Medical Implants Untested, Often Unsafe

April 6, 2012

Result X-RayThere are many different varieties of medical implants being used daily: catheters to perform surgeries, devices that support the body (like mesh), devices that replace parts like joints, and of course elective devices like those used to shrink stomachs.

And there are few rules (which are rarely enforced) about testing any of these products for safety before implanting them into thousands of patients.

As a result, thousands of people have severe complications with devices that are marketed to doctors as easier to perform, less expensive, or safer for patients. According to a new study done by Consumer Reports, these practices are leaving patients in trouble.

How? Devices can be grandfathered into service by even the loosest comparison to any other device used in medical history, even if it was decades ago, for a different part of the body, or made quite differently. Those that aren’t grandfathered in are only required a minimal (and, apparently, insufficient) amount of testing.

The problem isn’t necessarily that there’s no testing, however. It’s that it’s too easy to get the FDA to stamp their approval, and then market to doctors saying whatever you want. In at least one case—the use of wire mesh to support prolapsed uteruses—they were able to market to doctors that the product replaced a more complicated surgery that required more training on the doctor’s part. The wire mesh is at the top of the list of products Consumer Reports and Women’s Advocacy groups are advocating the FDA to recall.

Although the FDA is reviewing the product, the bureaucratic process to change it will take years.

Minimally, it’s necessary to keep patients informed. Most aren’t told they are guinea pigs for a new device, and thus not as quickly inclined to report problems with it like pain, swelling, or th product not working right.

Further, although many devices have serial numbers, it’s not practice to give those to patients. That means that if the device is recalled, it’s squarely on the doctor to inform the patient, a middle man who may have retired, died, or lost records.

If you have any sort of medical implant, or find yourself one day needing one, without change from the FDA you need to advocate for yourself:

  • Get records from your doctor about make, manufacturer, and serial number. Write on your calendar to follow up at least yearly about the device.
  • Keep in mind you may be testing something new, and make a journal about all the symptoms you experience post surgery. For example:
    • Some devices have a higher risk for infection. (Signs include pain, redness, and swelling).
    • Many devices marketed as a quick fix cause pain weeks after the surgery.
    • Unintended consequences—don’t assume your doctor is aware of symptoms or problems you face with the device, or that it’s working the way it’s supposed to.

What are your ideas for protecting yourself when receiving medical implant? Share below:

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