Concerns have been raised about a number of faulty medical implants potentially harming patients, a media investigation has found.
An investigation from 58 media organisations including BBC Panorama, International Consortium of Investigative Journalists, The Guardian and the British Medical Journal has led to calls in changes of the rules regarding implants.
The investigation was prompted by a Dutch investigative journalist and broadcaster, Jet Schouten, who led a sting operation by convincing notified bodies that mesh netting from a bag of mandarin oranges was in fact surgical mesh. Schouten said that the results made her want an investigation into device approval around the world.
Some of the key findings of the investigation include governments allowing products on the market with little or no human testing that went on to cause great harm; devices that have been pulled off the market over safety concerns in some countries, but which remain on sale in others. Other findings include the device industry and regulators’ struggle to quickly identify hazardous implants after they are released; while manufacturers, doctors and others potentially linked more than 1.7 million injuries and nearly 83,000 deaths to medical devices in reports to U.S. regulators over the last decade; and some of the highest profile controversies involve products marketed to women including: contraceptive coils, vaginal mesh, and breast implants.
“The Implant Files” have revealed that one company alone, Johnson & Johnson, has paid out $4.3 billion to people in the U.S. who claim they were injured by defective hips, mesh and surgical staplers.
The Guardian’s report on hip-on-hip replacements revealed that faulty implants caused tissue damage for patients as a result of two different procedures. One was a total hip replacement, where a metal ball and stem were attached to the thigh bone, and a metal cup attached to the pelvis. Another was a hip resurfacing system – where the ball of a patient’s hip joint was retained, but a metal cap was put over it surface which then sat on another metal cap on the pelvis.
As a result of the revelations, the Royal College of Surgeons has called for changes to regulation.
Its president Derek Alderson said: “All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long term.”
The BBC reports that the UK’s regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) said the regulatory system had been in place for 25 years.
It said: "The need to protect public health, whilst not stifling innovation, must be carefully balanced. The MHRA welcomes innovative medical devices that can bring huge health benefits to people as long as this doesn't compromise patient safety.
A spokesperson from the Department of Health and Social Care said: "We will work with the regulator to see what future changes may be required.”
