This week, Leigh Day Solicitors issued letters of claim on behalf of 11 women who are the first claimants, in the UK, to allege that a cosmetic breast implant product (Allergan Biocell textured implants) has caused them to develop a rare form of non-Hodgkin lymphoma, called anaplastic large cell lymphoma (ALCL), or breast implant-associated (BIA) ALCL.[i]
It is important to differentiate current accusations involving Allergan Biocell implants with the Poly Implant Prostheses (PIP) scandal, which uncovered that French breast implants, manufactured with unapproved silicone gel, were 2 to 6 times more likely to rupture than standard silicone implants.[ii]
The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR), in a Preliminary Opinion on the safety of Poly Implant Prothèse (PIP) Silicone Breast Implants (2013 update), concluded that BIA-ALCL in patients with PIP implants ‘was just a tragic coincidence and was not directly caused by the implants’.[iii] Meanwhile, an expert group, chaired by NHS Medical Director, Sir Bruce Keogh, published Poly Implant Prothèse (PIP) breast implants: final report of the Expert Group, which concluded that there was not enough evidence to recommend the early removal of PIP implants.
In December 2018, Allergan Biocell implants were removed from European markets after France’s national agency for the safety of medicines and health products (ANSM) suspended safety approval[iv] and the link between the product and BIA-ALCL was classified as a ‘disease’ by the World Health Organisation (WHO).[v]
However, a UK Medicines and Healthcare products Regulatory Authority (MHRA) Field Safety Notice on Allergan, published shortly after the CE certificate expired (sale and manufacture ceased), notified the public that:
‘There is currently no evidence of an increased risk to patients and there is no need for people who have Allergan breast implants to get them removed or have any additional clinical follow-up’.[vi]
As of February 2019, plastic surgeons had identified at least 688 cases of BIA-ALCL worldwide.[vii]
Early onset symptoms of BIA-ALCL include pain and swelling, as fluid, known as seroma, builds up in affected breast tissue, ‘usually between three and 14 years after implantation’.[viii] In the majority of cases, the cancer-type is found in scar tissue and fluid surrounding the implant, but in others, it has been known to spread throughout the body – especially if left untreated – which can be fatal.[ix]
Leigh Day Associate, Sarah Moore, admitted that the chances of developing BIA-ALCL post-breast augmentation is low, but contends that the MHRA is underestimating the risk, which it claims to be 1 in 24,000, as the Authority has not monitored every woman who has undergone the procedure:[x]
‘Until very recently there has been no proper breast implant register to track who may have had implantation or to track any potential problems reported from breast implant surgery. This means that there is no reliable data upon which to monitor the safety of breast implants and to determine accurately the incidence of injury or failure of any particular type of implant’.[xi]
Notwithstanding the position of the MHRA, Leigh Day is currently handling in excess of 350 enquiries from women who have Allergan Biocell implants. It is pursuing claims on behalf of those who have been diagnosed with BIA-ALCL and those who have not, but are nonetheless apprehensive about future health implications.[xii]
As such, letters of claim are being sent to Allergan and to private surgeries who supplied the implants. They are seeking to recover the cost of implant removal, as well as damages for personal injury, distress and financial loss.
It is asserted that this group of women were not made aware of the potential health risks at the time and could therefore not make an ‘informed choice’ when deciding whether to go ahead with the cosmetic procedure. This is significant, as the claimants further assert that as early as November 2008, it was known that there was an ‘association’ between breast prostheses and BIA-ALCL.
Looking more closely at the study of Mintsje de Boer et al (2008),[xiii] the ‘association’ is not as clear as proponents and the Sunday Express[xiv] would have you believe. While the Dutch researchers’ association demonstrated an increased relative risk (BIA-ALCL incidence in implanted group vs. BIA-ALCL incidence in non-implanted group) of BIA-ALCL in implanted individuals, the absolute risk (BIA-ALCL risk without context) remained ‘small’.
