FOI release

Freedom of Information request (FOI 22/993)

Published 17 January 2024

21st October 2022

FOI 22/993

Dear

Thank you for your information request, dated 27th September 2022.

I am pleased to provide you with the information requested, please see below.

1. For the 2021 calendar year could you please state the number of Adverse Reactions reported relating to breast implants used in breast enlargement surgery.

Note. If it is possible to isolate reports that relate to cosmetic surgery rather than reconstructive surgery following a different medical procedure then please provide separate answers for both types of surgical implant. Also I would be grateful if the response could be supplied on the same basis as that which was supplied to me in a similar request for 2013 data [Ref: FOI 14/378]

The total number of adverse incident reports received by MHRA in 2021 involving all types of breast surgery (not limited to breast enlargement surgery) from all manufacturers, members of the public and healthcare professionals was 949 for breast implants and 9 for tissue expanders. We have included tissue expander reports for a more complete picture of breast implant surgery. This is a device intended for implantation to develop tissue (skin) coverage by intermittent expansion. It is intended to remain in situ until desired expansion is achieved and it is replaced with a permanent breast implant.

We do not categorise reported incidents according to types of breast implant surgery. We cannot therefore provide the number of adverse events for breast enlargement surgery only.

Please note that although duplicate reports (i.e. reports of the same incident received from different sources) have been excluded where known, the results may still contain some duplicates because it is not always possible to identify duplicate reports from the information we receive.

1. For the 2021 calendar year’s Adverse Reactions to breast implants used in breast enlargement surgery please could you give me a complete breakdown of the side effects that the reporter has claimed.

During 2021, the MHRA changed the way we code adverse events. The MHRA now adopts International Medical Device Regulators Forum codes for Health Effects (IMDRF https://www.imdrf.org/working-groups/adverse-event-terminology/annex-ehealth-effects-clinical-signs-and-symptoms-or-conditions).

A table of reported adverse events in the form of IMDRF coding for the above cited breast implant and tissue expander reports can be found attached (Table 1).

Where there were no IMDRF codes provided in a report, the previous coding terminology ‘Reported Clinical Effect’ has been collated and can be found attached (Table 2).

The attached data should be read in conjunction with the notes below.

Where the number of reports are low (less than 5) this has been indicated as ‘<5’ in the table. This is to comply with our confidentiality obligations and ensure individual reports are not identifiable.

It is important to note that the attached reported health or clinical effects are not always an accurate representation of the clinical effects experienced by those involved in the reported incidents. The inclusion of a report on the MHRA adverse incident database does not necessarily mean that the events described were caused by the implant but could be due to unrelated patient/user factors (e.g. events due to underlying medical conditions). The tables therefore are not a summary of known or proven adverse events to the implant and should not be interpreted and used as such. In addition, details of the reports may have changed since the report was submitted.

The data should also be read together with the following explanations:

• The majority of reports indicate an issue experienced by a single user. However, some cases may represent the same user experiencing further issues.

• 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 the implantation of breast implants 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 say with certainty that we have linked every duplicate.

• It should be noted that this information may include a range of recognised complications related to this type of procedure and does not necessarily indicate a fault with any particular device.

• When interpreting the attached data, it is important to note that the number of reports received should not be used as a basis for determining the incidence of a health/clinical effect as neither the total number of effects occurring, nor the number of patients using the implant is known.

• It is important to note that inclusion of a report on the MHRA adverse incident database does not necessarily mean that the events described were caused by the implant.

• Any one incident may contain multiple adverse events. We have used the term ‘adverse events’ instead of ‘adverse reactions’ because the term ‘adverse reactions’ is generally used for medicinal products.

• The numbers include reports where the incident has been taken from published literature.

• These numbers of reports are accurate at the time they are extracted from our database and minor changes in the numbers can occur if the reporter of the incident gives us more details later.

• Adverse incident reports 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.

• Adverse incident reports include mandatory reporting by manufacturers to MHRA for certain types of incidents that occurred in the UK as part of the regulatory post market surveillance ‘vigilance’ system. The principal purpose of this system is to improve the protection of health and safety of patients. This is to be achieved by the evaluation of reported AIRs and, where appropriate, dissemination of information, which could be used to prevent such repetitions, or to alleviate the consequences of such adverse events.

As with all medical devices, MHRA continues to monitor their safety and performance and encourages reporting of any adverse incidents through its Yellow Card scheme on https://yellowcard.mhra.gov.uk/ . Any emerging evidence relating to possible risks associated with these devices will be carefully reviewed and, ifappropriate, regulatory action will be taken if any serious risks are confirmed.

The Freedom of Information Act only entitles you 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-mhrainformation/reproduce-or-re-use-mhra-information.

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

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

I hope this answers your query.

Yours sincerely,

FOI Team Devices Safety & Surveillance Group