Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 Boy, that's a pretty big " ouch " . While I sincerely hope no-one who was resurfaced suffered any serious health problems otherwise not anticipated, I imagine this is exactly why US surgeons are terrified of recommending resurfacing. Expect fallout. Des Tuck, Esq. In a message dated 5/25/2004 2:08:52 PM Pacific Standard Time, ether25@... writes: Did everyone see the warning letter to from the FDA today? Is it the conserve +? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 Boy, that's a pretty big " ouch " . While I sincerely hope no-one who was resurfaced suffered any serious health problems otherwise not anticipated, I imagine this is exactly why US surgeons are terrified of recommending resurfacing. Expect fallout. Des Tuck, Esq. In a message dated 5/25/2004 2:08:52 PM Pacific Standard Time, ether25@... writes: Did everyone see the warning letter to from the FDA today? Is it the conserve +? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 Boy, that's a pretty big " ouch " . While I sincerely hope no-one who was resurfaced suffered any serious health problems otherwise not anticipated, I imagine this is exactly why US surgeons are terrified of recommending resurfacing. Expect fallout. Des Tuck, Esq. In a message dated 5/25/2004 2:08:52 PM Pacific Standard Time, ether25@... writes: Did everyone see the warning letter to from the FDA today? Is it the conserve +? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 This could be true as a practical matter, but people exposed to legal liability tend to become overly paranoid and that's why I think it could turn out to be a bigger deal than it perhaps ought to be. Des Tuck (Wearing the lawyer's hat again) In a message dated 5/25/2004 3:37:08 PM Pacific Standard Time, kbrews@... writes: In another forum some people familiar with the industry said the letter was pretty much a slap on the wrist to get to get their act together on this study. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 This could be true as a practical matter, but people exposed to legal liability tend to become overly paranoid and that's why I think it could turn out to be a bigger deal than it perhaps ought to be. Des Tuck (Wearing the lawyer's hat again) In a message dated 5/25/2004 3:37:08 PM Pacific Standard Time, kbrews@... writes: In another forum some people familiar with the industry said the letter was pretty much a slap on the wrist to get to get their act together on this study. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 Well, let's face it, Steve, there are other reasons why insurance companies don't pay for things, and in my opinion you're being too kind. But this is a dignified site and I won't express what I feel about them here. Des In a message dated 5/25/2004 4:38:14 PM Pacific Standard Time, sog@... writes: And why insurance companies are reluctant to pay for it, too Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 Well, let's face it, Steve, there are other reasons why insurance companies don't pay for things, and in my opinion you're being too kind. But this is a dignified site and I won't express what I feel about them here. Des In a message dated 5/25/2004 4:38:14 PM Pacific Standard Time, sog@... writes: And why insurance companies are reluctant to pay for it, too Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 > Did everyone see the warning letter to from the FDA today? Is > it the conserve +? , I saw that, and based on some of the details in the letter, I believe it to be about the Conserve Plus study (the name of the device and some other details are blanked out for privacy). I have not asked anyone at about this, but they are always mum on FDA issues involving studies in progress. In another forum some people familiar with the industry said the letter was pretty much a slap on the wrist to get to get their act together on this study. To me this is making it seem very unlikely that the Conserve Plus will be approved this year. I am sorry to say that to those suffering while waiting. will have to answer the questions raised and work to increase the follow-up rate. Some of the things cited were relatively trivial reporting errors, the kind I imagine are easy to slip through the cracks when you are dealing with several hundred patients across the country. However, after the run-around the FDA gave them with the ceramic study and approving their supplier you would think they'd be extra careful on this PMA. There were no problems with the devices themselves failing or anything of that nature. They did cite a problem with missing follow-ups for a number of patients. As with the Corin study mentioned recently, please get your follow-ups done if you are behind on your one-year or two- year anniversary!! I know its hard to do when you are enjoying getting back into a pain-free life. Of course, we're probably preaching to the choir in this forum. - Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 > Did everyone see the warning letter to from the FDA today? Is > it the conserve +? , I saw that, and based on some of the details in the letter, I believe it to be about the Conserve Plus study (the name of the device and some other details are blanked out for privacy). I have not asked anyone at about this, but they are always mum on FDA issues involving studies in progress. In another forum some people familiar with the industry said the letter was pretty much a slap on the wrist to get to get their act together on this study. To me this is making it seem very unlikely that the Conserve Plus will be approved this year. I am sorry to say that to those suffering while waiting. will have to answer the questions raised and work to increase the follow-up rate. Some of the things cited were relatively trivial reporting errors, the kind I imagine are easy to slip through the cracks when you are dealing with several hundred patients across the country. However, after the run-around the FDA gave them with the ceramic study and approving their supplier you would think they'd be extra careful on this PMA. There were no problems