Breast Implant and Blood Cancer Advice Updated

Peter Russell

August 01, 2018

Health professionals have been reminded to continue to report suspected cases of breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) in patients who have had breast implants or who have had them removed.

In an update to two previous medical device alerts in 2011 and 2014, the Medicines and Healthcare products Regulatory Agency (MHRA) said it had received 48 reports of BIA-ALCL in the UK, 40 of which met diagnostic criteria for the specific type of ALCL set out by the World Health Organization (WHO).

BIA-ALCL is a rare sub-type of T-cell non-Hodgkin lymphoma (NHL). It is one of four sub-types of ALCL which has been found in association with breast implants in a small number of cases worldwide. This sub-type is always both CD30 positive and anaplastic lymphoma kinase (ALK) negative.

'Low Risk'

The MHRA, the Association of Breast Surgeons (ABS), the British Association of Aesthetic Plastic Surgeons (BAAPS), and the British Association of Plastic, Reconstructive and Aesthetic Surgeons (BAPRAS) issued a joint statement on July 26th 2018. It said the current estimate of risk was one case per 28,000 implants sold. However, the MHRA cautioned that it is possible that not all devices sold in the UK have yet been implanted.

It said symptoms of BIA-ALCL – often a rapid, painless swelling of one breast – can appear several years after implantation. Early diagnosis can lead to successful treatment, usually with surgery alone.

Current evidence indicated an association between breast implants and BIA-ALCL, the statement said.  One possible theory was the role of the surface texture of implants. The Association of Breast Surgery (ABS) said BIA-ALCL tumour cells might be caused by a sustained T-cell immune response to bacterial antigens in biofilm on the implant surface. However, there was no substantive evidence for this, it said.
 

Reporting Suspected Cases

Health professionals have been asked to report all suspected cases of BIA-ALCL involving breast implant patients to the MHRA in England and Wales, the Incident Reporting and Investigation Centre (IRIC) in Scotland, or the Northern Ireland Adverse Incident Centre (NIAIC).

Information should include details of the breast implant at diagnosis and any previous implants, diagnostic criteria (including CD30 and ALK status), treatment and outcome, the MHRA said.

The advice said that health professionals should encourage patients to self-examine their breasts and axillae for any changes such as lumps, swellings or distortions, and to consult their implant surgeon or GP if they had any concerns. Also, clinicians should discuss the potential risk of BIA-ALCL for patients considering breast implants.

Breast implant patients without symptoms should be reassured that cases of BIA-ALCL are rare, the MHRA said.
 

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