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FDA Approval Process Allows Defective Devices to Get By

A recent study has found a major flaw in the Food and Drug Administration’s process that approves medical devices. At least four dangerously defective medical devices were expedited through FDA’s approval process with minimal testing. The four devices were the DePuy ASR hip implant, transvaginal mesh, heart rings, and defibrillator lead wires. Each of these devises has caused severe injuries and sometimes death. All of these devices were used in patients without any significant testing of their safety. The hip implant released metal fragments into the body and caused the surrounding tissue to decay. The transvaginal mesh broke through the vaginal wall. The heart ring was used in patients without being approved by the FDA at all, and the defibrillator wires short-circuited because they were not properly insulated.

The FDA’s approval process is known as the 510(k) clearance process. The purpose is to allow manufacturers to market medical devices to US consumers. It allows a device that is “substantially equivalent” to another device that is already being marketed to consumers. The FDA defines substantial equivalence as “the new device is at least as safe and effective as the predicate.” It also provides a list of factors that can determine whether the standard of “substantial equivalence” has been met.

“A device is substantially equivalent if, in comparison to the predicate it: has the same intended use as the predicate and has the same technological characteristics as the predicate or has the same intended use as the predicate and has different technological characteristics and the information submitted to the FDA does not raise any new questions of safety or effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed device.”

The Government Accountability Office (GAO) and the Institute of Medicine examined several of the medical devices that were marketed to consumers after being cleared through the 510(k) process. The study found that 75% of the recalled devices were approved through the 510(k) process. The Institute of Medicine has called for a complete revamping of the FDA medical device approval process. The Institute suggested that the process be “replaced with an integrated premarket and post market regulatory framework that effectively provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”

What does this mean for legal practitioners with clients who have been injured by these dangerous medical devices? It is possible that the federal government’s lax approval process contributed to these dangerous devices being implanted in unsuspecting patients. It is however, very difficult to hold a government entity civilly liable. Only an experienced medical malpractice attorney will be able determine whether the government should be held accountable for its failure to properly test medical devices prior to being implanted into patients. If you would like to speak with a Pennsylvania medical malpractice attorney about a potential claim, contact one of our experienced medical malpractice attorneys today for a free consultation at (267) 809-8250.

Source:FDA Clearance Process Misses Defective Medical Devices Report Finds,” published at

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