safely, as possible was immense. DePuy business leaders (and their
surgeon consultants) knew that a successful hip implant launch could
generate billions of dollars of revenue, and no doubt were buoyed with
optimism with McMinn’s early orthopedic meeting presentations.
DePuy submitted the ASR to the FDA for approval, and in a unique
twist, two versions of the ASR hip were submitted, both of which used the
same hip cup (acetabular component), but differed on the femoral side in
having either a long stem that would be impacted down the femoral canal
like a railroad spike (“ASR XL”), while the other “stemless” option would
essentially be a cap on top of the femoral head with a small central peg
designed to go down the femoral neck. It is surprising that the FDA never
approved the latter, stemless, option that most resembled the Birmingham
Hip, instead only authorizing the ASR XL in 2003. Both versions gained
approval in Europe and Australia that same year,^16 and soon the marketing
campaign was ramped up, with glitzy brochures and technique guides
being distributed to surgeons around the world.
Surgeons in Australia and throughout Europe began implant ASR hips
in 2004, and in America in December 2005,^17 but it only took a few years
(outside America) to know that something bad was happening with ASR
patients. The FDA, and its CDRH, were oblivious early on about early
implant failure within our borders, because there is no national implant
registry in the United States.
The first registry on joint prostheses was created almost fifty years ago at
the Mayo Clinic, the same year that one of its physicians became one of
the first surgeons in America to implant Charnley’s total hip.^18 In 1975,
Göran Bauer, professor of Orthopedics at Lund University, Sweden,
conceived a plan of establishing a national total knee registry (the
Swedish Hip Arthroplasty Register followed in 1979), requiring all
orthopedic surgeons in the country to collect baseline information and
faithfully track all patients. Bauer had trained in Sweden but spent seven
years in New York at the Hospital for Special Surgery where he served as
director of research. He returned to Sweden in 1969, just as joint
replacement was becoming an accepted procedure, and in decentralized