Patients raise concern about failing medical devices

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Jackie Lange likes to stay active and wanted to make sure the need for a new hip didn’t slow her down.

“I was a big hiker, used to hike Mount Si at least once a week,” she says, “My hip had just gotten so bad I couldn’t do the activities I wanted to do.” She and her doctor decided on the Biomet metal on metal implant, marketed as a "lifetime hip." “The newest technology was metal on metal. He liked Biomet because it was an engineering company.”

It was the same choice made by Kristen Elwell’s doctor: “He told me I could get back to skiing with the type of joint he was going to put there.” Both women described a relatively easy recovery with no complications. A decade later, both women started experiencing what they describe as a “clunk” or a “squeak” in their hips.

What happened next is why both women are now suing Biomet and its parent company Zimmer. According to the complaints, doctors for both women found high levels of chromium and cobalt and additional imaging showed the implants needed to be removed. “The imaging showed that the pelvic bone was thinning significantly, so he basically said you don’t really have a choice, you need to get this out.” Lange told KIRO 7.

Lange and Elwell are among the hundreds of patients who have taken legal action against Zimmer Biomet over the last 10 years, claiming the company knew its metal on metal implant was defective.

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“It’s spinning off metals into people’s blood streams and causing a host of serious medical problems,” says attorney Talis Abolins, who represents both women. He says those medical problems include:

-Metallosis, a build-up of metal debris in soft tissue
-Bone deterioration
-Pseudo tumors

“These are things that might be avoided if people are warned, surgeons are warned, that patients are warned that in fact this product isn’t the lifetime hip they were representing it to be,” Abolins says.

By 2015, regulators in Australia, Canada and the United Kingdom had issued advisories about metal on metal implants. The U.S. did not. The Food and Drug Administration cites the differences in how devices are used and designed in other countries.

Abolins counters: “One of the things the U.S. does not have, at least to the same extent as we see in Europe and in Australia, are these device registries where they are collecting in a much more thorough way, the performance of a particular medical device.” Instead the FDA relies on companies to self-report any issues with products and recalls are almost always voluntary. “These products are, in many ways, a ticking time bomb,” says Abolins. Lange agrees, “As soon as they know a device isn’t safe, that these are issues with the device, they need to give you that information so you can make an informed decision.”

Beyond the questions about product warnings is how many devices, like the Biomet implant, are making it to market without clinical trials or significant oversight through a process called 510(k).

In 2017, the FDA cleared more than 3,100 products through this process, 82% of the total devices cleared or approved. "As long as they can base a new product that existed before 1976, and show that their new product is somehow equivalent to this older product, they can go to market immediately without the kind of clinical testing or the rigorous safety checks that go into other devices," explains Abolins. He says that's what happened with the Biomet metal on metal hip implant: "That is the true, sad irony here is this product was grandfathered based on a failed product and today, it should be no surprise, the same problems are happening to people throughout the country."  What Abolins calls an industry backed loophole could soon change. The FDA is now studying how to modernize the process.

No matter what happens with the government regulations, Lange and Elwell want companies that make medical devices to take more responsibility when enough patients raise concerns about their products. “When you’re told you’re going to get this new product that’s better than before, it’s hard to ask questions about ‘oh are you sure? And what can I do if I have problems?” says Elwell. Lange agrees, “I feel like the company should have told us, just like the recall you get on your car or your baby stroller, that we’re seeing significant issues with this hip.”

Zimmer Biomet stopped marketing the metal on metal hip replacement in 2015, citing business reasons and continues to maintain that the product is safe and there is no need for a warning.

The company would not respond to any questions for our story citing pending litigation.