Guest guest Posted April 30, 2004 Report Share Posted April 30, 2004 > Hello everyone! My brain is exploding with all of the information I > have been getting. > > I am still struggling with insurance, but hoping for the best. > Apparently, my case is in 'utilization review' & I may find out at > the last minute & be off to Dr. Gross in 2 weeks. > > At this point I feel confident that most of the Doctor's discussed > are very good. > > I have one last major question before I go, maybe some of you know: > > In researching JRI in California, I found out that they use s > Conserve + for Hip Resurfacing, & the same company for Total Hip > Replacement. They say that these devices fit well together if you > need to convert the resurfacing to a total hip in the future. (You > don't have to replace all the parts, just add some) > This is one big advantage. > > I am trying to plan for the future & potential problems. Does > anyone know what device Dr. Gross uses for a hip resurfacing & for a > total hip. If I were to need to have my resurfacing converted in > the future, would I have to fly to South Carolina, or can local > doctors in Colorado access the same device from the company that Dr. > Gross uses? > > Does anyone know if the device he uses is the same one they use at > JRI? > > Obviously, I am hoping for the best & hoping that I won't have to do > another surgery, but I do have to plan for that in case it becomes > reality. > > Thank you for all of your support & help! > > I have already learned so much! > > ...be advised that and Nephew (a medical equipment company) has just purchased the emormously popular Birmingham Resurfacing device and it will be available for use in the United States very soon. It's the one that's been used very sucessfully in Europe for many years. Just thought you might want to take that into consideration when discussing resurfacing devices with the OS's. The only reason I happen to know this is because a friend of ours works for and Nephew. Best of Luck with your search. Susie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 30, 2004 Report Share Posted April 30, 2004 > Hello everyone! My brain is exploding with all of the information I > have been getting. > > I am still struggling with insurance, but hoping for the best. > Apparently, my case is in 'utilization review' & I may find out at > the last minute & be off to Dr. Gross in 2 weeks. > > At this point I feel confident that most of the Doctor's discussed > are very good. > > I have one last major question before I go, maybe some of you know: > > In researching JRI in California, I found out that they use s > Conserve + for Hip Resurfacing, & the same company for Total Hip > Replacement. They say that these devices fit well together if you > need to convert the resurfacing to a total hip in the future. (You > don't have to replace all the parts, just add some) > This is one big advantage. > > I am trying to plan for the future & potential problems. Does > anyone know what device Dr. Gross uses for a hip resurfacing & for a > total hip. If I were to need to have my resurfacing converted in > the future, would I have to fly to South Carolina, or can local > doctors in Colorado access the same device from the company that Dr. > Gross uses? > > Does anyone know if the device he uses is the same one they use at > JRI? > > Obviously, I am hoping for the best & hoping that I won't have to do > another surgery, but I do have to plan for that in case it becomes > reality. > > Thank you for all of your support & help! > > I have already learned so much! > > ...be advised that and Nephew (a medical equipment company) has just purchased the emormously popular Birmingham Resurfacing device and it will be available for use in the United States very soon. It's the one that's been used very sucessfully in Europe for many years. Just thought you might want to take that into consideration when discussing resurfacing devices with the OS's. The only reason I happen to know this is because a friend of ours works for and Nephew. Best of Luck with your search. Susie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 30, 2004 Report Share Posted April 30, 2004 : Oh, an exploding brain - sounds messy! Dr. Gross uses the Corin Cormet 2000 resurfacing system. I asked him what he would do if I needed to be revised someday and he said Corin makes a " conventional " stemmed femoral component that is sized to work with the Cormet acetabular (socket) component and it would be no problem if it was ever necessary. By the way, this is true of all three major systems (C+, C2K, and BHR). I have heard from others on this list that Dr. Desmet has stemmed femoral components that match the BHR cups. Any doctor who works with Corin devices, and is well versed in revision surgery should be able to do it - it's available anywhere (it's not part of the resurfacing system that is not yet FDA approved). Personally, I would go back to Dr. Gross - I think you will understand this after you meet him and talk to him for a while. Besides, think positive, you are not going to need a revision! Others will have to fill you in with regards to JRI. Best of luck with the insurance companies! RC2K Dr. Gross 3/24/04 > Hello everyone! My brain is exploding with all of the information I > have been getting. > > I am still struggling with insurance, but hoping for the best. > Apparently, my case is in 'utilization review' & I may find out at > the last minute & be off to Dr. Gross in 2 weeks. > > At this point I feel confident that most of the Doctor's discussed > are very good. > > I have one last major question before I go, maybe some of you know: > > In researching JRI in California, I found out that they use s > Conserve + for Hip Resurfacing, & the same company for Total Hip > Replacement. They say that these devices fit well together if you > need to convert the resurfacing to a total hip in the future. (You > don't have to replace all the parts, just add some) > This is one big advantage. > > I am trying to plan for the future & potential problems. Does > anyone know what device Dr. Gross uses for a hip resurfacing & for a > total hip. If I were to need to have my resurfacing converted in > the future, would I have to fly to South Carolina, or can local > doctors in Colorado access the same device from the company that Dr. > Gross uses? > > Does anyone know if the device he uses is the same one they use at > JRI? > > Obviously, I am hoping for the best & hoping that I won't have to do > another surgery, but I do have to plan for that in case it becomes > reality. > > Thank you for all of your support & help! > > I have already learned so much! > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 30, 2004 Report Share Posted April 30, 2004 : Oh, an exploding brain - sounds messy! Dr. Gross uses the Corin Cormet 2000 resurfacing system. I asked him what he would do if I needed to be revised someday and he said Corin makes a " conventional " stemmed femoral component that is sized to work with the Cormet acetabular (socket) component and it would be no problem if it was ever necessary. By the way, this is true of all three major systems (C+, C2K, and BHR). I have heard from others on this list that Dr. Desmet has stemmed femoral components that match the BHR cups. Any doctor who works with Corin devices, and is well versed in revision surgery should be able to do it - it's available anywhere (it's not part of the resurfacing system that is not yet FDA approved). Personally, I would go back to Dr. Gross - I think you will understand this after you meet him and talk to him for a while. Besides, think positive, you are not going to need a revision! Others will have to fill you in with regards to JRI. Best of luck with the insurance companies! RC2K Dr. Gross 3/24/04 > Hello everyone! My brain is exploding with all of the information I > have been getting. > > I am still struggling with insurance, but hoping for the best. > Apparently, my case is in 'utilization review' & I may find out at > the last minute & be off to Dr. Gross in 2 weeks. > > At this point I feel confident that most of the Doctor's discussed > are very good. > > I have one last major question before I go, maybe some of you know: > > In researching JRI in California, I found out that they use s > Conserve + for Hip Resurfacing, & the same company for Total Hip > Replacement. They say that these devices fit well together if you > need to convert the resurfacing to a total hip in the future. (You > don't have to replace all the parts, just add some) > This is one big advantage. > > I am trying to plan for the future & potential problems. Does > anyone know what device Dr. Gross uses for a hip resurfacing & for a > total hip. If I were to need to have my resurfacing converted in > the future, would I have to fly to South Carolina, or can local > doctors in Colorado access the same device from the company that Dr. > Gross uses? > > Does anyone know if the device he uses is the same one they use at > JRI? > > Obviously, I am hoping for the best & hoping that I won't have to do > another surgery, but I do have to plan for that in case it becomes > reality. > > Thank you for all of your support & help! > > I have already learned so much! > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 30, 2004 Report Share Posted April 30, 2004 In response to what Susie wrote: Whoa!!! Not so fast! Being purchased by a US company does not mean the BHR will be automatically approved by the FDA. If it does speed up the process, something's wrong with the process. Not to put a wet blanket on the party ... but that's reality. Fred Gross C2K 1/21/04 > > Hello everyone! My brain is exploding with all of the information > I > > have been getting. > > > > I am still struggling with insurance, but hoping for the best. > > Apparently, my case is in 'utilization review' & I may find out at > > the last minute & be off to Dr. Gross in 2 weeks. > > > > At this point I feel confident that most of the Doctor's discussed > > are very good. > > > > I have one last major question before I go, maybe some of you know: > > > > In researching JRI in California, I found out that they use s > > Conserve + for Hip Resurfacing, & the same company for Total Hip > > Replacement. They say that these devices fit well together if you > > need to convert the resurfacing to a total hip in the future. (You > > don't have to replace all the parts, just add some) > > This is one big advantage. > > > > I am trying to plan for the future & potential problems. Does > > anyone know what device Dr. Gross uses for a hip resurfacing & for > a > > total hip. If I were to need to have my resurfacing converted in > > the future, would I have to fly to South Carolina, or can local > > doctors in Colorado access the same device from the company that > Dr. > > Gross uses? > > > > Does anyone know if the device he uses is the same one they use at > > JRI? > > > > Obviously, I am hoping for the best & hoping that I won't have to > do > > another surgery, but I do have to plan for that in case it becomes > > reality. > > > > Thank you for all of your support & help! > > > > I have already learned so much! > > > > > > ...be advised that and Nephew (a medical equipment > company) has just purchased the emormously popular Birmingham > Resurfacing device and it will be available for use in the United > States very soon. It's the one that's been used very sucessfully in > Europe for many years. Just thought you might want to take that into > consideration when discussing resurfacing devices with the OS's. The > only reason I happen to know this is because a friend of ours works > for and Nephew. Best of Luck with your search. Susie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted April 30, 2004 Report Share Posted April 30, 2004 You are correct. The BHR will still be subject to clinical trials because it is a Class III device. This will be true even after the Corin and devices are finally approved. in NC C+ 3/31/03 (L), Dr. Vail > > > Hello everyone! My brain is exploding with all of the > information > > I > > > have been getting. > > > > > > I am still struggling with insurance, but hoping for the best. > > > Apparently, my case is in 'utilization review' & I may find out > at > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > At this point I feel confident that most of the Doctor's > discussed > > > are very good. > > > > > > I have one last major question before I go, maybe some of you > know: > > > > > > In researching JRI in California, I found out that they use > s > > > Conserve + for Hip Resurfacing, & the same company for Total Hip > > > Replacement. They say that these devices fit well together if > you > > > need to convert the resurfacing to a total hip in the future. > (You > > > don't have to replace all the parts, just add some) > > > This is one big advantage. > > > > > > I am trying to plan for the future & potential problems. Does > > > anyone know what device Dr. Gross uses for a hip resurfacing & > for > > a > > > total hip. If I were to need to have my resurfacing converted > in > > > the future, would I have to fly to South Carolina, or can local > > > doctors in Colorado access the same device from the company that > > Dr. > > > Gross uses? > > > > > > Does anyone know if the device he uses is the same one they use > at > > > JRI? > > > > > > Obviously, I am hoping for the best & hoping that I won't have > to > > do > > > another surgery, but I do have to plan for that in case it > becomes > > > reality. > > > > > > Thank you for all of