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The FDA's weak policy for medical device approval


You may be like many in South Carolina and across the country who rely on the approval of the U.S. Food and Drug Administration before agreeing to take any medication, even aspirin or vitamins. The FDA does extensive testing on most drugs and runs a variety of trials before designating them safe for humans and effective for treating the condition drug manufacturers design them to treat.

What you may not know is that the same rigorous testing pills and medicines undergo does not always apply to medical devices. In fact, the catastrophic failure of numerous medical devices in recent history is causing the FDA to rethink its policies for approving some medical devices.

Approved does not always mean safe

Two of the most prominent medical device failures are the transvaginal mesh and metal hip implants. Despite FDA approval, these devices left many patients suffering with pain, infection, internal damage and subsequent surgeries. Many were never the same after the devices failed. Perhaps you are among those who received a device that left you struggling for months or years instead of repairing a medical problem.

The differences between FDA approval for devices and the process used for medications are stark. Devices generally do not go through a human testing phase, and many are not even tested on animals. Here are some facts about FDA approval of medical devices that you may find interesting:

  • The manufacturer of a device need only submit information demonstrating the design of the device is similar to other devices that are FDA approved.
  • Those previously approved FDA devices also did not go through any human or animal testing.
  • Some of those other devices to which a manufacture can refer may be decades old, and the FDA has pulled some from the market because of defects.
  • A new device based on a previously approved device may use the same defective construction.
  • Medical devices do not always perform the same way when undergoing laboratory tests as they do inside your body.

While you may be aware that any procedure, medication or device comes with risks, you may not have enough information to make an informed choice, especially if a device manufacturer does not fully disclose those risks. If you have suffered injury because of a faulty medical device, you have the right to seek answers and to learn about your options.

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