A GROUP of women is taking legal action after being sterilised with a device which they say caused horrendous side effects including seizures.
High court proceedings have been lodged in Belfast against Bayer Plc, the pharmaceutical company which distributed the 'Essure' device on the grounds of safety concerns as well as patient consent.
One woman who is among the seven involved was just 28 when she underwent the procedure in 2014 that "destroyed her life" until it was removed six years later.
Speaking to The Irish News, the mother-of-four said the implantation itself was "agony" and she was barely able to walk afterwards.
She ended up attending A&E after experiencing non-epileptic seizures.
"I did not want any more children and made the decision to get sterilised. I also have Cystic Fibrosis. My health trust referred me to a private consultant doing NHS work. He told me the procedure could be carried out on my lunch break and was 'pain free'. But it was absolutely horrendous," said the woman, who wishes to remain anonymous.
"At no point was I told it was Essure I was getting. My body changed and I started to bloat. I also began to experience seizures. I went to A&E several times but they couldn't find the cause.
"It wasn't until last year that a gynae consultant advised the device should be removed. To remove it safely, I had to undergo a full hysterectomy. My body is only now starting to return to normal."
Introduced globally in 2002 (its usage in the UK began in 2009) the Essure implantable non-hormonal device was promoted as an easy, non-surgical procedure.
Resembling a small spring, it was designed to permanently block the fallopian tubes.
However, women who received the implant began reporting serious adverse reactions including pain, hair loss, chronic fatigue, heavy bleeding and unplanned pregnancies resulting from the device failing.
In 2017, the European Union suspended sales of Essure in its bloc countries for three months in response to regulatory concern, with Bayer fully withdrawing Essure from the UK market in late 2017, citing commercial reasons.
Almost 40,000 women have taken legal action in the US resulting in Bayer last year saying it will pay $1.6 billion (£1.2 billion) to settle claims.
Human rights lawyer Eoin Murphy of Ó Muirigh solicitors in Belfast is representing the Northern Ireland women and said he hopes it will result in a class action, similar to that undertaken in America.
His firm been approached by 20 individuals affected and has commenced proceeding on behalf of seven.
"The claims centre on Bayer’s failure to safely regulate the design, manufacture, sale and supply of the Essure devices provided to our clients under the NHS," Mr Murphy said.
"In addition, we believe the relevant trusts failed to obtain informed consent (both written and verbal) pre and post procedure.
"Given the widely publicised criticisms of Essure, the importance of informed consent would have been all the greater and the trusts' failure to adequately set out the risks associated with the device is of great concern. The lead plaintiff’s case is approaching a hearing and it would be hoped that it would pave the way for this larger group action."