your support & help! > > > > > > I have already learned so much! > > > > > > > > > > ...be advised that and Nephew (a medical equipment > > company) has just purchased the emormously popular Birmingham > > Resurfacing device and it will be available for use in the United > > States very soon. It's the one that's been used very sucessfully > in > > Europe for many years. Just thought you might want to take that > into > > consideration when discussing resurfacing devices with the OS's. > The > > only reason I happen to know this is because a friend of ours > works > > for and Nephew. Best of Luck with your search. Susie Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 1, 2004 Report Share Posted May 1, 2004 > > > > Hello everyone! My brain is exploding with all of the > > information > > > I > > > > have been getting. > > > > > > > > I am still struggling with insurance, but hoping for the best. > > > > Apparently, my case is in 'utilization review' & I may find out > > at > > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > > > At this point I feel confident that most of the Doctor's > > discussed > > > > are very good. > > > > > > > > I have one last major question before I go, maybe some of you > > know: > > > > > > > > In researching JRI in California, I found out that they use > > s > > > > Conserve + for Hip Resurfacing, & the same company for Total > Hip > > > > Replacement. They say that these devices fit well together if > > you > > > > need to convert the resurfacing to a total hip in the future. > > (You > > > > don't have to replace all the parts, just add some) > > > > This is one big advantage. > > > > > > > > I am trying to plan for the future & potential problems. Does > > > > anyone know what device Dr. Gross uses for a hip resurfacing & > > for > > > a > > > > total hip. If I were to need to have my resurfacing converted > > in > > > > the future, would I have to fly to South Carolina, or can local > > > > doctors in Colorado access the same device from the company > that > > > Dr. > > > > Gross uses? > > > > > > > > Does anyone know if the device he uses is the same one they use > > at > > > > JRI? > > > > > > > > Obviously, I am hoping for the best & hoping that I won't have > > to > > > do > > > > another surgery, but I do have to plan for that in case it > > becomes > > > > reality. > > > > > > > > Thank you for all of your support & help! > > > > > > > > I have already learned so much! > > > > > > > > > > > > > > ...be advised that and Nephew (a medical equipment > > > company) has just purchased the emormously popular Birmingham > > > Resurfacing device and it will be available for use in the United > > > States very soon. It's the one that's been used very sucessfully > > in > > > Europe for many years. Just thought you might want to take that > > into > > > consideration when discussing resurfacing devices with the OS's. > > The > > > only reason I happen to know this is because a friend of ours > > works > > > for and Nephew. Best of Luck with your search. Susie The time frame for approval of the Birmingham seems to be sometime in the next year. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 1, 2004 Report Share Posted May 1, 2004 > > > > Hello everyone! My brain is exploding with all of the > > information > > > I > > > > have been getting. > > > > > > > > I am still struggling with insurance, but hoping for the best. > > > > Apparently, my case is in 'utilization review' & I may find out > > at > > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > > > At this point I feel confident that most of the Doctor's > > discussed > > > > are very good. > > > > > > > > I have one last major question before I go, maybe some of you > > know: > > > > > > > > In researching JRI in California, I found out that they use > > s > > > > Conserve + for Hip Resurfacing, & the same company for Total > Hip > > > > Replacement. They say that these devices fit well together if > > you > > > > need to convert the resurfacing to a total hip in the future. > > (You > > > > don't have to replace all the parts, just add some) > > > > This is one big advantage. > > > > > > > > I am trying to plan for the future & potential problems. Does > > > > anyone know what device Dr. Gross uses for a hip resurfacing & > > for > > > a > > > > total hip. If I were to need to have my resurfacing converted > > in > > > > the future, would I have to fly to South Carolina, or can local > > > > doctors in Colorado access the same device from the company > that > > > Dr. > > > > Gross uses? > > > > > > > > Does anyone know if the device he uses is the same one they use > > at > > > > JRI? > > > > > > > > Obviously, I am hoping for the best & hoping that I won't have > > to > > > do > > > > another surgery, but I do have to plan for that in case it > > becomes > > > > reality. > > > > > > > > Thank you for all of your support & help! > > > > > > > > I have already learned so much! > > > > > > > > > > > > > > ...be advised that and Nephew (a medical equipment > > > company) has just purchased the emormously popular Birmingham > > > Resurfacing device and it will be available for use in the United > > > States very soon. It's the one that's been used very sucessfully > > in > > > Europe for many years. Just thought you might want to take that > > into > > > consideration when discussing resurfacing devices with the OS's. > > The > > > only reason I happen to know this is because a friend of ours > > works > > > for and Nephew. Best of Luck with your search. Susie The time frame for approval of the Birmingham seems to be sometime in the next year. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 1, 2004 Report Share Posted May 1, 2004 Susie, What are you basing approval of the BHR on? Medical (Conserve Plus) is the only company that has submitted an application to the FDA for marketing approval in the US and that was back in December. To my knowledge, it has not been approved by the FDA. The BHR will not be able to be submitted until their clinical trials have been completed. I hope that you are correct but there is a process that the FDA requires. I think that it's irresponsible to make statements that are not reality based, that may give people false hope in the timing of the approval. Fred Gross, C2K 1/21/04 > > > > > Hello everyone! My brain is exploding with all of the > > > information > > > > I > > > > > have been getting. > > > > > > > > > > I am still struggling with insurance, but hoping for the > best. > > > > > Apparently, my case is in 'utilization review' & I may find > out > > > at > > > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > > > > > At this point I feel confident that most of the Doctor's > > > discussed > > > > > are very good. > > > > > > > > > > I have one last major question