Congress Seeks to Close a Loophole in Approvals for Suspect Medical Devices

If the Food and Drug Administration (FDA) pulls a medical device from the market, shouldn’t the agency then scrutinize subsequent versions to ensure that the defect doesn’t continue? Lawmakers think so, and have introduced bills to close the gap, as reported in the newest issue of Bloomberg Businessweek.

Under current federal law, the FDA must release a device for sale without human testing if it is “substantially equivalent” to a prior device, a measure meant to streamline approval. But the positive legislative intent hasn’t always had a positive outcome.

Consider the case of vaginal mesh implants developed to treat feminine incontinence. Johnson & Johnson, C.R. Bard, and Boston Scientific manufactured and sold the devices after getting the nod from the FDA under the current law, resulting in nearly 300,000 implants each year. When complaints arose about pain and internal injuries, it was discovered that the implants were derived from a mesh product developed by Boston Scientific that was recalled in 1999.

House Democrats, led by Rep. Edward Markey (D-Mass.) want to fix the problem, and have introduced a bill that would give the FDA the power to disallow a medical device if a prior product – a “predicate” – was removed or was in the process of being pulled from the market. Also, if enacted, the law would require device manufacturers to explain the differences between their proposed products and recalled predicates, and would further mandate that the FDA review approved devices to determine whether there are any recalls in their “device lineage.”

Said Markey in a statement, “If an automobile is recalled for a major safety problem, we wouldn’t allow future models to repeat this same flaw, and the same should be true for the medical devices used in our bodies.”

Have you been the recipient of a medical implant that caused you additional pain or injury? Changes in the law, like those described above, impact you. Please contact us to tell us more about your situation – we may be able to help.

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