Put safety at forefront for patients

By Hooman Noorchashm

In July, the Food and Drug Administration called for an advisory panel to assess the risks involved in a routine gynecological practice known as morcellation, which is used in women with symptomatic fibroid tumors of the uterus.

The practice involves mincing up the enlarged uterine tumors for the purpose of extracting them from the body using small incisions. Of course, the fundamental problem with this practice is that there is no way to know if the uterine tumor being emulsified by the morcellator has a cancer lurking within.

The FDA, and others, have now recognized that one in 350 to 500 women with symptomatic uterine fibroids are at risk of having their aggressive cancers spread and upstaged by morcellation. The data is very clear. Morcellation upstages early contained cancers in a minority subset of women with symptomatic fibroids and creates a potentially deadly disaster for the families affected.

I feel uniquely qualified to speak on this subject, both as a surgeon and because of my family's recent personal experience. In October, my wife underwent morcellation at one of the top hospitals in our country. As a result of the procedure, her early-stage cancer spread and "upstaged" to a life-threatening disseminated stage.

Since the FDA advisory, the gynecological industry and device manufacturers have been scrambling to defend their practices and product - though some have, at least temporarily, halted the practice. The Wall Street Journal recently reported that many gynecologists and device manufacturers are continuing their practice and marketing. Some seem to believe that the case being made against morcellation is merely an overblown public-relations campaign. One gynecologist even said of the FDA advisory: "It is none of their business."

Those who defend morcellation refuse to accept that many women have suffered and died, prematurely or unnecessarily, because morcellation has upstaged their potentially curable, early-stage cancers. Or, if they do know of this deadly peril, they seem comfortable accepting the avoidable collateral damage to some women. For them, it is the cost of doing the business of medicine.

What is the role of our federal government in protecting patients? Clearly the FDA advisory has not caused all gynecologists or device manufacturers to act in the best interest of all their patients' safety.

A major part of the problem is that the FDA itself is a split agency. In the food and drug arena, if a product is shown to cause a deadly illness in one in 350 to 500 people, it is pulled off the market. But the FDA's Center for Devices and Radiological Health (CDRH) is a different story.

The primary mission of the CDRH is to get "life-saving" technologies to the marketplace efficiently. Patient safety is secondary. At the moment, the CDRH has not made a final judgment on the morcellator disaster - despite the clear-cut evidence of deadly harm. Apparently the primary stakeholder for the CDRH is the device industry, not the patient and her safety.

The legislation governing the approval of a majority of medical devices, known as 510(k), is not designed to ensure patient safety. As a comprehensive review by the Institute of Medicine in 2011 demonstrated, 510(k) is designed for streamlined device entry into the market - it cannot ensure patient safety.

Thus, the reality is that a large number of increasingly advanced and expensive medical technologies are being FDA-approved under the 510(k) process and similar mechanisms, and go on to being reimbursed by Medicare and other insurance carriers. But there is no requirement for these devices to be proven safe or superior to preexisting devices. And the outcomes-reporting mandate on 510(k) is not strong enough to even pick up on deadly problems that might exist. That is why morcellators were devastating lives for 20 years and the FDA was oblivious to the harm until December 2013.

In essence, the CDRH is serving industry interests with a federal label of approval. And this fools patients and practitioners into believing that patient safety is being guarded by the government.

Perhaps it is time for the public to demand that the federal government realign and correct the FDA's mission and ensure that the CDRH is primarily committed to protecting patient safety and public health - not the device industry's bottom line.

Let's learn from the morcellator disaster and maintain a robust health-care establishment that truly puts patient safety first.