Beware: Medical Devices Are NOT Tested for Safety

Monday, 30 Sep 2013 08:43 AM

By Rick Ansorge

If you’re one of the millions of Americans with an implanted medical device – an artificial joint, heart stent, defibrillator, gastric band, or others – you’re probably confident that it’s safe because it has been tested.

In most cases, you’d be wrong.

Manufacturers generally need only file some paperwork and pay a $4,000 fee to the Food and Drug Administration to start selling a product. Not until after an implanted medical device causes widespread health problems does the FDA act to remove faulty medical devices from the market.

Metal Hip Disaster

Even doctors can fall prey to bad medical devices. Consumer Reports documented the case of an orthopedic surgeon who received a metal-on-metal hip replacement. Dr. Stephen Tower was convinced that his new hip joint would be more durable than the older-generation metal-on-plastic joints. But after developing serious pain, vision problems, hearing loss, anxiety, and other problems, he had the hip replaced with a different model. His symptoms drastically improved afterward. A year later, the metal-on-metal hip was pulled from the market and the British Medical Journal called it “one of the biggest disasters in orthopedic history.”

Deadly Infections

Renowned neurosurgeon, Russell Blaylock, M.D., tells Newsmax Health: “Only if there’s no other choice should you use implantable devices. I think that’s probably a pretty good general rule.”

Dr. Blaylock is especially concerned about the metals contained in many devices. “The neurosurgeons and orthopedic surgeons are putting screws and plates in virtually everything,” he says. “There’s a considerable amount of literature on cobalt and nickel absorption producing significant neurological effects as well many other effects such as auto-immune disorders and immune dysfunction.”

With any kind of implanted medical device, infection is always a possibility. “About half the surgical infections are due to implantable devices,” Dr. Blaylock says. “These can be quite complex and deadly infections.” And when a medical device has to be removed, it can require multiple surgeries.

Consider Alternatives

Before getting a medical device surgically installed in your body, Dr. Blaylock strongly recommends that you thoroughly research possible alternatives.

For example, to treat bladder prolapse, some patients can be cured with simple pelvic exercises instead of having surgical mesh implanted.

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“Most of the time, if a doctor is making big money implanting a device, he’s not going to suggest pelvic exercise,” adds Dr. Blaylock. “Patients need to understand the dangers of complex surgery.”

Know the Risks

To better comprehend those risks, Dr. Blaylock says informed consent is essential. “Don’t just let the doctor say, ‘We need to put this device in.’ You need to sit down and ask, ‘What are the alternatives? What can we do other than that? What are complications from it? Where is the literature that shows it’s been adequately tested?’ You have to start by questioning your physician.”

Search the FDA’s website, FDA.gov, for the latest information about implanted medical devices, safety warnings, complaints, and recalls. Search Internet patient forums to find out if people are happy with the device you are considering.

Dr. Blaylock says there needs to be a shift away from the idea that newer and more complex treatments are always better and a return to the tried-and-true. “Most things can be fixed simply,” he says. “A lot of health problems can be fixed just by changing diet, getting more exercise, improving sleep patterns, and taking simple supplement combinations.”

In an effort to stem the problems caused by implants, the FDA recently instituted a new system that requires that all medical devices be labeled so that their performance can be tracked. The system is designed to make it easier to identify devices being recalled, improve the accuracy of reports of problems with devices, and provide a way to spot counterfeit devices, according to the FDA.

Implantable medical devices are one of the most profitable areas of the healthcare industry, generating some $85 billion annually in the U.S. The most-used implanted medical device in America is the artificial eye lens, used to replace those lost to cataracts. Ear tubes, commonly given to children who suffer ear infections, are the second most common. Number three is coronary stents, followed by IUDs used for birth control, and metal screws, pins, or plates used in orthopedic procedures. Other popular devices include artificial joints, breast implants, and pacemakers.

The complete version of this article first appeared in Health Radar. To read more, CLICK HERE.

http://www.newsmaxhealth.com/Headline/medical-devices-safety-FDA/2013/09/30/id/528320