before I go, maybe some of you > > > know: > > > > > > > > > > In researching JRI in California, I found out that they use > > > s > > > > > Conserve + for Hip Resurfacing, & the same company for Total > > Hip > > > > > Replacement. They say that these devices fit well together > if > > > you > > > > > need to convert the resurfacing to a total hip in the future. > > > (You > > > > > don't have to replace all the parts, just add some) > > > > > This is one big advantage. > > > > > > > > > > I am trying to plan for the future & potential problems. > Does > > > > > anyone know what device Dr. Gross uses for a hip resurfacing > & > > > for > > > > a > > > > > total hip. If I were to need to have my resurfacing > converted > > > in > > > > > the future, would I have to fly to South Carolina, or can > local > > > > > doctors in Colorado access the same device from the company > > that > > > > Dr. > > > > > Gross uses? > > > > > > > > > > Does anyone know if the device he uses is the same one they > use > > > at > > > > > JRI? > > > > > > > > > > Obviously, I am hoping for the best & hoping that I won't > have > > > to > > > > do > > > > > another surgery, but I do have to plan for that in case it > > > becomes > > > > > reality. > > > > > > > > > > Thank you for all of your support & help! > > > > > > > > > > I have already learned so much! > > > > > > > > > > > > > > > > > > ...be advised that and Nephew (a medical > equipment > > > > company) has just purchased the emormously popular Birmingham > > > > Resurfacing device and it will be available for use in the > United > > > > States very soon. It's the one that's been used very > sucessfully > > > in > > > > Europe for many years. Just thought you might want to take > that > > > into > > > > consideration when discussing resurfacing devices with the > OS's. > > > The > > > > only reason I happen to know this is because a friend of ours > > > works > > > > for and Nephew. Best of Luck with your search. Susie > > > The time frame for approval of the Birmingham seems to be sometime in > the next year. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 1, 2004 Report Share Posted May 1, 2004 Hi Fred I think Sue could be correct from what posted a little while ago. BHR manufacturers could apparently present their case based on the similarities of the prothesis and shortcut the system. Please ask to explain as I'm not an American but just remember his post. Rog BHR both sides 2001 Treacy Re: Exploding Brain > In response to what Susie wrote: Whoa!!! Not so fast! Being > purchased by a US company does not mean the BHR will be > automatically approved by the FDA. If it does speed up the process, > something's wrong with the process. Not to put a wet blanket on the > party ... but that's reality. > Fred > Gross C2K 1/21/04 > > > > > Hello everyone! My brain is exploding with all of the > information > > I > > > have been getting. > > > > > > I am still struggling with insurance, but hoping for the best. > > > Apparently, my case is in 'utilization review' & I may find out > at > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > At this point I feel confident that most of the Doctor's > discussed > > > are very good. > > > > > > I have one last major question before I go, maybe some of you > know: > > > > > > In researching JRI in California, I found out that they use > s > > > Conserve + for Hip Resurfacing, & the same company for Total Hip > > > Replacement. They say that these devices fit well together if > you > > > need to convert the resurfacing to a total hip in the future. > (You > > > don't have to replace all the parts, just add some) > > > This is one big advantage. > > > > > > I am trying to plan for the future & potential problems. Does > > > anyone know what device Dr. Gross uses for a hip resurfacing & > for > > a > > > total hip. If I were to need to have my resurfacing converted > in > > > the future, would I have to fly to South Carolina, or can local > > > doctors in Colorado access the same device from the company that > > Dr. > > > Gross uses? > > > > > > Does anyone know if the device he uses is the same one they use > at > > > JRI? > > > > > > Obviously, I am hoping for the best & hoping that I won't have > to > > do > > > another surgery, but I do have to plan for that in case it > becomes > > > reality. > > > > > > Thank you for all of your support & help! > > > > > > I have already learned so much! > > > > > > > > > > ...be advised that and Nephew (a medical equipment > > company) has just purchased the emormously popular Birmingham > > Resurfacing device and it will be available for use in the United > > States very soon. It's the one that's been used very sucessfully > in > > Europe for many years. Just thought you might want to take that > into > > consideration when discussing resurfacing devices with the OS's. > The > > only reason I happen to know this is because a friend of ours > works > > for and Nephew. Best of Luck with your search. Susie > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 1, 2004 Report Share Posted May 1, 2004 > > > > > > Hello everyone! My brain is exploding with all of the > > > > information > > > > > I > > > > > > have been getting. > > > > > > > > > > > > I am still struggling with insurance, but hoping for the > > best. > > > > > > Apparently, my case is in 'utilization review' & I may > find > > out > > > > at > > > > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > > > > > > > At this point I feel confident that most of the Doctor's > > > > discussed > > > > > > are very good. > > > > > > > > > > > > I have one last major question before I go, maybe some of > you > > > > know: > > > > > > > > > > > > In researching JRI in California, I found out that they > use > > > > s > > > > > > Conserve + for Hip Resurfacing, & the same company for > Total > > > Hip > > > > > > Replacement. They say that these devices fit well > together > > if > > > > you > > > > > > need to convert the resurfacing to a total hip in the > future. > > > > (You > > > > > > don't have to replace all the parts, just add some) > > > > > > This is one big advantage. > > > > > > > > > > > > I am trying to plan for the future & potential problems. > > Does > > > > > > anyone know what device Dr. Gross uses for a hip > resurfacing > > & > > > > for > > > > > a > > > > > > total hip. If I were to need to have my resurfacing > > converted > > > > in > > > > > > the future, would I have to fly to South Carolina, or can > > local > > > > > > doctors in Colorado access the same device from the > company > > > that > > > > > Dr. > > > > > > Gross uses? > > > > > > > > > > > > Does anyone know if the device he uses is the same one > they > > use > > > > at > > > > > > JRI? > > > > > > > > > > > > Obviously, I am hoping for