A letter about FDA Approvals and Off Label 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 and drugs.
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