Breast implant associated anaplastic large cell lymphoma (BIA-ALCL)

What is BIA-ALCL? overview

In 2016, the the World Health Organisation (WHO) (WHO) defined a new type ofof Anaplastic anaplasticLarge largeCell cellLymphoma lymphoma(ALCL), (ALCL), which isis, itselfitself, an uncommon type of non-Hodgkin lymphoma with several subtypes. The WHO labelled this new variant as breastBreast implantImplant associatedAssociated anaplasticAnaplastic largeLarge cellCell lymphomaLymphoma oror BIA-ALCL^†. BIA-ALCL*. It has specific diagnostic criteria, which include positive expression of the cell membrane marker of ALCL, CD30, negative for anaplastic lymphoma kinase (ALK), and a distinct cell morphology.

The MHRAMHRA’s investigation intointo BIA-ALCL continues BIA-ALCL continues and, as with all issues examined by us, we takeanalyse anevidence evidence-based approach across a range of data sources. Research into this area is yet to provide the answer ashow BIA-ALCL develops tobut howthere BIA-ALCL develops. There are several theories. One potential theory is that surface texturing on implants may play a role.role; Therethere are 3three main surface textures which coat a breast implant:implant, smooth, textured, and polyurethane. Research is continuing in the UK and in other countries around the world to better understand how BIA-ALCL develops.how BIA-ALCL develops.

Current UK advice

Information for patients

The most common symptom for people with BIA-ALCLBIA-ALCL around around breast implants is fluid collecting around the implant (‘late’ seroma). You might notice a fairly quick, but painless, increase in size of the affected breast, usually over a few weeks. In some cases, itthe canswelling may affect both sides at the same time.

Most cases have happened several years after surgery. Very rarelyuncommonly BIA-ALCLBIA-ALCL has has been found when a lump develops nextwithin to an implant, or in the tough fibrous tissue that canbuilds build up around an implant (called a capsule).

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) ‘final opinion’ on BIA-ALCL reportsstates that the occurrence of BIA-ALCL is uncommon.

However, it is important that you know about the risks if you already have, or are considering having, breast implants. If you develop a seroma, a breast lump or swelling around your implant more than a year after having the breast implant, you should ask your implanting surgeon for advice. Also tellspeak to your GP, who maywill need to refer you to your local NHS breastBreast careCare service.

Before you have breast implant surgery, it is important that you talk with your surgeon to discuss the benefits and risks as part of a shared decision-making process. You should make sure that you understand the risks involved before giving your informed consent**^†† to the treatment option that is right for you. The MHRA recommends that prospective individuals looking to have this surgery are provided with information about breast implant surgery and its possible complicationscomplications, either in written format or via an online link to information sheets jointly written by the Association of Breast Surgery (ABS)(ABS,), British Association of Aesthetic Plastic Surgeons (BAAPS)(BAAPS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS)(BAPRAS.). These associations are some of our clinical stakeholders. They aim to increase understanding of their field, share learnings,learning, inform patients and align with our patient safety goals.

The MHRA has developed a new cosmetic breast augmentation risk awareness tool to help people understand the risks associated with breast implants and make informed choices. This follows a project by the MHRA to understand how people having breast implant surgery perceive the risks associated with having implants. The project highlighted the need for clearer communication about the risks. If you are considering cosmetic breast augmentation, please use this tool to support the discussions you have with your surgeon during the consent process.

If you have developed a problem with a breast implant youor a tissue expander,  you should tellspeak to your surgeon and GP and also report it through the MHRA MHRA Yellow Card Schemescheme.

Breast tissue expanders are medical devices used to expand the breast tissue in preparation for breast implant surgery. To date, there have been no confirmed cases of BIA-ALCL where only a tissue expander has been used reported to the MHRA.

Information for healthcare professionals

Clinicians have a legal obligation to discuss the potential risk ofof BIA-ALCL when BIA-ALCL when seeking the informed consent of new patients, and with any patient returning for review of their breast implants.

