Has a surgeon exceeded his role and performed operations not prescribed by the protocol on his patients?
The prosecutor of Gap has just seized the Central Office for the fight against attacks on the environment and public health (OCLAESP) following serious accusations launched by a surgeon of the hospital of Gap against the 'one of his colleagues to whom he accuses of having used a hundred patients as "guinea pigs" to experiment with a surgical technique not validated in France.
A preliminary investigation was opened for "biomedical research without obtaining the favorable opinion of the committee for the protection of persons and the authorization of the National Medicines Safety Agency" and "biomedical research on a person without his consent".
It was the results of a forensic expertise that prompted the prosecutor Florent Crouhy to seize the OCLAESP investigators.
"A vital risk in the event of hemorrhage"
At the start of 2018, when he was head of the orthopedic surgery department at the Gap hospital, Dr. Raouf Hammami, 52, said he discovered that Dr. Gilles N. "played the sorcerer's apprentice with a hundred patients with back pain.
I came across a study conducted between 2015 and 2017 by this surgeon colleague, a specialist in the spine, who tested a new technique on 87 patients, disc cementoplasty, outside of any legal framework.
In France, cement (a kind of resin) can be injected into weakened vertebrae to strengthen them.
However, he injected this cement directly into the discs of the column.
When you do hard in soft, it can't hold.
There may be cement leaks and complications in the nerves, arteries.
With a vital risk in the event of hemorrhage, estimates the doctor Hammami, the whistleblower doctor who speaks for the first time.
The latter therefore warns in 2018 the director of the hospital, the Regional Health Agency (ARS), the council of the order but also the prosecutor, as required by law.
For “willful serious misconduct” and “endangering the life of others”.
A technique considered as not validated in France
The ARS requests an expertise from two professors of medicine in Nancy.
Their conclusions, submitted in 2019, are overwhelming: “It appears that Doctor N. used a technique that did not comply with the data of surgical science at the time of the facts.
Doctor N. should have sought the opinion of an ethics committee or a CPP (Committee for the Protection of Persons) ”.
And to add: “In accordance with the law, Doctor N. should have explained to them clearly, intelligibly and fairly, for each patient, the so-called
innovative
aspect
of the technique he was to use.
Doctor N. thus did not respect the code of medical ethics.
"
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The French Society of Spinal Surgery has also concluded "that in the current state of knowledge, the technique of disc cementoplasty should be considered as not validated in France".
In total, around a hundred patients have "experimented" with this technique.
Asked by us, Doctor Gilles N. left the floor to his lawyer: “My client considers that the technique of disc cementoplasty was not innovative, that it was used by other colleagues, in particular at 'foreign, but also presented in medical congresses' explains his lawyer, Maître Alexis Chabert.
“The study conducted by Dr. N. on patients was carried out in full transparency, with the consent of the CHU de Nice.
My client is therefore not a sorcerer's apprentice ”.
Contacted, the Nice University Hospital had not responded to our requests on Monday evening.
"Since the operation, I have a lot of pain"
Bruno Chevalier, a 53-year-old coach driver, was operated on in July 2016 by this surgeon for a collapsed spine.
“Since the operation, I have had a lot of pain.
I have difficulty walking and have been recognized as an 80% disabled worker.
In 2018, I consulted a surgeon from Marseille who told me that Doctor N. had used an unrecognized technique, that the cement injected into the discs had overflowed, causing a narrowing of the lumbar canal.
He even advised me to file a complaint.
I had to be operated again for the cement to be removed.
But there are still some, near an artery.
I was taken for a guinea pig by Doctor N. who never told me he was going to use a new technique.
I have just taken legal action and I want to create an association of victims, ”says Bruno Chevalier.
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Another astonishing aspect of this case: while Dr N. continues to practice, the whistleblower, Dr Hammami, has been suspended for nearly 19 months. "If he was suspended, it is because several hospital practitioners were threatened by him, and this climate of tension no longer guaranteed the safety of care within the service" explains Yann Le Bras, director of the Gap hospital. To which Raouf Hammami replies: “They want to silence me but I will go to the end. The administrative court ordered my reinstatement. However, I remain without work. They are baited on me while the urgency is to inform all the patients operated by Dr. N. Some are in danger following cement leaks. Several have already had to be reopened. "
