Why 510(k) Medical Device Review Harms Consumers

Within the past two years, American consumers have received warnings from the Food & Drug Administration (FDA) that certain medical devices may cause adverse medical events. Two of the largest warnings were to patients who received DePuy hip replacements and transvaginal surgical mesh implants.

Concerned about the FDA's system of review for medical devices, the Institute of Medicine (IOM) conducted a study about devices approved under the FDA's 510(k) approval process. The results of the study were alarming and prompted the IOM to recommend that the FDA scrap its 510(k) approval process completely.

510(k) Has Been Used by the FDA Since the 1970s
Under the current laws, the FDA can approve a moderate-risk device that is substantially equivalent to a device already on the market, also known as a predicate device. These include medical devices that:

Have been cleared through 510(k)
Were legally marketed before May 28, 1976
Were originally on the U.S. market as a Class III device, but were later downgraded to a Class II or I device
Are a 510(k)-exempt device.

Substantially equivalent devices must have the same intended use and the same technological characteristics as their predicate devices. Further, the new device being approved under 510(k) cannot raise new safety or effectiveness concerns and must be at least as safe and as effective as the predicate device.

Under 510(k), low risk devices can be approved in as few as 90 days, which consumer advocates argue is not enough time to determine whether a device will pose adverse risks to consumers.

What do the Different Device Classifications Mean?
The FDA sorts medical devices into three different classes. Class I medical devices are subject to the least regulatory control, because they pose a minimum harm to consumers and are simple in design. Low- to moderate-risk medical devices fall into Class II. At this level, general controls are insufficient to ensure the safety and effectiveness of a device, but existing methods provide assurance. Finally, Class III medical devices are the most risky and carry with them insufficient information to ensure their safety and effectiveness.

How Does the FDA Track the Safety of Medical Devices Already on the Market?
Once a medical device has been cleared under the 510(k) approval process, the FDA requires the manufacturer of the device to report any serious injuries or malfunctions associated with the device to the FDA within 30 working days of the manufacturer becoming aware of the event. Deaths associated with the device must be reported within 10 working days of the manufacturer becoming aware of the event.

Additionally, the FDA looks for signals, or information regarding a medical device, suggesting that there are unexpected risks to patients or users of the device. The FDA can require the manufacturers of Class II or III devices to conduct post-market studies in certain situations, including instances where:

Failure of the device is reasonably likely to have serious adverse health consequences
The device is expected to be substantially used in pediatric populations
The device will be implanted for a year or longer
The device has life supporting or sustaining use outside the device user facility.

Finally, patients who have experienced adverse events related to the use of a medical device are encouraged to report these adverse events to the FDA's Adverse Event Reporting System (AERS).

Results of the IOM's Study
After reviewing data regarding medical devices that are approved under 510(k) and are subsequently recalled, the IOM found that a staggering 75 percent of all these approved devices are recalled at least one time. Recall rates for medical devices are highest in the first three years after a device has been cleared. Further, the IOM found that devices that have been assigned to the anesthesia, chemistry, and cardiovascular advisory committees for review are generally higher risk devices and have higher recall rates.

The most common cause of the recalls was manufacturing process errors. This includes an inadequate control of the manufacturing process, an inadequate control of the environment in which the devices are manufactured, and errors in storage, packaging, and labeling of the devices. A failure of the device to perform correctly due to its design was the second most common cause of the recalls. Contaminated, degraded, counterfeit, or inadequately tested materials and components of a medical device came in as the third most common cause of the recalls.

Other problems with the devices included a change in the manufacturer's procedures, adversely affecting the components or devices, and employee errors.

Why the IOM Recommends the FDA Scrap 510(k) Review
Based on the results of its study, the IOM determined that 510(k) review is flawed based on its legislative foundation. Rather than save 510(k) review, the IOM recommended that the FDA scrap the process entirely and start anew with a premarket and post-market regulatory framework to provide a reasonable assurance of safety and effectiveness throughout the device cycle.

The IOM noted that an improved approval process would be "clear, fair, and predictable, and make use of regulatory tools and authority to ensure safety and effectiveness throughout the duration of a product's use."

Under the current system, devices that have not been thoroughly tested are being approved and sent out on the market, posing a danger to consumers. So far, thousands of Americans have experienced serious personal injury or death from these flawed medical devices. More recently, the DePuy hip replacement implants and transvaginal surgical mesh have harmed patients.

If you were harmed by a defective medical device, you may have a claim against the device manufacturer. The experienced dangerous products attorneys at Van Wey Law can answer your questions about defective medical devices. Call Van Wey Law today at (214)329-1350 or (800)489-5082.

Don't hesitate to contact Kay Van Wey at (800)489-5082 for a free, no obligation consultation.

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