Guidance

Breast implants and Anaplastic Large Cell Lymphoma (ALCL)

Information for clinicians and patients.

What is ALCL?

Anaplastic Large cell Lymphoma (ALCL) is a rare type of non-Hodgkin’s lymphoma of which there are several sub-types. In 2016,the World Health Organisation (WHO) defined a specific type of ALCL called Breast Implant Associated Anaplastic Large Cell Lymphoma or BIA-ALCL*. This has specific diagnostic criteria which includes expression of the marker CD30+ and negativity for ALK.

MHRA’s investigation into BIA-ALCL continues and as with all issues we take an evidence-based approach. Research into this area is yet to provide a definitive answer as to how BIA-ALCL develops although there are several competing theories. One suggested theory is that surface texturing on implants may play a role in how some patients react to having an implant in place. Research is ongoing in the UK and worldwide to better understand how BIA-ALCL develops.

Current UK advice

Patients

The most common symptom for patients, who have developed BIA-ALCL around their breast implants, is to present with a ‘late’ seroma (a collection of fluid) forming around the breast implant. The fluid collection often results in a relatively rapid, but painless increase in size of the affected breast. 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 within a tough fibrous tissue, which can build up around an implant (this is often referred to as capsular contracture).

BIA-ALCL is rare, but it is important healthcare professionals and patients who have implants know about it. If you develop a seroma, a breast lump or swelling around your implant more than a year after having the breast implant (regardless of how many years later), you should seek advice from your surgeon or clinic.

If the surgeon or the clinic which performed the original implant operation is no longer contactable, it is important you see your GP to get referred to another surgeon who specialises in breast disease.

As with any implant it is important anyone undergoing breast implant surgery discusses the risks and benefits with their surgeon and following this discussion understands the relative risks involved.

If you have had an issue with a breast implant you should report it through the MHRA Yellow Card Scheme so we can investigate further.

Clinicians

Clinicians should discuss the potential risk of BIA-ALCL when seeking the consent of new patients, and with any patient returning for review of their breast implants.

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

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

This information is vital to enable MHRA to build an accurate picture of the prevalence of this issue and assist in the global effort to understand this disease better. Reports should be made to MHRA via the Yellow Card Scheme (for cases in England and Wales), to NIAIC (in Northern Ireland) or to IRIC (in Scotland).

Please also ensure patients’ details are included in the Breast and Cosmetic Implant Registry (BCIR). Clinicians should note patient consent for this is no longer required for this information to be recorded.

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

MHRA reports

MHRA continues to collect and analyse reports of ALCL in patients with breast implants from manufacturers, UK healthcare professionals and patients.

It is important to note a report does not automatically mean the events described were caused by an implant, because sometimes they could have occurred even in the absence of the device perhaps due to an unrelated medical condition. The number of reports received, therefore, cannot be taken as an accurate reflection of issues directly attributable to implants, but we still need this information to build up a better picture of what is happening.

As of April 2020, MHRA has received 68 reports of BIA-ALCL in patients with breast implants which meet the WHO diagnostic criteria for BIA-ALCL. This figure includes cases reported where the original implantation did not occur in the UK.

In the UK, the estimated risk of BIA-ALCL, based on the reported confirmed cases, is 1 per 20,000 implants sold. This estimate is based on data for all types of breast implants including breast tissue expanders known to be sold in the UK and reported cases of BIA-ALCL confirmed to meet the WHO criteria until December 2019. This is only an estimate because some cases may not have been reported to the manufacturer or to MHRA during this time, and also every device known to be sold in the UK may not have been implanted.

In cases of ALCL in people with breast implants reported to MHRA there have been 3 deaths. Only 1 of these is confirmed to meet the WHO diagnostic criteria for BIA-ALCL. The other two deaths did not meet the diagnostic criteria.

MHRA actions

Patient safety remains our highest priority. MHRA continues to collect and analyse information from UK healthcare professionals and other sources about this issue so we can build a fuller picture of the occurrence of this rare disease in association with breast implants.

