FOI release

Freedom of Information request on yellow card reports relating to a coil (IUD) fitting (FOI 21/968)

Published 25 February 2022

20th September 2021

FOI 21/968

Dear

Thank you for your information request, dated 20th August 2021, where you asked “ how many yellow card reports have been submitted each year in the last five years pertaining to the following:

1. Pain or discomfort during a coil (IUD) fitting?

2. Problems with a coil (IUD) after fitting?” You also asked:
3. “Breakdown by the different types of coil (IUD). I believe these are the copper coil, the Mirena coil and that there is another smaller brand (the name of which I am unsure of).”

I am pleased to provide you with some of the information requested, see below:

To note, intrauterine devices are split into two categories: hormonal and non-hormonal. This changes the way they are regulated and disclosure of information. Hormonal IUD’s (e.g. Mirena coil) are regulated as medicines and non-hormonal (copper) are medical devices. We have therefore provided the data separately.

The information provided below relates to IUD’s that are regulated as medical devices. Response to questions 1 and 2: Table 1 and 2 shows the number of adverse events submitted in relation to ‘IUDs’ from January 2016 to December 2020 inclusive. The data was extracted on 7th September 2021 and includes reports received from healthcare professionals and members of the public.

Table 1: Total of adverse incident reports regarding IUDs which are considered medical devices

Number of reports per year	2016	2017	2018	2019	2020	Total
Yellow card reports only	4	7	3	N/A	N/A	14

Information regarding when the pain or discomfort occurred is not a mandatory requirement when submitting a Yellow Card. Therefore, the information provided below is for all reports of pain irrespective of whether they occurred during or after fitting.

Table 2: Number of incidents where “pain” is reported as an adverse clinical effect

Number of reports per year relating to pain	2016	2017	2018	2019	2020	Total
Yellow card reports only	0	1	0	0	?	1

When considering this data, it is important to be aware of the following points

• These numbers are accurate at the time we extract them from our database. Minor changes in the numbers can occur if more details are provided later.

*These figures need to be interpreted with caution. Consideration must be given to the individual procedures being undertaken, skill of the healthcare professional implanting the device and individual patient conditions. 

• These figures are not the same as complication rates. 

• A report does not necessarily mean it has been caused by IUD, only that the reporter had a suspicion it may have.

• A report of an adverse incident involving a medical device does not mean that the medical device caused the incident.

• Use of our Yellow Card scheme by members of the public (and the healthcare sector) is voluntary but we strongly encourage it. It does not provide absolute adverse incident report figures.

• Reports do not necessarily represent an individual patient. Individuals may report an incident at any time after the event and people can make multiple reports at any time after a device has been implanted and on the same issue.

Where possible, multiple reports for the same event are linked. However, as reporters are not required to complete all fields, we cannot always be sure enough to link every duplicate.

• Adverse incident reports (AIRs) by members of the public are voluntary but play a substantial part in the successful operation of the vigilance system. All reports received via Yellow Card are sent to the relevant manufacturer (if known and anonymised as appropriate) to feed into the vigilance system to monitor the safety of medical devices and to act on safety signals.

Response to 3 :

This information is exempt from release under 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. In this instance release of information relating to a breakdown of the medical devices by brand is exempt from disclosure.

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 a business which continues to exist.

On that basis we are satisfied that section 44 of FOI Act applies and the information is exempt from release.

The information provided below relate to IUD’s that are regulated as medical devices.

The information below provides a breakdown of the number of UK spontaneous suspected Adverse Drug Reaction (ADR) reports the Agency has received for intrauterine devices (IUDs) which contain levonorgestrel. Table 3 below provides a breakdown by brand where any pain or discomfort related reactions have been reported in the last 5 years. Please note, where brand specific information has not been provided a search of reports for the drug ingredient levonorgestrel where the route of administration was provided as ‘intrauterine’ has been included in the table.

Table 3: Number of ADR reports received over the last 5 years for each brand of IUD containing the levonorgestrel where the report included a pain or discomfort reaction.

	2016	2017	2018	2019	2020
Mirena	42	39	32	42	22
Jaydess	3	3	1	4	2
Kyleena	0	0	0	2	4
Levosert	0	0	0	0	1
Brand information not provided	0	0	0	1	0

Please note, it is not mandatory for reporters to provide specific brand information or details of route of administrations when reporting a Yellow Card report, this should be taken into account when reviewing this data. Please be aware information regarding when the pain or discomfort occurred is not a mandatory requirement when submitting a Yellow Card and therefore the information provided is for all pain or discomfort reactions irrespective of whether they occurred during or after fitting.

When considering spontaneous data, it is important to be aware of the following points:

• A reported reaction does not necessarily mean it has been caused by IUD, only that the reporter had a suspicion it may have. The fact that symptoms occur after use of an IUD and are reported via the Yellow Card scheme, does not in itself mean that they are proven to have been caused by it. Underlying or concurrent illnesses may be responsible and such events can also be coincidental.

• It is also important to note that the number of reports received via the Yellow Card scheme does not directly equate to the number of people who suffer adverse reactions and therefore cannot be used to determine the incidence of a reaction or compare the safety profile of different vaccines. ADR reporting rates are influenced by the seriousness of ADRs, their ease of recognition, the extent of use of a particular IUD, and may be stimulated by promotion and publicity. Reporting tends to be highest for newly introduced medicines during the first one to two years on the market and then falls over time.

The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit https://www.gov.uk/government/publications/reproduce-or-re-use-mhra-information/reproduce-or-re-use-mhra-information.

If you disagree with how we have interpreted the Freedom of Information Act 2000 with regards to your request, you can ask for the decision to be reviewed. The review will be carried out by a senior member of the Agency who was not involved with the original decision.

If you have a query about the information provided, please reply to this email.

Yours sincerely,

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU

Telephone 020 3080 6000