The Big Business of Devices

In an analysis of federal data, conducted and reported on by The New York Times, the Food and Drug Administration has received more than 5,000 reports since January of 2011 about several widely used hip replacement devices using metal-on-metal joints.  The number of reports the agency received surpassed the total amount about those devices in the previous four years combined.  All-metal replacement hips are on a trajectory to become the the largest medical implant problem since Medtronic recalled a widely used heart device component in 2007.

The report also noted that one of the most problematic hip replacement devices, the ASR, or Articular Surface Replacement, and was recalled last year by Johnson & Johnson accounted for 75 percent of the complaints.  While the increase in reports may be attributed to an increased awareness among the public and FDA because of the recall, the situation brought to light the FDA’s difficulties in relying upon device manufacturers to self-police.

Not surprisingly, in May of this year the FDA ordered postmarket surveillance studies be conducted by the manufacturers of the hip systems distributed in the U.S. to better understand possible adverse events associated with metal debris from metal-on-metal hip systems.  In the case of all metal implants, both the ball and socket of the artificial joint are made of metal.  When those two parts rub together during normal wear and tear, minuscule particles of metal can shed and be released into surrounding tissue and even into the bloodstream.  A valid concern of these patients is whether long-term exposure to the devices’ toxic metals can lead to health issues, localized as severe damage to tissue, including necrosis, infection and allergic reactions, and systemic as renal problems and cancer.  Even amid concerns about certain models of artificial hips, most patients have no problems.

The unconventional FDA action was partly driven by consumer complaints that the metal bearings, which should last up to 15 years, were exhibiting early failures.  Although the order was unprecedented, the problem with the FDA’s review is that thousands of patients already have had the replacement systems implanted and unfortunately too late to be of much good for those in pain.  As discussed earlier this month, the mounting pressures on the agency support the notion that the medical device approval process has notable flaws. 

Regardless of whether the device manufacturers or FDA is at fault, whether it is a consequence of hyper-aggressive marketing by the device companies to sway physicians to use their products or lack of oversight by the FDA, patients stand to lose the most.  More than 800,000 joint replacement procedures are done in the United States every year, according to the American Academy of Orthopaedic Surgeons.  Knee replacements are the most common, followed by hips.  With this sheer number of joint replacement surgeries performed annually, it is surprising that the government still does not have a national joint registry in place. 

Countries such as the United Kingdom, Australia, and Sweden have national joint registries, which monitor the performances of these types of devices.  The national joint registry is used to gather a patient’s basic information, hospital and surgeon information, the procedure and device used, as well as note if a patient has a revision surgery. The registries can used to identify a device that is defective or malfunctioning and is not working on par with other comparable devices.

The ASR system that was used extensively prior to its recall may have benefited from a U.S. joint registry to inform physicians and their patients of possible complications.  For instance, Australian surgeons had access to information in their national joint registry regarding the higher rates of revision surgery for the ASR system in 2007, leading to Australian physicians reluctance to use the device in hip replacement surgeries.  This played a role in the eventual withdrawal of the device from the Australian market in 2009 – in advance of the general recall here in the U.S. in 2010.

U.S. physicians do not have a national government-affiliated registry to reference regarding how well a certain device is performing.  There are various enterprises associated with hospital networks, but the dearth of information on a national scale is pronounced.  Additionally, in the current environment, the FDA typically relies upon companies to provide the agency with safety reports on their products.  In turn, the hip replacement safety issues support the idea that at times there is a basic difficulty with letting industry – and one can choose whichever industry one wants – be self-policing.  For instance, a medical journal alleged that Medtronic downplayed the risks of its spinal repair protein and failed to disclose millions of dollars in payments to the authors who wrote the initial studies of the product.  The spinal repair protein accounted for 85 percent, or $750 million, of Medtronic’s total spinal repair business, which is its second largest.

Medical devices are big business. Caveat emptor.