Medicines Healthcare Products Regulatory Agency
What is ALCL?
Anaplastic Large cell Lymphoma (ALCL) is a rare type of non-Hodgkins 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.
MHRAs 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
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 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 patients 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 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.
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 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 Reco