14 September 2017
Essure Implant Patients Warned to Contact GP As Women Experience ‘Unbearable Pain’
I read with great concern the news of women experiencing “unbearable” pain as a result of Essure sterilising implants, which have left some recipients suicidal.
Reports include Essure implant patients feeling ‘suicidal’ and requiring hysterectomies to remove the devices.
Most troubling is that hospitals have been warned by regulators to stop using the metal implants, which have left patients in agony after the operation. One may certainly question how these devices were deemed safe to be used on such a wide level.
What is it?
An Essure implant is used in hysteroscopic sterilisation, a procedure for women unable to undergo keyhole surgery. The nickel and polyester coil permanently sterilises patients by aggravating their fallopian tubes, causing them to be sealed by scar tissue, which blocks eggs from reaching the womb.
It has been reported that the nickel and plastic fibres have caused bad reactions for some patients, while in other case cases the implant has perforated the fallopian tube, becoming embedded elsewhere in the patient’s body. In these cases the coils have been taken out by removing the fallopian tubes and, in some cases, the uterus.
The full extent of physical and psychological harm caused in the UK is unknown at this point. It is worrying that the NHS cannot provide figures for the number of women who have been fitted with Essure, or who have had it removed as a result of the complications especially in light of the fact that all sales of the implants in the EU have been temporarily suspended as a result of these concerns.
Essure obtained a CE Marking, which declares that a product meets the requirements of European medical standards. The National Standards Authority of Ireland has now said the certification would be suspended for 90 days, meaning that no further devices will be sold.
It has emerged that the clinical trial that preceded the approval of the device has been criticised for not sufficiently testing the long-term effects of the implants. It is incomprehensible that the clinical trial for the device being approved failed to consider the long-term effects of these Essure implants.
The manufacturer, Bayer, insists the product is safe, but has asked UK hospitals to temporarily refrain from using it during the period.
Women have reported a range of symptoms including severe abdominal pain, an unusual taste in the mouth and a loss of hair. If you have any of these symptoms and are concerned they may be related to a defective Essure implant, I would urge you to seek medical attention immediately to find out what your options are and potentially have the implant removed.
Shikha Maini is a clinical negligence solicitor at Slater and Gordon Lawyers in London.
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Wednesday 21st November 2018