the best & hoping that I won't > > have > > > > to > > > > > do > > > > > > another surgery, but I do have to plan for that in case it > > > > becomes > > > > > > reality. > > > > > > > > > > > > Thank you for all of your support & help! > > > > > > > > > > > > I have already learned so much! > > > > > > > > > > > > > > > > > > > > > > ...be advised that and Nephew (a medical > > equipment > > > > > company) has just purchased the emormously popular > Birmingham > > > > > Resurfacing device and it will be available for use in the > > United > > > > > States very soon. It's the one that's been used very > > sucessfully > > > > in > > > > > Europe for many years. Just thought you might want to take > > that > > > > into > > > > > consideration when discussing resurfacing devices with the > > OS's. > > > > The > > > > > only reason I happen to know this is because a friend of > ours > > > > works > > > > > for and Nephew. Best of Luck with your search. Susie > > > > > > The time frame for approval of the Birmingham seems to be sometime > in > > the next year. Fred, I apologize for any false hopes....but don't be so defensive... was just asking a very general question...and I wanted to let her know about the BHR because I personally have a very unusual hip disorder, Protrusio Acetabulum, or " Otto Pelvis " and am more of a candidate for this device than the others because of the various stems available with the BHR which are not available on the others. ....and if she happened to have a quirky joint geometry that was more suited to the BHR maybe it would be worth the wait, or a trip to Belgium or England. Quite possibly she doesn't have any special considerations at all in which case she could just use the other devices that are further advanced here in their trials. Back off, Fred, I'm just trying to be helpful. The and Nephew rep is the one who quoted the aproximate time frame. Do you work for Medical? Have you had a resurfacing? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 2, 2004 Report Share Posted May 2, 2004 I think there is a way they can argue their device is " substantially similar " as another device but I don't know the exact regulations. I would have thought that could have used that same approach since their M-o-M total hip system was FDA approved as was the Conserve Hemi-Resurfacing system. I would have thought they could make the point that Conserve Plus is just a combination of those two, already approved, devices. Let's all hope the BHR can get approved quickly - that's just one more good option for patients in the U.S. RC2K Dr. Gross 3/24/04 > > > > Hello everyone! My brain is exploding with all of the > > information > > > I > > > > have been getting. > > > > > > > > I am still struggling with insurance, but hoping for the best. > > > > Apparently, my case is in 'utilization review' & I may find out > > at > > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > > > At this point I feel confident that most of the Doctor's > > discussed > > > > are very good. > > > > > > > > I have one last major question before I go, maybe some of you > > know: > > > > > > > > In researching JRI in California, I found out that they use > > s > > > > Conserve + for Hip Resurfacing, & the same company for Total Hip > > > > Replacement. They say that these devices fit well together if > > you > > > > need to convert the resurfacing to a total hip in the future. > > (You > > > > don't have to replace all the parts, just add some) > > > > This is one big advantage. > > > > > > > > I am trying to plan for the future & potential problems. Does > > > > anyone know what device Dr. Gross uses for a hip resurfacing & > > for > > > a > > > > total hip. If I were to need to have my resurfacing converted > > in > > > > the future, would I have to fly to South Carolina, or can local > > > > doctors in Colorado access the same device from the company that > > > Dr. > > > > Gross uses? > > > > > > > > Does anyone know if the device he uses is the same one they use > > at > > > > JRI? > > > > > > > > Obviously, I am hoping for the best & hoping that I won't have > > to > > > do > > > > another surgery, but I do have to plan for that in case it > > becomes > > > > reality. > > > > > > > > Thank you for all of your support & help! > > > > > > > > I have already learned so much! > > > > > > > > > > > > > > ...be advised that and Nephew (a medical equipment > > > company) has just purchased the emormously popular Birmingham > > > Resurfacing device and it will be available for use in the United > > > States very soon. It's the one that's been used very sucessfully > > in > > > Europe for many years. Just thought you might want to take that > > into > > > consideration when discussing resurfacing devices with the OS's. > > The > > > only reason I happen to know this is because a friend of ours > > works > > > for and Nephew. Best of Luck with your search. Susie > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 2, 2004 Report Share Posted May 2, 2004 I think there is a way they can argue their device is " substantially similar " as another device but I don't know the exact regulations. I would have thought that could have used that same approach since their M-o-M total hip system was FDA approved as was the Conserve Hemi-Resurfacing system. I would have thought they could make the point that Conserve Plus is just a combination of those two, already approved, devices. Let's all hope the BHR can get approved quickly - that's just one more good option for patients in the U.S. RC2K Dr. Gross 3/24/04 > > > > Hello everyone! My brain is exploding with all of the > > information > > > I > > > > have been getting. > > > > > > > > I am still struggling with insurance, but hoping for the best. > > > > Apparently, my case is in 'utilization review' & I may find out > > at > > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > > > At this point I feel confident that most of the Doctor's > > discussed > > > > are very good. > > > > > > > > I have one last major question before I go, maybe some of you > > know: > > > > > > > > In researching JRI in California, I found out that they use > > s > > > > Conserve + for Hip Resurfacing, & the same company for Total Hip > > > > Replacement. They say that these devices fit well together if > > you > > > > need to convert the resurfacing to a total hip in the future. > > (You > > > > don't have to replace all the parts, just add some) > > > > This is one big advantage. > > > > > > > > I am trying to plan for the future & potential problems. Does > > > > anyone know what device Dr. Gross uses for a hip resurfacing & > > for > > > a > > > > total hip. If I were to need to have my resurfacing converted > > in > > > > the future, would I have to fly to South Carolina, or can local > > > > doctors in Colorado access the same device from the company that > > > Dr. > > > > Gross uses? > > > > > > > > Does anyone know if the device he uses is the same one they use > > at > > > > JRI? > > > > > > > > Obviously, I am hoping for the best & hoping that I won't have > > to > > > do > > > > another surgery, but I do have to plan for that in case it > > becomes > > > > reality. > > > > > > > > Thank you for all of your support & help! > > > > > > > > I have already learned so much! > > > > > > > > > > > > > > ...be advised that and Nephew (a medical equipment > > > company) has just purchased the emormously popular Birmingham > > > Resurfacing device and it will be available for use in the United > > > States very soon. It's the one that's been used very sucessfully > > in > > > Europe for many years. Just thought you might want to take that > > into > > > consideration when discussing resurfacing devices with the OS's. > > The > > > only reason I happen to know this is because a friend of ours > > works > > > for and Nephew. Best of Luck with your search. Susie > > > > > > > > > > > > Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 2, 2004 Report Share Posted May 2, 2004 Susie, I did not intend to offend you with my posts. I truly apologize that I did offend you and put you on the defensive. I did not think that I was being defensive, only advising caution in the FDA approval process. To answer your questions: Yes, I had my right hip resurfaced by Dr. Gross this past January. No, I do not work for Medical. My choice for Dr. Gross led to me receiving the Corin - Cormet 2000 hip prosthesis. The mfr. of the device did not matter to me as much as the surgeon. ly I don't care which one is approved first, don't care about the order in which devices are approved and hope that they all are approved this year. Personally, I probably would have had my resurfacing done a year earlier had I not naively assumed that the devices would be approved late 2002 or 2003. I could have changed insurance policies to make it happen but I had a belief, that resurfacing made sense, the components were approved for other procedures (hemi-arthroplasty and M-O-M THR but not when used together) and therefore it was logical for the FDA to approve it. Manufacturers like & Nephew are bound to show optimism in matters such as FDA approval of the device. It's good PR and justifies to stockholders their decision for purchasing the BHR. Your comments based on what you were told by the & Nephew rep struck a nerve with me and I thought that an unbiased discussion was warranted. Again, I'm sorry that I offended you. Thank you to and for adding to the discussion of this important subject. Fred Gross, C2K 1/21/2004 > > > > > > > Hello everyone! My brain is exploding with all of the > > > > > information > > > > > > I > > > > > > > have been getting. > > > > > > > > > > > > > > I am still struggling with insurance, but hoping for the > > > best. > > > > > > > Apparently, my case is in 'utilization review' & I may > > find > > > out > > > > > at > > > > > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > > > > > > > > > At this point I feel confident that most of the Doctor's > > > > > discussed > > > > > > > are very good. > > > > > > > > > > > > > > I have one last major question before I go, maybe some of > > you > > > > > know: > > > > > > > > > > > > > > In researching JRI in California, I found out that they > > use > > > > > s > > > > > > > Conserve + for Hip Resurfacing, & the same company for > > Total > > > > Hip > > > > > > > Replacement. They say that these devices fit well > > together > > > if > > > > > you > > > > > > > need to convert the resurfacing to a total hip in the > > future. > > > > > (You > > > > > > > don't have to replace all the parts, just add some) > > > > > > > This is one big advantage. > > > > > > > > > > > > > > I am trying to plan for the future & potential problems. > > > Does > > > > > > > anyone know what device Dr. Gross uses for a hip > > resurfacing > > > & > > > > > for > > > > > > a > > > > > > > total hip. If I were to need to have my resurfacing > > > converted > > > > > in > > > > > > > the future, would I have to fly to South Carolina, or can > > > local > > > > > > > doctors in Colorado access the same device from the > > company > > > > that > > > > > > Dr. > > > > > > > Gross uses? > > > > > > > > > > > > > > Does anyone know if the device he uses is the same one > > they > > > use > > > > > at > > > > > > > JRI? > > > > > > > > > > > > > > Obviously, I am hoping for the best & hoping that I won't > > > have > > > > > to > > > > > > do > > > > > > > another surgery, but I do have to plan for that in case > it > > > > > becomes > > > > > > > reality. > > > > > > > > > > > > > > Thank you for all of your support & help! > > > > > > > > > > > > > > I have already learned so much! > > > > > > > > > > > > > > > > > > > > > > > > > > ...be advised that and Nephew (a medical > > > equipment > > > > > > company) has just purchased the emormously popular > > Birmingham > > > > > > Resurfacing device and it will be available for use in the > > > United > > > > > > States very soon. It's the one that's been used very > > > sucessfully > > > > > in > > > > > > Europe for many years. Just thought you might want to take > > > that > > > > > into > > > > > > consideration when discussing resurfacing devices with the > > > OS's. > > > > > The > > > > > > only reason I happen to know this is because a friend of > > ours > > > > > works > > > > > > for and Nephew. Best of Luck with your search. Susie > > > > > > > > > The time frame for approval of the Birmingham seems to be > sometime > > in > > > the next year. > > Fred, I apologize for any false hopes....but don't be so > defensive... was just asking a very general question...and I > wanted to let her know about the BHR because I personally have a very > unusual hip disorder, Protrusio Acetabulum, or " Otto Pelvis " and am > more of a candidate for this device than the others because of the > various stems available with the BHR which are not available on the > others. ....and if she happened to have a quirky joint geometry that > was more suited to the BHR maybe it would be worth the wait, or a > trip to Belgium or England. Quite possibly she doesn't have any > special considerations at all in which case she could just use the > other devices that are further advanced here in their trials. Back > off, Fred, I'm just trying to be helpful. The and Nephew rep > is the one who quoted the aproximate time frame. Do you work for > Medical? Have you had a resurfacing? