As of September 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) has received 57 reports of Anaplastic Large Cell Lymphoma (ALCL) in patients with breast implants. Of the total number of cases reported, 45 of meet the World Health Organization (WHO) diagnostic criteria for breast implant-associated (BIA)-ALCL.
Among the cases of BIA-ALCL reported to the MHRA, there have been 3 deaths. However, only 1 of these has been confirmed as meeting the diagnostic criteria for BIA-ALCL. The other 2 deaths did not meet the diagnostic criteria.
In the UK, the estimated risk for BIA-ALCL based on reported confirmed cases is 1 per 24,000 implants sold. The estimate is based on data for all types of breast implants known to be sold in the UK and cases of BIA-ALCL confirmed to meet the WHO criteria that had been reported up until July 2018.
The MHRA cautions that the actual risk for BIA-ALCL may be higher or lower than this estimate as some cases may not have been reported to the manufacturer or to the MHRA during this period, and all devices known to be sold in the UK may not have been implanted.
The MHRA has formed an independent expert advisory group. The Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) is already engaged in the process of reviewing risks associated with breast implants.
The group has been tasked to consider BIA-ALCL, with the aim of providing 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, along with a patient advocate.
