“The medical implant system is part of a larger healthcare system and
consists of diverse relationships between regulatory and other governance
bodies, commercial organizations, practitioner stakeholders such as
surgeons, and patients,” writes Matthias Wienroth and his coauthors in
their analysis of the ASR failure.^33 In our “technological society,”^34
society itself operates as a laboratory, where the experimental space has
extended to include the market and consumers.^35 Testing of implants
should not stop in the lab; quite to the contrary, it is crucial that
continuation of testing and surveillance is mandatory. Even under the best
of circumstances, patients are, in effect, part of a large, uncontrolled
experiment,^36 and when the regulatory framework in a society is flimsy,
sluggish, or nonexistent, is it any wonder that patients can be harmed by
the thousands?
To this surgeon, it is unconscionable that there is no national joint
registry in the United States of America. One can be a free market
capitalist and simultaneously recognize that every stakeholder in
American medicine must do better. Eleven countries in the world track
every single total knee and total hip replacement performed, and it was
these countries that alerted American patients and manufacturers that
something terrible was occurring with the ASR hip. Momentum is slowly
building for an American joint registry, but until it becomes mandatory, I
can guarantee readers that regulatory rigor mortis will continue. The law
of unintended consequences has meant that the Health Information
Portability and Accountability Act of 1996 (HIPAA) actually complicates
the tracking of outcomes while protecting patients’ privacy, but serious
work is being done to establish a national and international joint registry.
The FDA’s International Consortium of Orthopedic Registries (ICOR) was
launched in 2010 to coordinate registries in fourteen nations, however
ironic it was to lead a consortium when the founding nation does not,
itself, have a registry.
Of course, an American joint registry should not stop with tracking
knee and hip replacements. For the millions of patients who undergo
implantation of pacemakers, heart valves, cochlear implants, shunts,
catheters, stimulators, anchors, vertebral cages, organs, and electronic
implants, a bona fide surveillance system is vital, in both senses of the
word. The implant revolution will lead to possibilities we simply cannot
fathom, and the recipients of implants (be they alloy, polymer, or tissue,