In edition 281 of BC Disease News (here), we reported that manufacturer, Allergan, had issued a worldwide recall of its Biocell saline-filled and silicone-filled textured breast implants and tissue expanders, succumbing to the US Food and Drug Administration’s (FDA) request.
Textured implants have been in production for around 30 years, but have been increasingly linked with breast implant associated-anaplastic large cell lymphoma (BIA-ALCL) cases, which has a latency period of between 3 and 14 years post-exposure (surgery). Scientists have suggested that BIA-ALCL may be caused by a reaction to the textured surface of implants or through bacterial infection, but until this is confirmed, the true cause remains unknown.
Following the revelation that products were being removed from the global market, the Medicines and Healthcare products Regulatory Agency (MHRA), which regulates medical devices in the UK, issued a field safety notice (FSN), regarding the safety of Allergan textured implants.[i]
The FSN confirmed the cessation of implant surgery and the completion of implant returns to CE Mark governed countries in Europe, while also noting that global health authorities collectively recommend not removing or replacing textured products in patients who do not present with symptoms.
Prior to January 2019, 52 BIA-ALCL cases had been reported to the MHRA.
Since then, the MHRA has been collecting more data and, on Wednesday of this week, the UK regulator announced that, as of July 2019, it had been informed of 72 cases of the rare cancer type. Further, that out of those 72 cases, 59 had met the official World Health Organisation (WHO) diagnostic criteria.[ii]
Leigh Day Solicitor, Sarah Moore, attributed the most significant upsurge in cases to-date to the ‘positive effect’ of ‘increased UK media attention’, yielding ‘quicker’ clinical diagnoses and more ‘efficient’ reporting to the MHRA.
Is BIA-ALCL ‘a genuinely new disease’, as Nigel Mercer, plastic surgeon and Chair of an advisory group of surgeons monitoring the disease for the MHRA, told the BBC? In the alternative, is it ‘not a “genuinely new disease” but ... a man-made disease that has gone underdiagnosed and underreported for too long’, as Sarah Moore, Leigh Day solicitor representing women with positive BIA-ALCL diagnoses, suggests?
In support of her argument, Ms. Moore added:
‘The first instance of BIA-ALCL was recorded in the academic literature in 1997, and between 1997-2010 there were 20 different academic articles published referencing the fact of BIA-ALCL and alerting surgeons and regulators to this issue.
The UK Breast Implant Registry was not established until October 2016 and did not produce its first report until November 2018. Both the MHRA and NHS Data, the body responsible for monitoring the Breast Implant Registry, recognise that there has been no comprehensive facility for the collection of data concerning instances of BIA-ALCL in the UK and that many clinicians have not had the knowledge to provide clear advice and diagnostic confirmation to patients’.
On the other side of the debate, another plastic surgeon, Professor James Frame, warned the BBC, that:
‘There needs to be a more robust information package to those delivering the service. [UK research around this] is dreadful’.[iii]
Mr. Mercer and Prof. Frame have jointly called for international collaboration between worldwide clinicians to share breast implant data.
In another update this week, claimant law firm, Leigh Day Solicitors, disclosed that 20 ‘Letters Before Action’, on behalf of women who have developed BIA-ALCL, will be sent to surgeons and manufacturers later this month.[iv] These are additional to the 11 pre-action Letters sent in July, which we reported in edition 279 (here).
Claimants will pursue ‘the costs of the implants and their removal, and compensation for personal injury, distress and any potential financial loss they suffered’.
Elsewhere, around 100 individuals have joined a Korean product liability lawsuit[v] against Allergan and, like UK claimants, will be ‘seeking monetary compensation for the cost of removing the Allergan implants if they require a removal surgery, and for the psychological effects caused by fear of developing breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)’.
[i] ‘Solicitors for women with BIA-ALCL welcome Allergan MHRA field safety notice’ (15 August 2019 Leigh Day) https://www.leighday.co.uk/News/2019/August-2019/Solicitors-for-women-with-BIA-ALCL-welcome-Allerga> accessed 21 August 2019.
[ii] ‘MHRA reports increase in the number of BIA-ALCL cases in the UK’ (21 August 2019 Leigh Day) <https://www.leighday.co.uk/News/2019/August-2019/MHRA-reports-increase-in-the-number-of-BIA-ALCL-ca> accessed 21 August 2019.
[iv] ‘Legal action over textured breast implants’ (16 August 2019 Leigh Day) <https://www.leighday.co.uk/News/2019/August-2019/Legal-action-over-textured-breast-implants> accessed 21 August 2019.
[v] Bahk Eun-ji, ‘Koreans to sue Allergan over breast implants linked to rare cancer’ (The Korean Times) <https://www.koreatimes.co.kr/www/nation/2019/08/119_274229.html> accessed 21 August 2019.