Lax Oversight Blamed for Medical-Device Injuries in Global Study

(Bloomberg) — Global health authorities have failed to protect patients from inadequately tested medical implants over the past decade, according to a global study by a consortium of journalists.

Medical devices have been linked to more than 1.7 million injuries and nearly 83,000 deaths in reports to U.S. regulators from manufacturers, doctors and others since 2008, the review from the International Consortium of Investigative Journalists said.

Medtronic Plc figured prominently in the study, which found that one in five adverse event reports filed last year with U.S regulators was linked to a device from the company. About 9,300 deaths since 2008 are potentially linked to products made by the company or its subsidiaries, the report found. The company denied any wrongdoing in the report.

Key Insights

Globally, the ICIJ report found that some medical devices are approved too quickly by regulators sometimes with no human testing, and flawed products aren’t yanked from hospitals fast enough. Devices pulled from the market in some countries remain for sale in others. Reports filed with authorities in Japan, Norway and Australia placed Medtronic among the manufacturers with the most adverse event reports during the last five years.Manufacturers have paid at least $1.6 billion since 2008 to settle charges of corruption, fraud and other violations with regulators in the U.S. and other countries, according to the report.Some of the industry’s biggest controversies involve women’s products, such as contraceptive coils, vaginal mesh and breast implants.

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Since 2015, Johnson & Johnson has agreed or been ordered to pay $4.3 billion to U.S. patients who claim they were injured by defective hips, mesh and surgical staplers, the data found.Olympus Corp. told its U.S. unit in 2013 that there was no need to actively warn health-care providers on the use of its duodenoscopes that are the subject of lawsuits over superbug infections, Kyodo, a partner of the ICIJ review, reported.Sales of medical devices have more than doubled to about $400 billion in 2018 from $118 billion in 2000, according to the ICIJ.

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Market Reaction

Olympus fell as much as 4.6 percent in Tokyo on Monday.The iShares U.S. Medical Devices exchange-traded fund has returned more than 120 percent over the past five years, outpacing a nearly 46 percent gain for the benchmark S&P 500. Medtronic shares have about tripled over the past decade.

To contact the reporter on this story: Jeff Sutherland in Tokyo at

To contact the editor responsible for this story: K. Oanh Ha at

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