Taken from the January/February 2013 issue of The Women's Health Activist Newsletter.

The new metal hip prosthesis had been hailed as an innovation that would be more durable, and enable Katie to have more mobility, than a traditional plastic prosthesis. In 2010, however, the ASR^TM hip device was recalled when it was found that the metal’s wear and tear released toxic metal debris into patients’ bodies. Katie had to have a painful surgical procedure to replace her hip with a non-metal device. What Katie didn’t know when the ASR^TM model was recommended to her was that her surgeon had received over $600,000 in consulting income from DePuy, which may have influenced his decision to use that particular type of hip replacement.ⁱ

Making the Sale in Device Marketing

Consumers are increasingly aware that pharmaceutical companies market their products directly to physicians. But people are much less aware that medical devices — like prosthetic hips — are also promoted this way. (Medical devices are instruments and implements used in the diagnosis or treatment of a disease or other condition; devices can be simple, like bandages and crutches, or complex, like CT scanners and pacemakers. ⁱⁱ

As patients, we need to be aware of external influences in health care and of behind-the-scenes interactions that can affect our treatment, including surgeries. These influences include marketing drugs and devices to doctors who rely on industry representatives for information about new and forthcoming products. Marketing of both drugs and devices involve expensive, often aggressive campaigns. And, as with pharmaceutical companies’ marketing to doctors, medical device marketing to surgeons can affect patient treatment and outcomes. Drug and device manufacturers alike send sales representatives to meet with physicians and share information about their products — and both industries provide gifts, travel, and consulting opportunities that are designed to influence physicians’ care-giving decisions.

Device Representatives in the OR

Medical device representatives, however, don’t just make a sales pitch like drug reps; they actually train and assist surgeons before and during surgical procedures.ⁱⁱⁱ Many device reps have an active role in the operating room (OR). Reps are trained and certified in OR procedure and attend operations with the surgeon and surgical assistants. There, the reps may observe procedures, calibrate devices, provide instructions, troubleshoot and, in some cases, even direct the surgeon how to insert and/or position the device.

The device industry argues that the reps help both surgeons and patients by providing useful information and training. Their presence in the OR, proponents say, helps ensure that physicians use devices correctly and can reduce the amount of time needed for surgical procedures, thereby improving patient safety.^iv Yet, the device rep’s role in the OR raises crucial ethical questions about what’s best for the patient. Although the rep surely wants the surgery to be a success, he is still a salesperson promoting his company’s products and making a commission on any of his company’s products that are used in the OR.

While patients might feel uneasy about a sales rep taking an active role in their surgery, they may be even more concerned to learn that the reps could know more about the device and procedure than the surgeons themselves. Device companies teach reps how to use the products, and these reps then train surgeons to use the products. According to one device company spokesman, in the training classes, “the hands-on training is done mostly by the sales reps.”⁴

One might think that, after implanting a device numerous times, surgeons wouldn’t need to keep depending on reps for guidance. A nurse anesthetist at a large university hospital, who wished to remain anonymous, commented that the reps are needed when a surgeon is new to the equipment, then not needed as much “until the manufacturer comes up with a new device, which can be as small as a new type of screw.” She added that this sort of update “seems to occur rather frequently.” So, by the time surgeons are familiar enough with the device to operate without the rep’s presence, the device company has created an updated product. This makes the device appear to be newer (and therefore better), and the modification requires the device rep to continue troubleshooting surgeries, which maintains the relationship between sales rep and the surgeon, and builds sales and commissions.

This practice has led to nightmare scenarios. In one instance, EndoVascular Technologies found that a device that was used to treat aortic aneurysms was getting stuck in some patients’ bodies during surgery. In response, the company reps coached surgeons through an unapproved method to remove the company’s device by breaking it. This maneuver kept EndoVascular from having to file an adverse event or surgical conversion report to the Food and Drug Administration (FDA); the maneuver ended up causing 12 patient deaths and required many more patients to have more invasive surgeries to correct the problems caused by the unsafe procedure.

