Consumer Group Calls for More Rigorous Medical Device Testing

The proliferation of lawsuits over adverse events associated with invasive medical devices including metal-on-metal hip implants and transvaginal surgical mesh speak to a recent call by Consumers Union to strengthen the testing requirements for high-risk implants.

Consumers Union, as described by AboutLawsuits.com, is the lobbying arm of Consumer Reports. Last month, it sent a letter to the FDA urging it to require full research and testing under the agency’s premarket approval (PMA) process for Class III implantable devices.

The FDA has three classes of medical devices categorizing approximately 1,700 different generic types. Each type of device is classified, according to the agency, “based on the level of control necessary to assure the safety and effectiveness of the device.”

Class I devices require the least amount of regulatory intervention, and Class III, such as the hip and mesh implants, the most. For Class III devices, PMA is required unless there’s a substantially similar product already on the market. If so, newer versions of it get what’s known as a 510(k), or fast-track exemption, excusing it from all the testing required of the earliest device.

As reported on AboutLawsuits, many fast-tracked Class III devices are quite dissimilar from the originally approved device they are based on. Often, they are marketed as using new techniques and new designs “at the very same time the FDA is approving them for being identical enough to an existing device so as not to warrant clinical trials.”

Many 510(k) devices now on the market weren’t clinically tested before the 510(k) program or PMA process existed. So potentially dangerous new devices, notes AboutLawsuits, are given “grandfathered” approval without warranting it. A Consumer Reports investigative study that we wrote about last year concluded that most medical devices being implanted in U.S. patients have not been tested.

Thousands of people, the Consumer Union letter says, have suffered severe and debilitating injuries from implants that weren’t thoroughly evaluated by the FDA, and the agency should reclassify all high-risk implantable medical devices to require that those receiving PMA undergo clinical trials to prove that they are safe and effective.

FDA action seems to prove this case: In January, the agency issued a safety warning about metal-on-metal hip implants that said they have “unique risks” including soft tissue damage and other problems. (See our blog about a large damages award to a patient who learned this sad truth.)

Transvaginal mesh also should fall under this scrutiny, the Consumers Union letter said, because it has been known to puncture organs and cause autoimmune disorders. And it, too, was the subject of an FDA warning and a subsequent letter to manufacturers ordering additional studies to evaluate their risks.

According to AboutLawsuits, “many manufacturers have decided to cease commercialization of their products, hoping to avoid the need for testing that many believe should have been done before the devices were ever sold in the United States.”

If you want to report or research adverse events associated with medical devices, visit the FDA’s MedWatch site. For additional guidance on informing yourself about medical devices, and protecting against their risks, see our blog “Protecting Yourself from Dangerous Medical Devices.”

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