flimsy tail. The “tail” portion of the device was a porous thread, later
determined to be the cause of infections. Inserted into millions of women
starting in 1971, it led to thousands of hospitalizations, pregnancy
complications, pelvic inflammatory disease (PID) cases, infertility, and
even death. By 1975, it was obvious that a catastrophe was brewing, and
over 150,000 women filed lawsuits against the manufacturer, A.H. Robins
Company, the largest tort liability case since asbestos.^13 The Dalkon
Shield calamity was the type of crisis that forced Americans to ask, “How
can we let this happen?” Instead of young children dying, as in the
Sulfanilamide elixir tragedy, the victims were young women of
childbearing capability, now permanently scarred from PID and infertile.
The outrage over the lack of regulatory surveillance of the Dalkon Shield,
and similar concerns over faulty pacemakers, demanded a change from
Congress.
After several years of administrative and legislative wrangling, the
Medical Device Amendments of 1976 were signed into law by President
Gerald R. Ford—the most significant legislation ever passed regarding
medical devices. The Bureau of Medical Devices was formed, overseeing
the implementation of the 1976 Amendments. The law meant that any new
implantable device had to undergo a “premarket approval” (PMA); no
longer could a tinkerer fabricate an implant in his workshop garage and
implant it the next day, as John Charnley had been doing with total hip
implants for twenty years in Wrightington, England. As with drugs, the
new law stipulated that an application be filed by the device manufacturer.
For devices already on the market, a “grandfathering-in” was outlined, but
for new devices, a new PMA application was now necessary.
In 1982, the medical device and radiological bureaus were merged into
one organization, the Center for Device and Radiological Health (CDRH),
a division within the FDA. The CDRH regulates all medical devices and
radiological testing machines, and any device that emits electromagnetic
rays, such as microwave ovens and mobile phones. Perhaps its most
important role is sorting through applications for medical implants, such
as pacemakers, deep-brain stimulators, orthopedic joint replacements,
cochlear implants, and cardiac valves.
Similar to the dual pressures faced by the drug approval process,
manufacturers and patients are often frustrated by the FDA’s toilsome
exactitude and slow pace, but in the rare instance of a drug or device