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Clinical Negligence Solicitors

Essure sterilisation device causes some to have hysterectomy (6 September 2017)

Date: 06/09/2017
Duncan Lewis, Clinical Negligence Solicitors, Essure sterilisation device causes some to have hysterectomy

The Victoria Derbyshire Show has documented the controversies surrounding Essure sterilisation device, on the BBC.

Bayer, the manufacturer of the Essure implant, has asked the NHS to suspend usage, whilst an investigation into its safety is underway.

Sale of the sterilisation device has been suspended in the EU after criticism that the side effects have caused a number of women to have repeat surgeries, resulting in some having hysterectomies. This comes two years after reassurances were made into the safety of the implant, which is fitted in the fallopian tube. The device works by compelling the body to produce scar tissue around the nickel and polyester (PET) coil, which blocks the tube, preventing eggs from being released.

Laura Linkson had her Essure device fitted in 2013. As a mother, she has been left bedridden from the pain, unable to care and interact with her children.

“I felt like a burden to everyone around me,” Laura explains.

The device, developed to give women more freedom, has left some feeling trapped by their own bodies.

"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," Victoria Dethier revealed.

Victoria had her Essure coil fitted in 2012 and later had a hysterectomy to remove the device in 2015.

Many women, like Laura and Victoria, feel they were not aware of the risks before they had the procedure done.

Consultant obstetrician and gynaecologist Ben Peyton-Jones assures that the device is safe when used correctly. He promotes the benefit of the device to those who cannot have ‘keyhole’ surgery. This is backed-up by Bayer, who claims that the benefits of Essure outweigh the risks.
Concerns over the safety of Essure were raised back in 2014.

Carl Heneghan, from the Centre for Evidence-Based Medicine at Oxford University, places heavy criticism on the company’s failure to act. He feels the issue stems from the clinical trial stage, which monitors the patient for no longer than a year. The long-term side effects are unknown and that means many women are not aware of the potential risks.

The Medicines and Healthcare Products Regulatory Agency (MHRA) have rejected Victoria Derbyshire programme’s request for Freedom of Information, which would reveal how many women have reported problems.

"There are many women coming forward... we need to be acknowledged." Victoria Dethier believes they are being ignored.

The MHRA’s refusal could be linked to the lack of accurate data from the NHS, specifically the number of women who have had Essure fitted and those who have had it removed.

Bayer insists that it places priority in the safety of the women using this permanent form of contraception.

"Many women with Essure rely on this form of contraception without any side effects."

MHRA claims that there is no evidence that the product is unsafe and that the recent suspension of usage does not reflect an increased risk.
Nonetheless, they have reminded doctors that it is important to discuss all benefits and risks prior to the procedure.

Rebecca Thomas,Director of Clinical negligence at Duncan Lewis Solicitors states:

“We know that over 750,000 women are using Essure worldwide, the majority of which are in the United States. For those that are suffering side effects, the physical and psychological toll and the impact that this is having on the users and their families is unacceptable and the manufacturer needs to expedite the investigation and account to the MHRA as a matter of urgency”.

Duncan Lewis Clinical Negligence Solicitors

The Duncan Lewis Clinical Negligence team has significant experience acting in a vast array of claims. Varying from accident and emergency failures to GP negligence claims, to misdiagnosed fractures to wrongful death matters claims. They also act for children and adults who have suffered profound and permanent brain, spinal or neurological injuries and associated disabilities as a consequence of failings in medical care in both NHS and private hospitals. If you have any queries relating to Clinical Negligence or think that you may have a claim, please do not hesitate to contact our team of expert solicitors on 03337720409.


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