{"paper_id":"a44afe6c-7652-45dc-8bbc-d0ae66995633","body_text":"Clin. Exp. Obstet. Gynecol. 2023; 50(1): 18\nhttps://doi.org/10.31083/j.ceog5001018\nCopyright: © 2023 The Author(s). Published by IMR Press.\nThis is an open access article under the CC BY 4.0 license .\nPublisher’s Note: IMR Press stays neutral with regard to jurisdictional claims in published maps and institutional affiliations.\nOpinion\nHow to Avoid Medico-Legal Litigations in Performing High Intensity\nFocused Ultrasound Ablation for Treating Fibroids and Adenomyosis\nFelix Wong1,*, Peng Hao Wong 2, Thomas Kwok To Li 3\n1Division of Women’s and Children’s Health, Medical Faculty, The University of New South Wales, 2033 Sydney, NSW, Australia\n2Medical Clinic, Hong Kong Pacific Centre, Kowloon, Hong Kong, China\n3Department of Obstetrics and Gynaecology, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China\n*Correspondence: fwong3@hotmail.com.hk (Felix Wong)\nAcademic Editor: Christos Iavazzo\nSubmitted: 14 September 2022 Revised: 24 November 2022 Accepted: 24 November 2022 Published: 16 January 2023\nAbstract\nHigh-intensity focused ultrasound (HIFU) ablation is the latest advance in surgery. It is an accepted treatment for uterine fibroids and\nadenomyosis in Asia. Even though it is a non-invasive surgery, with preliminary results of a very low complication rate, adverse events\nand complications occur. In modern medicine, patients are likely to file claims should a complication or injury occur and treatment\nresults fall short of expectations. The increasing trend of litigations in Obstetrics and Gynaecology undoubtedly generates anxiety among\ngynaecologists operating with this new surgical technique. This paper is written to guide doctors performing this new HIFU treatment\nto reduce and steer clear of potential medico-legal problems.\nKeywords: HIFU ablation; training; credentialing; medico-legal litigations; gynaecologists; fibroids; adenomyosis\n1. Introduction\nIn the Asia Pacific region, gynaecologists increasingly\nembrace ultrasound-guided High Intensity Focused Ultra-\nsound (USg-HIFU) ablation as an effective and safe treat-\nment for fibroids and adenomyosis. Nevertheless, in HIFU\nablation surgery, adverse events may arise, similar to all\nsurgical treatments [ 1,2]. Patients attracted by advertis-\ning information through the Internet, promotion leaflets and\nsensationalised media interviews may have a certain mis-\nconstrued impression of this new technology. These pa-\ntients will likely file claims if complications or injuries arise\nbecause they may feel ‘cheated’.\nOur medical group have painstakingly learned this\nnew surgical technology [3] in China, which has a different\nlegal system from western countries. Currently, no known\nmedico-legal litigations have arisen from the early devel-\nopment of HIFU ablation in Hong Kong. However, the\nmedico-legal problems are anticipated to be similar to other\nnew surgical procedures in gynaecology [ 1]. The authors\nused information from a report “How to avoid medico-legal\nproblems in Obstetrics and Gynaecology” written by the\nMedico-Legal Committee of the Royal College of Obste-\ntricians and Gynaecologists [4], to guide doctors who prac-\ntised USg-HIFU treatment in Gynaecology to reduce and\nsteer clear of medico-legal problems.\nThe approach starts with the prerequisites of adequate\ntraining and supervision, consent to treatment, patient com-\nmunication, adequate human and equipment resources, and\ninvestigations, followed by a safe and effective HIFU abla-\ntion treatment.\n2. Subsections Relevant for the Subject\n2.1 Adequate Training and Supervision\nSurgical malpractice claims point to the need for ad-\ndressing training. Supervision is an activity related to surgi-\ncal training facilitated through observation, knowledge and\nskills acquisition by instruction, modelling and assessment.\nIn the early development of robotic surgery, Lee et al. [ 5]\nreviewed the medico-legal liability cases in robotic surgery,\nand many originated from a lack of training. Jha and Row-\nland [6], in 2014, also pointed out the issues of education,\ntraining and clinical governance in the litigation in gynae-\ncology. They viewed a doctor’s greatest asset is their ad-\nvanced training and experience.