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Report Highlights US-Made Medical Devices Classified as “Export Only”

Dec 28, 2018

NBC Nightly News reported on medical devices manufactured in the US, but which “are approved for sale and use only overseas” Correspondent Catie Beck highlighted Wolfgang Neszpor, who Beck said lives in Australia and had an operation there “to replace a damaged shoulder joint with a new one made of carbon fiber.” However, Neszpor’s condition worsened, and the doctor took the carbon device out and discovered that it had cracked. The carbon fiber shoulder joint, PyroTITAN, is produced by Integra Life Sciences in New Jersey, and the FDA forbids its sale in the US. According to Beck, “The PyroTITAN is one of about 4,600 medical devices with the designation, which some device makers say can be registered faster for less money and with less oversight.” Beck added that an investigation by NBC News “found more than a dozen export-only devices with concerning records.”

From the news release of the American Association for Justice.

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