"With devices, that rigour is not there".
Led by the International Consortium of Investigative Journalists, the group found that more than 1.7 million injuries and almost 83,000 deaths suspected of being linked to medical devices had been reported to the U.S. Food and Drug Administration over a 10-year period.
"It is vital that reported complications from medical devices are taken seriously and investigated thoroughly and in a timely manner so that the public can be protected from risky medical devices", she said.
"It has been found that from coronary stents and pacemakers to breast and knee implants, from pelvic meshes to intrauterine devices - nearly every medical device is advertised, sold, surgically implanted in a regulatory system that, effectively, doesn't exist".
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Vuela en ala delta sin sujetarse y se salva de milagro
Ya en ese momento, y sabiendo lo que ocurre, se puede ver de un simple vistazo que el pasajero no lleva el arnés atado al aparato. Tuvo que ser operado para colocarle una placa de titanio , además de que su bíceps izquierdo también terminó desgarrado.
Something similar came to light earlier this year in India, when Johnson and Johnson, a medical device manufacturer, was accused on implanting 1000s of patients with poorly designed hip implants that led to metal poisoning, loss of hearing, pain for some, death for others.
Data provided to the Guardian reveals a collapse in the proportion of complaints reported by doctors or member of the public through the MHRA's yellow card scheme that it assigns a specialist to investigate. The ICIJ Report has revealed startling details on faulty medical devices; the global investigation exposes a complete lax regulation on the part of the shareholders. It is, however, only 141 of these cases had been reported.
A "yellow card" system put in place by the MHRA to report and investigate issues with implants "doesn't work and is ineffective", Lady Cumberlege added.
She said patients "can't rely on" the system now in place to protect them from being harmed by surgical implants.
Baroness Julia Cumberlege said regulations on the devices - including pacemakers, hip replacements and breast implants - are not good enough. "We must have surgeons who are trained to do this operation so it's not just everybody having a go", she said. Users can use the "search" feature of the database to enter the name of the device and check recalls, safety alerts and field safety notices initiated across countries.The database also allows a patient with a device who lives in a country where no data is available to see whether the device is listed as high risk elsewhere.
'This requires government funding and support, and potentially national guidelines on the introduction of new procedures and technologies'. Professor Derek Alderson, president of the Royal College of Surgeons, said the findings "underline the need for drastic regulatory changes".