\nLike laparoscopic and robotic surgery [7], HIFU train-\ning, supervision, and assessment are prerequisites for grant-\ning privileges and credentialing on the HIFU treatment\n[8]. Even experienced gynaecologists cannot operate HIFU\ntreatment without proper training and supervision. There\nwill always be a learning curve for HIFU surgery, and\nnew trainees should be assisted or supervised, follow safety\nprotocols, and be proctored by more experienced doctors.\nCommonly in litigation, the accused doctor’s level of train-\ning and competency will come into question.\n2.2 Consent to Treatment\nInformed consent for HIFU treatment should include\npotential risks of HIFU ablation, such as postoperation pain,\nskin burn, intestinal, bladder and nerve injuries. These\nHIFU complications are mild; most will recover with symp-\ntomatic non-specific treatment [ 9–11]. Y et, doctors should\nalso inform patients of major or minor material risks and\n\nalternative treatment, as we learned from the Montgomery\nv Lanarkshire Health Board case [ 12]. Also, HIFU treat-\nment does not remove the entire organ or excise any tis-\nsue for pathology. It is important to discuss it with pa-\ntients. Persistent heavy menstrual bleeding or dysmenor-\nrhoea after treatment for fibroid or adenomyosis may fall\nshort of the patient’s expectations. It may lead to undue\nangsts among patients and doctors. Another critical issue is\ninadequate medical documentation to substantiate the treat-\nment options and proper counselling. In a review of 113\nmedico-legal files originating from laparoscopic bile duct\ninjuries, de Reuver et al. [ 13] found documentary evidence\nof informed consent in only 23% of cases and details of the\nactual informed consent discussion in just 11.5%. At least\nhalf the cases showed either poorly documented or undoc-\numented.\n2.3 Patient Communication\nCanadian Medical Protective Association (CMPA),\nreported a rapid 85% increase in complaints from 1983 in\n2007 to 3387 in 2016. The CMPA ’s data showed that com-\nmunication is a key issue in most cases [ 14]. It recom-\nmended patient-targeted communication and behaviour to\nreduce patients’ complaints. For a HIFU surgeon, not only\nshould one inform the patients of the benefits of HIFU treat-\nment, but other alternative treatments. One of the plaintiff’s\ncommon claims was a lack of other treatment options and a\ncomparison of these options.\n2.4 Adequate Human and Equipment Resources\nA shortage of nurses, doctor’s supervision, and well-\nmaintained medical equipment may adversely impact the\nmedico-legal decision. Medical product liability is espe-\ncially important for HIFU treatment. As HIFU technology\ndepends on the accurate targeting of solid tumours, a reli-\nable computer and clear real-time ultrasound images during\nthe ablation will improve the safety and efficacy of treat-\nment. The mechanical manipulation of the HIFU and imag-\ning ultrasound transducers during the procedure and the\ntemperature control of water in the ultrasonic chamber must\nfunction smoothly, properly and reliably to avoid inflicting\ninjury to patients. Regular maintenance of the HIFU ma-\nchine is paramount. The case law “Greenman v Y uba Power\nProducts, Inc” in 1963 clearly defined product liability that\n“a manufacturer is strictly liable in tort law when a prod-\nuct was to be used without inspection for defects, proved to\nhave a defect that causes injury to a human being” [ 15,16].\n2.5 Investigations Relating to HIFU Treatment\nMagnetic resonance imaging (MRI) scan of the pelvis\nis mandatory for HIFU treatment. It is for a pre-op as-\nsessment of the pathology and as the actual guide during\nthe HIFU procedure. Blood tests such as complete blood\npictures, liver function tests, renal function tests, and co-\nagulation profiles can assess a patient’s health condition\nbefore the procedure. However, patients should not un-\ndergo unnecessary investigations and invasive procedures\n[6]. As HIFU ablation does not give a pathological diagno-\nsis, doctors performing HIFU need to be aware of this, es-\npecially with rapid growing uterine tumours that might sug-\ngest the risks of malignancy or uterine sarcoma. MRI im-\nages and serum Lactate dehydrogenase (LDH) might help,\nbut a definitive diagnosis of uterine sarcoma or atypical\nleiomyoma might be difficult [ 17].