A lax study suspected of injuries related to medical devices

(Bloomberg) – Over the past decade, global health authorities have failed to protect patients from insufficiently tested medical implants, according to a global study by a consortium of journalists.

Medical devices have been associated with more than 1.7 million injuries and nearly 83,000 deaths in reports of manufacturers, doctors and others to US regulators since 2008, the Consortium Review reported investigative journalists.

Medtronic Plc featured prominently in the study, which revealed that a report of five adverse events reported to US regulators last year was linked to a device of the company. About 9,300 deaths since 2008 are potentially related to products manufactured by the company or its subsidiaries, according to the report. The company denied any fault in the report.

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Globally, the ICIJ report revealed that some medical devices are approved too quickly by regulators, sometimes without any human testing, and that defective products are not removed from hospitals quickly enough. Devices removed from the market in some countries remain for sale in others. Reports filed with the Japanese, Norwegian and Australian authorities have ranked Medtronic among the manufacturers with the highest number of adverse event reports in the past five years. Since 2008, manufacturers have paid at least $ 1.6 billion to settle charges of bribery, fraud and other violations. According to the report, the United States and other countries. Some of the biggest controversies in the industry concern women's products, such as contraceptive streamers, vaginal trellises and breast implants.

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Since 2015, Johnson & Johnson has accepted or been ordered to pay $ 4.3 billion to US patients who say they have been injured by defective hips, trellis and surgical staplers, according to the data. Olympus Corp. told his US unit in 2013 that it was not necessary Kyodo, partner of ICIJ magazine, reported that sales of medical equipment more than doubled to about 400 billion dollars in 2018, rising from 118 US dollars in 2018 to warning health care providers about the use of its duodenoscopes being prosecuted. billion in 2000, according to ICIJ.

Market reaction

Olympus lost up to 4.6% in Tokyo on Monday. IShares US Medical Devices has traded more than 120% over the last five years, surpassing the S & P 500 by almost 46%. Medtronic shares have almost tripled. during the last decade.

To contact the reporter about this story: Jeff Sutherland in Tokyo at [email protected]

To contact the publisher in charge of this story: K. Oanh Ha at [email protected]

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