FDA Will Change How it Approves Medical Devices

hush-naidoo-382152-copy-300x200Patients in Vista and elsewhere in Southern California who have suffered injuries as a result of defective medical devices may have been the victims of an outdated medical device approval process. According to a recent article from Global Data Healthcare, patients across the U.S. received medical devices that ended up being dangerous for use and may not have been assessed as well as they could have been by the U.S. Food and Drug Administration (FDA).  

Now, in response to a report on tens of thousands of deaths caused by dangerous medical devices, the FDA has plans to change the way it approves medical devices for patient use.

Investigative Report Exposes Tens of Thousands of Medical Device-Related Fatalities

Many Americans have heard about large-scale medical device recalls and class action lawsuits related to them. For example, both knee replacements and hip replacements made national news in recent years, as have transvaginal mesh lawsuits. While these defective medical devices certainly caused patient injuries, it is important to understand that there are a wide variety of medical devices that can pose harm to patients—not just those that are commonly in the news.

A recent report from the International Consortium of Investigative Journalists (ICIJ) indicated that in the last 10 years alone, more than 80,000 patients have died as a result of receiving defective or hazardous medical devices. Some of the most dangerous devices listed in the report include defective heart valves, insulin pumps, and breast implants.

FDA Responds to Investigative Report and News of Patient Deaths

How did more than 80,000 people receive defective medical devices? Did the FDA really approve all of these devices for patient use? In large part, the answer to the second question is yes. Currently, and for quite some time, the FDA has approved a high percentage of both low-risk and moderate-risk devices that come up for approval through the 510(k) program. In 2017, the FDA approved more than 80% of the devices in this category. Of those devices that were approved, about 20% “were based on predicate devices that are over 10 years old.”

The FDA now plans to change the approval process through the 510(k) program, emphasizing attention to “modern technology and safety practices.” In addition, the article underscores how the FDA “has additional plans to more actively engage safety monitoring through the development of the National Evaluation System for Health Technology (NEST).” Moreover, the FDA has indicated that it has plans to gather data on patients and medical device injuries, and to do a better job of tracking safety issues related to medical devices that have been received by patients across the country.

Seek Advice from a Vista Product Liability Lawyer

Medical devices can cause serious and fatal injuries to patients in California and throughout the country. While patients should be able to rely on FDA approval processes to ensure that they are not receiving defective devices, the recent ICIJ report makes clear that the FDA needs to improve its processes for approving medical devices.

In the meantime, if you or someone you love suffered injuries as a result of a dangerous medical device, you should speak with a Vista product liability lawyer about filing a claim for compensation. Contact the Walton Law Firm to speak with a personal injury attorney today.


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