When reporting a case ofof BIA-ALCL in BIA-ALCL in patients with breast implants, surgeons are reminded to include (where it is known):

• the patient’s CD30+/-, ALK +/- statusstatus.
• full details of the device, including manufacturer, model, surface texture (as identified by the manufacturer)manufacturer).
• the presenting clinical features and the subsequent managementmanagement.
• other information including the dates of initial implantation, revision, and explantationexplantation.
• information on previous implants, particularly whether tissue expanders have been used and for how longlong.

This information is vital to enable the MHRA to build a better picture of the prevalence of this issue, which contributes to the global effort to better understand this disease.

ReportAlso, clinicians must report any suspected or actual adverse incidents involving these devices through yourtheir healthcare institution’s local incident reporting system and/or yourthe national incident reporting authority as appropriate:

• reportappropriate incidentsfor; in England and Wales
• report, incidents in Scotland
• report, incidents in Northern Ireland

, Wales.

PleaseClinicians must also ensure the patient’s details are includedrecorded in the Breast and Cosmetic Implant Registry (Registry (BCIR).). Patient consent is no longer required for this information to be recorded and doing so will not breach General Data Protection Regulation (GDPR) rules.

Providing this information to the registry is a legal obligation under section 259(1)(a) of the Health and Social Care Act 2012.

Reports2012 toand thepatient MHRA

Anyoneconsent canis reportno anylonger incidentrequired relatingfor tothis ainformation medicalto devicebe orrecorded. medicineThe toclinician uswill throughnot ourbreach YellowGeneral CardData scheme.Protection WeRegulation collect(GDPR) andrules analysein alldoing reportsso.

Reporting of ALCL indata patientson withBIA-ALCL

MHRA breastcollects implantsinformation and tissueanalyses expanders.all Tissuereports expandersof ALCL in arepatients medicalwith devicesbreast usedimplants toand expand the breast tissue in preparation for breast implant surgery.expanders.

Reporting data on BIA-ALCL

As of 31 December 2023,2024, weMHRA had received 81114 reports of confirmed BIA-ALCL associated with breast implants, where the surgery occurred in the UK and 6 reports where the surgery occurred outside of the UK.

• The current estimatedreporting incidencerate of BIA-ALCL,BIA-ALCL, based on confirmed cases where surgery occurred in the UK, is 1 per 16,50012,187 breast implants and breast tissue expanders sold.

• All confirmed cases met the WHO diagnostic criteria for BIA-ALCL. The number of confirmed cases reported to the MHRA has increased by 25 since the last update in December 2021.  BIA-ALCL.

Obtaining confirmation of reports from 20242025 is currently in progress.

The estimated incidencereported rate is calculated by dividing the number of confirmed cases of BIA-ALCL by the total number of breast implants and breast tissue expanders sold in the UK. It does not include BIA-ALCL cases where the implanting surgery occurred outside of the UK. This is called an ‘estimate’estimate because some cases of BIA-ALCL may not have been reported to the manufacturer or the MHRA, and not all implants sold in the UK have been implanted into patients.

Of the confirmed cases of BIA-ALCL inof BIA-ALCL in people with breast implants in the UK, there has been one death reported to the MHRA. Three deaths from other forms of ALCL were reported to the MHRAMHRA, which did not meet the WHO diagnostic criteria for BIA-ALCL.BIA-ALCL. The overall survival rate for patients diagnosed with BIA-ALCL is 89% at 5 years. This rate is significantly higher for patients with Stage I diseasedisease, whowhere undergothe completetumour capsulectomyis andconfined to the capsule around the implant removaland (seewho Journalundergo of‘complete Clinicalcapsulectomy’ Oncology).and implant removal^†††. Furthermore, studies show, 93% of appropriately treated patients are disease free at 3 years follow-up, which is an excellent prognosis^††††.

Other whenforms treated appropriately (see American Society of Plastic Surgeons).

ALCL can also occur in the breast due to other causes.causes Therefore,and therefore, the number of reports we receive may not only be related to the breast implants. However, we still need to collect reports of all cases of all types of ALCL in people with breast implants to build up a better picture of whatthe is happening.situation.

