Dodgy medical implants getting approved
British patients could be at risk from potentially fatal medical implants following news that European regulators are licensing substandard materials for sale in the UK.
An investigation carried out by the Daily Telegraph and British Medical Journal has revealed that regulatory bodies, which have the power to pass and fail various treatments, were prepared to give the go ahead for “toxic” hip replacements.
The investigation surrounded one particular company, EVPU, which assesses products on behalf of the Slovakian government. Products are put forward to this firm from medical companies across the globe, if accepted the items can be used throughout Europe.
In this instance, the undercover reporters approached EVPU posing as a Chinese company that hoped to get a hip implant approved for use in Europe. The implant was actually based on a design which had years before been outlawed throughout the world due to the risk of blood poisoning.
The journalists simply submitted a literature review based on simple products on the market and after some advice on how to speed up the process from EVPU the product was accepted.
The Slovakian company was recorded as saying: “We are on the side of the manufacturer and their products, not on the side of patients.”
Similar to PIP situation
Regulatory firms are strictly prohibited from acting as consultants to companies on how to gain approval and therefore EVPU had broken more than one cardinal rule in this investigation.
More than 70 private regulators currently compete for business across Europe, which opens the system up for corruption and greed. An example of how deadly this kind of practice can be is the PIP breast implant scandle earlier this year.
Dozens of private companies have been accused of putting profit ahead of safety as they compete with each other to offer licences for devices that may not actually fit specific medical safety criteria.
- Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs (telegraph.co.uk)
- Report: Sub-standard hip and knee replacements being licensed for use on NHS (itv.com)
- FINALLY – New rules to end secrecy over safety of medical implants – Telegraph (earlsview.com)
- Hip implant probe sparks call for better NZ system (radionz.co.nz)
- Analysis: When implanted medical devices go wrong, who pays? | Reuters (earlsview.com)
- Video: Faulty hip implants have ruined lives says Orthopaedic Professor – Telegraph (earlsview.com)
- Silk-Based Electronics Dissolve on Cue for Vanishing Medical Implants (blogs.scientificamerican.com)
- Medical Implant Solutions, LLC announces addition of key personnel (prweb.com)