Alternative Summary Reporting Is Going Out the Window

By Gilreath & Associates

There’s no such thing as perfect. But when it comes to your medical devices, you want them to come as close as possible.

The U.S. Food and Drug Administration (FDA) announced in May 2019 its intention to end a program they call the “alternative summary reporting.” In the past and present, medical device makers have used this program to hide countless defects in their products.

According to PBS, the initial objective of alternative summary reporting was to allow for “more efficient internal review of well-known risks.” But with so many reports floating under the radar with such high risks, the program is set to be terminated in the near future.

Breast implants and pelvic mesh are the 2 products which initially brought the number of hidden reports to the FDA’s attention. A staggering 1.1 million reports have gone through this program since 2016 for other medical devices, from tooth implants to pacemakers.

Dr. S. Lori Brown, a former FDA official, said this:

“The #1 job of the FDA—it shouldn’t be ‘buyer beware’—is to have the information available to people so they can have information about the devices they are going to put in their body.”

Since it began winding down the program in 2017, the FDA has gone over many thousands of reports that went unnoticed concerning medical devices implanted in patients which have led to serious injuries.

Device makers still have the option to file for other types of exemptions that are withheld from the public, however. No announcement has been made concerning these reports.

If you are a victim of a defective medical device, Gilreath & Associates wants to help. Our experienced Tennessee defective medical device lawyers are waiting for your call. Contact us for your free consultation.

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