The MHRAMHRA, with PRASEAG’s professional advice about breast implants, is working to deliver greater transparency of medical device data. This will ensure that both patients and clinicians are better informed on the benefits and risks associated with breast implants when patients are deciding on the option that is right for them. Greater transparency includes providing a more detailed breakdown of the total number of confirmed reports of adverse incidents as shown below.

Cases of BIA-ALCL where the patient has only had one implant or one pair of implants (primary cases)

Cases of BIA-ALCL where the patient has only had one implant or one pair of implants at the time of diagnosis of BIA-ALCL are classed as primary cases, which are shown in TableTables 1.1 and 2.

Table 1. Breast Implants and Breast Tissue Expanders

Breakdown of 6270 primary confirmed BIA-ALCL cases as of 31 December 20232024 byby; manufacturer, surface texture and all-time sales of breast implants and breast tissue expanders, all of which have been implanted in the UK.

N.B. The table excludes 3 reports with an unknown manufacturer and 3 reports associated with non-UK surgeries, leaving 64 total cases.

Confirmed cases
by implant surface texture	Allergan	Eurosilicone SAS	Mentor Medical Systems B.V.	Nagor Limited	Silimed	Total
Smooth implant cases (number of sales)	0 (9,827)	0 (3,329)	0 (26,969)	0 (17,250)	0 (125)	0 (57,500)
Textured implant cases (number of sales)*	46 (522,175)	1 (30,721)	5 (433,833)	10 (148,140)	0 (22,996)	62 (1,157,865)
Polyurethane implant cases (number of sales)	0 (0)	0 (0)	0 (0)	0 (0)	1 (22,711)	1 (22,711)
Cases of implants with an unknown texture	1	0	0	0	0	1
Sales of implants with unknown texture	0	48,598	0	0	0	48,598
Total cases (total sales breast implants and tissue expanders)	47 (532,002)	1 (82,648)	5 (460,802)	10 (165,390)	1 (45,832)	64 (1,286,674)

^{*This figure includes devices with a surface texture that have been categorised by the manufacturer as either microtextured or macrotextured.}

Table 2. Breast Implants

Breakdown of 70 primary confirmed BIA-ALCL cases as of 31 December 2024 by; manufacturer, surface texture and all-time sales,sales of breast implants, all of which have been implanted in the UKUK.

Note:N.B. theThe table excludes 3 reports with an unknown manufacturer and 3 reports associated with non-UK surgeries, leaving 6264 total cases.

Confirmed cases bycases
by implant surface texture	Allergan	Eurosilicone SAS	Mentor Medical Systems B.V.	Nagor Limited	Silimed	Total
Smooth implant cases (numbercases (number of sales)	0 (9,827)0 (9,496)	0 (2,867)0 (1,007)	0 (24,466)0 (23,090)	0 (19,773)0 (17,045)	0 (3)0 (125)	0 (56,936)0 (50,763)
Textured implant cases (numbercases (number of sales) *	42 (522,163)46 (505,941)	1 (29,862)1 (30,619)	5 (400,043)5 (415,651)	11 (161,172)10 (146,838)	0 (22,625)0 (22,996)	59 (1,135,865)62 (1,157,865)
Polyurethane implant cases (numbercases (number of sales)	0 (0)0 (0)	0 (0)0 (0)	0 (0)0 (0)	0 (0)0 (0)	2 (22,531)1 (22,711)	2 (22,531)1 (22,711)
Cases of implants with an unknown texture	1	0	0	0	0	1
Sales of implants with unknown texture	0	48,598	0	0	0	48,598
Total cases  (totalcases sales)(total sales of breast implants)	43 (531,990)47 (515,437)	1 (81,327)1 (80,224)	5 (424,509)5 (438,741)	1110 (180,945)(163,883)	2 (45,159)1 (45,832)	62 (1,263,930)64 (1,244,117)

*This figure includes devices with a surface texture that have been categorised by the manufacturer as either microtextured or macrotextured.

History of multiple implants

Where a patient has had multiple implants over time, and they are all of the same texture and from the same manufacturer, they can be linked to a case of BIA-ALCL,BIA-ALCL, as shown in Table 2.3.

