That might mean the same operators would be using the same devices repeatedly, and problems with the devices noticed more quickly.
However, Nissen insists FDA's rules need to be changed so that many of these dangerous, life-sustaining or life-saving devices will get more scrutiny.
AdvaMed struck back this week calling the Archives study "seriously flawed," inaccurate and misleading, and said the bulk of 510(k) devices are safe and have not been recalled. The organization said "the real problem at FDA is growing delays and inconsistency in product reviews, which is denying patients access to safe and effective diagnostics and treatment.
"Today, because of FDA delays and inefficiency, foreign patients benefit from new treatments two to three years sooner than American patients," even when those products are manufactured in the U.S., the group said.
The volume on this controversy is certain to be turned up on this issue today, as the Health subcommittee of the House Committee on Energy and Commerce convenes to hear the issue.
Nissen attended, telling the lawmakers that "it is no longer reasonable to compare modern medical products with devices marketed as long as 35 years ago."
Co-author Zuckerman agrees. "You have to understand how obvious a problem with one of these devices has to be before it is recognized and a device is recalled," she tells me. "If a 75-year-old person has a heart valve, and they die years later, that's just recorded as a death from heart disease. If there is no autopsy, no one will know if it was caused by a defective heart valve. But these less obvious problems would show up in well-designed clinical trials."