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 2, 2004 Report Share Posted May 2, 2004 Thank you also to in N.C. for his post after my origninal post. Fred Gross, C2K 1/21/04 > > > > > > > > Hello everyone! My brain is exploding with all of the > > > > > > information > > > > > > > I > > > > > > > > have been getting. > > > > > > > > > > > > > > > > I am still struggling with insurance, but hoping for > the > > > > best. > > > > > > > > Apparently, my case is in 'utilization review' & I may > > > find > > > > out > > > > > > at > > > > > > > > the last minute & be off to Dr. Gross in 2 weeks. > > > > > > > > > > > > > > > > At this point I feel confident that most of the > Doctor's > > > > > > discussed > > > > > > > > are very good. > > > > > > > > > > > > > > > > I have one last major question before I go, maybe some > of > > > you > > > > > > know: > > > > > > > > > > > > > > > > In researching JRI in California, I found out that > they > > > use > > > > > > s > > > > > > > > Conserve + for Hip Resurfacing, & the same company for > > > Total > > > > > Hip > > > > > > > > Replacement. They say that these devices fit well > > > together > > > > if > > > > > > you > > > > > > > > need to convert the resurfacing to a total hip in the > > > future. > > > > > > (You > > > > > > > > don't have to replace all the parts, just add some) > > > > > > > > This is one big advantage. > > > > > > > > > > > > > > > > I am trying to plan for the future & potential > problems. > > > > Does > > > > > > > > anyone know what device Dr. Gross uses for a hip > > > resurfacing > > > > & > > > > > > for > > > > > > > a > > > > > > > > total hip. If I were to need to have my resurfacing > > > > converted > > > > > > in > > > > > > > > the future, would I have to fly to South Carolina, or > can > > > > local > > > > > > > > doctors in Colorado access the same device from the > > > company > > > > > that > > > > > > > Dr. > > > > > > > > Gross uses? > > > > > > > > > > > > > > > > Does anyone know if the device he uses is the same one > > > they > > > > use > > > > > > at > > > > > > > > JRI? > > > > > > > > > > > > > > > > Obviously, I am hoping for the best & hoping that I > won't > > > > have > > > > > > to > > > > > > > do > > > > > > > > another surgery, but I do have to plan for that in > case > > it > > > > > > becomes > > > > > > > > reality. > > > > > > > > > > > > > > > > Thank you for all of your support & help! > > > > > > > > > > > > > > > > I have already learned so much! > > > > > > > > > > > > > > > > > > > > > > > > > > > > > > ...be advised that and Nephew (a medical > > > > equipment > > > > > > > company) has just purchased the emormously popular > > > Birmingham > > > > > > > Resurfacing device and it will be available for use in > the > > > > United > > > > > > > States very soon. It's the one that's been used very > > > > sucessfully > > > > > > in > > > > > > > Europe for many years. Just thought you might want to > take > > > > that > > > > > > into > > > > > > > consideration when discussing resurfacing devices with > the > > > > OS's. > > > > > > The > > > > > > > only reason I happen to know this is because a friend of > > > ours > > > > > > works > > > > > > > for and Nephew. Best of Luck with your search. > Susie > > > > > > > > > > > > The time frame for approval of the Birmingham seems to be > > sometime > > > in > > > > the next year. > > > > Fred, I apologize for any false hopes....but don't be so > > defensive... was just asking a very general > question...and I > > wanted to let her know about the BHR because I personally have a > very > > unusual hip disorder, Protrusio Acetabulum, or " Otto Pelvis " and > am > > more of a candidate for this device than the others because of the > > various stems available with the BHR which are not available on > the > > others. ....and if she happened to have a quirky joint geometry > that > > was more suited to the BHR maybe it would be worth the wait, or a > > trip to Belgium or England. Quite possibly she doesn't have any > > special considerations at all in which case she could just use the > > other devices that are further advanced here in their trials. Back > > off, Fred, I'm just trying to be helpful. The and Nephew > rep > > is the one who quoted the aproximate time frame. Do you work for > > Medical? Have you had a resurfacing? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 2, 2004 Report Share Posted May 2, 2004 > I think there is a way they can argue their device is " substantially > similar " as another device but I don't know the exact regulations. I > would have thought that could have used that same approach > since their M-o-M total hip system was FDA approved as was the > Conserve Hemi-Resurfacing system. I would have thought they could > make the point that Conserve Plus is just a combination of those two, > already approved, devices. Well, a reasonable person might suppose that since both the acetabular and the femoral component were individually approved, that the two of them together would be okay, but the FDA doesn't operate that way. One might also have supposed that, since the FDA has committed itself to streamlining the approval process, they might have acted on 's December application for approval rather than sitting on their hands for the last 5 months. Again, comonsense expectations are not always applicable to the behavior of large bureaucracies. The FDA may well accept the " substantial similarity " argument, but if so they certainly won't do it until after the C+ is approved, and probably not until after the C2K is approved as well. I wonder if the approval cycle would have been reduced had the many European docs performing this procedure published more. Considering that there are 27,000+ resurfacings worldwide, the volume of peer-reviewed clinical data on the procedure from Europe is pretty sparse indeed (a couple of papers by McMinn, a couple of papers by DeSmet, and that's about it). After all, even though the British NHS has approved the procedure, they did coment on both the scarcity and the poor quality of the published clinical data. > Let's all hope the BHR can get approved quickly - that's just one more > good option for patients in the U.S. Let's just hope *SOMETHING* gets approved in the US, so that all those currently being denied access to this technology by their insurance companies will have a shot at it before they're no longer candidates for the procedure. Not everyone can afford to jet to Europe or even shell out $6050 (cash, in advance, thankyouverymuch) to cover the cost of the bare implant in the US (assuming their insurance will pick up the rest). This procedure really shouldn't be confined only to those well-off enough to get it in spite of their insurance. Steve (bilateral C+ 4/20/04, Amstutz) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 2, 2004 Report Share Posted May 2, 2004 Dear Surface Hippies: This is a repeat of a posting which I sent last year. I hope