Australian women to launch class action over failed contraceptive device
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Mother-of-four Tanya Davidson struggled daily with pain from the contraceptive implants wreaking havoc in her body, but it was years before she discovered the pain was being triggered by a major allergic reaction.
- Dozens of women have signed up to a class action against pharmaceutical giant Bayer, the makers of Essure
- Essure is a permanent contraceptive system
- Lawyers say women with Essure have reported abdominal pain, stabbing pain to the ovaries, and irregular menstrual bleeding
The culprit was nickel and it was being exposed by the corrosion of an Essure device doctors had assured her was "safe and effective".
Essure is a permanent contraceptive system that involves two metal coils inserted in a woman's fallopian tubes.
The coils stimulate scarring, which permanently blocks the tubes and prevents an ova and sperm meeting.
Ms Davidson had the metal coils implanted in 2010 as a way to avoid surgery associated with a traditional tubal ligation.
"When I saw the Essure brochure it was saying that it's a gentler approach, and the big fact for me with it was it was non-surgical," she said.
"When you've got four little ones crawling around you can't afford to have the time off."
But within days of the procedure Ms Davidson experienced heavy bleeding. Within weeks she had severe pelvic pain and hair loss.
A doctor recommended a second intra-uterine device called a Mirena to control bleeding.
Ms Davidson later learned this caused the two metal devices inside her to react and spark off each other.
When she insisted her gynaecologist remove the Mirena, the doctor controlled the bleeding using a method called ablation.
This heated up the metal in her Essure and the device broke down further inside her.
All the while her gynaecologist kept assuring her the Esssure device was completely safe and many of her symptoms were psychological.
"He said he would be happy to insert the coils in to any of his female relatives," she said. "I was seeing red. I couldn't believe it."
Eventually a second specialist took one look at the rash on Ms Davidson's face and diagnosed a nickel allergy from the coils corroding insider her.
Nickel allergies are common and it is estimated up to 17 per cent of women and 3 per cent of men are allergic to the metal.
He tried to remove Ms Davidson's fallopian tubes all together, and Ms Davidson, having discovered more about Essure's effects, advised not to pull at the coil because it was known to break up.
But the surgeon did pull at the device and it broke, leaving shards of nickel and plastic insider her abdomen. She had to have a full hysterectomy.
While those shards linger in her abdomen, the immune symptoms associated with a severe nickel allergy from the device still remain.
"I want someone to be accountable to for doing this," she said. "Not just to me but to my kids, they've lost their mum, my partner lost his wife."
At least 3,000 Australian women affected
Ms Davidson is one of dozens of women who have signed up to be part of class action against international pharmaceutical giant Bayer, the makers of Essure.
The action is being brought by law firm Slater and Gordon and will mirror other class actions in countries like the United States, Canada and Scotland.
While there are no official figures on the number of Australian women with an Essure, rough estimates suggest between 3,000 and 5,000 women across the country have the permanent contraceptive device.
Bayer recalled the product from market last year after the regulator, the Therapeutic Goods Administration (TGA), issued a hazard alert.
Investigating solicitor Ebony Birchall said the firm had been contacted by dozens of women with concerns, and expected there may be hundreds more who have experienced problems.
She said the main problems with the device had been corrosion of the stainless steel exterior, which exposes women to the nickel inside, perforation of the uterus, and dislocation of the device into the uterus or abdomen.
"Common between all of the women that I've spoken to are things like abdominal pain, stabbing pain to the ovaries and irregular menstrual bleeding," Ms Birchall said.
"A lot of the women I have spoken to have had to have a hysterectomy to try and overcome some of these symptoms.
"Then there's also been issues like auto immune diseases that are possibly related to things like chronic fatigue."
Dr Bernadette White from the Royal Australian and New Zealand College of Obstetricians and Gynaecologists said there was anecdotal evidence that Essure was linked to pelvic pain.
But she is sceptical that the device could have caused problems such as auto-immune diseases.
"It's more difficult to see how you would link the Essure device with some symptoms that women have linked to it," she said.
