A group of Kiwi women are speaking out about their harrowing health battles after being fitted with a contraceptive device.
Christchurch woman Shay Hodgson visited her doctor in 2015 seeking a permanent contraceptive following her experience of multiple miscarriages. It was during this consultation that she was first told about Essure.
Essure is a permanent contraceptive device for women where two metal coils are inserted into the fallopian tubes where they stimulate scarring, permanently blocking the tubes.
Bayer, the manufacturer of Essure, says the device - which has since been discontinued - is safe.
"It was put to me that the Essure was fast and effective and it was something that could be done in the [doctor’s] office with no major recovery time, that it was the best thing to be done," Hodgson told Newshub.
"They were selling it. Being in the state of mind that I was in, as well as my husband, we were like 'OK, cool' and we jumped at it."
However, six years later the now-32-year-old wishes she didn't get the contraceptive.
"The day those were put in me I lost ownership of my body," she said.
Hodgson explained that her Essure device failed to prevent pregnancy, as it is believed to have been inserted wrong. It meant she also had to use another contraceptive - the Mirena hormonal intrauterine device (IUD).
Over the past few years, Hodgson has also developed numerous health issues which she believes are a result of Essure.
Hodgson said she has been diagnosed with chronic fatigue and chronic pelvic pain, her hair is falling out, she often gets cysts that rupture, and she has to self catheterize because her bladder is now affected.
"Those first couple of years weren't too bad [I just had] a wee bit of pain… Then about the last three years have been really sh*t and the last two have been hell," she said.
The health issues have affected not just her daily life but also her ability to do her job.
"I can't do anywhere near the amount of stuff I used to be able to do and I'm currently doing a prehabilitation program so I'm seeing a pain specialist to see whether I will be able to qualify for surgery to get them removed. It's been a pretty long journey… and I'm just one of many."
Essure
More than 750,000 women worldwide have been fitted with Essure devices since the United States Food and Drug Administration (FDA) first approved them in the early 2000s. The device was discontinued in 2018 by manufacturer Bayer Pharmaceuticals.
While Bayer says the decision was due to a decline in use, some people have speculated it's due to thousands of women coming forward claiming they have suffered severe side effects and health issues related to the devices.
In the United States, almost 40,000 class action lawsuits were launched against Bayer over Essure. Hundreds of women in Canada, the United Kingdom, Brazil and Australia have also launched legal action.
However, ACC remains a barrier for Kiwi women who say they have suffered from Essure.
Hodgson says "it's frustrating, incredibly frustrating".
"You see the class action suit going on and we've got no support here in New Zealand."
Sarah
Auckland woman Sarah, who received the Essure device in May 2017, agrees.
She told Newshub she wished Kiwi women impacted by Essure could join the Australian lawsuit.
"Bayer should be made accountable for all the pain and suffering ladies around the world have encountered, not those just in the US and Australia.
"There are still a few ladies in NZ still waiting to have theirs removed, but have to wait on the public waiting list as they can't afford to go private."
Sarah, who is now in her 40s, decided to get the Essure after it was touted to her as "a quick 10-minute procedure that you can get done in your lunchtime".
But her problems with Essure began when her doctor tried to implant the device.
"The doctor could only insert one coil, the left tube was too small and after several attempts I asked her to stop. The pain was excruciating. My quick 10 minute procedure turned into a 60 minute procedure. I would say it is worse than childbirth."
Because only one coil could be inserted, it meant Sarah still had a 50 percent chance of getting pregnant and she had to remain on the contraceptive pill.
Then from the end of 2018, Sarah says she started developing side effects from the device including vaginal bleeding, pelvic pain, headaches, pelvic cramping, painful intercourse.
But she was fortunate to have a doctor who connected the health issues to the Essure device and was referred to a gynecologist. Just a month after her first visit she received a hysterectomy through her private health care.
'Totally safe'
But many woman are still living with the device, including Bethany*, a Māori woman in her 40s who received the Essure contraceptive in 2011 while living in Auckland as "it seemed like a reasonable option".
But within a few months of receiving the device, Bethany says her blood pressure appeared to be getting "out of control" and she was constantly feeling fatigued, dizzy and nauseous.
"Over the next 18 months I also started bleeding heavily and erratically, was experiencing significant pain, abdominal bloating, large clusters of breast lumps, cold sweats, severe allergic reactions and asthma attacks, brain fog, hair thinning, and extreme pain for days following smears, internal exams and sex."
She said she has struggled to get her health issues taken seriously and health professionals recommended a range of medications including beta blockers, other contraceptives, blood clotting medication, antihistamines, and they tested her for food intolerances and allergies, and menopause.
"Not once did I get the care I was asking for - a return to the 'specialist' who put the [Essure] in or a gynecologist."
After paying for her own ultrasound to check the coils and the state of her uterus, Bethany confirmed she had adenomyosis and is working with health professionals to see if she can get a hysterectomy to completely remove the coils.
Ministry of Health
Essure was distributed through Medical and Scientific Ltd in New Zealand between 2009 and 2017, although it isn't known how many Kiwi women received the device.
A spokesperson from the Ministry of Health said there is no pre-market assessment or approval requirement for medical devices in New Zealand, but there is a requirement for devices (with some limited exceptions) to be notified to a database held by Medsafe.
"When supplied in New Zealand the device had gained regulatory approval in a number of other international markets. The company marketing the device later withdrew the product from the market. We understand that the device was removed due to lack of demand.
"At the time of the product withdrawal, Medsafe required the parent company overseas to provide an assurance that patients in New Zealand would continue to be supported."
The Ministry said Medsafe continues to receive reports from Bayer regarding safety updates on Essure, which are required by the US Food and Drug Administration. The latest of which was from September 30, 2021.
Bayer Response
In a statement to Newshub, Bayer said it continues to stand behind the safety and efficiency of Essure, which is "supported by a robust body of scientific study data".
"This body of data includes the results of 10 clinical trials and more than 70 real-world observational studies, conducted by Bayer and independent researchers over the past 20 years, and involving more than 270,000 women," a spokesperson said.
"Patient safety and appropriate use of our products remain our greatest priorities. Women who currently have Essure in place may continue to confidently rely on the device.
"If a woman with Essure has concerns or questions about the device, she should discuss these with her healthcare professional. Bayer will continue to support women with Essure and their healthcare providers."
