FOI release

Freedom of Information request on adverse reactions following breast implants since 2020 (FOI 21/1054)

Published 27 April 2022

13th October 2021

FOI 21/1054

Dear

Thank you for your information request dated 15th September 2021.

Responses to your requests can be found below:

1) For the 2020 calendar year could you please state the number of Adverse Reactions reported relating to breast implants used in breast enlargement surgery.

The total number of all reports received by MHRA in 2020 involving all types of breast surgery (not limited to breast enlargement surgery) from all manufacturers, members of the public and healthcare professionals was 573, this includes 2156 adverse reactions.

We do not categorise our incidents according to types of breast implant surgery therefore we cannot provide a 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 as the ability to merge multiple reports depends on the quality of the information supplied to the MHRA.

2) For the 2020 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.

A table of adverse reactions relating to all types of breast implant surgery in 2020 can be found below. Please ensure the notes below the table are read alongside the data.

Clinical effect terms	Count
Abdominal Pain	5
Adhesions/fistulae/fibroses	<5
Adverse Psychological effect	34
Adverse/ Allergic reaction	66
ALCL	19
Alteration in Body Temperature	<5
Anemia	<5
Anxiety	79
Arthralgia (joint pain)	33
Arthritis	5
Asthma	<5
Autoimmune Disorder	22
BIA-ALCL	20
Blood/ Fluid loss	<5
Blurred vision	7
Breast Cancer	<5
Breast discomfort/ Pain	74
Breast Mass	42
Burn	<5
Burning sensation	9
Cancer	<5
Capsular Contracture	174
Central or peripheral neurological complication	<5
Chest Pain	20
Chills	<5
Cognitive Changes	35
Connective Tissue Disease	<5
Cramp(s)/ Muscle Spasm(s)	<5
Cuts/bruises	<5
Deformity/Disfigurement	31
Delay to treatment	<5
Depression	28
Diaphoresis (profuse sweating)	18
Dizziness	<5
Double Capsule	11
Dry Eye(s)	12
Dry Mouth	11
Extreme Exhaustion	19
Eye Pain	<5
Fatigue	83
Foreign body retention	<5
Hair Loss	37
Headache	32
High blood pressure/ hypertension	<5
Hormonal imbalance	5
Hot Flashes/Flushes	<5
Hypersensitivity/allergic reaction	5
Hypothyroidism (underactive thyroid)	<5
Inadequate/ inappropriate treatment	35
Incontinence	<5
Increased sensitivity	9
Infection	43
Inflammation	26
Irritable bowel syndrome (IBS)	6
Low white blood cell count	<5
Memory loss/ impairment	11
Menstrual Irregularities	<5
Muscle Weakness	13
Myalgia (muscle pain)	26
None	49
Not determined at this stage	13
Numbness	13
Pain	119
Palpitation	18
Paresthesia (pins & needles)	11
Physical Asymmetry	18
Planned revision	35
Prosthetic/ implant pain	17
Rash	22
Recognised procedural complication	21
Respiratory affect	31
Revision	394
Rheumatoid Arthritis	<5
Seroma	40
Shaking/ Tremors	<5
Skin disorders	13
Skin inflammation/irritation	19
Sleep dysfunction	17
Solid tumour	<5
Suicidal ideation	<5
Swollen Lymph Nodes/ Glands	41
Taste Disorder	<5
Tinnitus	5
Unexpected deterioration	28
Unspecified gastrointestinal problem	20
Unspecified heart problem	<5
Unspecified Infection	<5
Urinary Frequency	5
Vertigo	<5
Visual Disturbances	11
Vitamin Deficiency	<5
Vomiting	<5
Weight Changes	13
White blood cell count decreased	<5
	2156

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 because when the numbers of reports are low and if they are put together with other information, it might make the individual reports identifiable to specific patients or healthcare organisations.

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 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 table therefore is not a summary of known or proven adverse reactions to the implant 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 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 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 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 the safety and performance and encourages reporting of any adverse incidents through its Yellow Card scheme on https://yellowcard.mhra.gov.uk/.

I hope this answers your query.

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

If you disagree with how we have interpreted the Freedom of Information Act 2000 in answering your request, you can ask for an internal review. Please reply to this email, within two months of this reply, specifying that you would like an Internal Review to be carried out.

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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

Yours sincerely

MHRA Customer Service Centre

Medicines and Healthcare products Regulatory Agency

10 South Colonnade, Canary Wharf, London E14 4PU