We emphasised, as recently as last week (here), that using epidemiological data to establish legal causation is a controversial subject. As Richard Goldberg explained:
‘It is arguable that the so-called doubling of risk approach mooted in Sienkiewicz is overly simplistic. In particular, doubling of risk does not consider absolute risk (that is, the risk of something occurring without any context) and the severity of the outcome’.[xvii]
To find out more about the supposed link between Allergan textured breast implants and cancer, watch Channel 4’s Dispatches investigation: Britain's Breast Implant Scandal (here).
[i] Neil Rose, ‘Leigh Day begins action over breast implant linked to cancer’ (2 July 2019 Litigation Futures) <https://www.litigationfutures.com/news/leigh-day-begins-action-over-breast-implant-linked-to-cancer> accessed 2 July 2019.
[iii] ‘PIP implant breast cancer link ruled out’ (30 October 2013 NHS) <https://www.nhs.uk/news/cancer/pip-implant-breast-cancer-link-ruled-out/> accessed 4 July 2019.
[iv] Swerdlow SH et al., The 2016 revision of the World Health Organization classification of lymphoid neoplasms. Blood. 2016 May 19;127(20):2375-90. <http://www.bloodjournal.org/content/bloodjournal/127/20/2375.full.pdf> accessed 3 July 2019.
[v] ‘Evaluation of the use of silicone breast implants (other than PIP) in France 2010-2013’ (May 2014 ANSM) <https://www.ansm.sante.fr/var/ansm_site/storage/original/application/7fd4f94f69f8a07befd7f1e2753187ab.pdf> accessed 4 July 2019.
[vi] ‘MHRA statement on Allergan’ (19 July 2018 GOV.UK) <https://www.gov.uk/government/news/mhra-statement-on-allergan> accessed 4 July 2019.
[viii] ‘Allergan breast implant claims’ (Leigh Day) <https://www.leighday.co.uk/Product-safety-and-consumer-law/Healthcare/Allergan-breast-implant-claims> accessed 4 July 2019.
[ix] Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL)’ (4 February 2019 US FDA) <https://www.fda.gov/medical-devices/breast-implants/breast-implant-associated-anaplastic-large-cell-lymphoma-bia-alcl> accessed 3 July 2019.
[x] ‘Breast implants and Anaplastic Large Cell Lymphoma (ALCL)’ (4 April 2019 GOV.UK) <https://www.gov.uk/guidance/breast-implants-and-anaplastic-large-cell-lymphoma-alcl> accessed 4 July 2019.
[xi] ‘Women with Allergan breast implants considering legal action’ (24 June 2019 Leigh Day) <https://www.leighday.co.uk/News/2019/June-2019/Women-with-Allergan-breast-implants-considering-le> accessed 4 July 2019.
[xii] ‘Latest stage in potential legal action over breast implants’ (1 July 2019 Leigh Day) <https://www.leighday.co.uk/News/2019/July-2019/Latest-stage-in-potential-legal-action-over-breast> accessed 4 July 2019.
[xiii] Mintsje de Boer MD et al., Breast Implants and the Risk of Anaplastic Large-Cell Lymphoma in the Breast. JAMA Oncol. 2018 Mar; 4(3): 335–341. <https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5885827/> accessed 4 July 2019.
[xiv] Lucy Johnston, ‘Breast surgery scandal: Experts ignored proof of implant cancer risk’ (30 June 2019 Sunday Express) <https://www.express.co.uk/news/uk/1147182/breast-implant-cancer-breast-enlargement-surgery> accessed 4 July 2019.
[xv] ‘Absolute Risk vs. Relative Risk: What’s the difference?’ (1 March 2017 EUFIC) https://www.eufic.org/en/understanding-science/article/absolute-vs.-relative-risk-infographic> accessed
[xvi] Andrade C, Understanding relative risk, odds ratio, and related terms: as simple as it can get. J Clin Psychiatry. 2015 Jul;76(7):e857-61. <https://www.ncbi.nlm.nih.gov/pubmed/26231012> accessed 4 July 2019.
[xvii] Goldberg, R. (2014). Epidemiological Uncertainty, Causation, and Drug Product
Liability. McGill Law Journal / Revue de droit de McGill, 59 (4), 777–818. <http://lawjournal.mcgill.ca/userfiles/other/30625-Article__2___Goldberg.pdf> accessed 4 July 2019.