A letter about FDA Approvals and Hip Resurfacing Components
by Dr. Gross
The Birmingham (Smith & Nephew, Richards)
total HSR was the first to get FDA approval in the US based on
an unprecedented FDA decision to approve this implant on the
basis of single (developing) surgeon’s foreign data. Cormet 2000
(Corin Ltd., Stryker) total HSR was the first to be approved
based on the usual mechanism of a US run Multi-center FDA study(
approval 7/2007, I was the lead investigator). Therefore, there
are now 2 implants available in the US that have an FDA
indication for total HSR.
The Recap/Magnum (Biomet), Conserve Plus (Wright Medical) and
ASR (Depuy) are all also FDA approved implants in the USA. They
may be legally used by any surgeon for the purpose of total Hip
Surface Replacement. (The FDA does not regulate how surgeons may
use approved implants.) However, the implant companies may not
promote them as total HSR devices. (The FDA does regulate how
implant companies may market approved implants.)
Approximately 20 different companies sell total HSR implants on
the worldwide market, including all of those mentioned above.
A specific use of an implant (or drug) that is approved by the
FDA is termed an FDA approved indication. As soon as a company
has received one indication for use of their implant (or drug),
the implant (or drug) is FDA approved. The use of this same
implant (or drug) for a purpose other than for the approved
indication is termed an off–label use. Off-label use is legal.
In fact, much of American medical practice involves off-label
use of drugs and implants. It would be impossible for the FDA to
regulate doctors’ practice in every situation. Actually the
Supreme Court has expressly stated that this is not the FDA role
(see Rehnquist opinion).
Many insurance companies do have contract clauses that deny
payment for "experimental" treatment. How to define what is
experimental is very controversial. However, "experimental" is
something altogether different than off-label use of implants
Therefore, an insurance company would be treading on thin ice if
they were to use FDA indications as a basis to deny payment.
South Carolina Joint Replacement Center