with the devices themselves failing or anything of that nature. They did cite a problem with missing follow-ups for a number of patients. As with the Corin study mentioned recently, please get your follow-ups done if you are behind on your one-year or two- year anniversary!! I know its hard to do when you are enjoying getting back into a pain-free life. Of course, we're probably preaching to the choir in this forum. - Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 > Boy, that's a pretty big " ouch " . While I sincerely hope no-one who was > resurfaced suffered any serious health problems otherwise not anticipated, I imagine > this is exactly why US surgeons are terrified of recommending resurfacing. And why insurance companies are reluctant to pay for it, too. > Expect fallout. I'm really glad I didn't wait any longer. Steve (bilat C+ 4/20/04, Amstutz) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 > Boy, that's a pretty big " ouch " . While I sincerely hope no-one who was > resurfaced suffered any serious health problems otherwise not anticipated, I imagine > this is exactly why US surgeons are terrified of recommending resurfacing. And why insurance companies are reluctant to pay for it, too. > Expect fallout. I'm really glad I didn't wait any longer. Steve (bilat C+ 4/20/04, Amstutz) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 > Did everyone see the warning letter to from the FDA today? Is > it the conserve +? > > Hi , What letter is this? Please post. Dr. Mark Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 > Did everyone see the warning letter to from the FDA today? Is > it the conserve +? > > Hi , What letter is this? Please post. Dr. Mark Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 > > Did everyone see the warning letter to from the FDA today? > Is > > it the conserve +? > > , I saw that, and based on some of the details in the letter, I > believe it to be about the Conserve Plus study (the name of the > device and some other details are blanked out for privacy). > > I have not asked anyone at about this, but they are always mum > on FDA issues involving studies in progress. In another forum some > people familiar with the industry said the letter was pretty much a > slap on the wrist to get to get their act together on this > study. To me this is making it seem very unlikely that the Conserve > Plus will be approved this year. I am sorry to say that to those > suffering while waiting. will have to answer the questions > raised and work to increase the follow-up rate. > > Some of the things cited were relatively trivial reporting errors, > the kind I imagine are easy to slip through the cracks when you are > dealing with several hundred patients across the country. However, > after the run-around the FDA gave them with the ceramic study and > approving their supplier you would think they'd be extra careful on > this PMA. There were no problems with the devices themselves failing > or anything of that nature. > > They did cite a problem with missing follow-ups for a number of > patients. As with the Corin study mentioned recently, please > get your follow-ups done if you are behind on your one-year or two- > year anniversary!! I know its hard to do when you are enjoying > getting back into a pain-free life. Of course, we're probably > preaching to the choir in this forum. > > - HI , Thanks for the post. However I must add that this is where the Device Companies and the involved surgeons in the trials need to step up and be responsible. It is unacceptable for there to be problems with follow-up since this is the primary endpoint which is going to determine success or failure as far as the FDA is concerned. Shame on Medical and all the surgeons involved. They deserve the slap on the wrist. I hope Corin is better at it. For everybody out there who has undergone hip resurfacing - if you have not had your yearly follow-up clinic visit please get it scheduled! You owe it to the rest of us who have not been surfed as of yet. Please do not rob us of the chance to get the right operation for the the right disease. To not be responsible for your follow-up is being selfish and not consistent with the spirit of this website. Everyone involved has to be responsible for this procedure and that means device company, surgeon, administrator, and patient alike! Regards, Dr. Mark Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 25, 2004 Report Share Posted May 25, 2004 > > Did everyone see the warning letter to from the FDA today? > Is > > it the conserve +? > > , I saw that, and based on some of the details in the letter, I > believe it to be about the Conserve Plus study (the name of the > device and some other details are blanked out for privacy). > > I have not asked anyone at about this, but they are always mum > on FDA issues involving studies in progress. In another forum some > people familiar with the industry said the letter was pretty much a > slap on the wrist to get to get their act together on this > study. To me this is making it seem very unlikely that the Conserve > Plus will be approved this year. I am sorry to say that to those > suffering while waiting. will have to answer the questions > raised and work to increase the follow-up rate. > > Some of the things cited were relatively trivial reporting errors, > the kind I imagine are easy to slip through the cracks when you are > dealing with several hundred patients across the country. However, > after the run-around the FDA gave them with the ceramic study and > approving their supplier you would think they'd be extra careful on > this PMA. There were no problems with the devices themselves failing > or anything of that nature. > > They did cite a problem with missing follow-ups for a number of > patients. As with the Corin study mentioned recently, please > get your follow-ups done if you are behind on your one-year or two- > year anniversary!! I know its hard to do when you are enjoying > getting back into a pain-free life. Of course, we're probably > preaching to the choir in this forum. > > - HI , Thanks for the post. However I