I was interested to read Lord Howe’s recent report into the response by UK regulators to the PiP breast implant scandal.
This found that the Medicines and Healthcare products Regulatory Agency (MHRA) and the Department of Health had acted properly, but that lessons needed to be learned.
Problems with breast implants manufactured by the Poly Implant Prothèse (PiP) Company first came to public attention late last year, when a French regulator urged French women with PiP implants to have them removed. This was because the implants had been found to contain non-medical grade silicone – and had a high rupture rate.
However, the concerns about PiP implants have been around for some time – so much so that in March 2010 the MHRA issued an alert advising breast implant surgeons not to use them.
But was this enough? Should more have been done? Health Minister Lord Howe was asked to find out.
According to Lord Howe, the regulator did do its job – acting appropriately and following scientific and clinical advice – but improvements must be made in communication and data collection, and in the Europe-wide system and processes for gathering and analysing data.
The report reveals that the MHRA’s investigations “were hampered by a lack of reliable and comprehensive information about all the adverse incidents relating to PIP breast implants.”
It was also trying to “draw evidence-based conclusions about the performance of a device from data that were incomplete, and which we now know were filtered through a manufacturer that turned out to be fraudulent”.
“It must be emphasised that this case was one of deliberate fraud by the PiP manufacturer which purposefully misled European regulators. Regulation alone cannot prevent fraudulent activity such as this,” said Lord Howe. “But serious lessons must be learned from this scandal. The MHRA needs to look at how it gathers evidence so it is able to identify problems early. It needs to better analyse reports about higher risk medical devices. And it needs to improve the way it communicates with the public.”
I’m glad to say that Mrs Thom has not been caught up in the scandal but, through my friends at Thompsons Solicitors, I know of many women who have been affected by it.
If you are worried that you are one of them, you should:
- Find out if you have a PiP implant
- Speak to your specialist or GP, if you had the implants on the NHS, or to your clinic if your original operation was carried out privately
- Get advice on whether further assessment is necessary, and discuss appropriate action with your doctor
- Consider speaking to a solicitor, as you might be entitled to compensation.