Gary Schwitzer writes on his blog “Health News Review” that he was “jolted” by a television commercial he saw recently for an artificial hip joint sold by medical device-maker Smith & Nephew.
The ad features athletic, fit, male body forms engaged in all sorts of strenuous pursuits; playing soccer, surfing, rock climbing up a craggy peak (!). The figures are rendered as stylized silhouettes but if I had to guess, I’d say they were designed with highly active men, age 40 to 50, in mind. Triatheletes and Ironmen wouldn’t be a stretch.
As Schwitzer notes, “it struck me that this younger demographic was the sole focus of the figures depicted in the commercial.”
Schwitzer would be right. The Smith & Nephew hip implant, called the Birmingham Hip Resurfacing System, is a newer kind of device that replaces just the damaged joint surfaces; not the complete joint. The femoral head is shaved down and covered by a metal cap and the hip socket is replaced with a metal cup. This procedure preserves some 3-4 inches more of the thigh bone than traditional total hip replacements. It’s being marketed as an alternative for active, younger patients (under 60) who are likely to outlive the implant and will need a total hip replacement 15 or 20 years down the road. By preserving more of the original joint, the theory is that the second surgery will be easier to perform and more successful. Two other companies now sell similar products; the Cormet Hip Resurfacing device (sold by Stryker) was approved by the FDA in 2007 and the Conserve Plus implant (sold by Wright Medical Group) got the nod in 2009.
According to data from the Millennium Research Group, the number of hip replacement or reconstructions in the US grew 2.0% in 2009 to 444,600 procedures. Some 60% of these procedures were total hip replacements, 24% were partial hip replacements, and 13% were “revision” hip replacements—meaning they were done to replace a worn-out or defective device. Just 4% were classified as hip resurfacings.
With the resurfacing procedure making up such a small segment of the market, you might wonder why Smith & Nephew would mount such a wide-spread—and expensive—direct-to-consumer marketing campaign for a rather arcane Class-III medical device. After all, the Birmingham system is no eyelash growing tonic or sleeping aid. Yet, it turns out that the company’s strategy is a good one: There’s serious money to be made in bringing younger people into the hip replacement market—especially if you are the one selling the implantable device.
Most hip replacements are used to alleviate severe pain and disability caused by osteoarthritis in the joint. The average age for a total hip replacement is currently 67 and most patients don’t live long enough to need revision surgery. But two main factors are fueling a growing demand for joint replacement in younger people—high levels of obesity (heavier people are more likely to have arthritis in weight-bearing joints and receive hip replacements some seven years earlier than non-obese adults) and the increased desire by many Americans to remain physically active long past middle age. A 2009 report on joint implants by Millennium Research Group found that, “hip resurfacing will be the fastest-growing segment of the large-joint reconstructive implant market through 2013, rising at a compound annual growth rate of over 25%.”
According to research from UBS, U.S. sales of total hip replacement implants increased 4.7% in 2009 to $2.54 billion. Of this total, Smith & Nephew implants made up just 12% of the market. Gaining a larger slice of that pie—or, better yet, expanding the pie to include a whole new demographic of young, active Americans, is sure to boost sales and profits. It also helps that hip resurfacing devices cost at least 20% more than the average price of a total hip replacement implant. And patients getting the surgery are far more likely to be covered by private insurance that pays a premium for the device, not the lower-reimbursing Medicare.
On their website, which features the advertising tag line, “Rediscover Your Go,” Smith & Nephew are quick to point out that the Birmingham device is not a total hip joint but a “hip resurfacing system” that conserves more bone than standard devices. “The benefits to patients of the BHR Hip technique and implant are significant. The implant’s head size, its bearing surfaces and its bone-sparing technique make it a preferred choice for active patients.”
But, the company adds, this “system” is not for everyone;
“Hip resurfacing is intended for active patients who are under 60 years of age and in need of a hip replacement. Adults over 60 who are living non-sedentary lifestyles may also be considered for this procedure. However, this can only be further determined by a review of bone quality.” [Note, the company doesn’t mention obesity as a barrier to the surgery. And in an on-line chat session about hip resurfacing conducted by the Cleveland Clinic, orthopedic surgeon Peter Brooks tells one participant, “Obesity is not a problem. My heaviest patient was 440 pounds.”]
Despite this seemingly limited market for hip resurfacing, patients are watching the television ads, visiting the website (which features a dozen or more testimonials from thrilled implant recipients who are out on the golf course, skiing and competing in weekend soccer leagues) and thinking, “Why can’t this be me?”
