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澳大利亚参议院关于经阴道网状装置的委员会报告。

Australian Senate Committee Report on Transvaginal Mesh Devices.

作者信息

Thompson Chloe, Faunce Thomas

机构信息

Australian National University Law School.

Professor, Australian National University Law School and Australian National University Medical School.

出版信息

J Law Med. 2018 Jul;25(4):934-943.

Abstract

On 28 March 2018 the Australian Senate Community Affairs References Committee issued its final report on transvaginal mesh devices. It found these devices have caused unnecessary physical and emotional pain and suffering to thousands of women who were not told by their doctors of the objective material risks associated with their use. The Senate Committee concurred with the description by the Public Health Association of Australia of the complications resulting from transvaginal mesh implants as constituting a serious public health issue requiring a response at both an individual and at a population level, including counselling, public education, clinical interventions and long-lasting protective mechanisms. The committee's inquiry highlighted significant shortcomings in Australia's reporting systems for medical devices, with flow-on consequences for the health system's ability to respond in a timely and effective way. Among other recommendations, the Senate Committee backed the establishment on a cost recovery basis of a national registry of high-risk implantable devices linked to a system of mandatory reporting of adverse events.

摘要

2018年3月28日,澳大利亚参议院社区事务参考委员会发布了关于经阴道网状装置的最终报告。报告发现,这些装置给数千名女性带来了不必要的身体和精神痛苦,而她们的医生并未告知她们使用这些装置存在的客观重大风险。参议院委员会认同澳大利亚公共卫生协会的描述,即经阴道网状植入物引发的并发症构成了一个严重的公共卫生问题,需要在个人和群体层面做出应对,包括咨询、公众教育、临床干预和长效保护机制。该委员会的调查凸显了澳大利亚医疗器械报告系统的重大缺陷,这对卫生系统及时有效做出应对的能力产生了连锁影响。除其他建议外,参议院委员会支持在成本回收的基础上建立一个与不良事件强制报告系统相关联的高风险可植入装置国家登记册。

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