Thousands of medical devices made in U.S. are approved ...

This is misleading. F D A does not allow export-only devices to be sold in the U.S. -- not for any reason of safety or effectiveness --but simply because F D A has not reviewed and approved, or maybe even received, a marketing application for these devices.

Important to note: Companies seeking to export devices from the U.S. must assure that the devices meet the regulatory requirements of the destination country. Generally, this means confirming the devices satisfy the specifications of the foreign purchaser; are not in conflict with the laws of the country to which they are exported; are labeled as intended for export; and are not sold in U.S. commerce.

Thousands of medical devices made in U.S. are approved only for sale overseas

NBC Nightly News transcript: 11/24/18

Now to our NBC News investigation into medical devices and the danger some of them may pose. It's part of a global reporting effort with the International Consortium of Investigative Journalists. Tonight, we look at devices that are made here in the U.S. but are approved for sale and use only overseas. Katie Beck reports on one patient and what he went through as he battled excruciating pain.

Wolfgang Neszpors was thrilled to find a solution to his failing shoulder.

Wolfgang: "I thought I was really gonna get something out of it."

He had surgery in Australia, where he lives, to replace a damaged shoulder joint with a new one made of carbon fiber. 2 months later, the 36-year-old's condition had gone from bad to worse.

Wolfgang: "It was a stupid amount of pain"

His doctor eventually removed the device and found it had cracked.

Dr. Desmond Soars: "underneath in the bone there was black powdery fragments which was obviously the disintegrating carbon from the pyroTITAN implant."

Neszpor's shoulder implant - called the pyroTITAN - is made in New Jersey by Integra Life Sciences. While it is made in the USA, the FDA won't allow it to be sold here. It's classified as export only, meaning it can be sold only in foreign countries a practice questioned by consumer health experts.

Dr. Sidney Wolfe: "Why should any medical device that isn't good enough, approvable enough, in this country to be sold, be sold to other people in other countries?"

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. Export only products are just part of the $41 billion industry of U.S. medical devices sold overseas.

Dr. Sidney Wolfe: "and the device industry is growing"

An NBC News investigation found more than a dozen exportonly devices with concerning records, but the FDA says it 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. Australian authorities ordered a recall in 2016 , and 19 patients needed to have the pyrotitan removed. The device never lost FDA approval for sale outside the United States.

The maker says, "today the pyroTITAN meets all the regulatory, safety, and performance requirements." Meanwhile, Neszpor says the ordeal forced him to have a complete shoulder replacement. A tough prescription to swallow for the father of six.

Wolfgang (through tears): "you sit here and mull over it, you can't do the things that you wanna do."

He trusted an American product, and assumed its safety had U.S. approval. Katie Beck, NBC News.

Thanks, Katie. For more on medical device dangers, our NBC News broadcast exclusive global investigation spanning 36 countries. Visit NBC and watch NBC News tomorrow and Monday.

Dr. Wolfe is making a gross assumption. There are many reasons a company may choose to market a device in one country instead of another, including the size of the market; are providers willing to adopt a new technology; will there be adequate reimbursement; is there a distribution network in place; etc.

Again this is misleading. Exportonly devices are not evaluated by F D A because no U.S. marketing application has been submitted. F D A is not able to serve as the policeman for devices exported around the world that are not distributed in the U.S.

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