As of 30 June 2018, the Medicines and Healthcare products Regulatory Agency (MHRA) had received 48 reports of anaplastic large cell lymphoma (ALCL) in patients with breast implants, 40 of which met the World Health Organisation (WHO) diagnostic criteria for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL).
In the UK, the estimated risk of BIA-ALCL, based on confirmed cases is one per 28,000 implants sold. The estimate is based on data for all types of breast implants known to be sold in the UK and confirmed cases of BIA-ALCL up to December 2017. The MHRA pointed out that there may still be some cases that have not been reported to the manufacturer or to MHRA. Additionally, all devices known to be sold in the UK may not have been implanted, the agency adds.
Among the cases of ALCL in women with breast implants reported to the MHRA, there have been three deaths, of which only one was confirmed according to BIA-ALCL diagnostic criteria.
The independent Plastic, Reconstructive and Aesthetic Surgery Expert Advisory Group (PRASEAG) is continuing to review emerging evidence. To assist in the process, clinicians are being asked to report all cases of ALCL in patients with breast implants. Reports should include diagnostic criteria (eg, CD30 and ALK status); device details (eg, manufacturer, model, surface texture); clinical symptoms and management; implantation details (eg, dates of initial implantation, revision, explantation); and details of previous implants.
The MHRA also says clinicians should ensure that patients are informed about the Breast and Cosmetic Implant Registry (BCIR) and are given the option to consent to participation.