Medical Device Alerts (MDA)

MHRA has informed surgeons about the potential risks of BIA-ALCL in patients with implants in Medical Device Alerts initially 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 doctor if they have concerns.

MHRA regularly reviews the information it provides to hospitals, clinics and surgeons to determine if any updates are required. Further or updated advice is issued as appropriate.

MHRA Expert Advisory Group

To assist us in our work on implants we have formed an independent expert advisory group; the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG), who are reviewing 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 future necessary MHRA action.

PRASEAG Chair

PRASEAG is chaired by Mr Nigel Mercer (Consultant Plastic Surgeon and President of the Federation of Surgical Specialty Associations. He is past President of 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 Vice-chair

The Vice Chair of PRASEAG is Miss Fiona MacNeill (Consultant breast surgeon, past president of Association of Breast Surgery, and current National Clinical Lead for breast surgery on the NHS ‘Getting It Right First Time (GIRFT) initiative’.

PRASEAG Membership

PRASEAG membership currently consists of Presidents and/or representatives of the Association of Breast Surgeons (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)
  • Breast Cancer Now
  • British Society of Haematology
  • Global BIA-ALCL Network Forum
  • Royal College of Pathologists
  • Royal College of Radiologists

Areas of expertise covered by PRASEAG include:

  • Genetic Epidemiology
  • Haemato-oncology with a special interest in Lymphoma
  • Oncoplastic and Reconstructive Breast Surgery
  • Pathology- Surgical Infection and Microbiology
  • Pathology - Cellular and Molecular Tumour Biology
  • Patient Advocacy
  • Plastic & Reconstructive Surgery
  • Radiology (Medical Imaging)
  • Toxicology & Immunology

Collaborations

UK

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

Joint statement between ABS, BAAPS, BAPRAS & MHRA on BIA-ALCL, July 2018 (PDF, 78.5KB, 2 pages)

Clinicians are reminded of the importance of reporting to us as part of their professional obligations to reporting, any cases of ALCL in patients who have, or have had, breast implants.

The Breast and Cosmetic Implant Registry (BCIR)

The Breast and Cosmetic Implant Registry (BCIR) was launched by NHS Digital in October 2016 to capture the details of all breast implant procedures undertaken in England by both the NHS and independent healthcare providers.

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 MHRA in its role of monitoring the safety of breast implants for patients.

EU

MHRA has been a 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).

International activities

The MHRA’s response to recent international activity (26/9/19)

We continue to regularly monitor and review all current evidence and emerging information about the safety of breast implants. We will update our advice where necessary.

People with breast implants do not need to have them removed in the absence of any symptoms from this rare 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 their latest scientific advice in October 2017.

ANSM (the French regulator)

On 6-7 February 2019 the French regulator ANSM held a public meeting on BIA-ALCL. Their expert advisory group published their recommendations.

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.

PRASEAG have produced a joint statement.

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

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, they concluded that currently there is not enough scientific evidence of a causal relationship specifically between textured implants and BIA-ALCL. A summary of the meeting can be viewed here.

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 was published on 17 May 2019.

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

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

FDA (USA regulator)

On 25-26 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, 26.8KB, 2 pages)

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

TGA (Australian regulator)

On 26 September 2019 the TGA (Australia) announced a plan to take 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) which can be found on their website.

Engagement with other regulators

MHRA has also been in contact with regulators around the world, including Canada and Australia 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

UK professional associations

Regulatory agencies from outside the United Kingdom

Footnote

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

Published 26 July 2017
Last updated 2 July 2020 + show all updates
  1. Published new information about the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG)

  2. We updated factual information regarding report numbers and the EU task force

  3. Updated information following announcement by TGA.

  4. Added further information following ANSM announcement 4 April 2019

  5. Published updated information on advice to clinicians and our collaboration on this topic at EU level.

  6. We have updated figures on cases of BIA-ALCL reported to MHRA.

  7. Updated statistics and included a joint statement between ABS, BAAPS, BAPRAS & MHRA on BIA-ALCL

  8. First published.