BIA-ALCL

We now know that there is a small risk of developing a rare lymphoma called BIA-ALCL associated with textured breast implants. In the United Kingdom, the most up-to-date incidence is thought to be 1/24,000 implants, with 45 confirmed cases since the first case was reported in 2012. There has been 1 death confirmed in the UK as a result of BIA-ALCL. The cause is yet to be understood but, as yet, no cases of BIA-ALCL have been reported with smooth implants.

In the United Kingdom, the Medicines and Healthcare products Regulatory Authority (MHRA) is the equivalent to the Food and Drug Administration (FDA) in the USA. All the international regulatory bodies are liaising closely with each other over BIA-ALCL, sharing information. In the UK, we are not seeing the same distribution of cases relating to the amount of texturing of implants that has been seen in Australia or the ‘clustering’ of cases they have reported. Allergan implants still have their FDA approval (they are one of very few implants to have it) but they lost their CE mark before Christmas 2018 because the manufacturer had not filed the paperwork for its renewal in time, not because of links with BIA-ALCL. Patients who have Allergan textured breast implants do not have to be removed.

Currently, there is no screening test for BIA-ALCL and MHRA, the FDA and the other international regulators agree there is no indication for screening patients who have no symptoms (asymptomatic) and there is no evidence to suggest that patients should have asymptomatic breast implants removed.

BIA-ALCL presents with painless swelling of a breast, which happens over a period of a few weeks. The swelling is obvious and occurs typically at around 8-10 years out from the original implantation. Symptomatic patients must be referred urgently for ultrasound-guided aspiration of all the fluid, which must be sent for cytological examination by a specialist pathologist for CD30 and ALK negative cells. If the diagnosis is positive, a referral should be made to the the local breast care team for further assessment and treatment.

BIA-ALCL is eminently treatable with surgery when caught early. MHRA and the Breast Implant Register must be informed of any positive BIA-ALCL diagnosis.

If you develop swelling of a breast in which you have a breast implant you should contact your initial surgeon. If that is either Mr Mercer or Mr Orlando please call for an appointment to see them or see your GP as a matter of urgency.

January 2019