Assessing the incidence of symptoms referred to as Breast Implant Illness (BII) within primary care in England.

Study type
Protocol
Date of Approval
Study reference ID
24_004019
Lay Summary

Breast implants are Class III medical devices positioned between breast tissue and chest muscle or behind the chest muscle to increase the breast size (augmentation) or replace breast tissue (reconstruction). There are two types of implants: silicone gel-filled implants and saline-filled implants. Both implants have a silicone outer shell.
Soon after their first use in the 1960s, breast implants have been anecdotally linked with systemic symptoms and have been the subject of several reviews and monitoring. Since 2017, MHRA has been receiving a large volume of spontaneous incidents reporting a variety of health problems which are suspected to be related to their breast implants. There has also been significant media interest in the occurrence of a variety of symptoms in relation to breast implants, which were termed ‘breast implant illness’. This resulted in a peak of reports being received in 2019. The reports are not linked to a particular manufacturer or type of implant and include silicone and saline-filled implants.

The term 'breast implant illness’ (BII) refers to a variety of symptoms that occur after getting breast implants. It is not a recognised medical diagnosis and is commonly self-reported by patients.
This study is aimed at defining the group of symptoms commonly reported in association with breast implants and characterising the incidence and prevalence of these symptoms in a population with and without breast implants.

Technical Summary

A. Technical Summary (Max. 300 words)

Breast implant illness (BII) is an informal term and refers to a wide range of symptoms that may occur in people with breast implants. It is not a recognised medical condition; however, the term is used frequently online to describe symptoms that people can experience following cosmetic breast augmentation or reconstructive breast surgery with implants. It can also be known as breast implant disease, autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and silicone implant illness. Reports of symptoms, sometimes referred to as Breast Implant Illness (SRABII), have been received via the Yellow Card scheme by the MHRA since 2017.

A study using CPRD data on breast implant surgery can assist in defining the BII and examining an association between breast implants and systemic symptoms.

A cluster analysis will, therefore, aim to explore and group a range of symptoms reported after breast implant surgery, quantify their frequency in recipients of breast implants and compare them between indications and the types of surgery. After establishing a diagnosis in a cluster analysis, we will employ Cox regression analysis on general practice data linked to HES data to investigate the possible association and temporal relationship between breast implant surgery and an increased risk of the occurrence of BII in the UK. Our study population will be all breast implant recipients identified in the Aurum CPRD and HES data. The study will aim to characterise the symptoms of BII, provide an estimate of the relative incidence of BII, and examine the risk period post-surgery and the characteristics of patients with a diagnosis of symptoms relevant to BII. The study will be used alongside other evidence to advise on the need for regulatory action and communication on this issue.

Health Outcomes to be Measured

Frequency of symptoms known as BII in primary and/or secondary care

Collaborators

Svetlana Buzdugan - Chief Investigator - MHRA
Svetlana Buzdugan - Corresponding Applicant - MHRA
Sophie Scanlon - Collaborator - MHRA

Linkages

HES Admitted Patient Care