Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is a rare non-Hodgkin lymphoma that is usually found near the breast implant, contained within the fibrous scar capsule, and not in the breast tissue itself.
Typically a persisting seroma develops around the implant while more rarely patients will develop a lump with or without the enlargement of axillary lymph nodes.
The MHRA issued a medical device alert in the UK in 2011 and a similar alert was issued by the FDA in the US. The recommendation of these alerts was that patients who experience persisting seroma following breast implant use should be investigated for the possibility of ALCL development.
Earlier this year Penningtons Manches’ clinical negligence team wrote a couple of articles about this still-emerging medical issue and the purpose of this piece is to provide further updates.
An article in the August 2017 edition of the European Journal of Surgical Oncology set out recommendations on the management of BIA-ALCL based on data obtained between 2012 and 2016. During this period 23 cases of BIA-ALCL were diagnosed throughout the UK. Data was available for 18 of these patients, which showed that the average time from insertion of the implants to diagnosis was 10 years. All cases involved patients with textured implants or expanders. A total of 15 patients presented with early stage 1 disease and were treated with implant removal and capsulectomy alone. Three patients who had more advanced disease were also treated with chemotherapy. All of the patients remain disease free suggesting that the prognosis for BIA-ALCL is good.
In keeping with these findings, a recent study published in the Aesthetic Surgery Journal has demonstrated that the risk of dying from BIA-ALCL is low. The study is based on data collated by the FDA, which has shown that an estimated 35 million women worldwide have breast implants and the total reported deaths from BIA-ALCL is 12 to date. The study refers to a micromort analysis, which is a unique tool for measuring the relative risk of activities and exposures. It is defined as 1 micromort = 1:1 million chance of death. The study found that the risk of dying from BIA-ALCL is 0.4 micromort. In comparison, the micromort of a woman skiing for one day is 0.77 and drinking two glasses of wine is 1, so the conclusion was that BIA-ALCL rarely leads to death.
Elise Bevan, a solicitor in the clinical negligence team at Penningtons Manches, said: “One of the reasons for conducting the study was to provide clarification for both doctors and patients, and to bring real life perspective for all existing and potential breast implant patients who might have reservations about implants based on recent media coverage. The data currently available has shown that BIA-ALCL is a very rare and very treatable condition. That is not, however, to say that the risk does not exist. Additional research needs to be conducted to understand this elusive disease. The key, of course, with all malignant conditions is early diagnosis and proper investigation and this needs to be reinforced to both doctors and patients. Should BIA-ALCL develop, the earlier it is caught the less invasive the treatment and the better the outcome.”