A full implant history can be difficult to obtain for patients who have had multiple implants. It can also be difficult to ascertain which implants are associated with the BIA-ALCL because itBIA-ALCL can take years to develop. However, in their final opinion in 2021, SCHEER state that almost all cases of BIA-ALCL were found with breast implants with a textured surface.

Table 2.3. Breakdown of 8 confirmed BIA-ALCL cases as of 31 December 20232024 by manufacturer and all-time sales, implanted in the UK, where the patient has a history of multiple implants of the same type of breast implant and manufacturer.

Previous implants are from the same manufacturer and are the same surface texture as the implant at the time of diagnosis.

Manufacturer	Allergan	Mentor	Nagor	Silimed	Total
Confirmed cases where previous implants are from the same manufacturer and same surface texture as the implant at diagnosis	4	23	1	1	8
Manufacturer sales	531,990532,002	424,509460,802	180,945165,390	45,15945,832	1,182,6031,286,674

There are 4247 cases where patients have received multiple implants from different manufacturers,manufacturers or received implants of different surface textures,textures to the implant at the time of diagnosis of BIA-ALCL,BIA-ALCL, or where the manufacturer details are unknown, or the surgery happened outside of the UK. For these cases, BIA-ALCL cannot be linked to a particular implant, because it is known to occur with all types of textured implants that have been sold in the United Kingdom for more than 10 years and therefore are not shown in the tables above.

AnyAll breast implant surgery carries some risk, and each surface texture of implant has different benefits and risks. Breast implants are not designed to last the patient’s life time, revision surgery is very often required. For more information on this, please see Information about BIA-ALCL for people with breast implants.

Notes and limitations to the data data

The MHRA continually reviews data across implant types and all manufacturers that sell breast implants in the UK for trends in the incidencereports of BIA-ALCL.BIA-ALCL. We investigate any trends identified alongside all available evidence and if any new or increased risks are confirmed, we will take appropriate action to ensure these are communicated to patients and healthcare professionals.   professionals.

Global reports and literature indicate that BIA-ALCL cases are more often associated with macrotextured implants than implants with a microtextured or smooth surface. However, considering all available data, there is insufficient evidence to conclude that any one model or manufacturer of implants is solely responsible for the risk of BIA-ALCL compared to other implants.

The level of risk of developing BIA-ALCL remains low and there is no change in the advice; that there is no need for patients with textured implants to  have them removed unless they develop any symptoms associated with the implant. Implant removal surgery is complex and carries greater risk than the first operation to insert them. The benefits and risks of removal must be discussed with patients seeking advice about removal of breast implants.

The MHRA conducts extensive investigations and followsfollows-up up with manufacturers, surgeons and memberspatients who have reported a suspected case of theBIA-ALCL publicto us, to maintain the accuracy of BIA-ALCLthe reports. However, there are limitations and caveats to how the data should be interpreted:interpreted.

• theThe data shown is a representation of BIA_ALCLthe incidencerate of reporting of BIA-ALCL cases as of 31 December 20232024. Obtaining - obtaining confirmation against the WHO criteria of reports from 20242025 is currently in progress

  progress.

• theThe sales figures presented in the tables above are for each manufacturer and for all their breast implants and breast tissue expanders sold in the UKUK. (thisIf means that if the number of breast implants and tissue expanders sold increases, then the number of cases of BIA-ALCL may also eventually increaseincrease, -but however,at nota lower rate.

• Not all implants sold in the UK have been implanted,implanted. weWe do not know the number of breast implants that have been implanted into patients)
  patients, however, it is now a legal requirement for surgeons to register every breast implant inserted into a patient (or removed from a patient) with the BCIR and our data will progressively improve as a result but will take time with a disease that remains uncommon.

• thereThere are other breast implant manufacturers that are not named in the tables aboveabove. -This this is because these manufacturers do not have any UK reported cases of BIA-ALCL associated with their breast implants inat the UKtime (thisof publishing this webpage. This may be due to a number of factors, including manufacturers only recently selling onimplants theto the UK market,market; soso, their sales figures are lower,lower orand/or cases of BIA-ALCL associated with those implants may not yet have been reported to the MHRA, orbecause BIA-ALCL may nottake haveyears happenedto becausedevelop.

