Freedom of Information request on fitting or removal issues, nerve damage, or migration of the Nexplanon implant in the North West (FOI 21/831)
Published 20 January 2022
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17th August 2021
FOI 21/831
Dear
Thank you for your email dated 20th July 2021 where you asked for local data around fitting or removal issues, nerve damage, or migration of the Nexplanon implant in the North West.
I can confirm that the MHRA have received a total of 56 UK, spontaneous suspected reports which meet the above criteria, up to and including 05/08/2021. It may be helpful if I share some information about how the search was conducted. The MHRA use a standardised dictionary when classifying Adverse Drug Reaction (ADR) reports. MedDRA (Medical Dictionary for Regulatory Activities) is a clinically validated international medical terminology dictionary. It’s organised by System Organ Class (SOC), divided into High-Level Group Terms (HLGT), High-Level Terms (HLT), Preferred Terms (PT) and finally into Lowest Level Terms (LLT). The following HLTs were used in the search: Nerve injuries NEC, Peripheral nerve injuries, Complications associated with device NEC, Device issues NEC, Device malfunction events NEC, Device operational issues NEC, Device physical property and chemical issues, Device site reactions, Non-site specific procedural complications.
In order to provide this information specifically for the North West, we have extracted the ADR data based on the following postcodes:
BB-Blackburn, BD-Bradford, BL-Bolton, CA-Carlisle, CH-Chester, CW-Crewe, FY-Blackpool, HD-Huddersfield, HX-Halifax, L-Liverpool, LA-Lancaster, M-Manchester, OL-Oldham, PR-Preston, SK-Stockport, WA-Warrington, WN-Wigan,
When considering spontaneous data, it is important to be aware of the following:
- A report of a suspected ADR to the Yellow Card scheme does not necessarily mean that it was caused by the vaccine, only that the reporter has a suspicion it may have. Underlying or previously undiagnosed illness unrelated to vaccination can also be factors in such reports. The relative number and nature of reports should therefore not be used to compare the safety of the different vaccines.
- All reports are kept under continual review in order to identify possible new risks. For a medicine or vaccine to be considered safe, the expected benefits will be greater than the risk of having harmful reactions. It is important to note that most people take medicines and vaccines without having any serious side effects.
- As this data has been extracted based on postcode, only reports which provided a postcode will be included in the results.
Please also find below a link to the MHRA’s Drug Safety Update on Nexplanon implants:
I hope the information provided is helpful, but 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 of this response; and can be addressed to this email address.
Yours sincerely,
FOI Team,
Vigilance and Risk Management of Medicines Division