Limb Lengthening Forum
Limb Lengthening Surgery => Limb Lengthening Doctors => Topic started by: KiloKAHN on July 05, 2015, 11:02:56 AM
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General Information and response from Dr Betz of The Betz Institute, based in Neunkirchen, Germany. Contact them for specific information and latest updates.
Note: Previous Discussion Thread Linked Here http://www.limblengtheningforum.com/index.php?topic=132.0
(http://i.imgur.com/ejh6VNZ.png)
Process:
Our patients can gain up to 4-5 inches (10-12 cm) in one operation on upper legs (femurs) or lower legs (tibias). Patients may also gain a total of 8-9 inches (20-22 cm) in 2 operations.
1st operation on femur for 4-5 inches (10-12 cm)
2nd operation on tibias for 4 inches (10 cm). The amount of gain in tibias may vary from patient to patient. In many cases it is advised by Prof. Dr. Betz to lengthen up to 6-8 cm in tibias.
Patients gain an average of 7-10 cm in one bone region at the Betz institute.
The rate of lengthening is 1 millimetre per day. Every 10 days is 1 cm. Patients can gain up to 10 cm (4 inches) in 3 months.
Surgical Techniques
We offer different methods for limb lengthening depending on the individual belongings of the patients. For cosmetic limb lengthening we normally use our own nail "Betzbone" which is working similar to the Guichet nail. We just changed it in a few points: different interlocking, more stability and corrosion free. Also in special cases we are using external fixator. We don't use ISKD anymore because it is very unsafe and not to control.
Precice doesn't offer enough stability to walk without crutches when you do both legs at the same time. Fitbone was our own invention but it also doesn't offer enough stability and also not enough lengthening capacity. Meanwhile "Betzbone" is the best nail on the market with the highest stability and easy to control. It is certified and very safe.
Prof. Dr. Betz is the most experienced limb lengthening surgeon in the world with internal devices. Cosmetic limb lengthening is a routine procedure for Prof. Dr. Betz in which he has performed over 800 procedures approx. 8-10 procedures per month. Every operation has a risk. But this surgery is a used operation for us. We provide limb lengthenings since about 20 years. Complications are seldom and we never had a big complication like infection or loss or malfunction of a limb etc.
Physiotherapy has to be done daily during lengthening period and it is also helpful to do it in advance before starting the surgery. We have a paper with all necessary and helpful exercises to keep your joints flexible.
We encourage all potential patients to come for a consultation and visit our facility (hospital, residential centre, rehabilitation centre), see the accommodations, and meet current patients during different stages of lengthening so that they can see the results for themselves. When patients come for their consultations they have the option of having their picture taken for the purpose of manipulating it for patients to see what they would look like with different gains.
Cost
The whole procedure of both femurs costs approx. 49.100 Euros and covers the entire operation, implants, hospital stay up to 14 days, physical therapy during the hospital stay, and Prof. Dr. Betz post-operative visits. The cost to lengthen both tibias (lower legs) is approx. 52.700 Euros.
Please let us know if you have any further questions or would like to schedule a consultation with Prof. Dr. Betz.
Contact
BETZINSTITUTE
Medi-Tech GmbH
Hermeskeiler Str. 11
66687 Wadern-Wadrill
Tel. +49 6871 921870
Fax +49 6871 921907
Mobil: +49 151 174 279 60
www.betzinstitute.com
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Complications are seldom and we never had a big complication like infection or loss or malfunction of a limb etc.
Wow, Augustin Betz is again spreading his lies. Never had a big complication like infection or malfunction of a limb? What about MasterHY? Not to speak about the many other cases which have no diary. Betz is the most risky of all LL surgeons. He is a careless surgeon and a most despicable human being. He is not to be trusted.
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Just looking at the amount of the lengthening seems very risky. Knowing what the complications of the too much lengthening are, how can he do that? Seems the amount of lengthening he is offering is very attractive, but the complications behind it have not been taken into consideration. I am just curios, with people that had complications how much they lengthened.
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He is totally terrible
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Sorry it was the wrong forum.