• If BIA-ALCLa maymanufacturer takediscontinues breast implants in the UK market, their reporting rate of BIA-ALCL cases is likely to continue to rise as the estimated time to onset is many years after breast implants have been implanted and their sales figures will not have increased
• This data cannot be used to develop) 
  compare differences in reporting rate between manufacturers.
• Patients with BIA-ALCL in both breasts are rare, however when found, it is reported as two cases of BIA-ALCL.

• The sales data and case numbers are dynamic and may change based on the information provided to the MHRA at the time of publication.

Average Time for BIA-ALCL to present

On average, symptoms of BIA-ALCL occur 77-10 to 10 years after the implantationfirst -implantation. someSome manufacturers may show a proportionately higher number of cases compared to their total sales due to a longer presence on the market

ifmarket. If a manufacturer discontinues breast implants in the UK market, their reporting rate of BIA-ALCL cases is likely to continue to riserise.

Table as4. theBreakdown estimatedof time to onsetdiagnosis isof manythe years91 afterconfirmed breastprimary implantsand havesecondary beenBIA-ALCL implantedcases andwhere theirthe salesduration figuresof willimplantation notis have increased

available.

this

patients

Years datasince cannot be used to compare differences in incidence between manufacturers   Implantation	0	1	2	3	4	5	6	7	8	9	10	11	12	13	14	15	16	17	18	19	20	21
Number withof BIA-ALCL inDiagnoses both breasts are rare - however, when found, it is reported as 2 cases of BIA-ALCL Reported	<5	<5	<5	7	7	7	7	16	7	9	<5	5	<5	<5	<5	<5	5	<5	0	<5	0	<5

Incident reporting in the UK

As part of the regulating the use of medical devices, manufacturers must submit adverseAdverse incidentIncident reportsReports (AIRs) for incidents that occurred in the UK. This systemreporting isprocess contributes to ensurethe post-market surveillance system that ensures that the benefits of medical devices used in thepatients treatmentcontinue ofto patients outweigh any risks associated with the device. AIRs are reviewed and, where appropriate, action is taken to prevent the issue from happening again, or to reduce the risk of adverse events.events. 

We also receive AIRs directly from healthcare professionals and patients.patients via the MHRA’s Yellow Card scheme. It is not compulsory for healthcare professionals to report incidents directly to us, but we strongly encourage this, and it is recommended by many professional standards.

AIRs byAIRs/Yellow Card reports by members of the public are voluntary.

Every report counts. We monitor the safety and performance of breast implants and breast tissue expanders and encourage reportingreporting of of any adverse incidents through our Yellow Card scheme. We use a range of data sources to find any signals of harm and where necessary, take action to reduce risk and maximise benefit to patients.patients. 

All reports are sent to the manufacturer of the device (if known and patient details are anonymised as appropriate) to help the monitoring of the safety of medical devices.devices.   

Healthcare professionals should input patient details into the BCIR. As this registry progresses it will help us to get a better picture of the incidence of BIA-ALCL. This will further aid us in our role of monitoring the safety of breast implants and tissue expanders.

MHRA actions

Patient safety remains our highest priority. The MHRA continues to collect and analyse a range of information from patients, members of the public, UK healthcare professionals and other sources about this issue so we can build a fuller picture of the occurrence of this uncommon disease in association with breast implants. Where necessary, we will take further action as quickly as possible.

Medical deviceDevice alertsAlerts (MDA)

The MHRA has informed surgeons about the potential risks ofof BIA-ALCL in BIA-ALCL in patients with breast implants in medicalMedical deviceDevice alertsAlerts issued in February 2011 (MDA/2011/017(MDA/2011/017)) and updated in July 2014 (MDA/2014/027(MDA/2014/027)),, and most recently in July 2018 (MDA/2018/027(MDA/2018/027))..