As prescription drug manufacturers have known for the last two decades, these images of renewed health and vitality are powerful sellers of name-brand pharmaceuticals. Implant manufacturers are discovering the same can be true for Class III medical devices. The overweight 55-year-old who does nothing more active than carry the garbage cans out to the curb sees the “Rediscover Your Go” ad on the evening news and part of him believes that if only he had that implant, he too could be climbing mountains or surfing. Never mind the fact that losing just 10 or 20 pounds could greatly alleviate the pain from his arthritic hip or that physical therapy or anti-inflammatory agents might also help. The underlying message of the ad is that this surgery is a risk-free, far better solution.
Just as in the case of prescription drug advertising, what’s missing from DTC device marketing is a rational discussion of risk. There’s no mention of the fact that the learning curve for surgeons is relatively steep for hip resurfacing surgery, with experts recommending that it would take 20 to 50 cases for a surgeon to become competent and another 20-50 each year to maintain his expertise. Even though it’s classified as “minimally invasive,” the incision is larger for hip resurfacing and there is more damage to the surrounding tissue. It can also be tricky to position the device correctly.
Meanwhile, red flags were raised in 2008 about the use of hip resurfacing implants in women. The New York Times reports: “[S]tudies from some countries where resurfacing has been used longer than in the United States, including Sweden and Australia, have repeatedly shown a higher failure rate for women who undergo the procedure than for men. Such women are more likely to need a second corrective operation soon after the first, compared with women who get a conventional full replacement hip, a recent British study found.
“And earlier this week, researchers released a study of resurfacing patients in the United States that raised similar cautions. The study, conducted by researchers at Rush University Medical Center in Chicago, indicated that complications from hip resurfacing were more frequent in women — of all ages — and in men over 55."
The problem is that because hip resurfacing preserves more of a patient’s thigh bone, this bone has to remain strong for years in order for the implant to continue functioning well. Some younger women (50-60, for example) may have problems with the device because they are experiencing bone weakening that can come with menopause. This bone weakening is what makes many older patients—male or female—in their late 60’s and 70’s poor candidates for resurfacing too.
Finally, according to the Times, the newer (and more functional) hip resurfacing systems like the Birmingham use metal-on-metal implants that can generate metallic debris as they wear, causing “severe inflammatory responses in some patients, damaging muscles and other soft tissues, requiring a follow-up operation to replace the device soon after implant — instead of the 15 or more years artificial hips are supposed to last.”
It’s clear to some surgeons that patients are not getting complete risk information about hip resurfacing systems. "Patients are coming in to see us with information from the internet or from television or other advertising and are asking for a particular type of implant or a specific surgical procedure," said William Maloney, chair of orthopedic surgery at Stanford University during a meeting of the Academy of Orthopaedic Surgeons. He added that he thought that DTC marketing of medical devices was "unethical and should be made illegal." When moderating a media briefing on the debate over hip-resurfacing during the 2008 AAOS Annual Meeting, Maloney said he felt that “direct-to-consumer advertising is driving patients to ask for the procedure without really understanding what is involved or even if they are suitable candidates.”
Recent studies are bearing this out. In 2009, a paper published in the journal Orthopedics found that almost 60% of patients said they would prefer a hip resurfacing procedure versus 8% who said they would rather have a conventional total hip replacement. In those that preferred hip resurfacing, 82% felt it was a safer procedure (which it isn’t), 79% thought there would be less soft tissue damage (there is more) and 80% felt they could return to their activities more quickly (debatable). “Patients' perceptions of hip resurfacing arthroplasty are inconsistent with the known published advantages and disadvantages of the procedure when compared to conventional” total hip replacement, the authors wrote.
Not surprisingly, 81% of patients said that they found out about hip resurfacing from sources other than an orthopedic surgeon; including from the internet (42%), family and friends (37%) and the newspaper (33%). “[P]rior to evaluation and discussion of treatment options, many of these patients present with a strong emotional bias toward hip resurfacing arthroplasty,” write the Orthopedics authors. Were there to be a similar study conducted this year, it’s likely that television would be the top source of information for these patients.
In the best case scenario, an orthopedic surgeon would tell a patient who came to an appointment asking for hip resurfacing that he or she was either too old, too sedentary or had some other issue that would make them unsuitable for the newer implant. In this scenario, the surgeon would also tell the patient if he wasn’t sufficiently trained in the resurfacing technique or hadn’t done enough of these surgeries to make it a reasonable risk. But we know that isn’t always the case, especially when the doctor wants to please the patient and/or is receiving payments from the company that makes the requested device. Patients clamoring for a particular name-brand drug are far more likely to leave the office with a prescription for that medication rather than a cheaper generic; why shouldn’t the same be true for medical devices?
