US export-only medical devices fail
Australian Army veteran Wolfgang Neszpor was stunned when he heard his recently repaired shoulder squeak. ‘‘You could really hear it,’’ he said.
He recalled when the surgeon examined him and lifted up his arm, ‘‘It was a stupid amount of pain.’’
Two months earlier, Neszpor, 36, got a new shoulder joint, a PyroTitan made by Integra LifeSciences of New Jersey.
Neszpor lives in Brisbane, where his operation was performed. He believed the ‘‘Made in the USA’’ label meant he would be fixed with state-ofthe-art technology.
He did not know that even though it was made in the US, the US Food and Drug Administration has not deemed it good enough for Americans.
The agency permitted overseas sales under an obscure provision for registering ‘‘export-only’’ devices, requiring far less scrutiny than for devices sold in the US.
The PyroTitan is one of more than a dozen export-only devices with troubled track records identified by NBC News, a group of international news organisations and the International Consortium of Investigative Journalists, which previously uncovered the Panama Papers and the Paradise Papers.
One implant for losing weight led instead to emergency surgeries. There were US-made stents that could cut into arteries they were supposed to save, and insulin pumps that suddenly stopped delivering insulin. The FDA believed one company’s heart valves may have caused a 5-year-old child to die.
For US companies, exporting medical devices is big business, valued last year at more than US$41 billion. About 4600 devices are registered with the FDA as
‘‘Is an American life worth more than a British life or an Australian life.’’ Dr Sidney M Wolfe
‘‘export-only’’ devices.
Several medical device executives said registering the devices is faster, less expensive and has involved less oversight than getting them approved for sale inside the US.
The troubled devices identified by the investigative journalists have been sold around the world. The destinations range from the Netherlands to Namibia, Chile to Canada, Japan to Germany, but none so far have been identified in New Zealand.
The reporters found these problems by analysing 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.
‘‘Is an American life worth more than a British life or an Australian life?’’ said Dr Sidney M Wolfe, who helped establish the consumer health organisation Public Citizen. ‘‘I mean, that’s the reason they’re not being approved here, is because you’re protecting an American life. So why would it be OK for another country?’’
The FDA says its oversight 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 said.
The PyroTitan had documented problems before it was embedded into Neszpor’s shoulder. The company had alerted the medical community in 2012 that some could break. At least 19 patients needed to have the PyroTitan removed, Neszpor among them.
After his surgery and in pain, Neszpor turned to Dr Desmond Soares, who questioned how the PyroTitan was approved for general use. Australia’s version of the FDA, the Therapeutic Goods Administration, said the reason is the PyroTitan had earned a CE mark, Europe’s version of device approval.
Several experts, including Wolfe, said this underscores a flaw in the US export-only process, because regulators in many countries do not conduct their own rigorous evaluations.
– AP/NBC News