Guest guest Posted December 14, 2004 Report Share Posted December 14, 2004 > I thought I'd let everyone know the lumbar artifical disc have been > approved by the FDA I think it's very important to differentiate between the various lumbar intervertebral disc replacement procedures when mentioning something as important as this. The Link-Charite is the one referred to as having been approved recently, according to my information. The ProDisc (the only one I would consider and am still waiting for, despite the pain) is several months away from approval, hopefully by June. I think the Charite has a mediocre track record, with plenty of device failures. The ProDisc, on the other hand, is much better designed and has an insignificant number of failures, the postop negative results coming almost entirely from surgical complications surrounding the laparotic procedure rather than the preparation for and installation of the disc itself. These complications can be almost completely avoided with good operating room procedure, competent laparoscopic surgical technique and surgeon training and practice. The single device failure I'm aware of was due to faulty manufacturing technique of the disc insert itself, not overall device design, and was shortly thereafter replace easily with no further complications. After this experience I'm confident no further faulty discs will be allowed beyond the inspection stage of the manufacturer. If you look closely at the history of the ProDisc you will see that initial testing was started around 15 years ago on a very small number of patients and suspended for several years to determine long-range effectiveness before proceding on a wider scale. A very small number of modifications were made during the life of this device, none of which appear to have been directly as a result of device failure but rather intuitive improvements to an excellent pre-existing design. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 15, 2004 Report Share Posted December 15, 2004 The second link talks about this one I listed both for everyone to read. Anyone who has gone thru years of fighting lower back pain and multiple drs and surgeries will know that if you want to find answers LOOK FOR THEM YOURSELF! Many of our dr's are wonderful people BUT they are way too busy to find all the answers for everyone. I myself found out years ago if I left it up to the first few dr's I had seen I'd have NEVER HAD ANY RELIEF at all, from Meds or surgeries. Hence I pushed on and on to find the answers to my own problems. I Still refuse to stop looking for the answers I need and The prosdisc is the answer for me. I have spent hrs and hrs searching for the answers to help relieve my lower back and INTENSE Sciatic nerve pain that involves my ENTIRE nerve even around my foot. What I am saying to everyone is this: DON'T GIVE UP LOOKING FOR HELP, just because ONE dr says No doesn't mean another doesn't have the answer you seek. And if you want to wait for dr's to find the answers for you that is your decision but I WILL NOT and that is why I posted this note, to help others like me and you who are suffering. Both disc's are listed in that note, so everyone please read and follow the links if you want more answers. Happy holidays to all. Sharon ~*~*~*~* group owner*~*~*~*~*~* PRODISC®: A Type of Artificial Disc PRODISC® is the second artificial disc currently under investigation through an FDA study. In the early 1990's, Dr. Thierry Marnay, a French surgeon developed PRODISC®. In October 2001 the first PRODISC® was implanted at the Texas Back Institute, the primary investigator site of approximately 10 investigating sites in the United States. PRODISC® (Spine Solutions, New York, NY, USA) To date, approximately 70 patients have undergone implantation of the PRODISC® prosthesis. Good to excellent results with some patients returning to near-normal activities. General availability of this product in the United States is pending results from the FDA study, which are at least two years in the future. Conclusion Initial results seem positive, and artificial discs may prove to be a breakthrough for patients suffering chronic low back pain, who did not respond to nonsurgical treatment. We are hopeful that within the next two years we will have the ability to begin implanting artificial discs. Cervical Artificial Disc Preserves Neck Mobility: Part 2 Artificial Disc Replacement Case Report: 50-Year-Old Male Treated with PRODISC® Back Pain Treatment Options Back Care When Pregnant - Maintaining a Healthy Spine PRODISC® Artificial Disc Clinical Trial Centers > > > I thought I'd let everyone know the lumbar artifical disc have been > > approved by the FDA > > I think it's very important to differentiate between the various > lumbar intervertebral disc replacement procedures when mentioning > something as important as this. The Link-Charite is the one referred > to as having been approved recently, according to my information. > > The ProDisc (the only one I would consider and am still waiting for, > despite the pain) is several months away from approval, hopefully by > June. I think the Charite has a mediocre track record, with plenty > of device failures. The ProDisc, on the other hand, is much better > designed and has an insignificant number of failures, the postop > negative results coming almost entirely from surgical complications > surrounding the laparotic procedure rather than the preparation for > and installation of the disc itself. These complications can be > almost completely avoided with good operating room procedure, > competent laparoscopic surgical technique and surgeon training and > practice. The single device failure I'm aware of was due to faulty > manufacturing technique of the disc insert itself, not overall device > design, and was shortly thereafter replace easily with no further > complications. After this experience I'm confident no further faulty > discs will be allowed beyond the inspection stage of the manufacturer. > > If you look closely at the history of the ProDisc you will see that > initial testing was started around 15 years ago on a very small > number of patients and suspended for several years to determine > long-range effectiveness before proceding on a wider scale. A very > small number of modifications were made during the life of this > device, none of which appear to have been directly as a result of > device failure but rather intuitive improvements to an excellent > pre-existing design. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 29, 2007 Report Share Posted December 29, 2007 I was reading an interview about MR neurography, open MRI surgery, etc. And the article included the following paragraph about artificial disc patient outcomes. I think people considering the surgery may be interested in this. " ADRSupport: How many artificial disc patients have been imaged? What have you seen or learned from these studies? Dr. Filler: We are seeing significant numbers of patients with artificial disk replacement (ADR) who were not helped by their ADR surgery. The ADR causes some image artifacts, but the MRN scans are still very helpful. We have found that surgeons are more likely to place an ADR when they are uncertain of the diagnosis than in the old days of fusion only. In many cases, this is because of patient enthusiasm for the ADR as well as the perception that they are less invasive than a fusion. We have also imaged patients in whom the ADR was placed off center and is causing a nerve impingement. " Quote taken from http://adrsupport.org/eve/forums/a/tpc/f/7801036081/m/8851078891 Quote Link to comment Share on other sites More sharing options...
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