An interesting issue arose at the last BME seminar regarding TJA total joint arthroplasty, where joint replacement surgeries advertised individuals doing high intensity or extreme sports 129 days after surgery. The sports include skiing, water boarding, dirt biking etc. While only few in vivo studies have been conducted in very recent years, the understanding of the joint mechanics on the artificial limb during extreme activites is extremely limited. The clinical trials associated with the approval of the device did not explore the possibility of the device being used under extreme conditions and in fact traditionally such activities have been discouraged. The speaker went on to discuss the increasing number of patients who go shopping around for doctors that will give them the okay to do extreme sports.

The question I want to present to you all is, do these devices need to go through the approval process again because the intended use has changed and the conditions the device is currently being used under is outside validated conditions in the clinical studies used to get approval? While the company is not advertising this, hospitals that use the implants are.
Also, technically the device can withstand the conditions of extreme sports as advertised, but the lifespan advertised will not be true if those activities are done. Note all the components of the different advertisements are true but are not necessarily putting each other into consideration when making the claim even though it is a reasonable assumption that consumers will assume that all the benefits in the different commercials are combinable. Do the interactions of these advertisements fall under the FDA jurisdiction for looking at the claims of the device?