Understanding The Concerns Around 'Essure'

04/10/2017 14:20

There are a variety of reasons as to why women may opt for permanent sterilisation. A device called Essure, produced Bayer in Germany, paved the way for achieving permanent birth control and avoids the patient undergoing an invasive surgical hysterectomy.

The product is a small metallic coil, which is into each of the fallopian tubes and a barrier forms thereafter around the inserts. This is known as a hysteroscopic sterilisation and was an alternative "minimally invasive procedure".

The device was approved by the National Institute of Clinical Excellence (NICE) in September 2009. However in 2015, the British Medical Journal (BMJ) published a paper concerning issues of safety and effectiveness of the Essure product, in comparison with the more invasive surgical option. They carried out a large group study of a between 2005 and 2013 in New York State. They concluded that women who had a hysteroscopic sterilisation were ten times for likely to require a laparoscopic sterilisation thereafter.

The US Food and Drug Administration (FDA) have received a significant number of reports with concerns as to the safety and complications caused by the Essure implants. The matter had gained significant media attention in light of the EU's suspension of Bayer's commercial licence in respect of the Essure product and the NICE guidelines approving Essure are also currently suspended.

It was also recently reported in the BBC's Victoria Derbyshire programme that a number of women who had the Essure implant fitted suffered from severe side effects. For example, the story of Victoria Dethier highlighted the devastating complications suffered as a result of the implant. As well has pain and stomach cramps, she at times felt "suicidal desperation" due to pain and symptoms associated with the implant.

Unfortunately, the Medicine and Healthcare Products Regulatory Agency (MHRA) have not disclosed how many women had been affected by Essure, following a request by the Victoria Derbyshire program.

Whilst there are calls for the product to be withdrawn from the market, some doctors are of the view that the implant may still be used if and when there has been a full discussion of the options and risks with the patient.

If you believe that you have experienced an injury as a result of the Essure implant or as a result of a pelvic mesh implant, then please do not hesitate to call a clinical negligence law specialist who can guide you though your options and advise you whether you have a case with reasonable prospects of success.

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