How Well-Regulated Are Medical Devices?

Medical Device: Hip Prosthesis

Your dad has a pacemaker. Your next-door neighbor just got a knee replacement. Your coworker recently had a cardiac stent placed, and your sister confided that she's thinking about getting an IUD. If it seems to you that a lot of people are getting parts replaced or devices implanted in their bodies, you're right. According to a report by the AARP Public Policy Institute, millions of Americans have had surgery to implant some kind of medical device. This includes about a million knee and hip replacements and 370,000 pacemakers—per year. By some estimates, over seven million people in this country currently have joint implants.

And, of course, joint implants are not the only kind of implantable medical device. The list includes such things as:

  • cardiac pacemakers
  • defibrillators
  • replacement eye lenses
  • artificial hips
  • artificial knees
  • surgical mesh
  • cardiac stents
  • birth control devices
  • orthopedic rods, screws, and pins
  • nerve stimulators
  • artificial heart valves

So many people in the U.S., nearly 1 in 10, have implantable medical devices. Considering that they can literally mean the difference between life and death for patients, you would assume such devices would be strictly regulated. You might be surprised to learn the truth. Just how well-regulated are medical devices?

Regulation (or Not) of Medical Devices in the U.S.

There is no question that implantable medical devices have been a godsend for most people who use them. Artificial joints alone can mean regained mobility and release from pain. In many cases, however, they can lead to infection, loss of function, and even death.

Most people probably assume that, just as the FDA has a strict approval policy for drugs before they hit the market, medical devices must go through a similar approval process. When their doctor recommends a device, they therefore assume it has been rigorously tested and safe.

The U.S. Food and Drug Administration didn't even begin overseeing medical devices until 1976. At that time, devices already in the marketplace were "grandfathered" into approval, and devices deemed to be similar to those already available underwent relatively cursory scrutiny before being admitted to market as well.

That was decades in the past, though; surely oversight has gotten more stringent? Unfortunately not. For instance, if a medical device manufacturer informs the F.D.A. that they have made only a minor modification to a previously approved device, they can circumvent clinical testing for even high risk devices. As a result, according to the New York Times, many high-risk medical devices have undergone no testing at all. The Journal of the American Medical Association in 2009 published a study that revealed only five percent of high-risk implanted cardiac devices met. even partially, a standard equivalent to that of drug testing.

Failure of Implanted Medical Devices

What does the failure of an untested or insufficiently tested device look like? It could look like metallosis, a condition that may affect up to 5% of hip prosthetic patients. This condition can result in damage not only to local muscle, tendon, and other tissue, but to damage to other organs, including the brain and heart.

Device failure could look like a damaged lead to a cardiac pacemaker, leading to dangerously irregular heart rhythms. It could look like a birth control device that causes scarring and permanent infertility. It could look like vaginal mesh erosion that causes severe pain, bleeding, or infection. Medical device failure might look like the painful, unnecessary, and sometimes fatal shocks delivered to epileptics when an implanted nerve stimulator device malfunctioned.

Patients rely on their doctors to recommend a course of treatment and to make them fully aware of the risks that a given treatment involves. Without full knowledge of the risks and benefits, a patient cannot give informed consent. Encouraging a patient to undergo a treatment without informed consent could be medical malpractice.

Of course, doctors may not be able to warn about dangers of which they themselves have not been made aware. Often, due to the lack of rigorous testing, doctors rely on the assertions of the medical device manufacturers themselves as to the safety of a device. If a manufacturer fails to adequately test a device or fails to warn of known dangers from an existing device, they, too, could be liable for a patient's injuries.

If you have an implanted medical device such as an artificial joint or cardiac pacemaker, and you have experienced even more health problems since your device was implanted, you may be experiencing medical device failure. You may have been told your problems were "all in your head" or that people experience varying levels of success with treatment.

There is a good chance that in reality, the fault lies with the device or how it was implanted, not with you. Consider consulting an experienced medical malpractice attorney to discuss your symptoms and your experience. You may be entitled to compensation for your suffering, and to help pay for further treatment necessary to relieve it.

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Categories: Medical Malpractice

Blog Disclaimer

The information in this blog post is provided for informational purposes only and is not intended to be legal advice. You should not make a decision whether or not to contact a qualified medical malpractice attorney based upon the information in this blog post. No attorney-client relationship is formed nor should any such relationship be implied. If you require legal advice, please consult with a competent medical malpractice attorney licensed to practice in your jurisdiction.