Women’s pain inevitable, say contraceptive case lawyers
Karen Sweeney |
It was inevitable that many women who had a permanent contraceptive inserted experienced pelvic pain and abnormal bleeding, say lawyers defending its creators.
But there’s no evidence of any causal link between the Essure device and those conditions, which are common among women of reproductive age, the Victorian Supreme Court has heard.
Women are suing six companies involved in the design, manufacture, marketing and sale of the product in Australia in a class action, claiming they suffered harm as a direct result.
They include Bayer Australia and German parent company Bayer AG.
The action is led by Patrice Turner, who underwent a hysterectomy at 32, five years after the devices were inserted in her fallopian tube.
She says she suffered severe and at times constant pelvic pain, and heavy uterine bleeding in the years he had the device, which resolved after she underwent the major abdominal surgery.
David Collins KC, representing the companies, opened the defence case on Wednesday describing the 4cm coil, the production of which was discontinued in Australia in 2017, as a safe and important alternative means of permanent contraception.
The plaintiffs have claimed the device caused them chronic pelvic pain and chronic abnormal uterine bleeding disorders. But Mr Collins said experts from both sides agreed up to 25 per cent of women of reproductive age experience those conditions, and often no cause is identified.
“Once that’s accepted, it means unless the Essure device had the effect of preventing those conditions it would be inevitable that many women who had the device would subsequently suffer those conditions – because it was not going to prevent them,” he said.
“You can’t simply, from the bar table, refer to a number of adverse event reports and say ‘well a lot of women reported that they’ve suffered pelvic pain’ and draw the inference that it was caused by the device.”
He said that reasoning was fundamentally flawed and particularly so when an increase in adverse event reports was accompanied by a lot of publicity and social media reports.
“We say it’s compelling that after 20 years there’s been no statistical analysis performed by any of the experts that indicates an inference can be drawn,” Mr Collins said.
Fiona Forsyth KC, representing the women, said companies couldn’t escape liability by writing off problematic effects as “common women’s symptoms”.
“A gynaecological device can’t just escape scrutiny because the problems it potentially causes or exacerbates include chronic pain or abnormal uterine bleeding,” she said.
She said red flags appeared as early as 1999 when a document created by Conceptus, the device developer bought by Bayer in 2013, revealed worst case expectations from an inflammatory response included pain, tenderness, menstrual changes or discharge.
Hundreds of thousands of women worldwide were implanted with the Essure device.
Designed to permanently block the fallopian tubes, they were used in Australia for nearly two decades until being discontinued by Bayer for commercial reasons in 2017.
The trial before Justice Andrew Keogh is expected to run for 12 weeks.
AAP
