malfunction or calamity, the FDA is criticized for lax standards or
haphazard clearance. Among the worst FDA failures ever was the
inappropriate clearance given to the makers of Thalidomide, which
horrendously caused phocomelia in newborn infants, a condition in which
the intrauterine development of the babies’ arms and legs is short-
circuited, leading to grotesquely shorted limbs with the abnormal hands
and feet attached just inches from the shoulders or hips. In the worst cases
all four limbs were affected, and given the fact that the defects occurred in
so many children, with lifetime dire consequences, the FDA’s “never
again” response was understandable.
There have been similar failures among approved implants, and in these
instances, manufacturers, hospitals, physicians, and the FDA have blood
on their hands. One of the most prominent examples of systemic failure is
still ongoing, with injured patients all around us. Over 40,000 Americans
and almost 100,000 patients worldwide underwent total hip replacement
with the DePuy Articular Surface Replacement (ASR) hip implants, which
was finally withdrawn from the world market on August 26, 2010.
Settlements from almost ten thousand plaintiffs will likely require DePuy
(a Johnson & Johnson company) to shell out almost $4 billion. How did a
tragically flawed total hip arrive (and stay) on the market for seven years?
It is arguable that hip replacement is the most successful operation in
the world, considering the dramatic decrease in pain and improvement in
function, combined with a low incidence of infection and need for re-
operation. Some have even called it the “operation of the century.”^14 In
some ways, however, the spectacular success of hip replacement in the
elderly led to a temptation on the part of surgeons and patients to push the
boundaries of mechanical durability, attempting replacements in ever
younger and more active patients. From the 1960s to the 1990s the gold
standard in joint replacement was a stemmed implant down the femoral
canal (secured with bone cement), an acetabular (hip socket) component
impacted into bone, and a polymer (polyethylene) liner in the metal cup.
This proved to be long-lasting in the elderly, but the polymer lining, like
any mechanical bushing, was prone to wear and eventual failure.
Mechanical engineers continued to ponder “alternative bearing surfaces,”
wondering if there was another combination of metals and plastics that
could allow for arthroplasty in younger, more active recipients.