Orthopedic implants are known as “physician preference items” because individual surgeons—not hospitals—choose which individual devices they use in their operating rooms. Cost is almost never considered. In a 2010 study of 45 California hospitals, researchers found great variation not only between the price of hip implants used at each hospitals, but also high within-hospital variation—reflecting the effect of individual physician preference. Costs for implants ranged from $3,645 to $11,308, with an average of $6,531, even after controlling for patient age, complications, and other variables.
This “physician preference” is more likely to reflect an alliance with a particular device manufacturer—who offers training, research funding and other financial support. A review by reporters at the Connecticut Health I-Team, a non-profit on-line journalism project, found that DePuy, a medical device maker owned by Johnson & Johnson, paid out more than $80.8 million to 200 physicians across the country in 2009 for promotion of hip-replacement parts, research and consultation. Two of DePuy’s hip replacement devices (that together had generated more than $5.4 million in sales in 2009) were pulled off the market last year because of a higher-than-expected rate of failure. Earlier, the FDA warned the company about selling two other hip replacement devices for unapproved uses.
As more Americans become candidates for hip replacements, Medicare is looking harder for ways to cut costs associated with the surgeries. In 2007, over $15 billion was spent on hip replacements—60% of that was paid for by Medicare. The breakdown looks something like this: surgeon fees represent just 5% of total hip replacement costs; post-discharge costs (physiotherapy, home-care, etc.) were 10%, the device itself represented 26% and hospital charges accounted for 59% of the cost. In the more recent California hospital study, the cost of the implant represented even more of the total Medicare reimbursement; ranging from a low of 27.4% to a high of 98.3%, with an average of 47.4%. This study found that in the case of commercial payers (who would likely be paying for younger hip implant recipients) the price of the implant represented an average of 30.4% of total reimbursement.
If you look at the trends in reimbursement, device makers are the clear winners in the hip replacement market. A 2007 report in the journal Current Opinion in Orthopaedics found that Medicare reimbursements for surgeons actually dropped between 1994 and 2005 by 39%, payments to hospitals went up 24%, yet the price of hip implant devices increased by a whopping 127%. It’s hard to imagine that technological breakthroughs alone could drive device costs to rise so sharply.
Together, hip and knee replacement surgeries already represent the largest hospital expense for Medicare. And, according to an article in Time magazine, the money spent on these two procedures is expected to reach $65.2 billion by 2015.
There is no doubt that part of Medicare reform will involve looking at ways to reduce this cost. One approach is to move the choice of device away from vague “physician preference” and toward evidence-based criteria. The goal will be to use comparative-effectiveness studies to identify which implants are the best-performing, longest-lasting and most cost-effective devices. Many countries have established national registries for hip and knee implant surgeries that include a record of each surgery, the type of device used and reports of complications. Such a registry would improve patient safety and quality of care, according to a report by Kaiser Permanente researchers that was published in November in the Journal of Bone and Joint Surgery. It would make it easier to counsel patients, identify risk factors, track implanted devices during recalls and assess comparative effectiveness of devices, according to lead author Elizabeth Paxton, director of surgical outcomes and analysis at Kaiser.
The American Joint Replacement Registry was created recently, and just this January began a pilot project collecting hip and knee replacement information from 16 representative hospitals. In a statement, the organization (made up of surgeons, executives from the device industry, payers and patient representatives) said that its “long-term goal is to capture data from 90 percent of U.S. hospitals where hip and knee arthroplasty procedures are performed, which amounts to between 5,000 and 6,000 different hospitals, in the next 5 years.”
In the end, marketing devices directly to consumers is antithetical to these other measures that are designed to promote evidence-based treatments. One argument that drug companies have always made to support their DTC ads is that they are “educational” for consumers. And there may in fact be men in their 40’s or 50’s with degenerative hip disease or other painful, disabling condition that learn about hip resurfacing from a TV ad. Maybe they find out that they don’t have to spend 15 more years disabled as they wait for a total hip replacement. These newly educated fellows may then go to an orthopedic surgeon who (with no conflict of interest) helps them decide whether this is the right approach for them. That is educational.
But DTC ads cast a very wide net. And they work to draw in a wide customer base, raising expectations and brushing over risks and cheaper options. If they didn’t do this, companies like Smith & Nephew wouldn’t spend millions running them. Unless insurers—both public and private—start using evidence-based decision making to set coverage for new hip implant devices, the number of younger patients undergoing more expensive procedures will likely rise—sometimes for the wrong reasons.