The class action over the contraceptive Essure which began in Victoria this week highlights the need for a national register of implantable devices says a Bond University expert.
More than 1000 Australian women are suing pharmaceutical giant Bayer and related companies over the permanent contraceptive device which was recalled from the market in 2017 after a hazard warning from the Therapeutic Goods Administration.
Biotechnology law expert and Associate Professor Wendy Bonython said that implantable device tracking is often flawed due to a heavy reliance on doctors’ voluntary notifications.
“We sort of lose sight of which patients end up with which devices from the point of care onwards,” she said.
“There's a real breakdown in the way we track devices, keep tabs on them, communicate information about recalls in particular, and actually go back and make sure that these things are no longer existing in hospitals so they can’t be implanted after there have been concerns raised about them.”
Dr Bonython says up until now, Australia has relied on doctors voluntarily notifying authorities of adverse reactions experienced by patients.
She said new laws passed last month which make it mandatory for healthcare facilities to report negative reactions will take effect within the next two years.
“That’s something that’s been missing from the existing scheme for quite a long time, so that’s definitely an improvement,” she said.
Dr Bonython said women were disproportionately affected by failures in medical regulation, citing examples including the Poly Implant Prothèsesilicon breast implants and transvaginal mesh, along with Essure.
“It’s taken an incredible amount of energy and effort and persistence for women who have had these devices to be taken seriously and to be believed.”
Essure was a permanent contraceptive system which worked by inserting two metal coils into a woman's fallopian tubes. The coils caused scarring, which blocked the tubes and prevented an ova and sperm meeting.
More than half of the women involved in the class action have had hysterectomies to remove the devices, while others have chronic and severe pelvic pain and significant bleeding.
Bayer said it stood by the safety and efficacy of the device and that it had undergone rigorous testing including 10 clinical trials and over 70 real-world observational studies involving more than 270,000 women over the past 20 years.
The judge-only trial is expected to run for 12 weeks.