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Buried reports hide details of medical device failures

Analysis by Dr. Joseph Mercola Fact Checked

hidden harms from medical industry

Story at-a-glance -

  • Investigative journalism from Kaiser Health News discovered buried reports in the FDA detailing medical device malfunctions and patient injuries. While the reports could have guided device purchases and medical care, they were not known to most to physicians
  • The Manufacturer and User Facility Device Experience Database (MAUDE) is a public database forensic investigators, researchers and those responsible for medical device purchases use to make decisions and evaluate treatment options. For instance, spinal stimulators for pain relief had few public reports, but 1.7 million injuries and 83,000 deaths are recorded in in the alternative reporting summaries
  • Exemptions for reporting were made for manufacturers without public notification and records reveal more than 480,000 injuries or malfunctions were reported in just one year for over 100 medical devices, including those used during surgery or implanted in patients
  • The reported injuries have devastated countless families and patients, like Jim Taft, now bedridden after a spinal cord stimulator malfunctioned; April Strange who died in surgery after a stapler malfunction, leaving her husband and two small children; and Mark Levering who nearly lost his life as the result of a stapler malfunction
  • While there are times you need to seek medical attention, I believe the best course of action is to maintain optimal health using strategies such as getting quality sleep, maintaining a healthy gut microbiome, eating a nutritionally balanced diet and getting plenty of exercise and movement each day

According to the Medicare Payment Advisory Commission, the medical device industry has developed and sold an enormous number of products they feel play a crucial role improving the ability to diagnose and treat illness. However, there are a relatively small number of large diversified companies supplying these devices specific for therapeutic use.

In a report to Congress, the Medicare Payment Advisory Commission stated: “The industry is distinctive both for its tendencies to make frequent, incremental changes to its products and its extensive ties with physicians.”


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