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Experts Question Safety of Medical Devices Implanted in U.S. Patients

Medical devices are not uncommon. In fact, according to Consumer Reports tens of millions of Americans live with medical devices within their bodies. These devices include artificial joints, pacemakers and surgical mesh. Unfortunately, many of these devices are not thoroughly tested before released into the market.

The release and oversight of medical devices sold in the United States is regulated by The Food and Drug Administration (FDA) within the Department of Health and Human Services (HHS). This group regulates the devices by placing them within one of three categories:

  • Class I: not likely to cause harm, includes devices like reading glasses or tongue depressors
  • Class II: medium-risk, like mercury thermometers
  • Class III: high-risk, like pacemakers

Congress intended for class III devices to go through a pre-market approval process that requires the use of clinical data to support claims that the product is safe. A GAO investigation found that the FDA is not always completing these investigations on high-risk products and is allowing some Class III devices to enter the market without clinical tests.

A large percentage of these medical devices fail or are recalled. As a result, The Consumer Reports initiated an investigation focusing on problematic medical products. It found the Lap-Band, surgical mesh, artificial metal hips and a group of cardiac devices were sold with little or no prior safety testing, raising questions about the FDA's medical device approval process.

The investigation found that Allergan Inc.'s medical device, the Lap-Band, had a failure rate of 25 percent and five fatalities since 2009, and that patients receiving the untested artificial hips were suffering from metal poisoning and tissue destruction. Ultimately, this study focused on the lack of safety testing and concerns around the FDA's approval process. This investigation adds strength to a GAO report discussing issues associated with the FDA's approval process.

Issues with Approval Process

The FDA has received criticism from the public, media and government regarding its approval process. The Government Accountability Office (GAO) issued a report discussing these concerns. The GAO's director of health care, Marcia Crosse, stated that the FDA's current system contains gaps in post-market surveillance that result in patients using ineffective and unsafe products.

The GAO further determined that the FDA's approval process was faulty. A report was issued that specifically focused on review of the FDA's fast-track 510(k) approval process.

The 510(k) approval process allows manufacturers to release medical devices into the market that were not previously tested. This is allowed if the product is substantially similar to a medical device that was already tested and approved. The FDA finds a device to be "substantially equivalent" to another legally approved device if it has the same use, technological characteristics and finds that any differences do not raise new questions of safety. As a result, this loophole requires a manufacturer only file paperwork prior to releasing a medical device.

The traditional route of approval requires companies provide scientific and regulatory documentation to support the manufacturer's assertions that the proposed medical device is both safe and effective. This procedure is referred to as the premarket approval (PMA) process.

Generally, this more stringent PMA process is required for devices that are considered high-risk and fall into the class III category, like pacemakers and heart valves. Unfortunately, the GAO released a study finding that from 2003 to 2007 the FDA approved 24 different high-risk devices through the 510(k) process instead of the more stringent PMA process. As a result of these findings, the GAO recommended the FDA increase regulation of these products.

Implications for Patients

According to the Consumer Reports investigation, many medical devices including surgical mesh and artificial joints were never clinically tested on humans prior to market release. This lack of oversight can have dire consequences for patients. ABC News reports that more than 70 percent of recalled devices were cleared through the expedited 510(k) process. In contrast, only 19 percent of recalled devices were approved by the PMA system.

Many of these devices are surgically implanted within the patient, making recalls more difficult to follow than those issued for cars or appliances. Recalls have extended to artificial hip joints and cardiovascular devices. For some patients, this can mean a series of painful surgeries to remove the faulty device and replace it with a safer model.

If you or a loved one received a faulty medical device, compensation may be available to cover medical and rehabilitative expenses as well as pain and suffering. It is important to discuss your unique situation with an experienced medical malpractice attorney to better ensure that your legal rights and remedies are protected.

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