Consumer groups question safety of expedited medical device approvals
Medical device manufacturers spent more than $33 million last year and used 225 lobbyists to pressure lawmakers to support the Food and Drug Administration’s current practice of allowing moderate-risk devices to be approved without thorough testing for safety and efficacy. The practice has come under fire in recent months, in particular by consumer groups who argue that the agency’s expedited approval process puts patients at risk for serious injury or death.
This debate is currently being weighed by members of congress, who will also consider the FDA’s proposal to remedy the situation. The agency is proposing a fee increase for medical device manufacturers seeking approvals on new devices. This increase would allow the FDA to hire 200 employees over the next five years who would provide more oversight during the device approval process. Employees would also meet with manufacturers midway through the process to address any questions or provide more safety data.
Currently, moderate-risk medical devices are approved without clinical testing if similar products are already on the market. About 90 percent of medical devices are approved through this accelerated process.
Consumer groups have argued that this lack of testing puts devices on the market before they have been proven safe. And it can have devastating results. For example, medical device manufacturers developed a type of artificial hip that was designed with all metal parts to be stronger and more durable than traditional hip implants, which are made with plastic or ceramic parts. Because the design of the all-metal implants was similar to the traditional implants, these devices were quickly cleared by the FDA for sale and use in the United States.
However, not long after the metal-on-metal hip implants were introduced, problems began to arise. The devices did not prove to be more durable. In fact, they were failing at a higher than expected rate – often in five years or less. What was even more concerning is that as the metal ball moved against the metal socket, bits of metal debris were falling into the joint space, causing inflammation and pain. In some cases, the metal was leeching into the bloodstream, possibly causing a type of blood poisoning known as metallosis.
The FDA responded by ordering manufacturers of metal hip implants to conduct safety studies on patients who had received these devices. This data is currently being collected and will be reviewed by the federal agency. Meanwhile, many recipients of these defective implants are seeking legal counsel so they can be compensated for their pain and suffering.