Joint submission by Health Consumers Councils across Australia:
Health Issues Centre (Vic)
Health Consumers Queensland
Health Consumers’ Council (WA)
Health Consumers Alliance of SA
Health Care Consumers Association (ACT)
Health Consumers New South Wales
This submission was prepared by Dr Martin Whitely, Manager Policy and Research Health Consumers’ Council (WA) with substantial assistance from Carolyn Chisholm from the Australian Pelvic Mesh Support Group, Danny Vadasz of Health Issues Centre (Victoria) and Melissa Fox, CEO of Health Consumers Queensland. The survey cited in this paper was conducted by the Health Issues Centre (Victoria). Recommendations
For the reasons outlined above we support the call to action by the APMSG and recommend:
1. The suspension of the use of mesh for prolapse and stress urinary incontinence, due to the severity of complications, with the suspension not to be lifted unless and until their safety and efficacy is established.
2. Free medical expertise and help being made to women already injured including access to experienced mesh removal surgeons sourced internationally if necessary.
3. Acknowledgement and ongoing support for adversely affected women. The host organization, format and language of information and promotional materials should be co-designed with affected women and consumer organisations. The support provided should include:
i. A consumer help line.
ii. Website for women with evidence based information around risks and benefits of treatment options.
iii. Recognition and support for women with ongoing incontinence issues.
iv. Recognition and support for women with ongoing disability issues and facilitate access to NDIS funding.
v. Referral to specialist surgeon who can advise and treat the complications.
4. Explicit and clear warnings to clinicians, patients and families of potential adverse effects of mesh (Including appropriate information for women with hearing or sight impairment or from CALD backgrounds).
5. Full public disclosure of the clinical trials and other evidence used by the TGA in determining that the products were fit for market.
6. Full public disclosure of how the TGA has responded to adverse events reported by women injured through pelvic mesh devices.
7. A broader Senate inquiry into the operations of Therapeutic Goods Administration TGA in relation to its failure to ensure the safety and efficacy of pharmaceuticals and medical devices in Australia.
8. We call on the Commonwealth Government to:
Establish a Gynecological Mesh User Registry along the lines of the Australian Orthopedic Association National Joint Replacement Registry (AONJRR). The purpose of the AONJRR is to ‘benefit patients by enhancing the outcome of joint replacement surgery through the provision of comprehensive, quality, validated information’. A Gynecological Mesh User Registry would fulfill a similar purpose for women suffering from, or concerned about, potential adverse effects. The database should also have a consumer-friendly interface which facilitates women logging in and self-reporting their complications.
9. Consider having a Register for all mesh devices implanted in patients. In line with previous Senate inquiry recommendations we also call on the Commonwealth Government to direct:
10. Commonwealth Government to legislate to introduce mandatory reporting for health practitioners and pharmacists to the Therapeutic Goods Administration for a range of (yet to be specified) severe adverse events for medications and medical devices.
11. Furthermore, we recommend that the TGA regularly publish full de-identified details (not just summaries) of adverse events associated with the use of medications and medical devices on a publicly accessible website.
12. The Department of Health to undertake further work to address the issue of inducements paid by pharmaceutical companies and medical device manufacturers to doctors and teaching hospitals, in line with the Physician Payment Sunshine provisions of the Patient Protection and Affordable Care Act of 2009 in the United States. The definition of inducements should include a commercial interest in a company or device; any cash payments or discounts offered to medical practitioners; and any other gifts provided to medical practitioners.
We also recommend that:
13. There needs to be enhanced participation of consumers in all the TGA processes with a formal place in the assessment for input from consumers and consumer organisations which would form part of the data package used for that assessment in line with international best practice on consumer involvement in health technology assessment. There should be robust consumer participation on all TGA committees with a transparent process for nominating and publication of the results of any such process.
14. In our efforts to gather women’s experiences of transvaginal mesh, we have heard of concerning complications experienced by men and women who have had mesh inserted for other conditions. We think this warrants the further investigation of use of all mesh devices. ###