Implant Files: A Global Investigation of the Medical Device Industry

Implant Files Investigation

In 2018, the medical device industry and the FDA came under fire from:

  • The powerful Netflix documentary, The Bleeding Edge, which chronicled the pain and suffering caused by complications of medical devices with little or no testing.
  • The Implant Files, a year-long investigation by the International Consortium of Investigative Journalists focused on the medical device industry and its overseers.

The Implant Files took a global view of the medical device industry and included a team of more than 250 reporters and data specialists from 58 news organizations in 36 countries along with the ICIJ journalists.

Medical Device Industry In It for Profit?

The medical device industry is huge. Sales have more than doubled from 2000 to 2018 – growing from around $118 billion to $400 billion. And, the biggest market for devices is the ever-growing Baby Boomers, adults aged 65+. This segment is expected to grow by more than 60% by the year 2030, reaching almost 1 billion people.

It’s no wonder the ICIJ’s investigation called into question whether the “device industry is unnecessarily putting patients at risk of serious harm” in lieu of the all-mighty dollar, profit.

The sheer size and power of the device industry means it has a strong lobby in Washington, D.C., backing it. “Over a 10-year period through 2017, the industry has spent more than $335 million to influence legislation, according to the Center for Responsive Politics. And, the device industry also “funds 35% of the FDA device program’s budget through user fees that are renegotiated every five years.

Global Investigation Into Medical Devices

This video gives a brief overview of the ICIJ work, asking the question, “Why are these implants hurting the patients in our country?” The industry seems to focus on getting products to market more quickly rather than patient health and safety.

Key Findings include

The process to review, approve and even recall medical devices is not consistent on a global basis.

  • There is no question that medical devices improve and save lives; however, governments have allowed products on the market with little or no human testing that have gone on to cause great harm.
  • Devices pulled off the market in some countries over safety concerns remain for sale in others.
  • Manufacturers, doctors, and others potentially linked more than 1.7 million injuries and nearly 83,000 deaths to medical devices in reports to US regulators over the last decade.
  • Governments in many countries, including Africa, Asia and South America, do not regulate medical devices, they trust in the oversight provided by the European authorities and the US Food & Drug Administration.

More Implant Files Findings

  • One company, “Johnson & Johnson, has had to pay $4.3 billion to people in the US who claim they were injured by defective hips, mesh and surgical staples”
  • Nearly 500,000 reports mentioned an explant (a surgery to remove a device) in connection with an adverse event.
  • In 2017, the FDA approved more than three times as many devices as it did in 2010 yet its warnings to device manufacturers about product safety fell by nearly 80%.

It is long, but you can read the complete article.

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Report Adverse Events to the FDA

This is an important step you can take. Whether the device is a metal-on-metal hip replacement or a permanent birth control device or something else, you need to report your experience to the FDA.

Manufacturers of devices are required to report adverse events to the FDA, but this does not always happen. Loopholes are found to get around the system.

Knowing when a specific medical device is having problems or causing adverse events helps your doctor to diagnose issues you may be having.

We want to let the big corporations know that it is not all about profit; it is about your health.

File an FDA MedWatch Report

Experienced Attorneys Handle Medical Device Litigation

Complications from medical devices often pose serious, life-threatening health risks. If you have suffered complications due to a device such as a metal-on-metal hip replacement, contact one of our attorneys for a free, no-obligation review of your situation.

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