In the closing months of 2019, 8 national cancer centres, in Ireland, began alerting around 8,000 women with textured breast implants to the risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL) – an emerging risk that last featured in edition 297 of BC Disease News (here).
Advisory letters, sent at the behest of the Irish Health Service Executive (IHSE), have offered guidance to affected individuals. Moreover, correspondence has urged anyone with additional concerns (regarding breast tissue ‘swelling’ or ‘lumps’ beside implants) to contact their operating surgeon or hospital for personalised assistance.[i]
The majority of women contacted will have received Allergan BIOCELL implants, which lost CE (Conformité Européenne) safety approval, in December 2018, and were subsequently recalled in July 2019.[ii]
In the official IHSE press release, Dr. Vida Hamilton, National Clinical Advisor and Group Lead of Acute Operations, stated that:
‘The purpose of the letter is to inform people about this condition, and to ensure that individuals with implants are familiar with the symptoms and signs so they know when they should go and get a check-up. If you have no symptoms or signs there is no need for any action on your part’.[iii]
The Health Products Regulatory Authority (HPRA) [Ireland’s answer to the UK Medicines and Healthcare products Regulatory Agency (MHRA)] cites research conducted by Magnusson et al (2019), [iv] which estimated that there is 1 case of BIA-ALCL for every 3,345 BIOCELL implants used.[v]
Might global rates of detection increase with time?
Interestingly, last week, a member of a US Food and Drug Administration (FDA) advisory committee published an article in the Journal of Clinical Oncology, which highlights the best practices for recognising and diagnosing BIA-ALCL.[vi] Implementation of these measures could theoretically increase global rates of detection.
For now, though, the non-Hodgkin lymphoma (NHL) sub-type is still considered ‘rare’ and carries a ‘low risk’. As a result, international experts do not recommend that ‘at-risk’ cosmetic and breast reduction surgery outpatients, who are asymptomatic, undergo an implant removal procedure.
So, what prompted IHSE to involve itself with this emerging health risk?
‘The HSE advisory programme was initiated in response to an increased understanding of the incidence of the condition and emerging evidence based on international studies over the past year’.
The Sinn Féin politician inquired as to whether companies and insurers had met with the Department of Health, IHSE, or the HPRA to discuss the potential health effects of textured implants, but Mr. Harris did not supply any response. What he did do, albeit indirectly, was to dismiss Ms. O’Reilly’s query over whether IHSE or the HPRA had secured an undertaking to fund textured breast implant removal.
It will be interesting, in the coming months, to see if UK health service providers adopt a similar strategy.
[i] Eilish O’Regan, ‘8,000 women who received particular breast implant to be warned they are at risk of cancer’ (30 September 2019 Independent.ie) <https://www.independent.ie/irish-news/health/8000-women-who-received-particular-breast-implant-to-be-warned-they-are-at-risk-of-cancer-38546223.html> accessed 13 February 2020.
Paul Cullen, ‘HSE warns 8,000 women who had breast implants about risk of rare cancer’ (14 October 2019 Irish Times) <https://www.irishtimes.com/news/health/hse-warns-8-000-women-who-had-breast-implants-about-risk-of-rare-cancer-1.4049978> accessed 21 February 2020.
[ii] Hannah Devlin and Hilary Osborne, ‘Breast implants linked to cancer withdrawn from sale in Europe’ (19 December 2018 The Guardian) <https://www.theguardian.com/society/2018/dec/19/breast-implants-linked-to-cancer-withdrawn-from-sale-in-europe-allergan-textured> accessed 13 February 2020.
[iii] ‘HSE Information for people with breast implants and tissue expanders’ (9 October 2019 HSE) <https://www.hse.ie/eng/services/news/media/pressrel/hse-information-for-people-with-breast-implants-and-tissue-expanders.html> accessed 17 February 2020.
[iv] Magnusson M et al., The Epidemiology of Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand Confirms the Highest Risk for Grade 4 Surface Breast Implants. Plast Reconstr Surg. 2019 May;143(5):1285-1292. <https://insights.ovid.com/pubmed?pmid=30789476> accessed 13 February 2020.
[v] ‘Breast Implant Associated - Anaplastic Large-Cell Lymphoma (BIA – ALCL)’ (27 September 2019 HPRA) <https://www.hpra.ie/homepage/medical-devices/special-topics/breast-implant-associated---anaplastic-large-cell-lymphoma-(bia-alcl)> accessed 17 February 2020.
[vi] Jaffe ES et al. Best practices guideline for the pathologic diagnosis of breast implant-associated anaplastic large-cell lymphoma. J Clin Oncol. 2020 Feb 11:JCO1902778. <https://ascopubs.org/doi/pdf/10.1200/JCO.19.02778> accessed 21 February 2020.
[vii] ‘Cancer Awareness Dáil Éireann Debate, Tuesday - 26 November 2019’ (26 November 219 Houses of the Oireachtas) <https://www.oireachtas.ie/en/debates/question/2019-11-26/322/> accessed 19 February 2020.
[viii] ‘Tuesday, 10 Dec 2019 Written Answers Nos. 447-466’ (10 December 2019 Houses of the Oireachtas) <https://www.oireachtas.ie/en/debates/question/2019-12-10/section/413/> accessed 19 February 2020.