Sarah Moore calls on the MHRA to update its guidance to patients and clinicians about Breast Implant Associated Anaplastic Large Cell Lymphomas (BIA-ALCL) in light of latest research

In a week when the American Association of Plastic Surgeons (AAPS) has updated its advice about Breast Implant Associated Anaplastic Large Cell Lymphomas (BIA-ALCL) in line with the latest expert research on this disease, our own regulator, the MHRA, has not provided any similar patient or clinician updates.

As it stands, the MHRA’s guidance to patients and clinicians has not been updated since September 2019.

Advice currently available on the MHRA website reassures patients and clinicians that there is no need for women who have not developed BIA-ALCL to undergo prophylactic removal of their implants.

Yet this position is now at odds with the latest evidence presented by Dr Peter Cordeiro in the US this week, who highlights the fact that the length of a patient’s exposure to macro textured implants appears to increase her risk of developing BIA-ALCL.

We know, and it is important to reiterate, that the absolute risk of developing BIA-ALCL is low.

However, given the fact that longer implant exposure is linked with higher disease incidence, it is worrying that the MHRA is not requiring healthcare providers to make proactive contact with all women with textured implants, putting them on notice about the low but serious risks associated with their implants, which appear to increase over time.

Evidence presented by US medics Dr Cordeiro and Dr Mark Clemens this week indicates that:

  • The incidence rates of BIA-ALCL have gone up globally in the past six months
  • Global data now includes: three transgender cases; two gluteal implant related cases; two tissue expander cases (i.e. the disease does not just occur with implants)
  • Confirmed BIA-ALCL cases have now been reported across Asia – indicating that contrary to research six months ago, there does not appear to be a protective genetic factor in play.

While there remain areas of debate when it comes to BIA-ALCL, the following facts also attract consensus:

  1. On the reported data, the UK has the second-highest incidence rate of BIA-ALCL in the world
  2. All patients with confirmed cases of BIA-ALCL have a proven history of implantation with macro-textured breast implants
  3. The risk of developing BIA-ALCL is low, but if the disease does present it is serious
  4. The sooner BIA-ALCL is identified and treated the better the prognosis for the patient
  5. The longer an implant is in situ the greater the risk of developing BIA-ALCL
  6. Macro-textured implants have been used extensively within the NHS for patients undergoing reconstructive surgeries post mastectomy.

Put all of those facts together and it is understandable why many surgeons across the world have taken the decision to send information letters to all patients whom they have implanted with macro-textured implants.

The purpose of the letter is not to alarm their patients, but rather to put them on notice of the low, but serious, risks of developing BIA-ALCL.

This empowers the patient, and enables her to make her own risk-assessment in light of the latest research available on BIA-ALCL.

In the Irish Republic, it is now apparent that public hospitals are contacting all Irish women who have received macro-textured implants to inform them of the risks of developing BIA-ALCL, or in short – to forewarn and forearm.

By contrast, the MHRA does not currently require clinics to pro-actively alert women to the problem of BIA-ALCL unless they come into the clinic seeking assurance or advice.

There is also growing concern that the MHRA’s ‘keep calm and carry on’ position in the UK is directly informing both the manufacturers’ willingness to fund removal operations for women in the UK, in contrast with their US counterparts; and also the willingness of some NHS Trust providers to fund prophylactic removal operations for breast cancer survivors implanted with Allergan, Nagor and other implants through the NHS.

The MHRA will no doubt say in response to questions concerning its current position that, as per its website, the risks of removal surgery outweigh the risks of a patient developing BIA-ALCL in any individual case. However, that guidance fails to take account of the following points:

  • This a risk/benefit analysis that each individual patient should have a right to weigh up for herself in light of the latest expert evidence and guidance.
  • Most patients undergoing implant surgery would, in any event, have to have undergone a removal operation. As such they have already consented to a removal risk as part of the process of receiving their implants.
  • Few patients would consent to a systemic cancer risk linked to their implants, no matter how low that risk.

We maintain that the MHRA’s current position needs to be updated and aligned more closely with the position of other regulators and the latest available data.

We are concerned that if the MHRA does not take urgent steps to update its position, particularly in requiring clinics to send out ‘recall’ correspondence to patients, this will negatively impact British women’s ability to access information and other treatment options in order to manage their risk of developing BIA-ALCL.