After years in the military and playing rugby, Wolfgang Neszpor was used to his battered body making noises, but he was stunned when he heard his recently repaired shoulder squeak.
"It was loud. You could really hear it outside my body," he said.
He went to his doctor, who, when examining him, lifted up his arm.
"I nearly went through the roof," Neszpor recalled. "I can take a fair bit of pain. But it was a stupid amount of pain."
Two months earlier, Neszpor, 36, had gotten a new shoulder joint made out of carbon fiber. It was a PyroTITAN, made by Integra LifeSciences, a New Jersey company that ranks among the biggest medical device companies in the world.
Neszpor lives in Australia, where his operation was performed in 2014. He believed the Made in the USA label meant his shoulder would be fixed with state-of-the-art technology.
Thousands of medical devices made in U.S. are approved only for sale overseas
NOV. 25, 201802:47
What he did not know is that even though it was made in the USA, the U.S. Food and Drug Administration had not, and still has not, deemed it good enough for Americans. A clinical trial is underway and the company said it hopes to get approval upon completion. But the agency has permitted its sale overseas since 2012 under an obscure provision in which the PyroTITAN was registered as an "export only" device, requiring far less FDA scrutiny than for devices that are sold domestically.
The PyroTITAN is one of more than a dozen export-only devices with troubled track records identified by NBC News, including U.S.-made implants for losing weight that instead led to emergency surgeries, stents that could cut into arteries they were supposed to save, and heart valves sold in Spain and Italy that, according to the FDA, caused severe infections and may have caused a five-year-old child to die. There may well be more. NBC News found these by analyzing and comparing databases in 10 countries, and a lack of international standards for identifying devices means it is difficult to know how many other troubled devices exist.
For U.S. companies, exporting medical devices is big business, valued last year at more than $41 billion. Currently about 4,600 devices are registered with the FDA as "export only" devices. Several executives for medical device makers said registering the devices is faster, less expensive and has involved less oversight than getting them approved for sale inside the U.S. The troubled devices identified by NBC News have been sold around the world. The destinations range from the Netherlands to Namibia, Chile to Canada, Japan to Germany.
NBC News probed export-only devices as part of a global project organized by the International Consortium of Investigative Journalists, a news organization notable for its work on the Panama Papers, to examine the medical device industry. More than 250 reporters in 36 countries worked on stories that began publishing Sunday.
Wolfgang Neszpor, after years in the military and playing rugby, was used to his battered body making noises, but the 36-year-old was stunned when he heard his recently repaired shoulder squeak.Cheryl Goodenough / Redland City Bulletin
The FDA says its oversight for these products is limited. "The FDA does not have the authority to take action on export-only devices marketed in other countries simply because they do not meet the agency's requirements for marketing in the United States," the agency told NBC News.
The PyroTITAN already had documented problems before it was embedded into Neszpor's shoulder. The company had alerted the medical community in 2012 that some models could break. After his surgery, more flaws emerged. In 2013, Australian authorities warned that, for some, the PyroTITAN broke in its first year. A 2016 recall cautioned the device needed so much friction to snap into place that it could burn the arm bone when it was implanted. Out of an untold number of implants, at least 19 patients needed to have the PyroTITAN removed. Neszpor is one of them.
"That raises a lot of ethical and moral and health questions," said Dr. Sidney M. Wolfe, who helped establish Public Citizen, a consumer health advocacy organization, and frequently testifies befo...
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