76 THENEWYORKER,APRIL20, 2020
death. In 2012, studies of stent implan-
tation in more than seven thousand
patients found no benefit in prevent-
ing heart attacks or death in patients
who had the devices placed electively,
rather than in emergency circum-
stances, such as during a heart attack.
In 2007, the F.D.A. recalled the Sprint
Fidelis defibrillator, affecting more
than a quarter of a million patients,
almost two-thirds of whom were in
the U.S. Recently, some breast implants
have been associated with an aggres-
sive form of lymphoma. In 2013, thir-
ty-three thousand inferior-vena-cava
filters were recalled, after it emerged
that, rather than stopping blood clots
from reaching the heart, they actually
caused them to form.
T
he root of the problem, of course,
is money. In medicine, progress is
driven by innovation, and, in our society,
innovation is driven by profit. “Among
implant manufacturers,” Schneider
writes, “market analysis drives research
and consideration of device innova-
tion.” The implantable-device indus-
try is even more lucrative, for many
companies, than the pharmaceutical
industry is. At the largest companies,
operating-profit margins are typically
twenty-five per cent or higher. In 2014,
the industry’s over-all estimated reve-
nues totalled more than a hundred and
thirty-six billion dollars.
The financial incentives within this
industry are one of the reasons that
its lack of regulation is troubling. The
design teams at implant companies
include not only the companies’ en-
gineers and market experts but also
surgeons, who are recruited as consul-
tants. Most of them, Schneider writes,
are ethical, but the prospective payoff
for a successful product is “so huge
that one’s ethical standards can be se-
verely tested.” There is also the risk
that a surgeon’s enthusiasm for a given
creation will blind him or her to its
flaws, bold confidence sliding into per-
ilous hubris.
Schneider writes, “It is more likely
for Toyota to know about faulty ex-
haust pipes in a Prius than DePuy to
understand how a new hip implant is
performing in the United States.” A
registry of implants would enable the
F.D.A., doctors, and patients to access
data on their risks and benefits over
time, but the U.S. has no such regis-
try, unlike Canada, Australia, New Zea-
land, Japan, and several countries in
Europe. Schneider emphasizes how
these systems provide “valuable in-
formation about the longevity of an
implant when used in real-world con-
ditions by all surgeons.” A registry pre-
vents surgeons from “cherry-picking”
to exclude cases that would sully pa-
pers about implants they may have de-
signed, and protects against the gam-
ing of data.
Repeated efforts to implement a
registry system in the United States
have failed. The implant industry has
a powerful lobby in Washington, and
the courts and recent legislation have
made regulatory oversight more fee-
ble. Since lawsuits in state courts, where
personal-injury claims are filed, effec-
tively threaten to establish require-
ments that differ from those imposed
by the F.D.A., medical-device com-
panies argue that such suits should be
prëempted. In 2008, at the Supreme
Court, Justice Antonin Scalia, writing
for an eight-to-one majority, set legal
limits on implant liability in Riegel v.
Medtronic. The Court affirmed that
states cannot impose requirements
that are different from, or additional
to, those established by the F.D.A. The
decision not only kept many patients
from obtaining redress but, Lenzer
notes, also kept potential patients ig-
norant of safety issues, given that law-
suits often bring such problems to
light. The Court seemed to assume
that the approval process is bulletproof
and provides sufficient protection to
the public. “If that were the case, the
FDA would not have to recall about
eleven hundred devices annually,” Len-
zer dryly writes.
The 21st Century Cures Act, which
was signed into law by President
Obama in December, 2016, exacer-
bated potential dangers. Intended to
assist drug and device companies in
getting their products on the market
quickly, the act severely curtails F.D.A.
oversight of the medical-device in-
dustry, by lowering the level of scien-
tific evidence required for F.D.A. ap-
proval, and by allowing companies to
submit such evidence as individual
case reports, observational studies, andretrospective subgroup analyses. None
of these methods are rigorous. The
Cures Act also includes a provision
that allows manufacturers to gain ap-
proval of devices without F.D.A. in-
put, by hiring a third party to assess
whether their “quality system” is “ad-
equate.” Once this certification has
been awarded, a manufacturer may
proclaim that its device is both safe
and effective.
Given the Trump Administration
and Congress’s aversion to regulation,
a national registry is the most realis-
tic next step. Optimally, the F.D.A.
would also insist that devices undergo
at least two randomized clinical trials
with appropriate control groups, as
well as with sham-device groups when-
ever possible, to account for the pla-
cebo effect. Judicial changes—which
may be even harder to achieve, given
the 2008 ruling—would also enforce
stronger precautionary measures, en-
shrining much needed patient protec-
tions. Lenzer argues that we need leg-
islation to restore the right of patients
to sue if they are harmed by devices,
and calls for Congress to pass the Sun-
shine in Litigation Act; this bill, spon-
sored by Jerrold Nadler, would insure
that information uncovered during
product-liability suits can’t be kept se-
cret under nondisclosure agreements,
which prevent attorneys from notify-
ing the F.D.A. of the harm their cli-
ents have suffered.
Schneider writes that, “even under
the best of circumstances, patients are,
in effect, part of a large, uncontrolled
experiment, and when the regulatory
framework in a society is flimsy, slug-
gish, or nonexistent, is it any wonder
that patients can be harmed by the
thousands?” He argues that our “tech-
nological society” is essentially a lab-
oratory, and that, as consumers, we
participate in experiments every day.
That may be fine for the latest smart-
phone, but our body’s health and safety
are another matter. Human experi-
mentation with implants cannot de-
pend on a “social laboratory.” When
we submit to being cut, and to having
something implanted in our body, we
have a right to feel some level of confi-
dence that it has been shown to be safe
and beneficial, meaning that it has a
chance to cure.