Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 > Dr. Mark, > > You're the guy with the medical letters after his name. Does the FDA > letter to give you any pause...or give you any reason to > reconsider your own resurf? To choose another direction, or only to > wait a while before your surgery? > > Alan Alan, Good questions. No it does not worry me. It seems like the main issue is violation of the protocols (ei poor follow-up, use of unapproved devices with approved devices, poor record keeping, bad patient selection (Some patients are just not good candidates for this kind of initial study. It is important to use the best patients to get the best results). The devices or technique are not in question. Obviously long-term follow-up is necessary for the final analysis as to whether this will be a successful procedure compared to THR. But it is not going to prevent me from proceeding onward with my surgery on July 21. Hope that answers your questions. Regards, Dr. Mark Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 26, 2004 Report Share Posted May 26, 2004 One tries not to presume answers to questions...but that's the answer I was hoping for. > > Dr. Mark, > > > > You're the guy with the medical letters after his name. Does the > FDA > > letter to give you any pause...or give you any reason to > > reconsider your own resurf? To choose another direction, or only > to > > wait a while before your surgery? > > > > Alan > > Alan, > Good questions. No it does not worry me. It seems like the main > issue is violation of the protocols (ei poor follow-up, use of > unapproved devices with approved devices, poor record keeping, bad > patient selection (Some patients are just not good candidates for > this kind of initial study. It is important to use the best patients > to get the best results). The devices or technique are not in > question. Obviously long-term follow-up is necessary for the final > analysis as to whether this will be a successful procedure compared > to THR. But it is not going to prevent me from proceeding onward > with my surgery on July 21. Hope that answers your questions. > Regards, > Dr. Mark Quote Link to comment Share on other sites More sharing options...
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