2023 | Volume 24 | Issue 5

Womens health

Author: Dr Ailsa Wilson Edwards FRACS, Urologist, South Australia, RACS representative, Women’s Health Products Working Group

The Therapeutic Goods Administration (TGA) Women’s Health Products Working Group (WHPWG) was established in 2022 and aligns with the Australian National Women’s Health Strategy (2020 – 2030) as a commitment under the Action Plan for Medical Devices. The WHPWG was born out of concerns identified by the pelvic mesh and breast implant inquiries and is a collaborative advisory forum.

Chaired by Adjunct Professor Robyn Langham (Chief Medical Adviser Health Products Regulation), the WHPWG brings together regulators, health professionals, academics, and patient groups to discuss issues related to therapeutic goods (medical devices and medicines) that are relevant to women. This includes specific products, access, safety, clinical trials, and patient reported outcomes initiatives. The working group provides advice to the federal Minister for Health and Aged Care on relevant issues.

Topics are determined by current affairs relevant to the working group’s terms of reference and include:

  • transvaginal mesh, particularly access to mesh for sacrocolpopexy, which has involved collaboration between the Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) and the Royal Australasian College of Surgeons (RACS).
  • the independent Ahpra review of the regulation of medical practitioners who perform cosmetic surgery
  • breast implant related squamous cell carcinoma and the FDA warning
  • real world evidence on women’s health products including the RACS-endorsed Australian Breast Device Registry and the Australasian Pelvic Floor Procedure Registry
  • medical abortion, resulting in recently amended prescribing restrictions for Mifepristone and Misoprostol (S-2 Step)
  • access to menstrual health products and cervical and breast screening for Aboriginal and Torres Strait Islander women
  • social media in Therapeutic Goods advertising
  • Zoledronic acid access for breast cancer
  • medical device regulation reform in Australia and internationally.

Discussions so far have focused on matters most relevant to surgical specialties—urology, plastic and reconstructive surgery, general surgery (breast section), and rural surgery—content of future meetings may be more applicable to other specialities and an invitation to comment will be extended to those craft groups.

The WHPWG discussion has aligned with a number of RACS active advocacy matters impacting surgeons, including regulation of cosmetic surgery and protection of the title of surgeon. The lens of women’s health has provided a timely new forum for RACS strong advocacy work.

The TGA has funded member attendance.

If you would like more information about our work or would like to provide feedback, please contact the Professional Standards team by email: [email protected]