There was a time when a label that stated “Made in the USA” was an assurance of quality, reliability, and safety. Not anymore. Patients in other parts of the world who are implanted with American-made medical devices such as artificial joints, stents, heart valves, and more are suffering needlessly because of manufacturing defects.
An investigation by NBC News has uncovered over a dozen “export-only” medical devices that have either been rejected by the FDA for domestic sales, or have not yet gotten FDA approval. NBC reports that at least 4,600 such devices have been registered with the FDA as “export only,” and that such exports make up over $41 billion in revenue for the industry.
Why? It is the same old story: profits over human health and safety. According to the story, several industry executives have admitted that registering new, untested devices as “export only” is “…faster, less expensive and has involved less oversight” than getting FDA approval for the domestic market. This was noted several years ago.
In 2011, a story in the New York Times reported that “medical device industry executives and investors are complaining vociferously… that the industry’s competitive edge in the United States and overseas is being jeopardized by a heightened regulatory scrutiny.” Those executives accused the FDA of overreacting in the face of heightened criticism brought on by recalls and accusations of lax oversight.
Meanwhile, the FDA says the issue is beyond their control. The agency “…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 NBC report was part of a larger effort by investigative reporters in 36 countries around the world in a project sponsored by the International Consortium of Investigative Journalists, which has been pursuing these stories for several months. It only covers a small part of what is becoming a major scandal, however.
Almost 40 years ago, Mother Jones published a story about the “dumping” in other countries of dangerous drugs and medical devices that have been forced off the US market. This practice has been going on since the 1960s, complete with the blessings and assistance of the State Department, the US Chamber of Commerce, and the Treasury Department.
Speaking out on the issue, Dr. Sidney Wolfe, co-founder of the consumer watchdog organization Public Citizen, said the issue “…raises a lot of ethical and moral and health questions…is an American life worth more than a British life or an Australian life?”
There were legislative attempts in the late 1990s to hold medical device manufacturers accountable for products sold overseas. Predictably, industry lobbyists pushed back hard, complaining that forcing such companies to track export products (as they are required to do for those sold domestically) would “impose substantial, unnecessary burdens.”
Today, those burdens are being borne by unsuspecting patients abroad who are being injured by medical devices determined to be unfit for those at home.