland at the time of his operation in June 2011.
Beyene suffered from cancer and had trouble breathing as a tumor the size of a golf ball had grown inside his respiratory tract.
In an interview with the BBC after the operation, which was considered to be groundbreaking, Beyene said he was excited about returning to Iceland to complete his studies so that he could move back to Eritrea and be reunited with his family, and meet his new three-month-old child.
Beyene managed to complete his geology studies in Iceland but two-and-a-half years after the operation, in January 2014, the implanted trachea became loose and he died.
Macchiarini’s technique involves modeling a structure or scaffold that is an exact replica of the patient’s own windpipe. Two days after the operation, tissue is supposed to form around the artificial trachea and become attached to it by way of millions of holes on its porous surface, keeping it in place.
Macchiarini, Tómas, another Icelandic doctor, Óskar Einarsson, and others, wrote about Beyene’s operation in medical journal The Lancet a few months after it was carried out, describing it as successful.
Following the operation, Macchiarini performed at least seven other synthetic trachea implants.
After Beyene’s death, some of Macchiarini’s co-authors began to suspect that there were inaccuracies in The Lancet article, including a lack of evidence for tissue growth surrounding and attaching to the artificial trachea transplants.
It then turned out that the Swedish medical ethics committee had not approved the operation, ruv.is reports.
Karolinska launched an investigation into the operations and discovered that Macchiarini had not provided sufficient information before carrying out the transplants. Bengt Gerdin, who led the investigation, told Uppdrag granskning that the results presented by Macchiarini in The Lancet did not correspond with those documented in his medical journals.
It was also indicated that Macchiarini stood to gain financially through his connection to the producer of the synthetic tracheas.
Belgian trachea implant specialist Pierre Delaere commented to Uppdrag granskning that the article in The Lancet is “one of the biggest lies in medical history” and that the operations had been doomed to fail.
The Swedish Medicines Agency has now filed charges against Karolinska because of the implants.
Neither Tómas, Birgir, nor Óskar have commented on the story.
However, Tómas told Vísir after it was reported last January that the operation on Beyene hadn’t been approved by the ethics committee, that Beyene had been sent to Sweden in “good faith” and that it wasn’t for him to determine whether the approval had been necessary.
Tómas was named Person of the Year in Iceland last year for saving a man who had been stabbed in the heart.