FOI release

Freedom of Information request (FOI 22/901)

Published 17 January 2024

FOI 22/901

26th August 2022

Dear

Thank you for your email dated 16th August 2022, where you requested:

For the calendar years a) 2019, b) 2020 and c) 2021 (separately), could you please tell me

i) the number of Adverse Reactions reported relating to dermal fillers

ii) for each calendar year, could you please provide a complete breakdown of the side effects that the reporters have claimed relating to dermal fillers

Responses to your questions can be found below:

A table of the number of adverse events submitted in relation to ‘dermal fillers’ from January 2019 to December 2021 inclusive can be found below. The table includes reports received from manufacturers, healthcare professionals and members of the public.

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.

Number of reports per calendar year	2019	2020	2021
-	305	217	195

For the adverse incidents reported in each calendar year a) 2019, b) 2020 and c) 2021 (separately), a breakdown of the reported side effects (including number of reports) can be seen below:

Reported Clinical Effects	Number of reports in:
-	2019	2020	2021
Blank / no recorded term	<5	<5	9
Adverse Psychological effect	<5	<5	<5
Adverse/Allergic reaction	134	68	38
Anxiety	0	<5	<5
Blood/Fluid Loss	0	<5	0
Blurred Vision	<5	<5	<5
Breast Mass	0	<5	0
Central/Peripheral neurological complication	<5	<5	0
Cuts/bruises	13	<5	<5
Deformity/Disfigurement	0	11	7
Delay to treatment	<5	0	0
Depression	0	<5	<5
Embolism	15	<5	<5
Eye Pain	0	<5	0
Hair Loss	0	<5	0
Headache	<5	<5	0
Hypersensitivity/Allergic reaction	<5	9	<5
Inadequate/inappropriate treatment	57	22	<5
Increased Sensitivity	0	0	<5
Infection	24	24	7
Inflammation	5	23	15
None	56	42	90
Not determined at this stage	<5	<5	<5
Numbness	0	<5	<5
Pain	<5	21	13
Perforation of organ/vessel	<5	0	0
Physical Asymmetry	<5	<5	0
Planned revision	<5	<5	0
Prolonged episode of care	11	<5	<5
Prosthetic/implant Pain	9	0	<5
Rash	0	<5	<5
Recognised procedural complication	0	<5	<5
Respiratory affect	<5	0	0
Revision	19	16	<5
Seroma	0	<5	<5
Skin Disorders	0	<5	<5
Skin Inflammation/ Irritation	<5	15	22
Sleep Dysfunction	0	<5	0
Swollen Lymph Nodes/Glands	<5	7	<5
Unexpected deterioration	8	5	6
Unspecified Infection	0	<5	0
Unspecified urinary problem	0	<5	0
Unspecified vascular problem	0	0	<5
Visual Disturbances	0	<5	0

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.
• When interpreting the above 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 reaction as neither the total number of reactions occurring, nor the number of patients using the dermal filler is known.
• 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.

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

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Yours sincerely

MHRA Customer Experience Centre