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How safe is your implanted medical device?

Your doctor may have described your surgery as routine, despite the serious nature of it. Many surgical procedures to implant devices in patients happen so commonly that to those surgeons performing them, they may seem routine. In fact, surgeons implant over 60,000 of one type of device, the spinal-cord stimulator, each year.

If you have recently had a hip replacement, defibrillator, surgical mesh or other device implanted, chances are you heard that your life would improve because of this new technology. However, you may be among the tens of thousands who suffer injuries because of defective medical devices.

Commonly defective devices

Researchers have compiled data that reveals that almost 2 million patients suffered injuries from defective medical devices, and almost 83,000 died in the past 10 years. Although there are 4,000 FDA-approved devices on the market, 25 percent of the injuries resulted from only six devices:

  • Surgical mesh
  • Hip replacement
  • Spinal stimulator
  • Defibrillator
  • Implantable insulin pump
  • Insulin pump with implantable glucose sensor

If your surgery involved the implantation of any of these devices, you have a much higher risk of injury. Many medical devices go through a rapid approval process that includes zero testing on humans or animals before they end up in a surgeon's hands.

Where does the FDA stand?

You may be like many in California and around the world who look to the U.S. Food and Drug Administration for authoritative information about the safety and effectiveness of medication and medical devices. However, it may shock you to learn how little it takes to gain FDA approval for a new device. Some reports claim the medical device manufacturers may be more interested in making money than in helping people like you who are suffering, and these actions by manufacturers may suggest that is true:

  • Spending almost $600 million on trips, consulting fees, entertainment and other expenses to persuade physicians to promote their product
  • Paying for positive studies to convince the FDA of the safety and efficacy of a device
  • Facing repeated fines for paying kickbacks to doctors who use their products in patients
  • Spending over $22 million in the past few years to sway legislation to reduce regulations and restrictions on their products
  • Promoting their products for unapproved uses, such as marketing a hormone replacement or ADD medication for weight loss

If you suffered injury, infection or other negative effects after implantation of a medical device, chances are others have as well. This means the manufacturer may be aware of the dangerous risks. You have the right to answers, and finding those answers begins with a complete evaluation of your case.

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