The Essure Hysteroscopic Sterilisation method provided permanent birth control via placement of a flexible micro-insert device into each fallopian tube. This procedure was withdrawn from the UK market in September 2017.
The small coil implants, which were made of nickel and polyester (PET) fibres, were used as a sterilisation device to stop eggs reaching the womb. They were inserted into the fallopian tubes where they triggered inflammation. This caused scar tissue to build up and eventually block the tubes. This is known as a hysteroscopic sterilisation.
The procedure needed contraception to be used for an additional 3 months until tubal occlusion had been confirmed by ultrasound scan or hysterosalpingogram.
Counselling required advice being given on the failure of placement of the second device in up to 19% of cases. Additional methods of sterilisation would then be required. This would be a repeat attempt or laparoscopic sterilisation.
Essure had a failure rate of 1:200. There is evidence of being 10 times more likely to need operative intervention within 1 year. In addition, 2% of women required alternative methods of sterilisation because of the inability to place the devices correctly. Some need the devices removed due to incorrect placement. Others require removal due to pelvic pain.
The intense pain due to placement or in some cases a reaction to the nickel and plastic. This creates intense chronic pain which cannot be alleviated until the device is removed. Due to the way the coils attach to the fallopian tubes, the only way to take them out is to remove a woman’s fallopian tubes and often her uterus.
Having a hysterectomy can then create prolapse and urinary incontinence issues. Women 60 years old and older who have previously undergone hysterectomies have a 60% higher risk of urinary incontinence later in life than women who have not had the procedure.
So many women simply seeking sterilisation as a method of birth control ended up needing prolapse surgery and lifelong incontinence treatment.
In other cases the device has been found to perforate a fallopian tube and fallen out, embedding itself elsewhere in the body.
Late failures resulting in pregnancy can occur at any time. There is a higher risk of ectopic pregnancy when failure occurs.
Sadly many women were ignored when reporting the pain that they associated with the device. This caused a delay in the withdrawal of the device from the market.
There are still many patients with Essure Hystereoscopic Sterilisation in place who may be seeking removal due to safety concerns or continued pain and discomfort.
If you think you may have a claim in relation to your sterilisation then call us in confidence to discuss your issue. We are happy to talk through what has happened and advise you on a potential claim. Call us for FREE on 0800 470 2009 or email Dr Victoria Handley at firstname.lastname@example.org