Breast implants expose FDA product safety flaws

by | Dec 11, 2018 | Uncategorized | 0 comments

For a decade, makers of breast implants were required by the U.S. Food and Drug Administration to report issues with their medical devices in bulk – one report standing in for thousands of cases.

That’s why until the fall of 2017, the FDA saw only about 200 complaints annually about breast implants. But the Associated Press reports that in mid-2017, the FDA instructed breast implant manufacturers to file individual complaint reports. That’s when the number of complaints jumped from about 300 in all of 2016 to more than 4,000 in the second half of 2017 and more than 8,000 in the first half of 2018.

Why the change in reporting?

According to the Associated Press, the change came about when a lawyer found his client complaints weren’t represented in data reported to the FDA.

Patient advocates who believe autoimmune problems are the result of faulty breast implants took up the issue and demanded transparency.

This caused the FDA to require manufacturers to file the individual reports which offered the better picture of complaints associated with breast implants.

Three current reporting problems

However, the FDA is changing its reporting standard. In August, it began allowing manufacturers of 160 types of implanted devices, including breast implants, to report malfunctions quarterly instead of individually. While FDA officials say the intent is to reduce the amount of paperwork manufacturers face, patient advocates say the move will cause the number of problems to again be underreported.

In addition, the FDA’s main database, which collects data on all patient deaths and serious injuries, relies on hand-typed entries from a variety of people. This leads to underreporting, missing and flawed data, the AP notes.

Also, while drug manufacturers and auto manufacturers use a single number to track their products from assembly all the way to the consumer (think of a car’s VIN), medical device implant manufacturers didn’t have an equivalent process until 2015 and won’t be required to put such an identifying number on less risky products until 2020, according to the AP. This means it will be years before this information filters into patient records, insurance claims and the FDA database.