It comes as a shock to most Americans that the vast majority of medical devices used in hospitals across the nation do not undergo any clinical trials, safety testing or surveillance for harmful outcomes. The Food and Drug Administration (FDA) uses a piece of legislation commonly referred to as "510(k)" to formally "clear" medical devices despite it leading to an astonishing absence of adequate safety checks.
How could this be? The answer is simple. The medical device industry has an incredibly powerful, well-funded and focused lobby capacity. Unlike big Pharma, medical device companies are distributed across the nation and range from small companies with a few employees to multinational conglomerates, like Medtronic Inc.
So, a great number of congressional districts, both Democratic and Republican, around the country have constituents in the medical device industry with the ability to rally votes and campaign dollars. With such distributed lobby power, the focus of federal device legislation tends towards: 1) streamlining efficient delivery of "life-saving" devices into the marketplace and 2) providing more economic advantage to a well-funded industry that creates jobs.
The very serious trouble with this approach is that it neglects what the very focus of such legislation should be: patient safety. In the current situation, neither our congressional representatives, nor the medical device industry itself, have demanded that patient safety be the first and foremost priority of FDA legislation. And the patients that have been harmed and suffer are rarely in a powerful lobbying position.
Interestingly, the patient safety deficit within the medical device industry is almost in diametric opposition to the culture of safety that seems ingrained in the pharmaceutical industry – albeit imperfectly. Apparent throughout regulation and post-market follow up, patient safety is clearly emphasized in drug development and marketing. Why such an asymmetry between the device and drug industries? Many of the devices used in medicine reside in patients' bodies longer and have a more significant impact than does, say, a pill. So, one would think that federal safety standards should be even more strict with devices. But, in fact, the exact opposite is the case.
So we have a situation in which the medical device industry in the United States leaves subsets of patients vulnerable to severe harm because of the lack of safety testing and tight surveillance. And the federal legislation governing device authorization for marketing exacerbates the danger quite significantly. One would think that our representatives in federal government would be very concerned about this problem.
But what's incredible is that even members of congress whose specific and stated political platform is to protect the safety of the American people from corporate interests, seem reluctant to voice a concern about medical device safety standards. They have all been briefed about it by the Institute of Medicine's expert panel and know just how unsafe FDA's medical device legislation is.
But, jobs, campaign contributions and votes are at stake. Of course some very distinguished and powerful names come to mind: Senator Al Franken (D-MN), Senator Bob Casey (D-PA), Senator Elizabeth Warren (D-MA), and Senator Lamar Alexander (R-TN), to name a few.
What makes this regulatory failure on the part of the United States congress terribly troubling is that medical devices, whether safe or not, carry a label of FDA authorization. This FDA label on medical devices, creates an illusion of safety for the patients and practitioners who do not know any better. But, perhaps more unacceptable is that the FDA's 510(k) clearance label on medical devices effectively also serves to sway our court system away from delivering justice - where patients have been harmed by, or died, because of faulty medical devices.
Every American agrees that when an industry's safety failures become apparent, our congress has only one ethical responsibility and that is to listen, look and intervene decisively on behalf of those in harms way. But it takes courage to look at a disaster when both campaign coffers and votes may be compromised – and courage is in short supply today.
We have asked senators Alexander, Casey, Franken, Warren and all their colleagues in congress to look closely at the picture collage associated with this article – it was delivered to their Washington D.C. offices nearly one year ago.
We will find out soon, indeed, if courage is alive in the United States congress.
The faces in the picture collage here are of a group of women harmed, some dead, because of the safety failure in the FDA's 510(k) legislation. This picture was presented, for the public record, to an FDA expert panel on July 10-11, 2014. This panel had been convened to examine the scope of a deadly disaster caused by a medical device known as the "power morcellator" used in gynecological surgery.
The Wall Street Journal reporter, Jennifer Levitz, confirmed these women's horrific stories of harm and published the picture collage below on June 16, 2014. These women are "the guardians" and each of their courageous battles across the nation, must awaken our apparently punch-drunk congress into action.
The "morcellator disaster" is a severe systemic alarm and warning to all our congressional leaders and to the president: the medical device industry and the legislation governing it in the United States are not safe - this poses a hazard to many unsuspecting American patients, to our healthcare establishment, its insurance infrastructure and to the device industry itself.
If the women in the accompanying picture collage had been harmed in an airplane crash or by a terrorist attack, our congress and the White House would act immediately. But because these women were harmed by "life-saving devices" bearing a seal of FDA authorization - and because their cancers were spread by our own doctors using an unsafe practice that is claimed to "benefit the majority" - our federal government and its agency stands lethargic and ambivalent.
It is a question for public health history and for the American people to ponder and answer: what is the role of our federal government and its agencies, if not to protect the lives, rights and property of individual American citizens from harm - when the cause of a great harm is made visible? Is our system of federal government now guided by the politics of money, power, and popularity rather than its framing mission "to protect and to preserve the people"?
When our federal representatives ignore overwhelming facts and choose money, local state economics and the politics of power over the lives of American people across the nation – federal politics quickly turns into corrupted cowardice.
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.