Women suffering from a debilitating illness caused by the permanent female contraceptive device Essure are now petitioning for an investigation into harm caused by the device.
Essure was a birth control device for women that was placed into each fallopian tube to induce fibrosis and blockage.
Medsafe group manager Chris James said in 2017 Medsafe issued a recall of any unused devices, noting potential for harm.
He said the company has received 11 reports of adverse events.
Medsafe sought and obtained an assurance from manufacturer Bayer/New Zealand Medical and Scientific (NZMS) that they had informed the relevant health care professionals who used the product.
Doctors were told they may need to inform patients about potential issues — but women 1News spoke to said they had not been informed of the risks.
Essure patient Shay Hodgson said it was through her own research that she discovered her device was the cause of her ongoing agony.
She said she still struggles some days to look at the "little devil" coil that holds huge impact on her life.
"Took my ability to be a mum, for a long time. [It] took my ability to be a woman."
The 34-year-old was eventually forced to have a hysterectomy to have the permanent device removed and now she struggles to walk and stand.
"No-one's hearing us. We've been screaming in a sound-proof room for years," Hodgson said.
As an Essure sufferer herself, petition organiser Catrina McGregor has called for all women with the device be contacted, and wants ACC to cover all their injury costs.
"I think the whole things been handled really poorly and it should not be allowed to continue," she said.
A class action has been launched against Bayer in Australia and the company has also settled similar claims in the US, paying out over $2 billion.
In a statement, Bayer said it stands behind the safety of Essure based on 10 clinical trials, and 150 studies involving nearly 300,000 women over the past 20 years. It stopped making the device in 2017 due to low sales.
McGregor said it was "wrong" and unfair that women were not made aware of what was going on inside them.
"If MedSafe requested they be monitored, they have a right to be monitored."
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