74 THENEWYORKER,APRIL20, 2020
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joints, especially shoulders, and, in the
later chapters of the book, he shifts his
gaze to what he calls “the implant rev-
olution,” looking toward a time when
surgery will mostly involve not the ex-
traction of diseased tissue but the plac-
ing of an artificial body part or other de-
vice within the patient. He celebrates
the innovators of such procedures, in-
cluding one in his own field, Charles
Neer, who co-authored a 1953 paper on
shoulder fractures which floated the idea
of using a prosthetic joint, a treatment
he went on to pioneer. Schneider writes
that Neer’s publication gave “a sneak pre-
view of the future, not just for surgery
of the shoulder, but for every joint. The
ability to implant foreign materials in
the body would awaken the imagination
of engineers, biologists, and surgeons,
and would usher in one of the most
significant upheavals in human history.”
I
n this country today, joint replace-
ment is commonplace, increasingly
just another rite of passage in aging.
Schneider catalogues the numbers. In
2014, surgeons replaced 522,800 hips,
723,100 knees, 90,000 shoulders, 15,000
elbows, 16,000 finger joints, 12,000 toe
joints, 2,000 ankles, and 2,000 wrists—a
total of nearly 1.4 million procedures.
By 2030, he estimates, there will be
some four million a year. Along with
metal and plastic implants, there are
electronic implants, such as cardiac
pacemakers; biological implants, such
as a transplanted heart or liver; and or-
ganic ones, in which a patient receives
a graft of sterilized non-living tissue,
such as bone or a hamstring, from a
deceased donor.
Implants such as pacemakers and
cardiac stents are clearly lifesaving, and
joint replacements, by keeping us mo-
bile, also extend and improve our lives.
But the benefits of many other devices
are more questionable. Some have
proved to be life-threatening, yet im-
plants continue to be marketed with
scant oversight. Writing that “Amer-
ica is embarrassingly behind the times
in tracking implants,” Schneider cites
Jeanne Lenzer’s “The Danger Within
Us” (2017), a carefully documented ex-
posé of the U.S. government’s abject
failure to regulate devices. Lenzer, an
investigative journalist who trained as
a physician associate, shows how the
medical-device industry has manipu-
lated the societal need for clinical in-
novation in order to prematurely mar-
ket products of unproven safety and
benefit.
By the end of the nineteen-sixties,
pressure was mounting for medical de-
vices to be regulated, in the way that
the Food and Drug Administration had
long done for pharmaceuticals. In 1970,
a committee of government officials,
led by the director of the National Heart
and Lung Institute, recommended con-
tinuing to treat devices differently. Six
years later, the Medical Device Amend-
ments to the long-standing Food, Drug
and Cosmetic Act put devices under
the supervision of the F.D.A. but with
a different system from the one that ap-
plied to pharmaceuticals. This system,
which remains the principal means of
regulating implants today, divided med-
ical devices into three classes. Class I
includes “low-risk” items, such as scal-
pels and bandages; Class II, “medi-
um-risk” devices, such as most artificial
hips and knees; and Class III, “high-
risk” devices, such as pacemakers.
In practice, there are few require-
ments that products in any of these
categories have to meet prior to wide
distribution. As Lenzer explains, most
Class I and some Class II devices are
“exempt from clearance or approval
and can simply be registered with the
FDA”; more invasive or complex de-
vices in these classes also face minimal
hurdles, requiring only that a manu-
facturer give the F.D.A. ninety days’
advance notice before marketing a
device. Unlike drugs, these items do
not need to be tested in clinical trials,
and they are said to be “cleared” rather
than “approved.”
The regulatory framework for
Class III devices is not much more
stringent. Although these tools are
meant to undergo a pre-market ap-
proval process, in which the manu-
facturer must provide “reasonable as-
surance” of their safety and efficacy, the
law has a major loophole: if a device
was sold before 1976, an updated ver-
sion can be released without new clin-
ical trials, so long as the manufacturer
deems it to be “substantially equiva-
