Bloomberg recently
announced that the Food & Drug Administration has bestowed its blessing on
a new “gender-specific” knee implant. Manufactured by Smith & Nephew, the new knee is designed to fit the
“unique anatomy” of a female. This is not the first knee- for- women-only. Last
year the FDA approved a similar knee made by Zimmer Holdings, the company that
takes credit for what it describes as a “bespoke knee” for women.
Will the new devices
allow women to function better? "In
theory, yes, but the evidence isn’t there," Kimberly Templeton, an
associate professor of orthopedic surgery at the University of Kansas Medical
Center and a spokesperson for the
seven studies now underway will look at patient satisfaction and range of
motion. Preliminary data will be available in a year or so.
In the meantime, these
couture knees for women are fetching twice as much as the plain-vanilla knees
that, until recently, were used for both men and women. But this is not the
FDA’s concern.
When it approves drugs
and devices it doesn’t ask whether the product is cost-effective, i.e. whether
it is any better than similar, less expensive products already on the market. And
neither does Medicare. Once a product receives FDA approval, Medicare usually
agrees to cover it (as it did in this case) and private insurers often follow
Medicare’s lead. Which means that in the end, we all pay for innovative new
products (whether or not they actually mark an advance in medical science) in
the form of higher insurance premiums, higher Medicare co-pays, and/ or higher
hospital bills. (Often Medicare’s reimbursements to hospitals that use an
expensive new device not reflect the added cost, and hospitals have no choice
but to shift the cost to other patients.
Which brings us to the obvious question: just
how different is the new design? Is it worth the extra dollars?
According to blogger Dr. William Barrett the new knee is both a little longer and a
little narrower than conventional knee replacements—and that’s about it. And in
fact, many manufacturers already offered knees that fit women perfectly well.
This isn’t really about design innovation, suggests Barrett, who practices with
Valley Orthopaedic Associates in Seattle, WA; it’s about marketing hype: “if we drill down and
look at the data,” he explains, we can see that the [companies’] claims are not
totally accurate…In general, there is a difference between the size of the male
and female knee with the male knee being slightly broader in the medial/lateral
direction in comparison to the female knee,” but Barrett points out that women
already get smaller knee replacements anyway. “When we look at the actual
implants used for the female, typically the smaller size range implants are
implanted in females and the larger size implants are implanted in males. If we
look at data from over 14,000 knee replacements performed at eight different
centers in the
over 75% of females received the smallest three sizes of a particular implant
line. Within these sizes, the fit for the female was ideal.”
“Less than a quarter of women had a larger sized implant”–-and in those
cases, Barrett acknowledges, “some overhang of the implant is possible” because
the knee is too wide. But he points out: “The company that promotes the
gender-specific knee . . . had wider implants then the average orthopedic company
in the marketplace. Therefore, they recognize an error in their implant
design and to correct this, added more implants (my emphasis). “The
reality,” he concludes, “is that most other implants fit the female knee quite
well.”
In other words, Zimmer saw that their
implants were too big and chose to create a new product to rectify this
problem. This is what marketers call “product extension.” You take a good
product, tweak it, and advertise it as the “new, new thing.” Tobacco companies have always been good at
this: recall the creation of “Virgina Slims” the sexy, sassy new cigarette for
women. (“You’ve come a long way baby”). Some years later, they created a new
longer, thinner version of Virginia Slims. The purpose was not entirely clear:
would it make your nose look shorter, your fingers look longer?
But
no doubt it sold, just as knees for women have sold. According to 2007
financial reports, knee replacements are Zimmer’s fastest growing product.
Reconstructive sales for the company are surpassing expectations: as of this past April,
there had been more than 14,000 implantations of the Gender Solutions Knee,
exceeding the company’s target of 12,000—despite the fact that the Gender
Solutions knees cost about twice as much as other implants.
no wonder. The gendered knee is backed by Zimmer’s first direct to consumer
marketing campaign, noted by commentators
as being a strategy attempting to “lure more women into the operating room.”
The gimmick of the campaign is a duo of “Blue Ladies,” created with the help of
R.O. Blechman, who is best known for his work with The New Yorker—check out a Zimmer ad incorporating his style here. With
television advertising rolled out in 23 markets around the country Zimmer is
spending $9.4 million on the ad campaign.
advertisements seem to be working: the company reports that “second quarter
[2007] sales significantly increased from the first quarter” and that the
company will now focus on “expanding availability in
market share.” And what a market it is: Women account for almost two thirds of
the 400,000 knee replacements performed annually in the
and the number of
knee replacements is expected to soar to almost 3.5 million by 2030. Zimmer is
readying a line of Gender Solutions hip implants as well. Women, we are told,
like the idea of custom-made joints.
But some doctors remain skeptical of the need for a knee specially made for
women. ABC
News quoted Dr. William Hozack, president of the American Association of Hip
and Knee Surgeons and professor of orthopedic surgery at
companies are attempting to do is make knee replacements with different shapes
that might better fit people (women among them) whose anatomy is slightly
different. That the companies are choosing to market to women is just that — a
marketing campaign.” Dr. Kevin J. Bozic, assistant professor of orthopedic
surgery and health policy at the
that “we don’t think the incremental change in the technology justifies the
cost.”
Still, Zimmer is doing all it can to make the Gender Solutions Knee a
must-have for doctors and surgeons, including sponsoring webcasts of knee transplants (performed,
perhaps unsurprisingly, by a doctor who “helped design” the Gender Solutions
Knee). And at the end of the day, if patients want a “gender-specific” knee,
doctors are likely to give it to them. This is something called consumer-driven
medicine—which sounds like a good idea. But can we afford it? I’ll be talking more
about this in the future.