A world leader in medical technology, the American firm Medtronic, may be linked to as many as 9,300 deaths and 292,000 injuries in the US alone, according to an analysis published Sunday by an international journalists' group.
Reports submitted to US regulators last year indicate that one in five medical implants using Medtronic products proved problematic, twice the rate of any competing firm, according to a wide-reaching analysis by the International Consortium of Investigative Journalists (ICIJ).
The ICIJ inquiry, titled "Implant Files" and drawing on contributions from reporters in 36 countries, found that authorities in Japan, Norway and Australia had also identified Medtronic products as the source of the largest numbers of complaints over the past five years.
Among the findings: Since 2008, insulin pumps or their component parts produced by Medtronic for diabetics have been potentially implicated in more than 2,600 deaths and 150,000 injuries in the US.
ICIJ reporters interviewed patients or family members of victims in Finland, Germany, Canada, India and the United States who said Medtronic was slow to provide answers about problems with insulin pumps -- and did not always inform them about their risks.
The US Food and Drug Administration (FDA), which oversees such products, said that it should not be surprising that the leading producer of medical instruments would also be the subject of the largest number of complaints since it makes the most devices, the ICIJ noted.
But in a lengthy article on its internet site, the consortium lists numerous cases in which Medtronic has been accused of legal or ethical breaches, either over debatable uses for its implants, or for questionable relationships with doctors who use the products or who are behind favorable studies about them.
In a written response to the ICIJ, a Medtronic spokesman, Rob Clark, insisted that patients' welfare was the company's top priority and that Medtronic respected "the highest standards of ethical practice."
"Allegations are not facts and should not be interpreted to suggest that Medtronic violated our legal, ethical or regulatory obligations in any way," Clark said, while adding that any medical product carries a degree of risk.
Medtronic makes devices to help control diabetes, manage chronic pain and alleviate Parkinson's disease, and has invented a wireless pacemaker the size of a vitamin pill.
The ICIJ credited the $400 medical device industry with developing lifesaving products, while saying it had also "pushed against or broken legal and ethical boundaries."
The Washington-based ICIJ brings together ad hoc collaborations of journalists from around the world to investigate issues of global interest. It won a Pulitzer Prize in 2017 for a series titled the "Panama Papers," an expose on offshore tax havens.