\n2.6 Safe and Effective HIFU Procedure\nNon-adherence to surgical safety protocols and poor\nclinical decision-making will lead to intraoperative surgical\ncomplications. For example, a prolonged ablation without\nintermittent rest periods may cause skin burns. A surgeon\nwho fails to define the anatomy and locate the lesion can\ninjure the endometrium or surrounding organs. Therefore,\ncarelessness in performing the procedure, not following the\nstandard treatment protocols, and not recognising the risks\nof HIFU thermal spread may breach the duty of care to pa-\ntients.\n3. Discussion\nAs HIFU ablation treatment has only recently been\nused in gynaecology, medico-legal issues relating specif-\nically to it have not been recognised. Doctors performing\nHIFU treatment should adhere strictly to the principles of\ngood professional care and anticipate specific medico-legal\nissues that might arise in various stages and aspects of HIFU\ntreatment of gynaecological conditions. Retrospective wis-\ndom in this area can be learned from studying medico-legal\nmatters which occurred in the early development of laparo-\nscopic and robotic surgery.\nDoctors performing HIFU treatment should learn an\nupdated diagnostic knowledge of MRI interpretation. They\nshould also practice HIFU diligently and learn to avoid and\nhandle complications. For the time being, postgraduate\ntraining in this new technology for gynaecologists in prac-\ntice is non-existent. Therefore, gynaecologists with insuf-\nficient training who perform HIFU surgery may potentially\nbe at risk for liability. The litigation complexity is similar to\nrobotic surgery’s early development [ 5,18]. Therefore, in-\nternational surgical associations should collaborate on this\nnew development to set up training requirements and cre-\ndentials for HIFU ablation treatment.\nFinally, in a medico-legal situation, a claim’s verdict\ndepends on the expert witness arguing the balance of neg-\nligence probabilities. If a claim arises in HIFU ablation in\nany country, expert witnesses called upon will be retired\nor out of tune with this new HIFU technology. They will\nspend their time examining records in detail, giving opin-\nions on any breach of the basic duty, e.g., a lack of detailed\nHIFU information, lack of adequate informed consent, de-\nlayed diagnosis of complications, and failure to repair the\ndamage early. Thus, doctors performing HIFU on patients\n2\n\n\nshould be aware of these considerations. Regardless of how\nadvanced and complicated a HIFU procedure is, the basic\nprinciples under which the medical profession must observe\nshould never be compromised.\nTo conclude, to avoid medico-legal litigations — one\nof the essential things is good communication with patients.\nInformed consent forms should be correctly filled in and\nsigned by patients before a witness. All medical records\nshould be dated and recorded at consultations before and\nafter HIFU treatment. HIFU doctors should work under all\nthree “adequacy”, i.e., adequate training, skills, and doc-\numentation. A better understanding of the importance of\nseeking assistance from proctors or experienced supervisor\nearly in HIFU training is likely beneficial.\nAuthor Contributions\nFW and TL designed and wrote the paper. PHW re-\nvised and gave advice to some of on medico-legal aspects\nin the papers. All contributed to editorial changes and ap-\nproved the final manuscript.\nEthics Approval and Consent to Participate\nNot applicable.\nAcknowledgment\nNot applicable.\nFunding\nThis research received no external funding.\nConflict of Interest\nThe authors declare no conflict of interest. FW is serv-\ning as one of the Editorial Board members of this journal.\nWe declare that FW had no involvement in the peer review\nof this article and has no access to information regarding its\npeer review. Full responsibility for the editorial process for\nthis article was delegated to CI.\nReferences\n[1] Hechenbleikner EM, Jacob BP . Medico-legal Issues in Robotic\nSurgery. Tsuda S., Kudsi O. (eds.) Robotic-Assisted Minimally\nInvasive Surgery (pp. 27–34). 1st edn. Springe: Berlin, Ger-\nmany. 2019.\n[2] Bass D. Laparoscopy and litigation: small access, small injuries,\nbig trouble. South African Journal of Surgery. 2020; 58: 7–9.\n[3] Wong WSF, Lee MHM, Wong PH. 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