FDA Panel Discussions on Metal-on-Metal Hip Implant Patient Safety Continues Today
June 28th, 2012 tmccoy
As discussed in my June 26th blog entitled Metal-on-Metal Hip Implant Safety Concerns to Be Addressed by FDA Panel on June 27 & 28, a U.S. Food and Drug Administration (“FDA”) advisory panel convened yesterday to explore whether new recommendations and advisements as to the safety of metal-on-metal (“MoM”) hip implants are warranted.
Of particular note was the position of multiple device manufacturers—including Johnson & Johnson (“J&J”) unit DePuy Orthopaedics, Inc.—that the respective companies’ implant devices are too dissimilar to be regulated as a single group. As a DePuy biostatistician commented, “[m]etal-on-metal products vary in their specific designs and in their clinical performance, and should be evaluated on their individual merits rather than as a class.” Additionally, Biomet and Medical Device Testing & Innovations, LLC vocalized their concern over a generalized class consideration, adding that there was growing frustration by a perceived lack of specificity in the data presented by researchers.
In contrast to the presentations by device industry was the patient recipient group, who focused largely on their intimate experience with device failure and the resulting health complications. A physical therapist who suffered three hip dislocations within a year of the initial implant strenuously argued in favor of a full FDA recall of all brands. Moreover, the patient presenter advocated for a national implant registry to track revision surgeries and thereby provide more accurate and real-time data for researchers.
The second-half of the panel is being held today; it is expected that today’s discussions will focus on soft tissue imaging and metal ion testing, with lengthy deliberations among panel members. There will not be a vote as to reclassification of the devices following today’s presentations.