must add that this is where the Device Companies and the involved surgeons in the trials need to step up and be responsible. It is unacceptable for there to be problems with follow-up since this is the primary endpoint which is going to determine success or failure as far as the FDA is concerned. Shame on Medical and all the surgeons involved. They deserve the slap on the wrist. I hope Corin is better at it. For everybody out there who has undergone hip resurfacing - if you have not had your yearly follow-up clinic visit please get it scheduled! You owe it to the rest of us who have not been surfed as of yet. Please do not rob us of the chance to get the right operation for the the right disease. To not be responsible for your follow-up is being selfish and not consistent with the spirit of this website. Everyone involved has to be responsible for this procedure and that means device company, surgeon, administrator, and patient alike! 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 Hi, Group.... I don't want to minimize a " warning letter " from the FDA whatsoever but it is quite possible that it is a relatively routine occurrence following on-site audits related to an IDE study. Many citations seem to be quite technical in nature and I would assume that there can be very good reasons and explanations for them. Conversely, other infractions are probably of greater concern to the FDA and, of course, they need to be corrected. I would be very surprised if sponsors of other IDE studies in recent years (eg, metal-metal THR, ceramic-ceramic THR, TKR, etc...) did not also receive similar " warning " letters. Could this be an indication that FDA approval is likely to be delayed? Well, I suppose that anything is possible but I would be very surprised. I didn't see anything reported in the letter nor am I aware of any adverse patient outcomes that would result in such a delay. Keep in mind that the FDA has the authority to " close " the study to further patient enrollments if serious problems are detected. The audit was conducted in January and patient enrollment continues unabated. I am not an authority on this subject nor this particular FDA audit and, of course, I defer to those who are. Note, too, that each study site is closely monitored by its own " IRB " committee at the host hospital. So, I want to assure you that protocol compliance is monitored not just by the FDA but also by the hospitals' IRB committees as well as the study sponsor. Finally, patient compliance with follow-up appointments at the required post-op intervals is our greatest challenge. A fair number of patients disregard requests to send us follow-up x-rays and other data that we are required to report and this makes our job more difficult. We truly appreciate members' comments that encourage all " surfacehippies " to keep follow-up appointments at the required intervals. Regards, Chuck JRI > > Did everyone see the warning letter to from the FDA today? > Is > > it the conserve +? > > > > > Hi , > What letter is this? Please post. > 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 Hi, Group.... I don't want to minimize a " warning letter " from the FDA whatsoever but it is quite possible that it is a relatively routine occurrence following on-site audits related to an IDE study. Many citations seem to be quite technical in nature and I would assume that there can be very good reasons and explanations for them. Conversely, other infractions are probably of greater concern to the FDA and, of course, they need to be corrected. I would be very surprised if sponsors of other IDE studies in recent years (eg, metal-metal THR, ceramic-ceramic THR, TKR, etc...) did not also receive similar " warning " letters. Could this be an indication that FDA approval is likely to be delayed? Well, I suppose that anything is possible but I would be very surprised. I didn't see anything reported in the letter nor am I aware of any adverse patient outcomes that would result in such a delay. Keep in mind that the FDA has the authority to " close " the study to further patient enrollments if serious problems are detected. The audit was conducted in January and patient enrollment continues unabated. I am not an authority on this subject nor this particular FDA audit and, of course, I defer to those who are. Note, too, that each study site is closely monitored by its own " IRB " committee at the host hospital. So, I want to assure you that protocol compliance is monitored not just by the FDA but also by the hospitals' IRB committees as well as the study sponsor. Finally, patient compliance with follow-up appointments at the required post-op intervals is our greatest challenge. A fair number of patients disregard requests to send us follow-up x-rays and other data that we are required to report and this makes our job more difficult. We truly appreciate members' comments that encourage all " surfacehippies " to keep follow-up appointments at the required intervals. Regards, Chuck JRI > > Did everyone see the warning letter to from the FDA today? > Is > > it the conserve +? > > > > > Hi , > What letter is this? Please post. > Dr. Mark Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 28, 2004 Report Share Posted May 28, 2004 I have two C+ devices and have not heard a word from anyone. Pamela 5/10/04 Bilat C+ Dr. S Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 28, 2004 Report Share Posted May 28, 2004 I have two C+ devices and have not heard a word from anyone. Pamela 5/10/04 Bilat C+ Dr. S Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 28, 2004 Report Share Posted May 28, 2004 Don't be alarmed. The warning letter was not sent to patients - it was sent to Medical from the FDA. It doesn't indicate a problem with the C+ devices but it does look like there have been some paperwork screwups that will have to be corrected. You can read it at: http://www.fda.gov/foi/warning_letters/g4697d.htm RC2K Dr. Gross 3/24/04 > I have two C+ devices and have not heard a word from anyone. > Pamela > 5/10/04 Bilat C+ Dr. S Quote Link to comment Share on other sites More sharing options...
