Update: Bayer ends sale of sterilisation device outside of US

Pharmaceutical company Bayer has announced it is ending the sale of its Essure sterilisation device in all non-US countries.

Bayer states in its press release that the decision to end sales of the product in the selection regions is not due to a ‘safety or product quality problem’ and is instead being made for commercial reasons.

More so, the company claims that the device’s ‘positive benefit-risk profile remains unchanged’ and that its ‘safety and effectiveness remain supported by more than ten years of scientific research and real-life clinical experience’.

The Essure device - made from nickel and polyester - is intended to prevent pregnancy and is inserted into the fallopian tubes to form a barrier that keeps sperm from reaching the eggs.

Earlier this year it was reported that some women were experiencing strong levels of pain and discomfort due to the devices. Some women were even reported to have had to undergo surgery to have their uterus removed.

In a premarketing study of the device, Bayer states that 12.9% of women experienced mild to moderate pain, 29.6% experienced vaginal bleeding and 6.8% experienced pelvic or back discomfort.

Laura Linkson told the BBC that fitting of the Essure device in 2013 had left her feeling suicidal. She said: “The device was sold to me as a simple and easy procedure. I was told that I'd be in and out of the doctor's office in 10 minutes and that there'd be no recovery time.

“I went from being a mum who was doing everything with her children, to a mum that was stuck in bed unable to move without pain, at some points being suicidal. I felt like I was a burden on everyone around me.”

Bayer argues that a number of factors such as the temporary suspension of the device’s CE marking and a recall of the device in France created an unfavourable environment and led to a ‘continuous decline in demand’.

The Medicines & Healthcare products Regulatory Agency has issued a comment regarding Bayer's decision to end sales of the device outside of the US. 

MHRA said in a statement: "Bayer has advised the Medicines and Healthcare products Regulatory Agency that they are withdrawing the Essure Device from the European Market.

The manufacturer has advised this is a commercial decision and is not related to any safety concerns and the device will continue to be available in the USA. They have also advised there is no need for women to have their device removed.

Patient safety is our highest priority and there is currently no evidence to suggest any increased risk to patient safety. Any women with questions should speak to their GP or healthcare professional.

We encourage any woman who has experienced a complication from her Essure device to report this to us through the Yellow Card scheme, regardless of how long ago the implant was inserted."