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 is ongoing 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
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.
Most cases have happened years after surgery. Very rarely BIA-ALCL has been found when a lump develops next to the implant, or within the tough fibrous tissue building up around the implant (known as capsular contracture).
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 clinic which performed the original implant operation is no longer available, then you should see your GP for referral to another surgeon.
As with any implant it is important anyone undergoing breast implant surgery discusses the risks and benefits with their surgeon.
If you have had an issue with a breast implant you should report it via the Yellow Card Scheme so we can investigate further.
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, please include:
- diagnostic criteria e.g. CD30+/-, ALK +/- status
- device details e.g. manufacturer, model, surface texture
- clinical symptoms and management
- implantation details e.g. dates of initial implantation, revision, explantation
- details of any previous implants (if known)
To enable MHRA to build an accurate picture of the prevalence of this issue, 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 are informed about the Breast and Cosmetic Implant Registry (BCIR) and given the option to consent to their information being recorded.
MHRA continues to collect and analyse reports of ALCL in patients with breast implants from manufacturers, UK healthcare professionals and patients.
A report does not necessarily mean the events described were causally related to an implant. Reports submitted to MHRA could be related to the implant or they could have occurred even in the absence of the device (e.g. an event 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.
As of September 2018, MHRA has received 57 reports of ALCL in patients with breast implants, 45 of which meet the WHO diagnostic criteria for BIA-ALCL.
In the UK, the estimated risk of BIA-ALCL, based on the reported confirmed cases is 1 per 24,000 implants sold. This estimate is based on data for all types of breast implants known to be sold in the UK and reported cases of BIA-ALCL confirmed to meet the WHO criteria until July 2018. This is an estimate as some cases may not have been reported to the manufacturer or to MHRA during this period, additionally all devices known to be sold in the UK may not have been implanted.
In cases of ALCL in women with breast implants reported to MHRA there have been 3 deaths. Only 1 of these is confirmed to meet the diagnostic criteria for BIA-ALCL. The other two deaths did not meet the diagnostic criteria.
Patient safety is our highest priority. MHRA continues to collect and analyse information from UK healthcare professionals and other sources about this issue in order to 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.
Formation of an expert advisory group
We have formed an independent expert advisory group, the Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG), who are already engaged in the process of reviewing risks associated with breast implants.
The group in the first instance have been tasked to consider BIA-ALCL, with the aim to provide a greater understanding of the disease and potential risk to patients and will help to guide any future necessary MHRA action. PRASEAG members represent specialties which include breast and reconstructive surgery, toxicology, immunology, pathology and imaging. There is also a patient advocate on the group.
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).
MHRA is part of an EU Task Force monitoring BIA-ALCL with the aim of getting a picture of the issue across Europe.
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, there is currently not enough scientific evidence of a causal relationship specifically between textured implants and BIA-ALCL. Our advice to patients has not changed.
Clinicians are reminded of the importance of reporting to us any cases of ALCL in patients who have, or have had, breast implants. This information will help us build a more accurate picture of the occurrence of this rare disease in association with 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 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.
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.
Additional information on ALCL
UK professional associations
- British Association of Aesthetic Plastic Surgeons (BAAPS)
- British Association of Plastic Reconstructive and Aesthetic Surgeons (BAPRAS)
- Association of Breast Surgery (ABS)
Regulatory agencies from outside the United Kingdom
- The Australian Therapeutic Goods Administration (TGA)
- The United States Food and Drug Administration (FDA)
- Health Canada