Guest guest Posted May 28, 2004 Report Share Posted May 28, 2004 Don't be alarmed. The warning letter was not sent to patients - it was sent to Medical from the FDA. It doesn't indicate a problem with the C+ devices but it does look like there have been some paperwork screwups that will have to be corrected. You can read it at: http://www.fda.gov/foi/warning_letters/g4697d.htm RC2K Dr. Gross 3/24/04 > I have two C+ devices and have not heard a word from anyone. > Pamela > 5/10/04 Bilat C+ Dr. S Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 1, 2004 Report Share Posted June 1, 2004 I have two C+ devices and have not heard a word from anyone. Pamela 5/10/04 Bilat C+ Dr. S ___________ I recieved a note from Dr. Monts office dated May 18, 2004 reminding me of my remaining followups for my 2 yr and 3 yr. Don't know if that has anything to do with the FDA Warning letter but i would assume so. I have not recieved anything like this in the past other than me personally calling and asking between what specific dates I need to have them done by. My 3 yr post op appt should fall between the dates of 9/9/2004 and 9/8/2005 and that was one of the dates they had highlighted on the letter. Has any other Mont patients recieved this notice??? The notice was headed: TO: All Research Patients (Conserve Plus Total Resurfacing Hip System) L C+ July 11th 2002 MONT Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 1, 2004 Report Share Posted June 1, 2004 I have two C+ devices and have not heard a word from anyone. Pamela 5/10/04 Bilat C+ Dr. S ___________ I recieved a note from Dr. Monts office dated May 18, 2004 reminding me of my remaining followups for my 2 yr and 3 yr. Don't know if that has anything to do with the FDA Warning letter but i would assume so. I have not recieved anything like this in the past other than me personally calling and asking between what specific dates I need to have them done by. My 3 yr post op appt should fall between the dates of 9/9/2004 and 9/8/2005 and that was one of the dates they had highlighted on the letter. Has any other Mont patients recieved this notice??? The notice was headed: TO: All Research Patients (Conserve Plus Total Resurfacing Hip System) L C+ July 11th 2002 MONT Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 1, 2004 Report Share Posted June 1, 2004 I have two C+ devices and have not heard a word from anyone. Pamela 5/10/04 Bilat C+ Dr. S ___________ I recieved a note from Dr. Monts office dated May 18, 2004 reminding me of my remaining followups for my 2 yr and 3 yr. Don't know if that has anything to do with the FDA Warning letter but i would assume so. I have not recieved anything like this in the past other than me personally calling and asking between what specific dates I need to have them done by. My 3 yr post op appt should fall between the dates of 9/9/2004 and 9/8/2005 and that was one of the dates they had highlighted on the letter. Has any other Mont patients recieved this notice??? The notice was headed: TO: All Research Patients (Conserve Plus Total Resurfacing Hip System) L C+ July 11th 2002 MONT Quote Link to comment Share on other sites More sharing options...
Guest guest Posted June 1, 2004 Report Share Posted June 1, 2004 : I received one also. I got this letter about 2 weeks ago. It was before anyone here mentioned the warning letter. However, they could still be connected. I just did my ONE year check up in March and thought it odd I was getting reminded about my 1, 2 + 3 year check ups so soon after. Lois C+ 3/27/03 Dr. Mont Re: warning letter I have two C+ devices and have not heard a word from anyone. Pamela 5/10/04 Bilat C+ Dr. S ___________ I recieved a note from Dr. Monts office dated May 18, 2004 reminding me of my remaining followups for my 2 yr and 3 yr. Don't know if that has anything to do with the FDA Warning letter but i would assume so. I have not recieved anything like this in the past other than me personally calling and asking between what specific dates I need to have them done by. My 3 yr post op appt should fall between the dates of 9/9/2004 and 9/8/2005 and that was one of the dates they had highlighted on the letter. Has any other Mont patients recieved this notice??? The notice was headed: TO: All Research Patients (Conserve Plus Total Resurfacing Hip System) L C+ July 11th 2002 MONT Quote Link to comment Share on other sites More sharing options...
Recommended Posts
Join the conversation
You are posting as a guest. If you have an account, sign in now to post with your account.
Note: Your post will require moderator approval before it will be visible.