When the law fails

FDA's 510(k) puts a seal of approval on medical devices with relative ease, leading both doctors and patients to believe that they are safe – but there is no safety testing or outcomes surveillance required or done.

by Hooman Noorchashm, MD, PhD, and Amy J. Reed, MD, PhD

Published Dec. 23, 2014, 5:30 a.m. ET

Consider this. Imagine a heavily travelled intersection with a faulty traffic light that turns green in both directions with a certain frequency. Imagine you and your loved ones are passing through that intersection, complete in your trust that the light will ensure safe passage. A deadly collision results. Your loved ones are severely injured, possibly dead. Now imagine you learn that this has been going on year after year, resulting in many deaths and immeasurable suffering. Now imagine that not only were your city officials aware of this problem, but that they sat together at a meeting where this specific faulty traffic light was discussed and warned against. Again imagine, the consensus was to do nothing. Who is to be indicted for such complacency? Are these democratically elected officials to even remain at their jobs?

This is the exact situation that is playing out in the case of a federal law governing the approval of a majority of medical devices by the United States Food and Drug Administration (FDA). It's called 510(k) and it puts a seal of FDA approval on medical devices with relative ease, leading both doctors and patients to believe that they are safe – but there is no safety testing or outcomes surveillance required or done.

In November of 2011, the distinguished United States senators of the Health, Education, Labor and Pensions (HELP) Committee were told that 510(k), "does not and cannot ensure patient safety". They were told this by a group of experts from the Institute of Medicine, after their exhaustive analysis of 510(k). But "Nothing" is exactly what our senators did about this public health hazard. Judge for yourselves here.

Let's be specific. In the November 2011 HELP committee hearing, US Senator Al Franken of Minnesota heard of this public health hazard and used his voice to promote and protect the interests of his state's medical device industry and economy over the safety of American patients. He chose to ignore or make light of the 510(k) safety hazard.

The overarching responsibility of our federal government and our senators is to protect the lives, property and rights of American citizens across the nation. Senator Franken may be a 'nice guy' and he may be a proclaimed progressive politician, but when it came to this single decisive opportunity to protect the American people, he sided with industry streamlining and local state economics – not the American lives that he must protect with resolve.

Pennsylvania Senator Bob Casey was there too, listening; seemingly distant.

And now this congressional failure to protect American lives has come knocking on all their doors. In December 2013, a set of 510(k) approved medical devices, known as power morcellators, were shown to have caused the premature or unnecessary deaths of many hundreds of American women for over 2 decades. The 510(k) hazard has come to roost for congress and the senators of the HELP committee.

The scale of danger intrinsic to the 510(k) legislation is larger than most Americans imagine. It is very certainly far more serious than most congressmen seem willing to admit. And its cost will be measurable in lives and dollars lost.

Do you think that the United States congress and our senators from PA will go back, revise their error and correct 510(k) to ensure patient safety?

In the coming weeks we will propose a few 'common sense' solutions for our senators to consider using to eliminate the 510(k) hazard.

Fixing 510(k) is not a political issue, it is a serious matter of public safety and good medicine in the United States – we wonder who, and what, our congressional representatives will choose to protect now.

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed's unsuspected uterine cancer was spread by the device during a routine hysterectomy.