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Surgeon Used Experimental Jaw Device Without Consent

By I. Hansana, Jadetimes News

 
Jadetimes Surgeon Used Experimental Jaw Device Without Consent
Image Source : Said Khatib

Melbourne Surgeon Sued for Allegedly Failing to Disclose Use of Experimental Jaw Device


A Melbourne surgeon, Dr. George Dimitroulis, is facing a lawsuit for allegedly not informing a patient that the device used in her major jaw surgery was experimental and invented by him. According to documents filed in a Victorian court, the surgeon also created the classification system used to diagnose the patient's condition as severe enough to necessitate jaw joint removal, which is central to the negligence claims.


Bianca*, the former patient, has filed a statement of claim with Victoria’s supreme court, accusing Dimitroulis of failing to fully advise her of the risks before the operation. She alleges the surgery resulted in life changing injuries, chronic pain, and rendered her unable to work.


The claim further contends that Dimitroulis's classification system was not widely used by other surgeons and that less invasive treatments were available. In his amended defense, Dimitroulis denied that any of Bianca’s injuries were due to his negligence or the OMX prosthesis device. His defense maintains that he always acted within the bounds of widely accepted professional practices in Australia.


An amended statement of claim, filed on June 21 on Bianca's behalf, reveals that Dimitroulis authored a 2013 research paper in the International Journal of Oral and Maxillofacial Surgery. The paper proposed a new classification system for diagnosing temporomandibular joint (TMJ) disorders, which informed decisions about TMJ surgery necessity. The TMJ connects the jaw to the skull, with one joint on each side of the head.


Dimitroulis used this classification system to diagnose Bianca with “level 5” TMJ disease, recommending surgery as her only option. His defense, filed on July 16, confirms his authorship of the paper but denies failing to inform Bianca about the experimental nature of the classification system or its limited use among surgeons.


The research paper states that patients classified with level 5 TMJ disease exhibit catastrophic joint deterioration, necessitating total joint replacement where feasible. Bianca alleges she was not informed that the OMX TMJ prosthesis was experimental, that the surgery might not succeed, and that it could potentially worsen her condition.


Bianca’s claims include that Dimitroulis did not disclose the inherent risks of TMJ replacement surgery, such as facial paralysis, chronic pain, and ear damage, which are not uncommon. Dimitroulis’s defense denies these allegations, asserting that he discussed known surgery risks with Bianca.


Additionally, Bianca claims that she experienced relatively low pain and functional jaw movement before the surgery and that Dimitroulis did not discuss non surgical treatment options with her. Dimitroulis refutes this, noting that Bianca rated her pain as moderate, at 4/10, prior to the surgery and that he did discuss alternative treatments.


Dimitroulis also denied allegations that he failed to disclose his commercial interest and directorial role in the company manufacturing the OMX TMJ prosthesis. He asserts that he informed Bianca of his involvement in the prosthesis's design and creation at their initial meeting.


Following disciplinary action from the regulator, Dimitroulis was required to undergo further education on informed consent and record keeping, which he successfully completed. There are currently no conditions on his practice.


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