(commercialappeal.com)–An international journalism investigation of the medical device industry describes dangerous devices, kickbacks to doctors and weak regulations – and shines a spotlight on a medical company with a big presence in Memphis.
That company is Medtronic, which has its main operations in Minneapolis and annual sales of about $30 billion.
One of its units, Medtronic Spine, is based in Memphis and employs some 1,500 people here.
Medtronic Spine sells a product called Infuse that promotes bone growth. The government has approved Infuse for a limited number of uses, including in lower back spine fusion surgeries.
But former employees and a Senate investigation said Medtronic pushed doctors to apply Infuse for “off-label” methods not approved by the U.S. Food and Drug Administration, including surgery in the neck bones. Deaths and injuries have been associated with the neck surgeries.
Details of the long-running Infuse affair and other Medtronic controversies are included in the “The Implant Files,” a series of news stories published by the Washington-based International Consortium of Investigative Journalists, or ICIJ, and its partners around the world.
“It is important to note that the ICIJ reporting on Infuse bone graft covers historical issues that have been thoroughly covered in the past,” Medtronic spokesman Victor Rocha said in an email.
Rocha also referred to Medtronic’s detailed responses to the ICIJ project, whichsays Medtronic sales staff aren’t allowed to push off-label uses.
Another section says: “At Medtronic, safety is our first and foremost priority and we reject any suggestion that Medtronic puts ‘innovation and profits’ over safety.”
The company also said the ICIJ reporting may cause “unnecessary alarm and confusion among patients and health care providers.”
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