Guest guest Posted March 17, 2000 Report Share Posted March 17, 2000 HI. This is what I was told at our last visit regarding our daughters helmet. The helmet isnt FDA approved yet but is in the process. The clinic where we got our helmet can no longer make them until it does become FDA approved. There is a few states that have already gotton it approved. Does anyone know why the band costs a lot more than the helmet when they both basically do the same thing? Dawn Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 17, 2000 Report Share Posted March 17, 2000 First! I must say: " Happy St. 's Day!! " and my condolences of you who are not of Irish descent!!! Now, on to much more serious matters. Dawn wrote: > > HI. This is what I was told at our last visit regarding our daughters > helmet. The helmet isnt FDA approved yet but is in the process. The > clinic where we got our helmet can no longer make them until it does > become FDA approved. There is a few states that have already gotton it > approved. Does anyone know why the band costs a lot more than the > helmet when they both basically do the same thing? I can comment on some of this. I became aware of the DOC band in 1991. At that time I was a research scientist at the Advanced Surgical Institute in Dallas, Texas. The reason I become involved is because (to be quite frank) we were a skeptical about the DOC band. " Helmets " had been tried before many time before and then abandoned. While this helmets did reshape the head, generally resulted in other deformities. My concern in 1991 was that the DOC band was another helmet. I was very surpised and pleased to discover that I was wrong. I went from skeptic (cynic) to supporter after seeing it work and have since worked with Cranial Tech to document and demonstrate that the DOC Band works (recent publications in major medical journals are available at http://www.plagiocephaly.org). I am not aware of any helmets that are FDA approved nor I'm I aware of any published reports of successful helmet programs. If any of you are visiting a clinic that can provide that information, please let me know. I'd be happy to make that information available at www.plagiocephaly.org. But, as I said I do not believe that that information exists for any helmet program. I should mention that the FDA does not approve " states " to use devices--they approve the devices (and drugs, etc.) The DOC Band is the only medical device has been approved by the FDA and is available in many states. Plus, the results of years of treatment have been published and are publicly available. Hope this information helps. Sincerely, M. http://www.plagiocephaly.org http://www.EyeOnIowa.com/StPats/ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 17, 2000 Report Share Posted March 17, 2000 Dawn, All I have heard about difference in cost had to do with FDA approval. If I understand correctly, the people responsible for band have spent a great deal of $$$$ for that approval. I guess they feel they are entittled to more money since it has been approved. I don't see much difference either. Belinda(Indiana) Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 17, 2000 Report Share Posted March 17, 2000 , Thank you so much for helping us out on the FDA discussion. I really appreciate you being here, A LOT! C./subscribe/Plagiocephaly ----- Original Message ----- From: M. Plagiocephalyonelist Sent: Friday, March 17, 2000 11:32 AM Subject: Re: helmet and FDA approval From: " M. " <kevin@...> First! I must say:"Happy St. 's Day!!"and my condolences of you who are not of Irish descent!!!Now, on to much more serious matters.Dawn wrote:>> HI. This is what I was told at our last visit regarding our daughters> helmet. The helmet isnt FDA approved yet but is in the process. The> clinic where we got our helmet can no longer make them until it does> become FDA approved. There is a few states that have already gotton it> approved. Does anyone know why the band costs a lot more than the> helmet when they both basically do the same thing?I can comment on some of this. I became aware of the DOC band in 1991. At thattime I was a research scientist at the Advanced Surgical Institute in Dallas,Texas. The reason I become involved is because (to be quite frank) we were askeptical about the DOC band. "Helmets" had been tried before many time beforeand then abandoned. While this helmets did reshape the head, generally resultedin other deformities. My concern in 1991 was that the DOC band was anotherhelmet. I was very surpised and pleased to discover that I was wrong. I wentfrom skeptic (cynic) to supporter after seeing it work and have since workedwith Cranial Tech to document and demonstrate that the DOC Band works (recentpublications in major medical journals are available athttp://www.plagiocephaly.org).I am not aware of any helmets that are FDA approved nor I'm I aware of anypublished reports of successful helmet programs. If any of you are visiting aclinic that can provide that information, please let me know. I'd be happy tomake that information available at www.plagiocephaly.org. But, as I said I donot believe that that information exists for any helmet program. I shouldmention that the FDA does not approve "states" to use devices--they approve thedevices (and drugs, etc.) The DOC Band is the only medical device has beenapproved by the FDA and is available in many states. Plus, the results of yearsof treatment have been published and are publicly available.Hope this information helps.Sincerely, M. http://www.plagiocephaly.orghttp://www.EyeOnIowa.com/StPats/ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 18, 2000 Report Share Posted March 18, 2000 , Hi, My son has a helmet and I was concerned when I read your message that helmets helped shape heads but resulted in other deformities. Could you please explain? --- " M. " <kevin@...> wrote: > First! I must say: > > " Happy St. 's Day!! " > and my condolences of you who are not of Irish > descent!!! > > Now, on to much more serious matters. > > Dawn wrote: > > > > HI. This is what I was told at our last visit > regarding our daughters > > helmet. The helmet isnt FDA approved yet but is > in the process. The > > clinic where we got our helmet can no longer make > them until it does > > become FDA approved. There is a few states that > have already gotton it > > approved. Does anyone know why the band costs a > lot more than the > > helmet when they both basically do the same thing? > > I can comment on some of this. I became aware of > the DOC band in 1991. At that > time I was a research scientist at the Advanced > Surgical Institute in Dallas, > Texas. The reason I become involved is because (to > be quite frank) we were a > skeptical about the DOC band. " Helmets " had been > tried before many time before > and then abandoned. While this helmets did reshape > the head, generally resulted > in other deformities. My concern in 1991 was that > the DOC band was another > helmet. I was very surpised and pleased to discover > that I was wrong. I went > from skeptic (cynic) to supporter after seeing it > work and have since worked > with Cranial Tech to document and demonstrate that > the DOC Band works (recent > publications in major medical journals are available > at > http://www.plagiocephaly.org). > > I am not aware of any helmets that are FDA approved > nor I'm I aware of any > published reports of successful helmet programs. If > any of you are visiting a > clinic that can provide that information, please let > me know. I'd be happy to > make that information available at > www.plagiocephaly.org. But, as I said I do > not believe that that information exists for any > helmet program. I should > mention that the FDA does not approve " states " to > use devices--they approve the > devices (and drugs, etc.) The DOC Band is the only > medical device has been > approved by the FDA and is available in many states. > Plus, the results of years > of treatment have been published and are publicly > available. > > Hope this information helps. > > Sincerely, > > M. > http://www.plagiocephaly.org > http://www.EyeOnIowa.com/StPats/ > > > > __________________________________________________ Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 18, 2000 Report Share Posted March 18, 2000 Belinda wrote: >Dawn, All I have heard about difference in cost had to do with FDA >approval. >If I understand correctly, the people responsible for band have >spent a great >deal of $$$$ for that approval. Maybe I should correct what seems to be a fairly standard misconception. Cranial Technologies did not go looking for FDA approval. The FDA came to Cranial Technologies and basically said " Hey, that device needs to have FDA approval. " Like other groups making cranial orthosis, Cranial Tech was working under that assumption that the device (i.e., the DOC band) was exempt. They were wrong! The DOC Band was not exempt, however now it is approved. Remember, companies (including those that make drugs and pacemakers) don't go to the FDA so they can charge more, they seek FDA approval so they can provide a product to consumers. Fortunately, Cranial Technologies had been proactive in establish treatment protocols, standard laboratory practices, etc. PLUS they had been collecting data on head shape and growth. So, all of that information was available to provide to the FDA. As a matter of fact the article, , KM, Littlefield, TR, Pomatto, JK, Manwaring, KH, and Beals, SP (1999) Cranial growth unrestricted during treatment of deformational plagiocephaly. Pediatric Neurosurgery, 30: 193-199. (available at http://www.Plagiocephaly.org) was written based one small part of FDA request. That's another thing, they tell you what information you will provide. I guess they feel they are >entittled to more >money since it has been approved. I do not know much about the companies finances. However, I can say that a great deal of time and effort is spent to assure that a DOC band put on an infant in North Carolina or Chicago or Spain is a good as one delivered in Phoenix. I'm not certain how may helmet programs there are, but it is event from the discussion on this list all helmet are not of the same design (plus seem my next comments.) Back to the money issue>>>>Plus--this is no big secret--they are spending considerable time and effort trying to understand the cause of plagiocephaly it can either be prevented or recognized and treated sooner. > I don't see much difference either. As I said earlier if anyone you know of a study that has compared helmet (the question is which helmet) and the DOC band, please let me know. All I can say is that information on the effectiveness of the DOC band has been published. I hope this information helps. I'm sorry that I cannot tell you how well that different helmets work--that information simply has not been made available. But if any of you ever have a question, you direct it to me on the list or privately. M. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 18, 2000 Report Share Posted March 18, 2000 >From: heidi bosinger-waldron <bosingerwaldronh@...> > >, > >Hi, >My son has a helmet and I was concerned when I read >your message that helmets helped shape heads but >resulted in other deformities. Could you please >explain? > I really can't comment about the helmets that are being used today. I'm gathering that there are a number of different kinds and so far, none of the recent helmet makers have published about a sufficient number to make for me to comment. My comment about " other deformities " was a general comment about helmets predating my exposure to the DOC band. In general those earlier devices--when they worked--produced rounder, higher head. You might ask " What's wrong with a rounder, higher head? " First, a normal head is not round. It's actually wider in the back than in the front. Second, higher head (noticeable a higher forehead) is also very noticeable. This rounder, higher head was evidence of restricted growth. That was the old helmet. Unfortunately, I have not seen any of the helmets that are being discussed here. So, I cannot comment on them. My recommendation is just to ask the physician who recommended the helmet. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted March 18, 2000 Report Share Posted March 18, 2000 >I don't see much difference either. Hi... just to shed a little more light on the picture (though knows the most out of all of us...) -- I just got some literature from Cranial Technologies to share with my pediatrician and the neurosurgeon. Some of the articles are the same ones on the web. There are also a couple of articles from Pediatric News and the Chicago Tribune -- one of these articles describes the helmet as something that "does not mold the head but simply provides a tight round space for the head to grow into, according to Dr. Argenta" (of course, there are probably a lot of different helmets out there, and this just describes one...) it further states: the [DOC] band is a "custom fitted, semi-rigid headband," and "applies pressure to bulging areas of the skull, according to Cranial Technologies in Phoenix" In our case, since Quinn has a scaphocephalic head shape, I definitely feel that the gentle pressure treatment would be more beneficial. And I also feel that the neurosurgeon who kind of dismissed the helmet for treatment (I didn't know about the band then, and just inquired about the possibility of using a helmet -- he said it was only used in the opposite case... flat back, protruding front...) probably doesn't have much knowledge of the band. For a lot of positional plagiocephlic cases though, the helmet works just fine because it keeps the child off the flat spot, and just gently gives the skull a new place to go/grow. Depending on the severity of the head shape, I would have to say that the helmet would probably be just as effective. The bottom line is what you and your doctor(s) feel is best for your child. As with all medical treatments, each case is individual and depends on a lot of factors. 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.