In April this year, amid a growing global clamour, the UK Government’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has no plans to ban ‘macrotextured’ breast implants, or breast implants with polyurethane-coated surfaces. And in spite of increasing concerns, I agree with them. It’s my view textured implants are not only being
In April this year, amid a growing global clamour, the UK Government’s Medicines and Healthcare products Regulatory Agency (MHRA) announced that it has no plans to ban ‘macrotextured’ breast implants, or breast implants with polyurethane-coated surfaces.
And in spite of increasing concerns, I agree with them.
It’s my view textured implants are not only being scapegoated, but by doing so we’re missing the bigger picture and creating an even more dangerous landscape.
As you may have read, textured implants have linked with a slight risk of developing a rare form of non-Hodgkin lymphoma, called Anaplastic Large cell Lymphoma, or ALCL.
This cancer has been given an official name by the World Health Organisation (WHO) – Breast Implant Associated Anaplastic Large Cell Lymphoma or ‘BIA-ALCL’.
As pressure mounted earlier this year, France’s National Agency for Medicines and Health Products (ANSM) banned the implants, as did Health Canada.
So if other countries are banning them, why isn’t the UK making similar moves to protect patients?
It’s my view that the MHRA are doing precisely the right thing by holding their nerve – as any knee-jerk reactions now could be extremely damaging for the future.
Because I believe it’s not the implants that are to blame, but instead it’s the surgical techniques, or poorly sterilised operating environments, that could be putting patients at risk.
And by ignoring this, and shifting the blame elsewhere, we do nothing to address the real problem.
Let’s take a look at the facts.
There is no evidence that BIA-ALCL is caused by textured implants.
The critics will argue that most cases of ALCL have occurred in textured implants – but in less than half the reported cases is the type of implant surface actually known.
So, they are basing their conclusions on less than half the reported cases.
Also, since textured implants are used by the majority of surgeons, if ALCL is evenly distributed, then it is expected that there would be more cases of ALCL with textured implants.
And, for me, the evidence so far suggests that it is the technique of the surgeon, or environment of implantation, which may be the causative effect on the risk of ALCL.
As I’ve mentioned in a previous blog, I suspect bacterial contamination could be the real guilty party.
If bacteria is able to contaminate the implant during insertion – due to poor practice – there could be the formation of ‘biofilm’, where microbial cells form on the surface.
It is these bacteria which could be stimulation the immune response, and potentially causing further complications.
The long and the short of it is that we don’t yet know the dangers of BIA-ALCL – other than the fact that in the UK, based on the reported confirmed cases, the risk of developing it is one per 24,000 implants sold.
And the subversive move to discredit textured implants needs to be re-thought.