A global investigation into medical devices and database from the International Consortium of Investigative Journalists (ICIJ), named the Implant Files, has exposed flaws in FDA.
The ICIJ conducted the investigation following a 2014 incident, wherein a Dutch journalist fooled European medical device regulators using a bag of mandarin oranges. The journalist submitted the grocery store netting to three regulatory bodies, saying it was a vaginal mesh, and the product got approved by all.
As a result of that experience, the ICIJ investigators decided to scrutinize how the medical devices get approved and recalled in over 35 countries. It focused on the consequences the patients have to bear due to a lack of reporting and transparency.
The year-long investigation by ICIJ found that health authorities around the world have failed badly at protecting patients from improperly tested implants, capable of puncturing organs, can give errant heart shocks, poison blood, rot bones, and can lead to numerous other health hazards.
According to a ten-year long data obtained from the FDA, in the United States over 80,000 deaths and more than 1.6 million injuries are possibly associated with medical devices. The FDA gathered the information from patients, doctors and medical device companies.
Healthcare providers are considered as the care takers of medical device industry, and the majority of devices approved by them, varying from breast implants to pacemakers, are doing justice to their role. But the investigation has shown that it is important for healthcare providers to vet selected devices, keeping in mind the safety of patients and their own investment.
Though the FDA has stern guidelines in comparison to those in other countries, medical devices aren’t required to undergo clinical trials. A majority of medical devices are fast-tracked to market as a part of the process wherein the companies only have to prove that they are ‘substantially equivalent’ to a product already making rounds in the market, no matter how old it is or what history of issues it has.
The federal agency is taking the required efforts to fix such discrepancies. It has banned just two devices in over last forty years. About two decades back, the federal agency used to take over 250 days as the average time for medical devices approval, but it has significantly decreased to less than 100 today, finds the Implant Files.
To track problems, the FDA relies on reports from healthcare providers and device makers, who are required to provide reports mentioning device-related worst events which caused health problems. But the self-reporting is more likely to result into faulty and lack of data. The agency is expected to take some powerful steps to curb the menace.