Faulty implants in both the US (metal-on-metal hip implants) and Europe (breast implants) have put pressure on regulatory bodies to increase postmarket surveillance, as we've discussed previously. But this does leave an interesting niche for manufacturers are there devices that can be developed that can specifically be used for surveillance postapproval.
For example, although the technology has been available for several years, a recent article discussed the more widespread use of radiostereometric analysis (RSA) beads, which can be used to determine if a reconstructive joint implant is shifting postimplantation. Implanted at the same time as the replacement joint, these beads serve as markers that can be analyzed throughout the life span of an implant, allowing potential problems to be identified and addressed before they become severe. In one study, it was found that the number of revisions for total knee replacements decreased by 22 to 35% when RSA beads were used. This data can also be used to compare implant stability and revision rates using different types of materials, such as metal, plastic, and ceramic.
Maybe there are some other nifty devices that can be developed to fill the demand for postapproval tracking.