Is it Time for the FDA to Require Clinical Testing of Metal Hip and Other High Risk Implants?

Bisnar Chase
April 22, 2013

Consumers Union, a consumer advocacy group, has urged the U.S. Food and Drug Administration (FDA) to adopt a proposed rule requiring metal hip implants to be reviewed through the agency’s premarket approval (PMA) process to prove that the devices are safe and effective.

The group sent a comment letter to the FDA signed by more than 11,000 consumers calling on the federal agency to re-classify all high-risk implantable medical devices under the PMA process so clinical evidence will be required to prove their effectiveness and safety before they are put on the market.

What are Metal-on-Metal Implants?

Metal hip implants manufactured by companies such as DePuy Orthopedics and Stryker have failed prematurely in patients causing them to have revision surgeries. What are all-metal hip implants and how are they different from others? The metal-on-metal implants have a ball and a cup component that are both made of metal. They were thought to be superior in some respects to traditional hip replacements made of plastic and metal.

Over the past decade, about 500,000 people in the United States received all-metal implants. As this consumer group points out, the implants were not adequately tested because of regulatory loopholes the FDA is now moving to close.

Serious Side Effects

Thousands of patients have had to replace these metal implants in painful revision surgeries. Hundreds more have suffered internal damage. Some of the side effects reported by patients and physicians as a result of these defective hips included long-term pain, continued inflammation and difficulty walking even after surgery. In some patients the implant came loose, bones were fractured or the device itself became dislocated. Metal debris has also been reported due to friction between the ball and socket units causing inflammation. Some patients have even reported serious conditions such as nerve damage and bone necrosis in the area surrounding the implant.

Flawed Regulatory Process

Researchers, who have used FDA documents to trace the decades-long ancestry of the DePuy ASR Acetabular Cup System metal hip implant that received the FDA’s 510(k) clearance in July 2008, say their work shows serious flaws in FDA’s regulatory procedure for metal hips, resulting “in the clearance of a new device that was never shown to be safe and effective.” A clinical trial may have highlighted the revision rate, researchers said in the study that was published in the New England Journal of Medicine.

In this revealing article, scientists traced the device’s ancestry back more than 50 years through a total of 95 devices. They report that the 510(k) clearance for the ASR XL was given based on the FDA’s determination that the DePuy implants were “substantially equivalent” to others in the market. However, the researchers said that the already existing implants the FDA was looking at were not metal-on-metal and were substantially different in design from the DePuy unit.

The problem was that these devices entered the market without much-needed clinical data showing safety and effectiveness. Thousands of Americans learned the painful way that these devices were prone to failing and causing serious health problems. Implanted body parts are not like other defective products such as auto parts that can be recalled with relative ease.

As the Consumers Union’s comment letter states, any change in the regulatory process is too late for thousands of people who have already been harmed by these implants. The group has also called for the FDA to push all metal hip manufacturers to remove their products from the market because of their high failure rates and adverse event reports.

Other Harmful Medical Devices

As the group points out, it is not just the hip implants that have slipped under the regulatory radar of the FDA. Several transvaginal mesh implant devices, which have injured tens of thousands of women, were also approved by the same flawed process. These mesh implants have caused women to suffer debilitating side effects including mesh erosion, severe pain and nerve damage. Thousands of women have undergone multiple surgeries to get the mesh removed. In some cases, the mesh broke apart and traveled to other parts of the body as well.

Protecting Consumers’ Rights

As we can see, not requiring clinical testing for high-risk implants can lead to serious health problems for patients who receive these implants. Manufacturers have the responsibility to ensure that the products they put on the market are properly tested.

However, not everyone does their due diligence especially when there is a way for them to get around the regulatory process. In the end, it is the consumer who gets shortchanged and pays for corporate greed and inadequacies in the regulatory processes.

Anyone who has been injured or harmed by defective hip implants or any other high-risk implant would be well advised to contact an experienced product liability lawyer who has experience handling similar cases. If you are looking into receiving one of these implants, it would be in your best interest to talk to your doctor and understand the risks involved before making a decision regarding the course of your treatment.