Ms Birchall said they hoped the legal case would force Bayer to answer questions about the device.
"The medical experts that we've spoken to have indicated to us that the risk of the eventual corrosion of the device should have been foreseeable," she said.
In a statement, a Bayer spokeswoman said Essure was placed on the market after going through TGA approval processes.
"While it was on the market Essure was maintained and updated in accordance with all health authority requirements to ensure the label reflected all current safety information," the statement said.
Ms Birchall said women had lost partners, jobs and their ability to care for their children.
"A lot of the women have said things to me like, 'I wasn't informed of any of these risks'. So something that was at first a safe, quick, efficient fix, has turned into something that has completely turned their lives upside down."
A Bayer spokeswoman said it discontinued Essure in Australia in 2017 "due to a low and declining trend in patient preference".
"We are always saddened to hear of anyone experiencing an adverse event with any medical device," she said.
"We make the health and wellbeing of our patients, and the integrity of all of our products, an absolute priority."
'Paint your bedroom walls red'
Despite Ms Davidson's health issue, it wasn't the worst experience she had with a gynaecologist.
That happened when she went to one in regional Victoria with her series of symptoms, including loss of libido.
"I got told I should paint a wall in my bedroom red and that was suddenly going to make everything perfect again," Ms Davidson said.
What she was actually experiencing was a nickel allergy, from the nickel inside her Essure.
Ms Davidson now has to make an eight-hour round trip from Swan Hill in northern Victoria to Melbourne, to visit a heavy metals toxicologist who is helping her deal with the remaining nickel shards in her body, eight years after she first had the device implanted.
To this day she suffers cognitive problems, weight gain, relationship problems, and bears a constant reminder of her ordeal in the form of a nickel rash on her face.
"I know it's not just me and I know there are thousands of women out there like me," she said. "I deserve to be told 'I'm sorry we did this to you'."
Dr White said physicians should take patients seriously.
How many Australian women are affected?
It's not known how many Australian women have an Essure device and Bayer said it was unable to release its Australian sales figures for "commercial reasons".
However, private health insurers told the ABC they paid for more than 1,000 devices between 2005 and 2017.
It includes Bupa (379), Medibank Private (320), HCF (228) and NIB (113), and together they control just under three-quarters of the health insurance market.
With private health making up just under half of the health sector, that equates to an estimated 3,097 Australian women with the devices — but potentially more when private patients treated in the public system are included.
The Facebook page Essure Problems Australia has just under 300 members and Health Issues Centre chief executive Danny Vadasz said they had been contacted by about 100 women with problems.
Should women with Essure be concerned?
The Royal Australian and New Zealand College of Gynaecologists and Obstetricians told the ABC those women with an Essure should contact their GP or specialist if they have any concerns about symptoms.
"My advice would be if a woman has had an Essure and she has not had problems with it, I think she does not have any grounds for concern," Dr White said.
"For women who have got a device and do have symptoms, and that might be pain or abnormal bleeding or other symptoms, they should have those symptoms evaluated thoroughly."
She said the problems with Essure showed the way devices were regulated needed to be reviewed.
"Both the issue around mesh procedures and now Essure does warrant some assessment," she said.
"Do we really have a sufficiently rigorous enough system in place to evaluate devices both before and after they are put into use, and maybe there is evidence that we do need to tighten up."
In a statement, a Bayer spokeswoman said there were more than 40 published studies on Essure involving more than 200,000 patients worldwide that supported its use.
"Women who currently have Essure in place may continue to use the device, and Bayer will continue to support healthcare providers in their management of these patients," it said.
"We encourage women who have any questions about Essure to contact their healthcare provider."
Ms Davidson said it was simply not good enough.
"I'm a firm believer that if there was a male implant, the minute there had been side effects it would have been taken off the market," she said.
"But because we're women I just feel we're the secondary class and it doesn't seem to matter.
"It's all about being the next person to develop the next best thing, I don't think it has the patient's best interest at heart."