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International Journalists Investigate Device-Related Health Records and Injury Reports

With rising concerns about unsafe medical devices, international journalists led an investigation known as “The Implant Files” to examine testing, approval, marketing and monitoring. The review involved more than 1.7 million injuries and nearly 83,000 deaths with possible connections to medical devices during 10 years. Findings were reported in only the United States.

Editors and reporters from the International Consortium of Investigative Journalists (ICIJ) planned the initiative for a year and spent an additional one completing the coverage. ICIJ partnered with more than 250 journalists in 36 countries. Scrutiny of more than 8 million device-related health records included death and injury reports and recalls.

Here are some of the ICIJ findings:

  • For years, the Food and Drug Administration (FDA) allowed breast implant companies to bury evidence of harm by reporting in a way that did not require public disclosure.
  • In 2017, medical device companies made payments to doctors and teaching hospitals for research, travel, royalties, consulting fees and more.
  • In the U.S., the average time for a new device to be approved through the FDA’s premarket approval process has dropped by more than 200 days since 1996.

  • Medical Device Companies Spending Millions to Direct Rules and Legislation

    A recent examination of the 10 largest publicly traded U.S. medical device companies found that, since the beginning of the Trump administration, medical device companies have spent more than $36.5 million in attempts to direct rules and legislation. Some of these companies manufacture a variety of medical products including pharmaceuticals and lab equipment. Four of the 10 exclusively manufacture devices, and lobbying disclosures for all of the companies reveal attempts to shape device policies.

    As “Big Pharma,” pharmaceutical companies and medical device makers spend more than any other industry to sway politicians. Nearly $2.5 billion of their funds have been used to lobby and finance members of Congress during the past decade.

    Lobbyists and politicians in Washington, D.C., receive hundreds of millions of dollars annually in efforts to influence their decisions about drug company laws and policies. The Center for Responsive Politics reported that the pharmaceutical industry, with approximately two lobbyists for every member of Congress, spent $152 million on shaping legislation in 2016. Here are other key points:

  • Drug companies contributed more than $20 million to political campaigns last year.
  • Approximately 60% went to Republicans. Paul Ryan, the former speaker of the House of Representatives was the largest recipient, with industry funds totaling $228,670.
  • During the past decade, manufacturers have also paid at least $1.6 billion to resolve charges of worldwide regulatory violations, including corruption and fraud.

  • Through significant funding, medical device manufacturers have developed influential power over corporations, politicians and the FDA. Big Pharma has waged a decades-long effort to decrease U.S. regulation of the pharmaceutical and medical device industry. The goal is to increase worldwide profit making and decrease international observation.

    A new FDA rule endorses limited reporting in nearly 9 out of 10 device categories. As a result, manufacturers may submit quarterly summarized reports for similar incidents rather than individual reports for every device malfunction. The outcome: a reduction in detailed documentation for individual cases raising flags about public safety.

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