Medical Device Marketing vs. Science

When a medical device fails, patients face a real possibility of death, disability, chronic medical problems, or the need for additional operations — not to mention the accompanying physical, emotional, and financial costs. According to Public Citizen, over 200,000 medical device-related injuries and malfunctions and more than 2,000 device-related deaths are reported to the FDA every year.^v  How can this happen?

This situation is possible, says Dr. Michael Carome, co-author of Public Citizen’s Health Research Group’s report on medical devices, because, “unlike prescription and over-the-counter drugs, many moderate- and high-risk devices, including many that are surgically implanted, have either never been tested to ensure that they are safe and effective, or have undergone woefully inadequate testing.”^vi The FDA approves over 95 percent of moderate- and high-risk medical devices through the “510(k) process.” Under this process, approval for a new device is granted if it has “substantial equivalence” to (i.e., is very similar to) an existing, FDA-approved device in terms of its design, material, mechanism of action, or intended use. The 510(k) process does not require clinical trials. This means that patients essentially act as the device’s first test subjects. New devices that have been approved through the 510(k) process are as diverse and critical as heart defibrillators, brain shunts, and artificial joints like Katie’s DePuy ASR^TM hip replacement.

The FDA does require clinical trials for moderate- and high-risk devices when the new device is notsubstantially equivalent to an existing device. Unfortunately, these trials can be small and short-term (lasting just one or two years), which may not be enough to identify long-term problems. And, there is a lack of safety and efficacy data comparing new versions of medical devices with older ones.

What Can Be Done?

It’s impossible to know how often sales reps participate in surgeries, and the EndoVascular situation may be rare. But, it illustrates the very serious problems that can occur when sales reps and device companies, who have a financial stake in a device’s use, are relied on for surgical expertise and treatment decisions. This practice — along with the procedures used to regulate and implant devices — is a significant cause for concern and must be re-evaluated.⁶

At the legislative level, the device industry spends millions of dollars each year to lobby Congress in efforts to diminish oversight, accelerate approval, and expand loopholes. The rationale is that patients can be helped sooner, but fast-tracking devices clearly cuts corners on safety. As Public Citizen notes, “Congress instead should insist that standards be strengthened and that the FDA step up its efforts to remove demonstrably dangerous devices from the market.”⁶ Proposed legislation to strengthen and improve the current device regulation policy includes the Safety of Untested and New Devices Act of 2012, sponsored by Representative Edward Markey (D-MA) in the last Congress. While the bill never made it through committee review, it will hopefully be reintroduced in 2013.

Other efforts come from outside groups, including PharmedOut, a project at Georgetown University’s Medical Center, which educates doctors about industry marketing practices and encourages rational prescribing and device use. PharmedOut is currently studying the relationships between device representatives and surgeons in order to guide educational efforts for both health care providers and consumers (http://pharmedout.org).

If you are a patient facing a surgical procedure that involves a device insertion, what can you do?

First, ask your surgeon what kind of device will be implanted in your body. Ask if that device has undergone clinical trials or was approved through the FDA’s 510(k) process, and if any adverse events have been reported about it. You can also do your own research on the device’s track record — five or more years of success is good, and over 10 years is best. The “latest” model, with only a few years of reported safety and adverse event data, may not be as reliable as an older model that has stood the test of time. You can request copies of published studies on the device, check device registries such as www.MedicalDeviceRegistry.org, and research alternative devices on www.MedLine.com.

You can research whether your surgeon has any relationships or financial ties to device companies, and ask if a device rep will be in the OR during your procedure. If the surgeon doesn’t know the answers, your questions will demonstrate that patients want this information. You can always get a second doctor’s opinion.

Finally, you can call your Congressperson to voice your support for legislation, like Representative Markey’s bill, to improve the system, and do your part to ensure this important legislation gets passed.

Patient knowledge is power when it comes to making educated decisions about surgery. Patients should feel secure when they go under the knife, and must be assured that their health outcomes will not hinge upon the judgment of someone other than their professionally-trained surgeon.

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Nicole Dubowitz is Project Manager of PharmedOut.