These alerts advise surgeons to strongly encourage patients to check for symptoms such as lumps, swelling or distortions through continued regular self-examination and to consult their GP or implanting surgeon if they have concerns. The alerts in 2011 and 2014 advised surgeons to report cases of BIA-ALCL to the MHRA and the alert in 2018 also advised surgeons to include the risks of BIA-ALCL in consenting patients for breast implant surgery as part of shared decision making.

WeThe MHRA regularly reviewreviews the information weit provides to hospitals, clinics and surgeons to determine if any updates are required. WeFurther will publish further or updated advice is issued as appropriate.

WeThe haveMHRA has changed the way weit issueissues safety information to healthcare providers. We stopped issuing medicalMedical deviceDevice alertsAlerts (MDAs) in September 2020. SafetyThis communications concerning medicines, medical devices and other healthcare productspage describes the different communications that wethe publish.MHRA publishes. Note that the advice in many MDAs remains valid until and unless they are archived. If you were signed up to receive medicalMedical deviceDevice alerts,Alerts, you need to now subscribe to receive nationalNational patientPatient safetySafety alertsAlerts and deviceDevice safetySafety information.Information.

MHRA expertExpert advisoryAdvisory groupGroup

To assist us in our work, and to advise us on how we communicate and engage with patients and healthcare professionals on implants,breast implants we have formed an independent expert advisory group:group; the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) who are working with us to review the risks associated with breast implants.

Members of the group have world-recognised expertise and are helping us to provide a greater understanding of the disease and potential risk to patients to help guide any further necessary MHRA action.

PRASEAG hashave published an information document:document Information(information about BIA-ALCL for people with breast implantsimplants) based on important questions the surgeons on the group have received during consultations with patients.

Information about BIA-ALCL for people with breast implants

PRASEAG hashave also been pivotal in creating UK clinical guidelines for healthcare professionals involved in the diagnosis and treatment of people with BIA-ALCL.BIA-ALCL. The clinical guidelines have been published in the following journals:

• British Journal of Haematology
  https://onlinelibrary.wiley.com/doi/epdf/10.1111/bjh.17194

• European Journal of Surgical Oncology

https://www.ejso.com/article/S0748-7983(20)30688-0/fulltext

• Journal of Plastic, Reconstructive & Aesthetic Surgery  https://www.jprasurg.com/article/S1748-6815(20)30562-3/fulltext

Certain members of the group have contributed to a paper providing guidelines on the pathological diagnosis and management of BIA-ALCLBIA-ALCL.  [link https://onlinelibrary.wiley.com/doi/10.1111/his.13932. or https://pubmed.ncbi.nlm.nih.gov/31166611/]

PRASEAG Chair

PRASEAG is chaired by Mr Nigel Mercer, Consultant Plastic Surgeon and immediate past President of the Federation of Surgical Specialty Associations. He is also a past President of the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) and the British Association of Aesthetic Plastic Surgeons (BAAPS) and twice past President of the European Association of Societies of Aesthetic Plastic Surgery (EASAPS).

PRASEAG membership Membership

PRASEAG membership currently consists of presidentsPresidents and one representative from the Association of Breast Surgery (ABS), the British Association of Aesthetic Plastic Surgeons (BAAPS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) along with representatives from the following organisations:

• Breast and Cosmetic Implant Registry (BCIR)(BCIR)
• British Society of Haematology
• GlobalGlobal BIA-ALCL Network BIA-ALCL Network Forum
• Royal College of Pathologists
• Royal College of Radiologists
• The Joint Council for Cosmetic Practitioners (JCCP) (JCCP)
• Cosmetic Practice Standards Authority (CSPA) (vacancy)

Areas of expertise covered by PRASEAG include:

• geneticGenetic epidemiology
• haemato-oncologyHaemato-oncology with a special interest in lymphoma
• oncoplasticOncoplastic and reconstructive breast surgery
• pathologyPathology- - surgical infection and microbiology
• pathologyPathology - cellular and molecular tumour biology
• patientPatient advocacy
• plasticPlastic and reconstructive surgery
• radiologyRadiology (medical imaging)
• toxicologyToxicology and immunology

Collaborations

UK collaborations

We work closely with clinical stakeholders including the Association of Breast Surgery (ABS), British Association of Aesthetic Plastic Surgeons (BAAPS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS).

