A Melbourne surgeon failed to tell a patient undergoing major jaw surgery that the device she was being implanted was an “experimental” one that he invented, and that he also created the classification system used to diagnose her condition as severe enough to warrant removing her jaw joints, according to documents filed in a Victorian court case accusing him of negligence.
The surgeon, Dr George Dimitroulis, is being sued by a former patient, Bianca*, who alleged in a statement of claim filed to Victoria’s supreme court that he did not fully advise her of the risks before the operation.
She alleges the operation left her unable to work, and with life-changing injuries and chronic pain.
The claim further alleges that his classification system was not widely used by other surgeons, and less invasive treatments were an option.
In his amended defence, Dimitroulis denied any of Bianca’s injuries were caused by his negligence, or by the device known as the OMX prosthesis. His defence states that at all times, Dimitroulis “acted in a manner that was widely accepted in Australia by a significant number of respected practitioners as competent professional practice”.
An amended statement of claim filed to the court on 21 June on behalf of Bianca states that Dimitroulis authored a research paper in which he proposed a new surgical classification system for diagnosing temporomandibular joint (TMJ) disorders to help decide which patients require TMJ surgery.
The TMJ connects the jaw to the skull, with one on each side of the head.
It is alleged that Dimitroulis used his classification system to diagnose Bianca with “level 5” disease, and recommend surgery as the only option available to her on this basis.
In his defence filed to the court on 16 July, Dimitroulis stated that he was the author of the paper, published in the International Journal of Oral and Maxillofacial Surgery in 2013.
But he did not agree that he failed to advise Bianca that he created the classification system used to diagnose her, or that he failed to tell her this system was not used by all surgeons.
The research paper, seen by Guardian Australia and referenced in Bianca’s statement of claim, says that if a patient’s TMJ deterioration is classified as level 5, “the recipient clinician will immediately appreciate that there are catastrophic changes in the joint so that none of the joint components are salvageable”.
“Patients in this category would benefit from condylectomy [partial jaw removal], discectomy [removal of a disc in the TMJ] and total joint replacement where feasible,” the paper says.
Bianca alleges she was not told the OMX TMJ prosthesis was experimental and that the surgery may not work and could leave her jaw condition worse.
“The defendant did not advise the plaintiff that, after the surgery, she would not be able to project her jaw forward or move her jaw side to side; that the inherent risks of the TMJ replacement surgery included facial paralysis, chronic pain and ear damage; [and] that the inherent risks were not uncommon,” it is alleged.
Dimitroulis’s defence states: “He does not admit the allegations.” Dimitroulis discussed the known risks of the surgery with Bianca, his defence states.
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Bianca alleges that she had relatively low pain and reasonable function of her jaw prior to the surgery, and that Dimitroulis failed to discuss nonsurgical treatment options with her. Dimitroulous denies this, saying Bianca claimed her pain to be at 4/10, and that she described her pain as “moderate” prior to the surgery.
Dimitroulis also denied that he did not advise Bianca of nonsurgical treatment options.
His defence alleges that he advised Bianca of his involvement in the design and creation of the OMX TMJ prosthesis at their first meeting, and otherwise denied her allegation that he did not advise her that he had a commercial interest in the company that manufactured the device, or that he was a director of that company.
In June, Guardian Australia reported that an investigation by the medical regulator found Dimitroulis failed to warn another patient, Jordan*, that she may be left with nerve injuries from TMJ replacement surgery, and that he failed to obtain informed consent from her before the surgery.
This failure lead to disciplinary action from the regulator, requiring Dimitroulis to undergo further education on informed consent and record keeping. He successfully completed this additional training, and there are no longer any conditions on his practising.
Dimitroulis has not responded to multiple requests from Guardian Australia for comment.
*Name changed to protect patient confidentiality