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Does the FDA care about the safety of medical devices?

Seeking necessary medical care can be stressful, but it is an important part of living a long, healthy life. You understand this, which is why you went to your doctor when you were experiencing health issues. Unfortunately, it is possible that you are suffering even more after treatment. Many medical devices that are currently on the market are not as safe as many companies and medical professionals claim.

The U.S. Food and Drug Administration provides easy pathways for companies seeking approval for their medical devices. When a new medical device is substantially equivalent to an existing device, the FDA will approve it on an accelerated path. However, there is little monitoring after approval.

Are medical devices monitored?

The answer to this question is complicated. While there are systems for reporting problems with medical devices to the FDA, they do not necessarily function as intended. One such reporting system is the Manufacturer and End User Facility Device Experience, or MAUDE. This database is available to the public. Surgeons and clinicians can also use the MAUDE database to help make safe medical decisions.

However, the FDA also maintains a secret alternative summary reporting database. Started in 2000, this database gives exemptions to manufacturers who make devices with well-known risks. The exemption allows a manufacturer to secretly submit regular spreadsheets to regulators instead of publicly reporting that information through MAUDE. These spreadsheets often contain thousands of incidents.

Who is getting reporting exceptions?

Through the alternative summary reporting system, FDA officials granted exemptions to manufacturers of breast implants. These manufacturers have submitted tens of thousands of individual reports, none of which appear in MAUDE. There have been approximately 350,000 breast implant complaints made to the FDA between 2009 and 2019. According to the International Consortium of Investigative Journalists, only about 17,500 of those complaints appear in MAUDE.

The FDA also granted exemptions to staple manufacturers. According to the FDA's public data, there were only 84 incidents of stapler malfunctions in 2016. The alternative summary reporting system contained 10,000 incidents of malfunctions and injuries that year.

The problem is widespread

Kaiser Health Network conducted an investigation into the alternative summary reporting system and came to an unsettling conclusion. In its 17 years of operation, there have been 1.1 million secret device failure reports. In 2017 alone, there were 480,000 secret reports. In May 2019, the FDA announced that it intends to close the alternative summary reporting system, but it is unclear if there is a timeline for this. It also does not erase the harm that these medical devices inflicted on you and many others.

It is possible to hold manufacturers who make defective or dangerous medical devices responsible for their actions. Through a product liability suit, you can seek compensation for your pain and suffering, related medical bills, emotional trauma and more. Going up against these big companies can be difficult, so having the right help on your side can be crucial for success. A knowledgeable Louisiana attorney experienced in such matters should be able to provide important guidance on this process.

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