The Jointjoint statement between ABS, BAAPS, BAPRAS & MHRA onon BIA-ALCL BIA-ALCL,remains Julyrelevant 2018 (PDF,(PDF, 78.5KB, 2 78.5pages)(PDF, 78.5KB, 2 KB, 2 pages) remains relevant.pages)

The Breast and Cosmetic Implant Registry (BCIR)

(BCIR)

The Breast and Cosmetic Implant Registry (BCIR)(BCIR) was launched by NHS Digital in October 2016 to capture the details of breast implant procedures undertaken in England, Scotland and Northern Ireland. Both the NHS and independent healthcare providers can submit data to the registry.

The registry aims to provide the data needed to detect any early safety signals in relation to an implant and provide a mechanism for managing patients in the event of an implant recall. This will further aid the MHRA in its role of monitoring the safety of breast implants forand patients.

Patientsbreast cantissue requestexpanders throughfor their surgeon, hospital, or clinic where they were treated, that their details are added retrospectively to the BCIR.patients.

Projects

We have worked with a research organisation to better understand how patients and the public perceive the risks associated with having breast implants.implants including BIA-ALCL. This research studyhas consistedbeen ofpublished in-depthalongside interviewsa andcosmetic surveysbreast withaugmentation patients.risk Weawareness aretool working to improvehelp howpeople theconsidering riskscosmetic arebreast communicatedaugmentation to patients,understand atthe consultations,risks through written materials, including all forms of advertising and socialmake media.informed choices. We have asked manufacturers of breast implants to clearly state the risk of BIA-ALCL on their product information leaflets.

EU

European Union

The MHRA was part of an EU taskforce monitoringmonitoring BIA-ALCL with BIA-ALCL with the aim of gettingestablishing a picture of the issue across Europe and to understand the scientific issues surrounding the disease. Further work was undertaken relating to this (see below).

International activities

The MHRA’s response to recent international activity (November (Nov 2020)

We continue to regularly monitor and review all available evidence and emerging information about the safety of breast implants. We will update our advice where necessary. Based on ongoing data, people with breast implants do not need to have them removed in the absence of any symptoms that have been associated with this uncommon form of cancer. This advice is consistent with all international regulators.

If people have any questions or concerns about their implants, they should speak to their implanting surgeon or GP.

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks

The European Commission’s Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) has a mandate to provide advice on the state of scientific knowledge regarding a possible connection between breast implants and anaplastic large cell lymphoma. SCHEER have published itstheir final opinion on theBIA-ALCL, safety of breast implants in relation to anaplastic large cell lymphoma, which was open for public consultation until December 2020. One of the recommendations is for more research to be undertaken and this is in line with advice issued by the MHRA in relation to the management of asymptomatic patients who have breast implants.

ANSM (French regulator)Regulator)

On 66-7 to 7 February 2019 the French regulator ANSM held a public meeting onon BIA-ALCL. BIA-ALCL. Their expert advisory group published their their recommendations on the use of textured breast implants.

On 4 April 2019 ANSM ANSM published a precautionary decision to to restrict the use of certain types of textured breast implants and polyurethane coated breast implants in France.France.

Implants with very strong texturing, such as macro-textured implants and polyurethane implants, remain prohibited in France.

PRASEAG produced a joint statement: statement.

Statement from the Chair of the PRASEAG, 4 April 2019 (PDF, (PDF, 66.6KB, 1 66.6 KB, 1 page)page)

In January 2023, ANSM published new data on breast implant market surveillance in France.

Dutch National Institute for Public Health and the Environment (RIVM)

On 19 November 2018 we participated in the workshop of an international expert group consisting of EU taskforce members, regulatory authorities, manufacturers and representatives of the scientific and medical professional bodies on BIA-ALCL.on BIA-ALCL.

