THOUSANDS of Australian women may have been harmed by a popular contraceptive implant which offers permanent sterilisation to those who no longer want to have children.
The 13-year-old Essure coiled device, which is spruiked by pharmaceutical giant Bayer as a safe non-surgical solution that only takes 15 minutes to insert into the fallopian tubes, has so far been taken up by 750,000 women worldwide.
But now thousands are coming forward with horrifying and sometimes deadly complications, including excruciating pain, haemorrhaging and punctured reproductive tissue, Seven’s Sunday Night reports
Some have had the implant shatter or migrate into other parts of the body. What’s more, many have fallen pregnant despite the controversial contraceptive’s promises.
NSW academic adviser Nina Bernius had the Essure contraceptive inserted nine years ago, and is only now recovering from her agony. She recently won a lawsuit against her gynaecologist over her lengthy ordeal, which saw her grapple with three pregnancies and two abortions.
The mum-of-three told Sunday Night she began feeling unwell within a year of insertion and was horrified to discover she was four months pregnant.
She was forced to make the difficult decision to terminate her pregnancy, and her doctor assured her it couldn’t possibly happen again. But it did, three years later, and Nina this time chose to give birth to her now five-year-old daughter Rya.
“I was horrified and I thought, “Well... What’s wrong with me? I’m sterilised, and yet I keep on getting pregnant”,” she said.
While desperately trying to get on with her career, Ms Bernius had a third devastating pregnancy two years ago, and had her second abortion.
Under the impression she was the problem, she decided to get surgery. During the procedure, it was discovered the Essure coils had pushed out of her fallopian tubes, causing the three pregnancies.
Fighting back tears, Bernius explained she had to have a full hysterectomy — the only acknowledged solution.
She believes the device should be banned, and urges women to “run away”.
“I feel like I was lied to,” she said.
“I’m just reaching out to other women, you know, to make them see that life can happen again, you know, after Essure.”
Lisa Flynn, a partner at Australian compensation specialists Shine Lawyers, believes “hundreds or even thousands” of women may be affected on our shores.
“Litigation can’t change what has happened. However, what it can do is it can provide compensation to women so that they can get the medical treatment that they need to move on with their lives,” Ms Flynn said.
Legendary consumer crusader Erin Brockovich has backed an unrelenting US campaign to have the controversial contraceptive pulled from the market due to the many reported side-effects.
“There are too many women harmed all by the same common denominator, and that is a device called Essure. How many women have to be harmed before we stop?” Ms Brockovich questioned.
She stressed she felt the fact that 20,000 women had been harmed so far was being unfairly ignored.
“I’d love to see the headline ‘20,000 men’s penises fall off’. I’m telling you, the world would stop,” she said.
Among the victims leading the fierce campaign against Essure’s manufacturer, Bayer, is New York mum Angie Firmalino, 43, who almost immediately suffered immense agony after having Essure embedded into her body six years ago.
The crippling pain left her unable to move. She has since been on strong painkillers and has undergone several operations, including a hysterectomy and two subsequent surgeries to deal with bleeding caused by broken coils left in her uterus.
“I really thought I was going to die. I didn’t think I was gonna make it out of that one,” she confessed.
Angie and her Facebook army recently took their case to the US Senate, lobbying hard to change laws. America’s Food and Drug Administration is conducting hearings.
Some medical professionals are also turning against the drug. US Dr Shawn Tassone had been performing Essure procedures for hundreds of women but over time found more of his patients were reporting problems, including pregnancy.
The concerned physician stopped insert the contraceptives, and has since done about 30 hysterectomies.
“I was kind of baffled,” Dr Tassone said.
“I don’t feel like we got properly informed from the company (Bayer) in the beginning.”
In a statement sent to Sunday Night, Bayer stood by the benefit-risk profile of Essure and said they took all adverse event reports seriously.
“Patient wellbeing is the top priority at Bayer and there is great sympathy for anyone who experiences an adverse event from a medicine or medical device, regardless of the cause,” they said.
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