Some medical devices deemed unsafe in other nations still sold in U.S.

Some medical devices deemed unsafe in other nations still sold in U.S.

- in Health
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By Emily R. Siegel, Andrew W. Lehren and Sarah Fitzpatrick

Andrew Chappell was in agony. The biology professor’s active life had included wrestling in high school and serving in the Army reserves. But by age 35, he was suffering from a painful disease called avascular necrosis — his hip bones were slowly dying from poor blood flow.

In 2011, his surgeon replaced both his hips with Biomet M2a Magnum hips. Promoted by Olympic gold medal gymnast Mary Lou Retton, the metal joints were advertised as “the choice for more active patients,” and strong enough to last two decades.

At first, Chappell was pain free. But just six years after the operation, he was crippled by excruciating pain. A surgeon found that not only were the implants causing extensive bone damage, but they were leaching metal into his bloodstream. The hip implants were taken out.

If Chappell had lived in another country, the Biomet hips might have been removed several years earlier.

By 2015, regulators in Australia, Germany, and five other countries were already issuing warnings about the product. But in the U.S., the Food and Drug Administration, which oversees medical devices, was silent.

Each year, flaws are found in thousands of medical devices. The FDA posted more than 2,000 recalls of medical devices last year, warning about how to avoid possible injuries or even deaths. Sometimes it posts these recalls before other nations impose their own regulations.

But there is no global system to make sure that a product found to be problematic in one country is not sold in another. An NBC News analysis found at least five devices about which other nations issued safety warnings and the FDA did not. These devices include a knee implant with high failure rates, a pregnancy test that gave false results, and dental drills that might damage nerves. In other instances, the FDA has lagged months behind warnings issued in other countries.

Doctors and experts around the world have expressed frustration over a chaotic global system that too often leaves physicians without essential safety information that is readily available in a nearby country.

“There exists no global nomenclature for medical devices,” said Adriana Velazquez Berumen, senior adviser on medical devices for the World Health Organization. “In each country they have different naming, different coding, different prepping. So that complicates everything.”

For Chappell, now 43 and teaching at a Kansas community college, this is frustrating.

“I could’ve gotten [the hips] out sooner,” Chappell said. “And that would have saved me three years of pain and suffering.”

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