While most cases ofof BIA-ALCL have BIA-ALCL have been reported in patients with textured implants, at that time they concluded there is not enough scientific evidence of a causal relationship specifically between textured implants andand BIA-ALCL. BIA-ALCL. See the A summary of the internationalmeeting expertcan meetingbe onviewed BIA-ALCLhere.

Following the French announcement in April 2019, the Dutch regulatorRegulator asked RIVM to interpret the French action relating to certain macro-textured and polyurethane coated breast implants. The The RIVM report on breast implants and the risk of BIA-ALCL was was published on 17 May 2019.

The Dutch regulator also also published a response to to the RIVM report on the ANSM action.action.

The advice provided by the Chair of PRASEAG in the 4 April 2019 statement above remains unchanged.

FDA (USA regulator)Regulator)

On 2525-26 to 26 March 2019 the FDA held a public meeting to discuss breast implants. At this meeting, an advisory panel considered the continued availability of breast implants, but no recommendation to restrict any type of breast implant was made to the FDA. The majority of patients who presented at the meeting highlighted the importance of the informed consent process.

The EU taskforce presented a joint oral statement at the FDA meeting: meeting.

Oral contribution from the European Taskforce on Breast Implant Associated-ALCLAssociated-ALCL for for FDA Hearing on Breast Implants, 25 – 26 March 2019 (PDF, (PDF, 26.8KB, 2 26.8 KB, 2 pages)pages).

The FDA released a a press statement on on the outcome of this meeting.meeting.

TGA (Australian regulator)Regulator)

On 29 October 2020 the TGA updated their webpage on the regulatory action to limit the use of some textured breast implants and tissue expanders sold in Australia. Australia operates under a different regulatory framework to the UK. Implants available in Australia are listed on the Australian Register of Therapeutic Goods (ARTG). More information iscan availablebe found on thetheir TGA website. .

In 2024, the TGA published Australia’s breastBreast implantImplant riskRisk

Management management frameworkFramework, which outlines their processes to identify and manage risk relating to breast implants.

Health Canada (Canadian regulator)Regulator)

Health Canada completed an update to its its 2017 safety review on breastBreast implant-associatedImplant-Associated anaplasticAnaplastic largeLarge cellCell lymphomaLymphoma (BIA-ALCL)(BIA-ALCL). This updated review was triggered by newly reported Canadian cases, as well as newly published literature and information issued by international regulatory agencies. agencies.

On 27 May 27, 2019, Health Canada notified Allergan of the suspension of the licences for Biocell breast implants.

Engagement with other regulators

The MHRA has also been in contact with regulators in other countries, sharing information about this disease to gain a global view of how it has been affecting their populations. Differences in the occurrence of the disease in different populations is important in understanding the mechanisms which may be involved in its cause.

Additional information on ALCL on BIA-ALCL

UK professional associations:associations

• British Association of Aesthetic Plastic Surgeons (BAAPS) (BAAPS)
• British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS) (BAPRAS)
• Association of Breast Surgery (ABS) (ABS)

Regulatory agencies from outside the United Kingdom:Kingdom

• theThe Australian Therapeutic Goods Administration (TGA) (TGA)
• theThe United States Food and Drug Administration (FDA) (FDA)
• Health Canada
• German regulator (BfArM) (BfArM)

Footnotes

• *(BIA-ALCL)’A^{† A provisional WHO entity distinguished from other ALK- ALCL’ – Blood Journal, Swerdlow, S.H, (2016), Vol. 127, No. 20, p.5p.5.}

• **Informed^{†† consentInformed -consent, links to websites for devolved administrations: Scotland, Northern Ireland, Wales.}

• ^{††† Complete Surgical Excision Is Essential for the Management of Patients with Breast Implant-Associated Anaplastic Large-Cell Lymphoma. Journal of clinical oncology: official journal of the American Society of Clinical Oncology Clemens, Mark W et al. (2016) Vol. 34, No. 2, p160-8. doi:10.1200/JCO.2015.63.3412}

• ^{†††† BIA-ALCL Resources By the numbers, and what they mean. American Society of Plastic Surgeons, Clemens, M (2019).}