Dangers medical implants have reportedly been used worldwide because of lax regulation. The main problems are the lack of transparency, and poor regulation, according to a wide-ranging investigation by an International Consortium.
Artificial joints, spine-correcting rods, pacemakers, and breast implants are among devices that have led many patients to suffer pain and in some cases die, according to the investigation.
More than a million people around the world have been injured by medical devices they assumed were safe.
However, life is unimaginable today without the hundreds of medical devices in our hospitals.
MedTech Europe, a body which represents the medical device industry, said: Millions of people have safely benefited from medical implants and can now have a healthier lifestyle, more productive and become more independent.
Most problems are systems-level issues, not unique to a single instance, for example where a whole batch has been found to defect by the manufactured. Grouping incidents allow us to see the bigger picture and discover the exact causes of issues and solve them.
The MHRA said reports received via its “yellow card” online reporting system did not necessarily mean there was a fault with a device, and that an adverse incident may be the result of a pre-existing medical condition, or the device may not have been used as intended.
How was, this allowed to happen?
Implants are sold worldwide to hospitals without any human clinical trials. However, testing innovative medical devices on animals in a laboratory doesn’t always mean the results can be replicated in human implantable devices; so human clinical trials are essential.
Surgeons are not always, aware of the risks posed by implants because of the lack of a central register. What’s needed is a global central register, showing the levels of scrutiny devices undergo before and after they go on the market. For instance, in Australia patients are given implants that the regulators have approved on the basis they have been adopted in Europe. We know there are substantial flaws in the way the Europen industry regulated itself.
There have now been enough indents involving, devices with flaws, to underline the need for drastic regulatory changes. This should include, more transparency, and the introduction of a new mandatory global register for all human implantable devices.
A global registration database would allow surgeons and clinical staff the opportunity to assess the device and its risks posed, via an implantable database before recommending it to a patient.
If devices are found to have developed faults, manufacturers should not be allowed to testing their product.
Even if you live outside the U.S., the Food and Drug Administration’s website can offer to be a valuable resource. If you live the U.S., the FDA relies on the voluntary reporting of problems by patients’ as well as mandatory reports by manufactures. To submit a report, go to the FDA’s website.
For a more detailed explanation here is how the World Health Organization defines a medical device.
The extent of the widespread suffering caused by faulty medical implants has had being investigated thoroughly — scientist around the world working together to reveal the pain caused to tens of thousands of people fitted with contraceptive devices, medical breast, and mesh implants, pacemakers, and other items.
Although lives have been devastated by what people thought was a routine implant procedure. Most medical implants are safe; millions of people around the world have a longer Life expectancy, and a better quietly of life due to innovative human implantable’s.
A patient who has suffered from has dementia, epileptic seizures, cardiac arrest, or end-stage renal failure; which are all potential killers. However, now, due to new sophisticated and innovative implantable that are life-saving, patient’s life expectancy has vastly improved.
For instance, many patients are now benefiting from leadless pacemakers and In-VIVO network with delivers power to implant without the need of batteries. So many more would benefit from innovation in medical technology in the future.
Now all implantable devices must be registered and tracked to monitor efficacy and patient safety over the long-term. New medical device regulation comes into force in Europe in 2020, but surgeons say the new rules do not go far enough.
A New regulatory legislation framework is needed, similar to drugs legislation, ware as all manufacturers of drugs must have tracking systems — any products on the market that are suspected or known to be seriously defective and pose a potential risk to patient health. This means a total recall of the devices. This is the responsibility of all government health agency regulator’s.
These legislations apply to all products manufactured and distributed from a site, including physician samples and commercial products used for market studies and clinical trials.
Our highest priority is making sure the medical devices available globally, work and are acceptably safe.
Acknowledgments & References
World Health Organization and the U.s Food and Drug Administration’s, International Medical Devices Database (IMDD) – Prof Derek Anderson, president of the Royal College of Surgeons.Prof Rita Redberg, one of the world’s leading cardiologists and from the University of California, San Francisco,