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Dispatches breast implant scandal investigation – what was missing from the MHRA response?

Channel 4’s Dispatches documentary series last night explored ‘Britain’s Breast Implant Scandal’. One of the issues raised in the show was the link between textured breast implants and a rare form of cancer known as BIA-ALCL. Solicitor Sarah Moore featured in the programme and is currently investigating a legal case on behalf of women with Allergan textured implants and those with confirmed BIA-ALCL diagnoses.

Sarah Moore on Dispatches
Related Areas of Practice:
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.
Last night John Wilkinson, Director of Devices for the UK’s  Medicines and Healthcare products Regulatory Agency (MHRA) appeared on Channel 4’s Dispatches ‘Britain’s Breast Implant Scandal’, to comment on the incidence of the rare form of lymphoma known as Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) cases in the UK.
 
He told Channel 4’s Dispatches team:
 
“We’ve been working extensively with the best expert input that we can get to establish the facts around the safety and performance of these devices and at this stage we have no reason to believe they should be taken off the market. We reckon that something in excess of a million implants have been placed in the UK – breast implants over time. That’s a number increasing rapidly all the time. Over all of that time we’ve had 57 reports of breast implant related ALCL.”
 
What Mr Wilkinson did not explain in his Dispatches appearance was that:
 
  1. Until 2016 there was no functioning breast implant registry in the UK
  2. The current breast implant registry in the UK is not compulsory – and it has been estimated that more than 80% of implants are not recorded within the registry
  3. BIA-ALCL was first identified in the medical literature in 1997, but the MHRA did not make any published statements in relation to BIA-ALCL until 2011
  4. In other countries, with functioning long-term breast implant registries, such as Australia, New Zealand and Canada, they are more able to track the performance of specific implant brands.
  5. In those countries they have identified a higher rate of incidence of BIA-ALCL with Allergan, and other textured implants 
  6. There was no distinction made between the numbers of textured and non-textured implantations in the UK
 
In that context, questions must be asked about how robust the MHRA’s monitoring systems are, and how competent they are to assess the true incidence of BIA-ALCL in the UK. 
 
In the Channel 4 programme Mr Wilkinson conceded that “it’s reasonable to assess that it [BIA-ALCL] probably is underdiagnosed” and the MHRA stated that “our focus is on the professionals to improve their knowledge and understanding of this evolving condition”.
 
The MHRA should ensure that awareness of BIA-ALCL is increased within the professional and wider community so that cases of BIA-ALCL can be diagnosed early ensuring a better prognosis.
 
What is conspicuously absent in Mr Wilkinson’s response is an acknowledgment that breast implants are mostly for cosmetic, not life-sustaining, purposes, and that there are alternative smooth implants available that do not carry any risk of BIA-ALCL. In those circumstances, surely the right thing to do is to follow the action of the French regulator and take a precautionary approach - banning all textured implants and requiring surgeons to contact patients with textured implants to educate them (albeit belatedly) regarding BIA-ALCL.
 
Whilst the MHRA fails to take that action Mr Wilkinson’s words may seem somewhat empty to the thousands of women with breast implants who are concerned about BIA-ALCL and who are looking to the British regulator for firm action and better protection.
 
My colleague Zahra Nanji and I are currently investigating a legal claim for over 250 women who have contacted us who have Allergan textured breast implants. The majority of these women have contacted us due to their concerns about the health implications of theses implants, however, ten of the women have already been diagnosed with BIA-ALCL.

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