Transvaginal Mesh Implants
Sometimes merely having what seems like the right processes in place is not enough to prevent disaster.
Health Issues Centre played a pivotal role in bringing to light a medical catastrophe that had gone virtually under the radar for more than two decades.
Australia’s national regulator, the Therapeutic Goods Administration (TGA), had a complaints reporting process in place and it seemed to be working. During the five years prior to Health Issues Centre’s involvement in the case, the TGA had received around 97 complaints about adverse reactions to transvaginal mesh. Given the thousands of implants carried out across the country, this seemed like a relatively low failure rate.
But our team was picking up signals that something bigger was going on. In January 2016 we met with a small group of courageous women who told us horrifying stories about their experiences after being implanted with transvaginal mesh – a product that was for many years the preferred treatment for pelvic prolapse and urinary stress incontinence.
The devastating stories of unbearable pain and life-changing physical injury we heard could not be ignored and it seemed likely the low number of complaints to the TGA did not represent the true scale of the problem.
In 2017, Health Issues Centre initiated a public investigation. Our social research identified over 2,000 cases of significant mesh-related injury in the space of just six weeks – more than 20 times the number of adverse outcomes reported to the TGA in in the previous five years.
Our analysis also identified multiple system failures, including:
- Underreporting due to:
- A faulty reporting system relying on doctors to report, which represented a fundamental conflict of interest
- Patient reluctance to report their treating physician
- Lack of informed consent – patients were not being adequately informed of potential risks prior to treatment
- Catastrophic failure to keep records, including:
- Which patients have received implants (meaning follow-up to monitor success or to conduct product recall is not possible)
- What proportion of patients received implants (meaning it is not possible to accurately calculate failure rates)
Changing for the better
HIC’s work on Transvaginal mesh has led to far reaching reforms, including:
- Changes to the information provided to women considering corrective measures
- The establishment of care pathways for injured women
- Changes to the risk rating applied to mesh by the TGA
But this is only the beginning. While some procedures have been banned, women are still being implanted for urinary incontinence and women who have been affected haven’t had sufficient remedy. More must be done.
Health Issues Centre continues to work on this issue, including consulting with the TGA on medical device regulation more broadly. Learn more about our work in this space here.
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