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Published on Apr 17, 2012 by Edgar Snyder

Many Medical Devices Aren't Tested Before They're Used on Patients

medical device testing

The Food and Drug Administration (FDA) is responsible for regulating everything from prescription drugs to cosmetics. They check and double check all sorts of products to make sure they're safe for consumers. According to Consumer Reports, dangerous medical devices are constantly slipping through the cracks and onto the market, putting patients at risk.

Consumer Reports showed that the FDA recalled 41 different medical devices last year. Below are ones that are particularly dangerous to patients' health.

Surgical mesh:

Hundreds of thousands of women have been implanted with transvaginal mesh since it was introduced in the early 2000s. Used to treat pelvic organ prolapse and urinary incontinence, manufacturers were able to introduce the product without advance safety testing. This was possible due to a loophole that says products don't need clinical testing if manufacturers can show they are "substantially equivalent" to a device that is already on the market.

There have been thousands of reports of adverse events and multiple lawsuits linked to the mesh. In January 2012, the FDA ordered 33 companies to conduct post-market safety studies on transvaginal mesh. The agency is now considering reclassifying it to the highest risk class, Class III, the only one that requires clinical testing.

Lap-Bands:

More than 650,000 Lap-Bands have been sold around the world to aid in people's weight loss. They were one of the rare products that couldn't be grandfathered into the marketplace because a similar product wasn't already in use. Therefore, they were supposed to undergo advance safety testing.

Only one study was conducted to get FDA approval for Lap-Bands, and it found that out of 299 people, 51 reported nausea, vomiting, or both, and 25 percent had to have their bands removed before the three-year study was over. According to experts, this recall rate would be unacceptable for other products, such as cars.

Metal-on-metal hip implants:

Metal-on-metal hips were cleared by the FDA without testing due to the grandfather rule even though they were on the agency's top priority list of products needing clinical trials. In August 2009, DePuy recalled 93,000 ASR XL hip implants after it was found the hips were failing at a high rate and resulting in serious injuries. An article in the British Medical Journal called it "one of the biggest disasters in orthopedic history."

Cardiac devices:

Implanted defibrillators – The FDA has received reports of about 29,000 deaths and injuries linked to these devices since 2009. There have been two major recalls of leads, the wires that connect the defibrillators to the heart, in the past several years.

Vena cava filters – Used to prevent pulmonary embolisms, these devices are supposed to be removed when the threat of a blood clot has passed, but many aren't. A 2010 study found that parts of the filter broke off and migrated to other parts of the body in one of four patients.

Automated external defibrillators – There have been approximately 90 defibrillator recalls in the past several years. From 2009 to 2001, the FDA received reports of 72 injuries, 686 deaths, and 20,667 malfunctions linked to the devices.

The FDA states that it "…weighs the benefits and risks of every medical device [they] review," but they must allow medical devices on the market until serious problems arise. Unfortunately, the complexity and nature of these devices mean that the recall itself could be dangerous. Some devices are embedded in patients' bodies and removing them involves a new set of risks and problems. Consumer Reports recommends that patients look up their device on the FDA website, ask about alternative medical procedures, and write down the serial number of the device.

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“Consumer Reports Warns of Lax Testing for Medical Devices.” ABC News. March 29, 2012.
"CR Investigates: Dangerous medical devices." Consumer Reports. May 2012.
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