醫美洢蓮絲注射案：洢蓮絲注射風險與醫療常規之界線【學習式判解評析】 試閱
Litigation of ELLANSÉ Injection in Aesthetic Medical Practice: Reassessing the Legal Boundaries of ELLANSÉ Injection and Medical Standards of Care
本案涉及醫師於病患鼻部曾植入Goretex永久性物質後，進行洢蓮絲注射而導致不良結果，是否構成業務過失致傷害罪。一審認定醫師未妥善評估患者病史與風險，劑量施打過量，構成過失；二審則認為難以確認洢蓮絲為傷害原因，且醫師施術過程未逾越臨床裁量與醫療常規，改判無罪。本案顯示藥品仿單作為醫療常規與合理臨床裁量標準之間的界線爭議，亦反映出臨床診療與法律判斷之交錯與困難。同時亦提醒醫師執業時，需更加謹慎評估風險並重視詳實記錄病歷之重要。
This case concerns whether a physician’s administration of Ellansé in a patient’s nasal region—previously implanted with a permanent Goretex material—constitutes professional negligence resulting in adverse result. The court of first instance found that the physician failed to adequately assess the patient’s medical history and associated risks, and administered an excessive dosage, thereby establishing negligence. However, the appellate court held that causation between the injury and the Ellansé injection could not be conclusively proven, and that the physician’s actions did not exceed the bounds of clinical discretion or violate the medical standard of care, ultimately rendering a not-guilty verdict. This case underscores the ambiguity between package insert warnings and the scope of reasonable clinical discretion, highlighting the complex interplay between clinical decision-making and legal assessment. It also serves as a cautionary note to physicians regarding the necessity of careful risk evaluation and the critical importance of maintaining comprehensive and accurate medical records.
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