'No evidence of patient safety risk' with controversial sterilisation device, says MHRA

The MHRA has advised women who have undergone hysteroscopic sterilisation with the Essure implant that there is 'no information to suggest that Essure devices used in the UK are unsafe to use', after it emerged that some users are having to undergo hysterectomies to remove their implants.

The Essure device is an option for women who cannot undergo sterilisation by keyhole surgery. | SCIENCE PHOTO LIBRARY
The Essure device is an option for women who cannot undergo sterilisation by keyhole surgery. | SCIENCE PHOTO LIBRARY

A BBC story has reported that some women fitted with Essure implants experienced ‘unbearable pain’ and other side-effects that resolved after they underwent hysterectomy to remove the devices.

However, the MHRA says ‘there is currently no evidence to suggest any increased risk to patient safety.’

The regulator advises women experiencing problems with their devices to discuss these with their GP, and encourages the reporting of any adverse incidents ‘regardless of how long ago the implant was inserted’.

Follow-up surgery

Essure is a small coil made of nickel and polyester fibres.

Sterilisation is achieved by placing the device into the fallopian tubes where it causes scar tissue to form, blocking the tubes and preventing eggs from reaching the uterus.

Because of the way the coils attach to the fallopian tubes, the only way to remove Essure is to take out the tubes and often the uterus.

In 2015, a study published in the BMJ suggested that women who had a hysteroscopic sterilisation were 10 times more likely to need follow-up surgery than those who had a traditional sterilisation - 2.4% of those surveyed, as opposed to 0.2% amongst those having a standard sterilisation.

Ben Peyton-Jones, consultant obstetrician and gynaecologist at Royal Devon and Exeter NHS Trust, said the device should still be used in some instances.

‘I think it has a place for women who can't have keyhole surgery and who are explained the risks very carefully,’ he said. ‘When used correctly, according to the manufacturer's guidance and in trained hands, it is safe.’

CE mark suspended

In a move unrelated to any safety concerns, the National Standards Authority of Ireland recently suspended the CE Mark on Essure (which certifies that the device conforms to European Standards) for 90 days, until outstanding queries related to its recertification are resolved.

The manufacturer of the device, Bayer, has consequently halted distribution in the EU and has recommended that healthcare professionals temporarily suspend implantation of the device until further notice.

Healthcare professionals are reminded to report any adverse events with medicines or medical devices via the Yellow Card Scheme

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