The report features the following recommendations
R 1 Noting the vital role of adverse reporting in post-market surveillance, the committee recommends that the Australian Government, in consultation with the states and territories and the Medical Board of Australia, review the current system of reporting adverse events to the Therapeutic Goods Administration to:
• implement mandatory reporting of adverse events by medical practitioners;
• provide guidance on what constitutes an adverse event for use by consumers, medical practitioners and device sponsors;
• improve awareness of the reporting system;and
• examine options to simplify the reporting process;
R 2 The committee recommends that the Therapeutic Goods Administration and the Australian Commission on Safety and Quality in Health Care develop an information sheet to be provided to recipients of patient cards for implantable devices providing guidance on appropriate action to take in the event of an adverse event, including guidance on seeking appropriate treatment and support and on reporting the event.
R 3 The committee recommends that the Australian Government prioritise consideration of the implementation of Recommendation 22 of the report of the Review of Medicines and Medical Devices Regulation recommending the establishment of a registry for all high-risk implantable devices, together with consideration of the feasibility of establishing such a registry on a cost recovery basis, and provide to the Senate by 29 November 2018 a progress report on work to date.
R 4 The committee recommends that the Medicare Benefits Schedule Taskforce prioritise release of the report of the Gynaecology Clinical Committee for consultation.
R 5 The committee recommends that the Australian Government prioritise the establishment of a more comprehensive post-market monitoring scheme and provide to the Senate by 29 November 2018 a progress report on work undertaken to date.
R 6 The committee recommends that the Australian Commission on Safety and Quality in Health Care prepare guidance material on effective informed consent processes, with a view to ensuring that a dialogue between a medical practitioner and patient should:
• clarify the rationale for the proposed treatment;
• discuss the range of alternate treatment options available and their attendant risks and benefits;
• discuss the likely success and potential complications of the recommended treatment as they relate to the individual patient;
• provide an opportunity for the patient to ask questions; and
• confirm that the individual patient has understood the information discussed.
R 7 The committee recommends that treatment guidelines developed by the Australian Commission on Safety and Quality in Health Care should clearly indicate that transvaginal mesh implantation should only be undertaken with fully informed consent and as a last resort when other treatment options have been properly considered and determined unsuitable.
R 8 The committee recommends that the medical professional specialist colleges and societies ensure that processes are in place to draw their members' attention to the resources released by the Australian Commission on Safety and Quality in Health Care and implement arrangements which require members to consider the resources in their practice.
R 9 The committee recommends that the Commonwealth, state and territory health Ministers require that guidance developed by the Australian Commission on Safety and Quality in Health Care for the credentialing of medical practitioners who perform transvaginal mesh procedures should underpin credentialing processes in all public hospitals and work with private hospitals to encourage the adoption of a similar requirement.
R 10 The committee recommends that medical professional colleges and specialist societies implement governance arrangements for transvaginal mesh procedures which require that their members:
• are trained in the use of the specific device;
• are adequately skilled to perform the specific procedure, including procedures for partial or full removal of transvaginal mesh devices;
• work within a multidisciplinary team;
• monitor and report patient outcomes; and
• maintain a record of the outcomes of such procedures, including any complications.
R 11 The committee recommends that Commonwealth, states and territory governments commission the Australian Commission on Safety and Quality in Health Care to undertake an audit of transvaginal mesh procedures undertaken and their outcomes since the introduction of transvaginal mesh devices for use in the Australian market.
R 12 The committee recommends that the Department of Health work with the Medical Technology Association of Australia and the Medical Board of Australia to review the systems in place within the device manufacturing industry and the medical professions to support consistent, high ethical standards, with specific emphasis on systems in place to prevent the payment of inducements to medical professionals and teaching hospitals. xi
R 13 The committee recommends that State and Territory governments continue to work with the Australian Commission on Safety and Quality in Health Care to review the provision of services for the use and removal of transvaginal mesh devices. In particular, the committee recommends that consideration be given to the establishment of:
• information and helplines that women who have received transvaginal mesh implants can contact for advice on the availability of treatment and support services, including financial support programs, in their state;
• specialist counselling programs, to assist women who have sustained injuries following transvaginal mesh procedures;
• specialist multidisciplinary units for the assessment and management of complications associated with transvaginal mesh procedures, comprising:
• comprehensive diagnostic procedures, including relevant diagnostic imaging facilities and expertise;
• specialist pain management expertise; and
• high level expertise in the partial or full removal of transvaginal mesh;
• advice and practical assistance for women who are seeking to access their medical records; and
• the provision of further guidance for medical professionals on recording the use of implantable devices on medical records and reporting adverse events to the Therapeutic Goods Administration.
