French authorities withdraw approval for Allergan textured implants
Are the MHRA's reporting requirements for breast implant related lymphoma enough?
Posted on 21 December 2018
The French “National Agency for the Safety of Medicines and Health Products” (ANSM) this week announced that they had withdrawn approval for the sale of Allergan’s Microcell and Biocell textured implants and have asked the breast implant manufacturer to recall the product1 . On 21 November 2018 the ANSM recommended that health professionals use breast implants with a smooth envelope, pending the opinion of a committee of experts due to meet on 7 February 2019.
The implants have been associated with a rare form of cancer associated-anaplastic large cell lymphoma (BIA-ALCL). BIA-ALCL is a rare type of non-Hodgkin lymphoma that is associated with breast implants. Reported symptoms tend to describe a late onset of painful swollen breasts with a fluid collection usually between three and 14 years2 after implantation. Although investigations into the pathology of BIA-ALCL continue3 , positive outcomes have been reported and in most cases patients have achieved complete remission.4
The UK Medicines and Healthcare products Regulatory Agency’s (MHRA) statement this week states that they “are aware Allergan have stopped selling textured breast implants and tissue expanders and intend to withdraw remaining supply in European markets.
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.”
This follows new guidance issued by the MHRA on the on 9 August 2018, to all GPs, medical directors, nurses, GPs, oncology departments and breast reconstruction units. The MHRA guidance requires all relevant clinicians and nurses to:
- report all suspected cases BIA-ALCL to the MHRA;
- encourage patients to self-examine their breasts and underarms to identify any lumps, swelling or other abnormalities and to report any concerns to their GP;
- discuss the potential risks of BIA-ALCL during the consent process for new patients;
- discuss the potential risks of BIA-ALCL with patients returning for review; and
- reassure asymptomatic patients that BIA-ALCL is a rare form of cancer that can be successfully treated when detected at an early stage.
Whilst this call to action is welcome, the timing, nature and extent of this intervention by the MHRA prompts some important questions:
- Why did it take the MHRA two years since the World Health Organisation (WHO) defined BIA-ALCL5 to issue the guidance?
- Is the MHRA proactive enough in responding to issues of patient safety? BIA-ALCL was first described as early as 19976 and the MHRA issued Medical Device Alerts - reacting to US Food and Drug Administration - in 2011 and again 20147 regarding BIA-ALCL.
- Is the substance of the latest advice sufficient and should the MHRA be doing more? Each of the alerts and the recent guidance recommended no changes to best practice and simply encourage continued reporting.
- Are the reporting requirements imposed by the MHRA sufficient and what are the implications for failing to report?
- Should the MHRA being doing more to prevent the continued use of Allergan textured implants in the UK.
These questions may be new in the context of BIA-ALCL, but they are worryingly familiar in the wider context of medical devices and pharmaceuticals, as recognised by the government itself and the ongoing Cumberlege Review.
Since publishing Medical Device Alerts in 2011 and 2014, encouraging healthcare professionals to report cases of anaplastic large cell lymphoma (ALCL) in patients with breast implants, the MHRA has received 57 reports of BIA-ALCL in the UK, 45 of which meet the World Health Organisation diagnostic criteria. In the UK, the estimated risk of BIA-ALCL, based on the reported confirmed cases is 1 per 24,000 implants sold8 .
Though there have also been more cases reported worldwide since publication of the WHO definition, reported cases of BIA-ALCL are thankfully still relatively few internationally with 55 cases reported in Australia and New Zealand between 2007 and 20169 . However, these figures need to be considered alongside The Breast and Cosmetic Implant Registry data, which reported that 18,308 breast implant procedures were performed between October 2016 and June this year. Those figures are a reminder that breast implantation surgery is increasingly common internationally, such that whilst incidence rates are reassuringly low at the moment - clinicians must be watchful for BIA-ALCL as an avoidable, effectively man-made, pathology specifically linked to implants.
Indeed, when one considers that early diagnosis is most likely to lead to successful treatment of BIA-ALCL, should the MHRA be going further – and requesting that the manufactures do more to cover and/or subsidize the costs of regular screening tests for patients to put thei minds at ease and go some small way to reducing the inexorable cost burden shouldered by the NHS as a result of medical device and other implant failures.
- Le marquage CE des implants mammaires texturés de la marque Allergan (Microcell et Biocell) n’a pas été renouvelé par l’organisme notifié GMED - Point d'information 18.12.18
- The truth about breast implant-related cancer risk Jeffrey Kenkel MD UT Southwestern Medical Center 31.3.17
- A study to find more about the causes of breast implant associated anaplastic large cell lymphoma (BIA-ALCL)
- ALCL risk from breast implants BAPRAS
- Blood Journal
- Keech JA Jr, Creech BJAnaplastic T-cell lymphoma in proximity to a saline-filled breast implant. Plast Reconstr Surg 1997;100(2):554-555.
- Breast implants - report cases of anaplastic large cell lymphoma (ALCL) 17.12.18
- Breast implants and Anaplastic Large Cell Lymphoma (ALCL) 26.7.18
- Breast Implant-Associated Anaplastic Large Cell Lymphoma in Australia and New Zealand: High-Surface-Area Textured Implants Are Associated with Increased Risk. Plast Reconstr Surg. 2017 Oct;140(4):645-654.