MHRA and Health Experts Ease Fears Regarding Essure Implant

UK regulators have moved to assuage speculation about the birth control implant Essure.

There have been safety concerns about the product in the United States.

Nonetheless, the Medicines and Healthcare products Regulatory Agency (MHRA) has reassured UK users that the implant is indeed safe.

However, the MHRA is monitoring potential side-effects in the meantime following a furore of attention regarding Essure in the US.

The regulatory agency has advised UK women who have experienced any problems from the implant to seek advice from a general practitioner.

This sterilisation device works by blocking the fallopian tubes in order to insure that it is impossible for an egg to travel from the ovaries to the womb.

Unfortunately, there have been reports from women in the United States of injuries during usage.

Although these incidents have been relatively rare, there have been disturbing instances of the Essure device puncturing neighbouring organs, such as the bowel, at least according to US reports.

And other women utilising the product have reported allergic reactions to the nickel contained within the implant.

The equivalent of the MHRA, the Food and Drug Administration (FDA) in the United States, is currently meeting in order to assess the safety or otherwise of the product.

US media has noted that there have been more than 5,000 negative reports about the implant in the 30 years that it has been available on the market, according to the FDA.

The MHRA has declined to provide similar data, but considering that Essure is currently distributed around 1,500 women in the UK annually, the potential for serious health problems is quite obvious.

A spokeswoman for the UK regulator made it clear that the organisation has no reason to believe that the implant is unsafe for general usage.

“We currently have no information to suggest that Essure devices used in the UK are unsafe to use. We liaise regularly with the US FDA and are aware of the recent open meeting of their obstetrics and gynaecology devices panel discussing post-market experience with the Bayer Essure female sterilisation device. We continue to monitor all adverse incidents reported to us.”

Emphasising that the reports are not necessarily anything to worry about, Dr Kate Guthrie, of the Royal College of Obstetricians and Gynaecologists, stated that Essure was a good option for some women.

“It’s quite a simple procedure to do and doesn’t require surgery, unlike other sterilisation methods. But as women and clinicians, we need evidence that it is safe. I’m confident in our system of regulation. If women are getting side-effects, then we need to know about it.”

Essure is usually inserted under local anaesthetic and does not require cuts to be made in the abdomen.


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