Freedom of Information request about Mirena and Essure IUDs (FOI-21-163)
Published 24 March 2021
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This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-15-february-2021/freedom-of-information-request-about-mirena-and-essure-iuds-foi-21-163
Thank you for your email of 08 February 2021 in which you asked for information on the Mirena and Essure coils. Please find our answers below.
- How many complaints have been received about the Mirena and Essure coil?
This information is exempt from disclosure under Section 44 of the Freedom of Information Act 2000 (FOIA).
Section 44 – Prohibitions on disclosure: the release of information is exempt as its disclosure is prohibited by other legislation. In this case, section 237 of the Enterprise Act 2002 prohibits a public authority from releasing information which came to it in connection with the exercise of its functions, and which relates to the affairs of an individual or business.
The MHRA is satisfied that the information you have requested:
constitutes information which came to us in connection with the exercise of the Agency’s functions. The MHRA has a duty of consumer protection under the Consumer Protection Act 1987 which is listed as a specified function under Schedule 14 of the Enterprise Act 2002 and receives information while exercising consumer protection functions in its role as the regulator of medicines and healthcare products.
relates to the affairs of Bayer, which is a business which continues to exist.
- Is the Essure coil still in circulation in the UK?
The CE mark for the device was suspended in 2017 and sales to the UK (and Europe) were stopped, for commercial reasons. MHRA published a statement in September 2017: https://www.gov.uk/government/news/mhra-statement-on-essure-devices
If you have a query about the information provided, please reply to this email.
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk
Due to the ongoing Covid-19 situation, we are not able to accept delivery of any documents or correspondence by post or courier to any of our offices
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Yours sincerely
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency
10 South Colonnade, Canary Wharf, London E14 4PU