Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs
The European Commission has admitted there are “weaknesses” in the regulatory system that could allow sub-standard and potentially dangerous medical devices to be legally used on patients.
10:14PM BST 24 Oct 2012
The commission, which is responsible for overseeing the regulation of artificial hips and other devices across the single market, said that it was “unacceptable” that patient safety may be in jeopardy.
However, it said it would “be some time” before new rules to protect patients and improve regulatory standards are introduced. The Government has pledged to implement its own, new, safeguards in the interim.
The Telegraph understands that the commission has been repeatedly warned that the system of regulation is open to abuse.
The commission has asked all countries to review the status of notified bodies, the regulatory organisations that issue the coveted CE-marked licenses which allow devices to be sold throughout the single market. There are more than 70 notified bodies competing for business.
A joint investigation by this newspaper and the British Medical Journal this week exposed a series of questionable practices. A spokesman for the commission said: “The commission recognises that there are some weaknesses in the current regulatory framework and of course anything which jeopardises patients’ health or safety is unacceptable.”
The commission has also acknowledged that the “Own Brand Labelling” system, where medical devices manufactured in Asia and India can be labelled as “made in Europe”, was “a grey area”.
In an investigation, The Telegraph established that regulators were recommending the system to foreign manufacturers to help with their “marketing”.
The commission said that, under new proposals, notified bodies would be subject to a joint inspection by experts from several European countries and the European Commission. There would also be additional oversight for the assessment of high-risk devices, including hip implants.
However, the commission admitted it would be some time “before they are agreed and enter into force”. In the meantime, they insisted they were working with the approval bodies to “improve the application of the current rules”.
The commission wrote to all the national authorities this year, asking them to make sure the notified bodies were operating to a suitable standard.
However, it is understood the national authorities in the Czech Republic and Slovakia did not respond and they will be required to address this point at a meeting next week. A full review of notified bodies will establish whether they have “the appropriate capacity and skills to properly assess the products which they are authorised to assess”.
The commission’s regulation system has suffered a series of scandals, including the PIP breast implant issue, when it emerged that the implants were being made out of non-medical grade silicon. About 47,000 women in the UK were given the implants, which had a high risk of rupturing in the body.
The Telegraph approached several notified bodies in Europe, posing as a fictitious Chinese company attempting to get approval for a potentially dangerous hip implant.
The implant was based on a product made by DePuy, which was withdrawn after causing health problems. None of the notified bodies raised safety concerns about the proposed hip even though medical experts said a simple internet search would identify it as unsafe.
Case study: I struggle to care for my baby
Sara Starkey, 33, suffered for months after receiving DePuy hip implants in 2007.
Miss Starkey, from York, pictured above, who suffered hip problems as a child, was left in constant pain after having both hips replaced.
After the initial operation, surgeons insisted there was nothing wrong with the implant and her X-rays were clear. But her partner says she would wake up screaming because of the pain.
After repeated visits to the doctor, tests were run at the end of 2009 that established that she had high levels of metal ions in her blood. Her metal-on-metal implant was causing friction and releasing ions.
The chromium levels in her blood were “off the scale,” according to Miss Starkey, leaving her struggling to hold her baby, Isobel.
The implants had to be replaced with porcelain devices. Miss Starkey said: “It makes it difficult carrying Isobel around. I don’t know when she gets older how much I’ll be able to play with her.” Miss Starkey loved to cycle and walk with her fiancée, but has said she is now fearful for her future. “The pain sometimes stops me in my tracks,” she said.
Miss Starkey was worried because it is impossible to carry out numerous hip revisions. Hips tend to last 10 to 15 years. “What will happen to me after that? I’m young enough to worry. Will I have to live the rest of my life in a wheelchair?”
- Dodgy medical implants getting approved – EasyBlog (earlsview.com)
- Faulty medical implants investigation: ‘We can help you label it European so China is not on packaging’ – Telegraph (earlsview.com)
- Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs (telegraph.co.uk)
- Faulty medical implants investigation: Patients failed by poor implant regulation, say surgeons (telegraph.co.uk)
- Faulty medical implants investigation: Patients’ health put at risk by unscrupulous EU regulators (telegraph.co.uk)
- FINALLY – New rules to end secrecy over safety of medical implants – Telegraph (earlsview.com)
- Analysis: When implanted medical devices go wrong, who pays? | Reuters (earlsview.com)
- Shake-up of EU medical device regulations shocks industry (earlsview.com)
- Video: Faulty hip implants have ruined lives says Orthopaedic Professor – Telegraph (earlsview.com)
- BMJ and Daily Telegraph’s fake hip exposes failing European device regulation: EU Places Personal Profit over Safety (engineeringevil.com)