A couple of investigative journalists wanted to test the approval process for medical devices. They presented the net used to pack fruits to the notified bodies as a vaginal mesh. To journalists’ horror, they approved it. Which means, the medical implants that could go into your body could be as crude as a fruit mesh. Over 250 reporters in 36 countries, headed by the International Consortium of Investigative Journalism (ICIJ), conducted a global investigation into the matter and were shocked by the results.
The study titled Implant Files showed that 1.7 million injuries and 83,000 deaths in the world could be caused by substandard medical implants, which form a $400 billion industry. Faulty Hip Implant Victims Demand Direct Involvement in Process of Ascertaining Compensation.
According to the investigation, medical implants such as pacemakers, rods, artificial knees, lenses and hips were tested only on pigs and dead bodies. Some of them had even failed in baboons.
These poorly-testing implants can cause extensive damage to human health. It can puncture organs, release toxins into the blood, weaken and damage the bones and deliver shocks to the heart.
“It’s not like drugs. You don’t have clinical trials for every medical device. A lot of these products are inserted into people without any testing,” says Madris Tomes, former FDA officer.
The regulations in Europe are so lenient that medical companies that sell these implants keep sending their products to safety organisations, until one them approves.
The investigation says that doctors may not be fully aware of the risks of the treatment involving this medical equipment.
The study gathers evidence from many patients around the world who are suffering from the ill effects of poorly-tested medical implants. A 51-year-old South African woman endured unbearable stomach pain for years after being fitted with a mesh implant.
A 44-year-old Mumbai man suffers from vision problems, walking difficulties and irregular heartbeats, which he believes is caused by his Johnson & Johnson artificial hip. Government to Soon Bring Indian Standardisation for Medical Devices: Senior Official.
The issue is worsened by the fact that such medical products are difficult to recall, even if the manufacture and regulators learn of the problem. That’s because hospitals and the device industry find it tough to locate all the people who are living with these faulty implants. Some manufacturers aren’t reporting the problem in the first place. Many patients don’t realise when their implants fail, because most of them aren’t told of the track record of the devices they are living with.
Implant Files was initiated with an aim to do what the medical authorities are not doing. The journalists who worked on the study are asked to submit freedom of information requests around the world to bring about more transparency in the medical field.