Women who claim a contraceptive device left them with crippling side effects are preparing for a Court of Session case which if successful could cost Scottish health boards millions of pounds in compensation.
A group of six women who received Essure implants made by German pharmaceutical giants Bayer say the device left them in pain, suffering bloating, bleeding and infections.
According to the Sunday Mail the women have also reported a string of mental health problems including mood swings and depression, and argue that the implant has made sex either painful or impossible.
Now lawyers acting for the group, personal injury specialists Thompsons in Glasgow, say they have been instructed to move on lodging a case at the Court of Session against manufacturers Bayer.
Similar actions in the US have cost the firm more than £300 million in compensation and costs.
The six Scots are aged between 35 to 50 and are said to live in the central belt, including two in Glasgow. It’s not known which health boards carried out the implant procedures.
One woman described the procedure to fit the device was “barbaric”, adding: “At one point, I wished I was dead. They then told me that only the first part of the device had gone in and not the second.”
They are expected to decide individually whether to pursue cases against the NHS board where the device was fitted for allegedly failing to make them aware of the risks.
The implant is a titanium coil that is placed in the fallopian tubes. It causes inflammation and triggers scar tissue to grow and block off the tubes, preventing eggs from reaching the womb.
While fitting the device takes around 30 minutes without the need for surgery, removal is more complex and in some cases has resulted in women having to undergo a hysterectomy.
It was offered to around 1500 women a year in the UK as a permanent sterilisation method. Around 2000 women in Scotland are thought to have been fitted with the device.
Bayer asked UK hospitals to stop using it in September last year and suspended sales of the implants in the EU. It insisted the suspension was temporary and the implants are safe, however rising numbers of women worldwide have claimed they have suffered a range of side effects and complications.
Solicitor Lindsay Bruce, who is acting for the women, told the Sunday Mail there are concerns NHS Scotland did not properly examine the suitability of the implant before its use.
“These women have described the pain when the devices are being inserted as barbaric. There was no pain relief, only a mild sedative at the time.
“I’m concerned that these devices were not fitted in the best interests of the patient.
“Given what we now know, I’m concerned the women were not offered other alternatives that are available.
“I’m also concerned that not enough advice or counselling was given prior to having the devices inserted.
“They were never told about the potential problems and dangers.”
Bruce added: “The six women tell almost identical stories about their painful experiences with Essure, even though they did not know each other. The side-effects have also taken a toll on their relationships and working lives. They’re in constant pain.
“When they went to their GPs about the pain, they were told it would settle down, which is not the case.”
More than 750,000 women have been fitted with the device worldwide. An estimated that 35,000 patients around the world have complained of side-effects, almost half of them in the US. The issue has been likened to the mesh implant scandal, in which devices used to treat pelvic organ prolapse and incontinence after childbirth were linked with crippling pain and in some cases life-changing side effects.
Bayer defended the implants and insisted the decision to suspend sales were for commercial reasons.
A company statement added: “Bayer has made the commercial decision to voluntarily discontinue the sales and distribution of Essure in all countries except the USA. This decision is not related to any product safety or quality issues and, according to our scientific assessment, the favourable benefit-risk profile of Essure remains unchanged.
“We would like to reassure women who use Essure as their form of contraception and their healthcare professionals that they should have no concerns based on this purely commercial decision.”
A Scottish Government spokeswoman said anyone with concerns should speak to their GP or healthcare professional.
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