Essure sterilisation device: What next?

Earlier this week the Victoria Derbyshire Show reported that some women are undergoing hysterectomies to remove the sterilisation device, Essure. The BBC has covered the story.

The non-hormonal medical device used by the NHS in the UK is manufactured by Bayer who claims it is 99% effective at preventing pregnancy.

The BBC reported that one woman revealed the pain she experienced caused her to feel suicidal. She later had her uterus removed.

Another woman, Victoria Dethier, said that she couldn’t work out why she felt ill after having an Essure implant.

"There were moments where I couldn't get out of bed I was in so much pain. It felt like I was dying, like something was killing me from the inside," the BBC reports.

Dethier had a hysterectomy in 2015.

Robert Rose, partner and head of the clinical and medical negligence team at Lime Solicitors, said: “The key issue here, is were these ladies properly consented before the Essure sterilisation device was implanted? Since 2015 (following the Supreme Court’s decision in Montgomery v Lanarkshire), the law is clear that rather than being a matter for clinical judgment to be assessed by a professional medical opinion, a patient should be told whatever they want to know, not what the doctor thinks they should be told .“There is now a duty on doctors to warn patients of material risks- the test of ‘materiality‘ being whether a reasonable person in the patient’s position would be likely to attach significance to the risk.“This more patient focused test could create opportunities for women to pursue medical negligence actions, and they stand every chance of success if they were not warned of the potential complications of this device- however small the risk of those complications arising.”

The device is made of nickel and polyester (PET). According to the Essure website the device is placed into the fallopian tubes. It works “with your body to form a natural barrier that keeps sperm from reaching the eggs, preventing pregnancy”.

According to the BBC Bayer has asked UK hospitals not to use the device at the moment and its sales in the EU have been suspended.

Peter Kelly is legal director at Lime Solicitors. Regarding product liability, he said: “This device has been in use for some considerable time, but from the point of view of a claim in Product Liability under the provisions of the Consumer Protection Act 1987, the fact that there has been a suspension of sales within the EU could prove significant. If it can be proved that the device is a ‘defective product’ within the meaning of this legislation, that is, if it can be shown that the safety of the device is not such as people generally are entitled to expect, then there could be liability on behalf of the manufacturers and suppliers, leading to substantial compensation awards in the courts. Such claims are never straightforward however, and are heavily reliant upon independent expert evidence, strong enough to prove defect and to rebut the defences available to the manufacturer under the Act.”

MPN contacted Bayer for a comment but the company has yet to reply. The BBC reports that Bayer says the benefits of the device outweigh the risks.