Medical Devices Deemed Unsafe Overseas but Sold in the US

Global device market withdrawals not always followed in US

In a world of global trade and instant communication, you might assume that a medical device deemed unsafe in one country would be pulled from shelves everywhere. But that’s not always the case — and for patients like Andrew Chappell, it can mean years of unnecessary pain.

Chappell, a biology professor and Army veteran, was just 35 when he underwent hip replacement surgery using Biomet M2a Magnum metal-on-metal hip implants. Marketed in the U.S. as durable and ideal for active lifestyles, the devices were even endorsed by Olympian Mary Lou Retton.

At first, the implants worked. But within six years, Chappell’s health deteriorated. He experienced severe pain and bone damage, and tests revealed dangerous levels of metal in his blood. The implants had to be removed.

What he didn’t know at the time: regulators in Australia, Germany, and other countries had already sounded the alarm about the Biomet hips — years before the FDA did.

A Global Patchwork of Safety Alerts

The U.S. Food and Drug Administration (FDA) is responsible for monitoring the safety of medical devices on the American market. But there is no international coordination system to ensure that warnings issued in one country cause similar actions elsewhere.

According to an NBC News investigation, at least five medical devices flagged by foreign regulators were still on the U.S. market without similar FDA warnings. These included:

• A knee implant with a high failure rate
• A pregnancy test that produced false positives
• Dental drills that risk nerve damage

Although the FDA issues thousands of recalls each year, sometimes ahead of other nations, it has also lagged in key cases. The result? A chaotic regulatory landscape where physicians — and patients — may not receive crucial safety information in time.

Why the disconnect?

According to NBC, the World Health Organization (WHO) has pointed out one of the core issues: there is no standardized global system for naming, tracking, or classifying medical devices. “Each country has different naming, coding, and prep requirements,” said Adriana Velazquez Berumen, WHO’s senior adviser on medical devices. “That complicates everything.”

This fragmented system leaves patients vulnerable. In Chappell’s case, a warning issued just a few years earlier — and acknowledged by U.S. regulators — might have spared him three years of suffering.

What can be done?

As medical devices grow more complex and global supply chains become the norm, the need for greater international collaboration and transparency in postmarket surveillance has never been clearer. Possible solutions include:

• Global databases to track device safety issues in real time
• Harmonized regulatory frameworks for faster information sharing
• Mandated reporting of foreign safety alerts to national agencies like the FDA

Final Thought

If you are a device manufacturer or healthcare professional, ask yourself: Are you actively monitoring international safety alerts for the devices you make or use? Being reactive is no longer enough.

At Medical Devices and Pharma (MDP), we help clients stay ahead of global safety trends, integrate risk management into their quality systems, and build compliance strategies that extend beyond borders.

Contact us today to learn how we can support your safety surveillance, regulatory strategy, or QMSR transition plan.