Claimant PI Firm Condemns UK Health Products Regulator for Not Banning Breast Implants Linked with Rare Cancer

After breast implant manufacturer, Allergan, issued a global recall of its textured implant products, in July 2019 (click here to read our report), we questioned what effect this would have on impending product liability claims handled by claimant personal injury specialist, Leigh Day.

When the product recall was issued, we had only just reported (here) that letters of claim had been sent by the firm on behalf of women who were alleging that textured implants cause a rare type of white blood cell cancer, called anaplastic large cell lymphoma (ALCL), and are therefore defective.

In the UK, there have been 61 diagnoses of breast implant associated (BIA)-ALCL, but unlike the French and Australian authorities, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has decided not to institute a ban on clinical use of all textured implants.

The Agency’s current position is that the paucity of BIA-ALCL cases does not give rise to a clinical need for operated individuals to endure breast implant removal (revision) surgery:

‘We understand the concern that some individuals may have about this very rare disease. Research is ongoing in the UK and worldwide to better understand how BIA-ALCL develops. Based on our analysis of the latest scientific evidence and expert clinical input, our advice remains unchanged: there is no new evidence of an increased risk to patients and there is no need for people with breast implants to have them removed in the absence of any symptoms’.

However, Sarah Moore, a Leigh Day solicitor who is representing over 40 claimants in active product liability litigation against multiple manufacturers, has this week called for all textured breast implants to be banned.

She told The Guardian that she had been ‘angered’ by the MHRA’s ‘keep calm and carry on’ attitude, which characterised the ‘unregulated’ nature of the cosmetic surgery industry:

‘I think there has been misdiagnosis and under-diagnosis ... I think we’re going to see a significant increase in diagnosis’.[i]

At present, NHS England, the MHRA and the NHS Business Service Authority are unable to confirm how many cancer patients with mastectomies have previously undergone textured breast implant-based surgery.[ii]

Nonetheless, the MHRA has assured that it is ‘working closely with clinical stakeholders to raise awareness’ and has requested that clinicians report ‘any cases of ALCL in their patients who have, or had, breast implants’ through its ‘yellow card scheme’, which will help to build ‘a more accurate picture’ of the disease risk.

 

[i] Sarah Boseley, ‘Anger over UK's failure to ban breast implants linked to 61 cancer cases’ (7 January 2020 The Guardian) <https://www.theguardian.com/society/2020/jan/07/women-sue-breast-implants-linked-rare-cancer-lymphoma> accessed 10 January 2020.

[ii] Jake Hurfurt, ‘Anger as Britain fails to ban breast implants that have been linked to cancer in at least 61 women’ (8 January 2020 The Daily Mail) <https://www.dailymail.co.uk/news/article-7863009/Anger-Britain-fails-ban-breast-implants-cause-cancer.html> accessed 9 January 2020.