New figures show 8,000 referrals as scandal continues to prompt reform of medical device regulatory process
A year after the PiP scare, the NHS has dealt with almost 8,000 referrals from women concerned the faulty implants could pose a threat to their health.
New figures have been published by the Department of Health which show a total of 7,917 referrals from women who had their implants put in privately. Of those 5,255 scans were ordered and 633 women decided to have their implants removed on the NHS.
New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our healthcare system, disseminated appropriately and monitored in the long-term
The NHS stepped in when it became apparent some private clinics would not support patients or had gone into liquidation so women had no way of getting help.
The move followed the revelation that the PiP implants contained non medical-grade silicon and had a significantly higher rupture rate than other brands, although experts have denied they pose a threat to women’s health. It was later discovered that the manufacturer, Poly Implant Prothese, changed the type of silicon used in the implants from that originally given CE Mark approval.
The finding led to widespread calls for an overhaul of the regulatory process for approving medical products in the UK and Europe, with fresh legislation due to be published shortly.
The proposed changes affect both the current directive on active implantable medical devices and the directive on medical devices, which cover a huge spectrum of products.
At present devices are subjected to a conformity assessment, which for medium and high-risk items involves an independent third party, known as a Notified Body. In the wake of the PiP scandal, the spotlight fell on these organisations, with criticism that they were operating to different standards across Europe and that their decisions and actions were not being properly scrutinised.
The issue brought into sharp focus the need for better regulation and surveillance for all surgical implants
The EU revamp proposal states: “In an internal market with 32 participating countries and subject to constant technological and scientific progress, substantial divergences in the interpretation and application of the rules have emerged, thus undermining the main objectives of the directives, i.e. the safety of medical devices and their free movement within the internal market. Moreover, regulatory gaps or uncertainties exist with regard to certain products (e.g. products manufactured utilising non-viable human tissues or cells; implantable or other invasive products for cosmetic purposes.
“This revision aims to overcome these flaws and gaps and to further strengthen patient safety. A robust, transparent and sustainable regulatory framework should be put in place that is ‘fit for purpose’. This framework should be supportive of innovation and the competitiveness of the medical device industry and should allow rapid and cost-efficient market access for innovative medical devices to the benefit of patients and healthcare professionals.”
Commenting on the impact the PiP scare has had, Professor Norman Williams, president of The Royal College of Surgeons, added: “The issue brought into sharp focus the need for better regulation and surveillance for all surgical implants. It is time to look to the future to ensure no patient experiences unnecessary harm or distress from substandard surgical implants.
“It is the view of the college that we should, as a minimum, have mandatory databases for all surgical implants and associated techniques that would provide ongoing patient safety data. New surgical devices, and the techniques required to implant them, must be regulated so that they can be safely introduced into our healthcare system, disseminated appropriately and monitored in the long-term.”
The college is now drawing up a set of professional standards for cosmetic surgery and will contribute to the Government’s review of the regulation of the cosmetic surgery industry when it begins.
It has been a worrying year for women affected by the PiP scare. It has been our number one priority since this issue came to light 12 months ago to make sure women have been kept well informed and received the appropriate clinical advice and care
Commenting a year after the initial scare, Health Minister, Lord Howe, said this week: “It has been a worrying year for women affected by the PiP scare. It has been our number one priority since this issue came to light 12 months ago to make sure women have been kept well informed and received the appropriate clinical advice and care.
“I hope it is a small comfort to women and their families to learn that the experts examined all the available evidence and concluded that the silicone contained in PiP breast implants does not pose a risk to human health.
“We want to do everything we can to prevent anything like this happening again. We can’t stop someone in another country committing a crime – as happened in this case – but we can make sure that people are properly supported and that they get all the information they need before deciding to have cosmetic surgery.”