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BI-ALCL and Allergan: Is the MHRA doing enough?

Consumer safety solicitor, Sarah Moore, discusses whether the MHRA are doing enough to protect patients from potential harm following reports linking Allergan breast implants to a rare form of cancer. 

Breast implants
Sarah Moore specialises in product liability and claims for groups of people who have suffered an injury because of unsafe products. She has written a number of articles on topics such as drug regulation, cigarette packaging and food safety.
The French medicines regulator (ANSM) decided to temporarily ban Allergan textured breast implants from the European market last December, in light of growing evidence linking a rare type of cancer (BI-ALCL) to Allergan implants in particular. In response to this our own UK regulator, the Medicines Health and Regulatory Agency (MHRA), made the following statement
“We 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.”

The intention, and in many cases no doubt the effect, of that statement was to reassure women implanted with Allergan textured prostheses that, despite the fact that the product has been pulled from the market due to safety concerns, there was, and is, no urgent reason for alarm.
Whilst the ‘keep calm and carry on’ tone of that statement makes perfect sense from a regulatory perspective, there is good reason to question the evidential basis from which it arises.
Indeed, in a statement on the front cover of the inaugural publication of the Breast and Cosmetic Implant Registry report (BCIR), published in November 2018, the MHRA, as co-contributor to the report, openly acknowledge that the detection and reporting of ‘possible trends and complications relating to specific implants’ is still purely aspirational in the UK. 

The statement on the front cover of the BCIR 2018 report, reads as follows: 
“The efficacy of product recalls based on the Breast and Cosmetic Implant Registry are reliant  on the quality of the data that it holds. Product recalls within the registry are only possible based on the manufacturer. As there are currently no validity rules available for device identifier, serial numbers, catalogue reference numbers and lot numbers, it is not possible to carry out a product recall based on these fields.”

In other words, by the MHRA’s own admission, only the manufacturer currently has sufficient data to evaluate whether a particular breast implant poses a health-risk to women. 
Setting aside the obvious fact that this seems to leave the fox in charge of the chicken-coop, this statement in the BCIR report is also starkly at odds with the MHRA’s December 2018 statement assuring Allergan patients that there is ‘no evidence of an increased risk’.
The MHRA’s statement clearly seeks to allay alarm about the risk of Allergan implants, however, given that there appears to be significant gaps in the quantity and quality of the data collected by the MHRA, are the MHRA currently capable of identifying and measuring that risk? The reasons why those gaps in data persist, seven years after the PIP scandal, and 30 years after Dow Corning, are subjects for another day, but on any reading of the BCIR report – there is good reason to question the authority with which the MHRA can make reassuring statements that ‘there is no evidence of increased risk’. 
Moreover, this isn’t just a question of semantics. As a result of the MHRA’s statement and position, women with Allergan implants in the UK are not being given access to clinical monitoring or removal of their implants unless they can pay the fees that many private breast augmentation clinics are now demanding. That leaves many women with Allergan implants very anxious about developing BI-ALCL – but with nowhere to turn for clinical help, unless they can afford to pay for it. 
Whilst the MHRA must always act to allay unnecessary fears regarding BI-ALCL, the fundamental role of any regulator must also be to protect patients from potential harm. For the reasons set out in this blog, it seems likely that the current available data may well underestimate the incidence of BI-ALCL in association with Allergan implants in particular. The French regulator has acted swiftly to protect patients from what is now perceived to be a real risk, albeit the incidence rate remains unclear. In this context, it is perhaps surprising that the MHRA has not acted more decisively recommending routine monitoring for women with these implants.

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