Breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
In 2016, the World Health Organisation (WHO) defined a new type of anaplastic large cell lymphoma (ALCL), which is itself an uncommon type of non-Hodgkin lymphoma with several subtypes. The WHO labelled this new variant as breast implant associated anaplastic large cell lymphoma or BIA-ALCL*. It has specific diagnostic criteria, which include positive expression of the marker CD30, negative for anaplastic lymphoma kinase (ALK), and a distinct cell morphology.
The MHRA investigation into BIA-ALCL continues and, as with all issues examined by us, we take an evidence-based approach across a range of data sources. Research into this area is yet to provide the answer as to how BIA-ALCL develops. There are several theories. One is that surface texturing on implants may play a role. There are 3 main surface textures which coat a breast 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.
The most common symptom for people with BIA-ALCL 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, it can affect both sides at the same time.
Most cases have happened years after surgery. Very rarely BIA-ALCL has been found when a lump develops next to an implant, or in the tough fibrous tissue that can 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 reports 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 tell your GP, who may need to refer you to your local NHS breast care 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 are provided with information about breast implant surgery and possible complications either in written format or via an online link to information sheets jointly written by the Association of Breast Surgery (ABS), British Association of Aesthetic Plastic Surgeons (BAAPS) and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS). These associations are some of our clinical stakeholders. They aim to increase understanding of their field, share learnings, inform patients and align with our patient safety goals.
If you have developed a problem with a breast implant you should tell your surgeon and GP and also report it through the MHRA Yellow Card Scheme.
Clinicians have a legal obligation to discuss the potential risk of BIA-ALCL when seeking informed consent of new patients, and with any patient returning for review of their breast implants.
When reporting a case of BIA-ALCL in patients with breast implants, surgeons are reminded to include (where it is known):
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.
Report any suspected or actual adverse incidents involving these devices through your healthcare institution’s local incident reporting system and/or your national incident reporting authority as appropriate:
Please also ensure the patient’s details are included in the Breast and Cosmetic Implant 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.
Anyone can report any incident relating to a medical device or medicine to us through our Yellow Card scheme. We collect and analyse all reports of ALCL in patients with breast implants and tissue expanders. Tissue expanders are medical devices used to expand the breast tissue in preparation for breast implant surgery.
As of 31 December 2023, we had received 81 reports of confirmed BIA-ALCL where the surgery occurred in the UK and 6 reports where the surgery occurred outside of the UK.
The current estimated incidence of BIA-ALCL, based on confirmed cases where surgery occurred in the UK, is 1 per 16,500 implants 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.
Obtaining confirmation of reports from 2024 is currently in progress.
The estimated incidence is calculated by dividing the number of confirmed cases of BIA-ALCL by the number of breast implants and tissue expanders sold in the UK. It does not include BIA-ALCL cases where the surgery occurred outside the UK. This is called an ‘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 in people with breast implants in the UK, there has been one death reported to the MHRA. Three deaths from ALCL were reported to the MHRA which did not meet the WHO diagnostic criteria for 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 disease who undergo complete capsulectomy and implant removal (see Journal of Clinical Oncology). Furthermore, studies show, 93% of patients are disease free at 3 years follow-up, which is an excellent prognosis when treated appropriately (see American Society of Plastic Surgeons).
ALCL can also occur in the breast due to other causes. Therefore, the number of reports we receive may not only be related to the breast implants. However, we still need to collect reports of ALCL in people with breast implants to build up a better picture of what is happening.
The MHRA 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 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 are classed as primary cases, which are shown in Table 1.
Table 1. Breakdown of 62 primary confirmed BIA-ALCL cases as of 31 December 2023 by manufacturer, surface texture of the implant and all-time sales, all of which have been implanted in the UK
Note: the table excludes 3 reports with an unknown manufacturer and 3 reports associated with non-UK surgeries, leaving 62 total cases.
| Confirmed cases by implant surface texture | Allergan | Eurosilicone SAS | Mentor Medical Systems B.V. | Nagor Limited | Silimed | Total |
|---|---|---|---|---|---|---|
| 0 (9,827) | 0 (2,867) | 0 (24,466) | 0 (19,773) | 0 (3) | 0 (56,936) | |
| 42 (522,163) | 1 (29,862) | 5 (400,043) | 11 (161,172) | 0 (22,625) | 59 (1,135,865) | |
| 0 (0) | 0 (0) | 0 (0) | 0 (0) | 2 (22,531) | 2 (22,531) | |
| 1 | 0 | 0 | 0 | 0 | 1 | |
| 0 | 48,598 | 0 | 0 | 0 | 48,598 | |
| 43 (531,990) | 1 (81,327) | 5 (424,509) | 11 (180,945) | 2 (45,159) | 62 (1,263,930) |
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, as shown in Table 2.
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 it 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. Breakdown of 8 confirmed BIA-ALCL cases as of 31 December 2023 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
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 | 2 | 1 | 1 | 8 |
| Manufacturer sales | 531,990 | 424,509 | 180,945 | 45,159 | 1,182,603 |
There are 42 cases where patients have received multiple implants from different manufacturers, or received implants of different surface textures, to the implant at the time of diagnosis of BIA-ALCL, or where the manufacturer details are unknown, or the surgery happened outside the UK. For these cases, BIA-ALCL cannot be linked to a particular implant, therefore are not shown in the tables above.
