FOI release

Freedom of Information request (FOI 22/839)

Published 17 January 2024

2nd August 2022

FOI 22/839

Dear ,

Thank you for your email dated 21st July 2022, where you requested:

For the 2021 calendar year, could you please state the number of ‘adverse events’ reported relating to face and lip fillers (dermal fillers).

For the 2021 calendar year’s ‘adverse events’ to face and lip fillers (dermal fillers) could you please give me a complete breakdown of the side effects that reporters have claimed?

Last year, I requested the same data (reproduced at the end of this email) via FoI from the MHRA but for the years 2018, 2019 and 2020 (reference: CSC 56586). It would be great if you could provide me with something similar for 2021’s data.

 Responses to your questions can be found below:

There were 195 number of adverse incident reports submitted to MHRA in relation to ‘dermal fillers’ from January 2021 to December 2021 inclusive. This number includes reports received from manufacturers, healthcare professionals and members of the public.

Adverse incident reports involving dermal fillers do not always provide information about area of injection, and our database does not categorise incidents by lip and face fillers only. Therefore, the figure above reflects incidents involving all dermal fillers injected into various parts of the body.

These figures need to be interpreted with caution. Consideration must be given to the individual procedures being undertaken, skill of the injector, the temporal relation to the procedure, the severity of the complication and what actions, if any, were required to address the complication. These figures are not the same as complication rates.

For the 195 adverse incident reports reported in 2021, a breakdown of the reported side effects can

be seen below:

Reported Clinical Effects:

Adverse/Allergic reaction - Not determined at this stage

Adverse Psychological effect - Numbness

Anxiety - Pain

Blurred Vision - Prolonged episode of care

Cuts/bruises - Prosthetic/implant pain

Deformity/ Disfigurement - Rash

Depression - Recognised procedural complication

Embolism - Revision

Hypersensitivity/Allergic reaction - Seroma

Inadequate/inappropriate treatment - Skin Disorders

Increased Sensitivity - Skin Inflammation/ Irritation

Infection - Swollen Lymph Nodes/Glands

Inflammation - Unexpected deterioration

None - Unspecified vascular problem

It is important to note that the above reported 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 our adverse incident database does not necessarily mean the events described were caused by that device but could be due to unrelated patient/user factors. The data provided, therefore, is not a summary of known or proven adverse reactions to the device and must not be interpreted and used as such. In addition, details of the reports may have changed since the report was submitted. When incidents are recorded on MHRA’s adverse incidents database, each incident is reviewed and then the reported clinical effects are recorded by selecting the respective term from a list of predetermined clinical effects.

The data must 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 use of dermal fillers 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

• 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.  

• The numbers may 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.

• In the UK, dermal fillers are regulated as medical devices where the manufacturer makes medical claims. This means that they must be UKCA or CE marked and meet the requirements of the medical devices regulations. Where dermal fillers have no medical claims and are intended only for aesthetic purposes, they are not considered to be medical devices. Products indicated only for an aesthetic purpose, but which contain lidocaine are a medicinal product and therefore subject to the medicines regulations.

• 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 the safety and performance and encourages reporting of any adverse incidents through its Yellow Card scheme on https://yellowcard.mhra.gov.uk/

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