The recent NY Times piece “Can Your Hip Replacement Kill You?” is a fine example of the importance of quality journalism. Jeanne Lenzer, an award-winning medical investigative journalist, writes a piece that is both compelling and revealing. She exposes the medical device industry for what it is- the “Wild West of medicine”.
Lenzer begins by sharing the story of Dr. Stephen Tower’s horrific ordeal with a metal-on-metal hip replacement, one that he specifically recommended to his surgeon. Tower specializes in complex hip replacement surgeries. What he endured and the medical nightmare that ensued has been experienced by thousands of ordinary citizens seeking hip replacement surgery.
Tower learned that surgical procedure was not the problem. The issue was solely defects in the medical device itself- the ASR XL, made by Johnson & Johnson.
Lenzer writes, “Despite Dr. Tower’s repeated efforts to warn his colleagues and the company that the implants were harming patients, Johnson & Johnson continued to market metal-on-metal hips. While it withdrew the ASR XL model from the market in 2010, citing slow sales, it continued to sell another, similarly problematic model, the Pinnacle, until 2013.
More than 9,000 patients filed suit against the company, and on Nov. 16, six New York patients won a $247 million trial verdict for serious harms caused by the Pinnacle hip implants and for failing to warn doctors and patients about its dangers.”
She notes, “About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, pacemakers, defibrillators, nerve stimulators, replacement lenses in eyes, heart valves and birth control devices. Medical interventions are now the third-leading cause of death in the United States, and devices play an increasing role in that statistic.”
Unlike the pharmaceutical industry, most high-risk devices on the market, including implants, have undergone no clinical testing at all. While the situation concerning medical devices is bad, it’s about to get worse if the Trump Administration has its way. The current administration believes that the industry should be further deregulated so that new technologies can get to the market and save lives. The truth, as exposed by Lenzer’s article, tells a different story. These untested and unregulated medical devices are costing lives, not saving them.
As a medical expert, Lenzer believes the only solution lies with the federal government assuming its proper role in oversight and regulation of an industry that has run amok. She concludes, “Returning to a system in which F.D.A. commissioners are civil servants is perhaps a first step, but it needs to be the first of many. As a government agency, the F.D.A. is supposed to serve as a bulwark between corporate profiteering and the public welfare. Its continued allowance of regulation loopholes like 510(k), despite the significant demonstrated cost to public welfare, calls into serious question the agency’s fulfillment of its stated mission to protect public health by ensuring safety, efficacy and security.”
Kudos to Jeanne Lenzer for a fine article and kudos to the NY Times for speaking truth to power.