Any breast implant surgery carries some risk, and each surface texture of implant has different benefits and risks. For more information on this, see Information about BIA-ALCL for people with breast implants.
The MHRA continually reviews data across implant types and all manufacturers that sell breast implants in the UK for trends in the incidence of 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.
The MHRA conducts extensive investigations and follows up with manufacturers, surgeons and members of the public to maintain the accuracy of BIA-ALCL reports. However, there are limitations and caveats to how the data should be interpreted:
As part of the regulating the use of medical devices, manufacturers must submit adverse incident reports (AIRs) for incidents that occurred in the UK. This system is to ensure that the benefits of medical devices used in the treatment of 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.
We also receive AIRs directly from healthcare professionals and patients. 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 by members of the public are voluntary.
Every report counts. We monitor the safety and performance of breast implants and tissue expanders and encourage reporting 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.
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.
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.
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.
The MHRA has informed surgeons about the potential risks of BIA-ALCL in patients with implants in medical device alerts issued in February 2011 (MDA/2011/017) and updated in July 2014 (MDA/2014/027), and most recently in July 2018 (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.
We regularly review the information we provides to hospitals, clinics and surgeons to determine if any updates are required. We will publish further or updated advice as appropriate.
We have changed the way we issue safety information to healthcare providers. We stopped issuing medical device alerts (MDAs) in September 2020. Safety communications concerning medicines, medical devices and other healthcare products describes the different communications that we publish. Note that the advice in many MDAs remains valid until and unless they are archived. If you were signed up to receive medical device alerts, you need to now subscribe to receive national patient safety alerts and device safety information.
To assist us in our work, and to advise us on how we communicate and engage with patients and healthcare professionals on implants, we have formed an independent expert advisory 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 has published an information document: Information about BIA-ALCL for people with breast implants based on important questions the surgeons on the group have received during consultations with patients.
PRASEAG has also been pivotal in creating UK clinical guidelines for healthcare professionals involved in the diagnosis and treatment of people with BIA-ALCL. The clinical guidelines have been published in the following journals:
Certain members of the group have contributed to a paper providing guidelines on the pathological diagnosis and management of BIA-ALCL.
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 currently consists of presidents 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:
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 Joint statement between ABS, BAAPS, BAPRAS & MHRA on BIA-ALCL, July 2018 (PDF, 78.5 KB, 2 pages) remains relevant.
The Breast and Cosmetic Implant Registry (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 for patients.
Patients can request through their surgeon, hospital, or clinic where they were treated, that their details are added retrospectively to the BCIR.
Projects
We have worked with a research organisation to better understand how patients and the public perceive the risks associated with having breast implants. This research study consisted of in-depth interviews and surveys with patients. We are working to improve how the risks are communicated to patients, at consultations, through written materials, including all forms of advertising and social media. We have asked manufacturers of breast implants to clearly state the risk of BIA-ALCL on their product information leaflets.
EU
The MHRA was part of an EU taskforce monitoring BIA-ALCL with the aim of getting 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).
The MHRA’s response to recent international activity (November 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 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 published its final opinion on the 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)
On 6 to 7 February 2019 the French regulator ANSM held a public meeting on BIA-ALCL. Their expert advisory group published their recommendations on the use of textured breast implants.
On 4 April 2019 ANSM published a precautionary decision to restrict the use of certain types of textured breast implants and polyurethane coated breast implants in France.
Implants with very strong texturing, such as macro-textured implants and polyurethane implants, remain prohibited in France.
PRASEAG produced a joint statement: Statement from the Chair of the PRASEAG, 4 April 2019 (PDF, 66.6 KB, 1 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.
While most cases of 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 and BIA-ALCL. See the summary of the international expert meeting on BIA-ALCL.
Following the French announcement in April 2019, the Dutch regulator asked RIVM to interpret the French action relating to certain macro-textured and polyurethane coated breast implants. The RIVM report on breast implants and the risk of BIA-ALCL was published on 17 May 2019.
The Dutch regulator also published a response to the RIVM report on the ANSM action.
The advice provided by the Chair of PRASEAG in the 4 April 2019 statement above remains unchanged.
FDA (USA regulator)
On 25 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: Oral contribution from the European Taskforce on Breast Implant Associated-ALCL for FDA Hearing on Breast Implants, 25 – 26 March 2019 (PDF, 26.8 KB, 2 pages)
The FDA released a press statement on the outcome of this meeting.
TGA (Australian 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 is available on the TGA website.
In 2024, the TGA published Australia’s breast implant risk management framework, which outlines their processes to identify and manage risk relating to breast implants.
Health Canada (Canadian regulator)
Health Canada completed an update to its 2017 safety review on breast implant-associated anaplastic large cell lymphoma (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.
On 27 May 2019, Health Canada notified Allergan of the suspension of the licences for Biocell breast implants.
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.
UK professional associations:
Regulatory agencies from outside the United Kingdom:
*(BIA-ALCL)’A provisional WHO entity distinguished from other ALK- ALCL’ – Blood Journal, Swerdlow, S.H, (2016), Vol. 127, No. 20, p.5
**Informed consent - links to websites for devolved administrations: Scotland, Northern Ireland, Wales.