that our international members will excuse some comments regarding the US FDA and the Current Clinical Trials for resurfacing devices. This information is from personal communication with an attorney with the FDA and from information on their website. Some is my personal speculation as explained below All countries have laws, regulations and agencies designed to protect their citizens. From the FDA Mission Statement: " Promote public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner; protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled; human and veterinary drugs are safe and effective; there is reasonable assurance of the safety and effectiveness of devices intended for human use; cosmetics are safe and properly labeled, and; public health and safety are protected from electronic product radiation " . The modern era of the FDA began in 1906 with the passage of the Federal Food and Drugs Act. The agency grew from a single chemist in the U.S. Department of Agriculture in 1862 to a staff of approximately 9,100 employees and a budget of $1.294 billion in 2001, comprising chemists, pharmacologists, physicians, microbiologists, veterinarians, pharmacists, lawyers, and many others. About one- third of the agency's employees are stationed outside of the Washington, D. C. area, staffing over 150 field offices and laboratories, including five regional offices and 20 district offices. Agency scientists evaluate applications for new human drugs and biologics, complex medical devices, food and color additives, infant formulas, and animal drugs. Also, the FDA monitors the manufacture, import, transport, storage, and sale of about $1 trillion worth of products annually at a cost to taxpayers of about $3 per person. For reference: http://www.fda.gov/oc/history/default.htm http://www.fda.gov/cdrh/ In order to market their resurfacing devices in the US, and Corin requested an (IDE) IDE Overview (From FDA WEBSITE) An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA. Only a small percentage of Premarket Notifications 510(k)'s require clinical data to support the application. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices. All clinical evaluations of investigational devices, unless exempt, must have an approved IDE before the study is initiated. Clinical evaluation of devices that have not been cleared for marketing requires: • An IDE approved by an institutional review board (IRB). If the study involves a significant risk device, the IDE must also be approved by FDA; • informed consent from all patients; • labeling for investigational use only • monitoring of the study and; • required records and reports. An approved IDE permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements of the Food, Drug, and Cosmetic Act (Act) that would apply to devices in commercial distribution. Sponsors need not submit a PMA or Premarket Notification 510(k), register their establishment, or list the device while the device is under investigation. Sponsors of IDE's are also exempt from the Quality System (QS) Regulation except for the requirements for design control. For more information click on link below. http://www.fda.gov/cdrh/devadvice/ide/index.shtml and Corin are engaged in clinical trials. When finished, they will request a PMA (Pre-marketing approval) from the FDA. This is initiated by the Manufacturer, not the FDA. All FDA IDE clinical trial information and the PMA are confidential. The FDA can not release any information until the process is complete. The Manufacturer can make public statements only. This is what got Martha Stuart and others in trouble. No " insider information " can be released. FDA Policy is to try to complete the PMA in no more than six months after the data is submitted by the manufacturer. The FDA may present the information to an Advisory Panel of independent experts. The panel submits recommendations to the FDA which are not binding. I HAVE SINCE SPOKEN WITH A CONTACT AT THE FDA WHOSE OPINION IS THAT THAT EVEN IF THE WRIGHT AND CORIN DEVICES ARE APPROVED, the 510k exemption will not allow marketing of a Class III device without some sort of clinical trial. It may expedite future trials of such devices. MICHAEL (MD) in NC (L) C+, 3/31/03 DR. vail > > I think there is a way they can argue their device is " substantially > > similar " as another device but I don't know the exact regulations. I > > would have thought that could have used that same approach > > since their M-o-M total hip system was FDA approved as was the > > Conserve Hemi-Resurfacing system. I would have thought they could > > make the point that Conserve Plus is just a combination of those two, > > already approved, devices. > > Well, a reasonable person might suppose that since both the acetabular > and the femoral component were individually approved, that the two of > them together would be okay, but the FDA doesn't operate that way. One > might also have supposed that, since the FDA has committed itself to > streamlining the approval process, they might have acted on 's > December application for approval rather than sitting on their hands > for the last 5 months. Again, comonsense expectations are not always > applicable to the behavior of large bureaucracies. The FDA may well > accept the " substantial similarity " argument, but if so they certainly > won't do it until after the C+ is approved, and probably not until > after the C2K is approved as well. > > I wonder if the approval cycle would have been reduced had the many > European docs performing this procedure published more. Considering > that there are 27,000+ resurfacings worldwide, the volume of > peer-reviewed clinical data on the procedure from Europe is pretty > sparse indeed (a couple of papers by McMinn, a couple of papers by > DeSmet, and that's about it). After all, even though the British NHS > has approved the procedure, they did coment on both the scarcity and > the poor quality of the published clinical data. > > > Let's all hope the BHR can get approved quickly - that's just one more > > good option for patients in the U.S. > > Let's just hope *SOMETHING* gets approved in the US, so that all those > currently being denied access to this technology by their insurance > companies will have a shot at it before they're no longer candidates > for the procedure. Not everyone can afford to jet to Europe or even > shell out $6050 (cash, in advance, thankyouverymuch) to cover the cost > of the bare implant in the US (assuming their insurance will pick up > the rest). This procedure really shouldn't be confined only to those > well-off enough to get it in spite of their insurance. > > Steve (bilateral C+ 4/20/04, Amstutz) Quote Link to comment Share on other sites More sharing options...
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