14 March 2014

Advanced Bionics Knowingly Implanted Defective Devices in Children, Wearers Electrocuted

Story and video courtesy NBC News: "A manufacturer of 'amazing medical' devices known as cochlear implants, which restore hearing to the deaf, sold defective implants to young children and adults for years — even after learning that a significant number of the devices had failed, according to documents obtained by NBC News...
  • January 2003 - Advanced Bionics engineer warns that a key component of the implant 'may be vulnerable for a potential leak.'
  • March 2004 – Advanced Bionics executive admits the company hadn’t conducted a key test “that mimics the human body."
  • August 2004 - FDA inspection finds 237 explanted devices with high levels of moisture.
  • September 2004 – Advanced Bionics HiRes 90k is recalled due to “unexplained moisture” causing some implant failures.
  • November 2004 – Advanced Bionics HiRes 90k is returned to the market.
  • February 2005 - FDA sends warning letter to Advanced Bionics.
  • February 2005 – Advanced Bionics company president states 'product failures continue to occur at an alarming rate.' He says the company is 'in significant danger of losing all of our key accounts in NYC i.e. NYU and Beth Israel because of failed devices.'
  • Summer 2005 – Advanced Bionics continues to receive reports of failed implants due to excessive moisture.
Despite all those warning signs, children received implants throughout 2005 and into 2006.
Another issue: Advanced Bionics didn’t tell anyone that it was selling the device with a different version of that key component than when it was originally approved by the FDA, a direct violation of government regulations." Read the full story at NBC News, and stay tuned on Redeafined for upcoming commentary.

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