![[DRAFT] Breast Implant Risk Management Framework input request](https://afmw.org.au/wp-content/uploads/2024/03/breast-implant-review-march.jpg)
Sharing this as a member of the TGA Post-market devices breast implant advisory group, for wider input.
Please note the consultation will close on 26 March 2024.
Overview
The Therapeutic Goods Administration (TGA) is seeking comments on a proposed Breast Implant Risk Management Framework. The draft framework describes how the TGA identify, communicate and manage the risks associated with breast implants and what patients can do.
Why your views matter
The draft framework was developed to ensure that healthcare practitioners and patients have a shared understanding of the potential risks associated with breast implants, enabling informed decision making, enhanced patient safety and continuous improvement in breast implant-related procedures. We encourage you to share your feedback during this consultation. Your input is instrumental in refining the framework, and in ensuring that the framework reflects the needs and expectations of the public.
Further Information
Visit the Health Technology Assessment Policy and Methods Review website.
Associate Professor Magdalena Simonis AM is the Immediate Past President of the AFMW (2020-2023), former President of VMWS (2013 & 2017-2020) and current AFMW National Coordinator (2024-2026). She is a full time clinician who also holds positions on several not for profit organisations, driven by her passion for bridging gaps across the health sector. She is a leading women’s health expert, keynote speaker, climate change and gender equity advocate and government advisor. Magda is member of The Australian Health Team contributing monthly articles.
Magdalena was awarded a lifetime membership of the RACGP for her contributions which include past chair of Women in General Practice, longstanding contribution to the RACGP Expert Committee Quality Care, the RACGP eHealth Expert Committee. She is regularly invited to comment on primary care research though mainstream and medical media and contributes articles on various health issues through newsGP and other publications.
Magdalena has represented the RACGP at senate enquiries and has worked on several National Health Framework reviews. She is author of the RACGP Guide on Female Genital Cosmetic Surgery and co-reviewer of the RACGP Red Book Women’s Health Chapter, and reviewer of the RACGP White book
Both an RACGP examiner and University examiner, she undertakes general practice research and is a GP Educator with the Safer Families Centre of Research Excellence, which develops education tools to assist the primary care sector identify, respond to and manage family violence . Roles outside of RACGP include the Strategy and Policy Committee for Breast Cancer Network Australia, Board Director of the Melbourne University Teaching Health Clinics and the elected GP representative to the AMA Federal Council. In 2022. she was award the AMA (Vic) Patrick Pritzwald-Steggman Award 2022, which celebrates a doctor who has made an exceptional contribution to the wellbeing of their colleagues and the community and was listed as Women’s Agenda 2022 finalist for Emerging Leader in Health.
Magdalena has presented at the United Nations as part of the Australian Assembly and was appointed the Australian representative to the World Health Organisation, World Assembly on COVID 19, by the Medical Women’s International Association (MWIA) in 2021. In 2023, A/Professor Simonis was included on the King’s COVID-19 Champion’s list and was also awarded a Member (AM) in the General Division for significant service to medicine through a range of roles and to women’s health.