Are there currently patients with betz..?
I want to go with him in october. Thus it would be good to have some Update about current Situation. Thx
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Wow, .... 52000 euros !!!!!!!!!
My height is 186 cm But my wife's height is 157,
I liked his LL surgery but 52000 euros ?????? I do not have 52000 euros.
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Man if you go to reliable doc like betz guichet or Paley thats the price
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Bump is he really that bad? Most people want to do stupid amount of LL anyways he just enables people to do it. Not really a bad sort of doctor he just seems to understand how people think in this world. I would only do 5cm, on my femurs with him probably. Then do Salem for my tibia.
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I rather go to him than doctors in India.
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Some people are against Betz but others say he is awesome. I think he is probably the best option in Europe. Guichet is also ok but I dont like his training programe.
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I wouldn't go with a controversial doc but hey, it's your legs!
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All doctors who do this surgery are controversial
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Some more than others.
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He has most patients. Very less complains.
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I looked at his website but its down! Is Dr. Betz retired or is the website being revised and updated at the moment? Any informations?
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http://www.youtube.com/watch?v=8xD-57oeB_0
https://www.youtube.com/watch?v=AwvCywLmIxs
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http://www.youtube.com/watch?v=8xD-57oeB_0
https://www.youtube.com/watch?v=AwvCywLmIxs
Has he changed his betz bone recently(He does mention on video-1 though)? I believe constantine had no nail bend issue.
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Is this doctor still considered satan by this board? 4-5 inches on femur does seem like alot to allow.
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Is this doctor still considered satan by this board? 4-5 inches on femur does seem like alot to allow.
Well, he has always been pretty crazy to allow those amounts. He definitely seems like he is more interested in seeing the results than in you as a patient.
From his recent work: it seems he never told Constantine to limit his lengthening goal of 10cm (if you're reading this, do let us know), and he did 6cm limb shortening on Olivia Jones (https://de.wikipedia.org/wiki/Olivia_Jones#Trivia) (it was his work - as far as I'm aware).
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Betz's wife told me via email that they often lengthen 10cm on femur. After that response I decided against Betz.
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Do more people get away with 9cm-10cm on femur than we may have originally thought? Or are alot of the procedures fabricated and there is very little evidence of 9cm-10cm ever being successful? For someone to maintain a decent reputation for a decent period of time and be highly regarded whilst lengthening ungodly amounts, means they must have had some successful outcomes, no?
Seems there were even stories from Sarin where people lengthened 9cm and were "fine" although there were no logs.
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the price that listed here is just for operation and 2 weeks in clinic,and doesn't include tbe other time (recovery etc)Am i understand it correctly ?
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"Die Behandlung der beidseitigen Oberschenkelverlängerung kostet etwa 52.000 €. Die beidseitige Unterschenkelverlängerung kostet ca. 55.700 €. In diesen Kosten sind die komplette Operation, beide Verlängerungsimplantate, der Krankenhausaufenthalt von ca. 14 Tagen, die physikalische Therapie während des Krankenhausaufenthaltes sowie sämtliche Kontrollen durch Prof. Dr. Betz während der Behandlungsdauer enthalten. Wenn Sie also beide Ober- und beide Unterschenkel verlängern, sind Sie mit dem Betzbone insgesamt bei ca. knapp 108.000 €."
Betzbone
Both femur: 52.000€
Both tibias 55.700€
Including: surgery, implants, clinic stay for 14 days, PT during the 14 days, all check ups during treatment
"Die Operation beider Oberschenkel würde sich dann auf ca. 63.000 € inklusive Krankenhausaufenthalt, Implantate und Operation belaufen, die Operation beider Unterschenkel würde ca. 67.000 € kosten."
Precise 2
Both femur: 63.000€
Both tibia: 67.000€
Including (see above)
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thanks!
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Wanting 9cm in femurs is so tempting.
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Do more people get away with 9cm-10cm on femur than we may have originally thought? Or are alot of the procedures fabricated and there is very little evidence of 9cm-10cm ever being successful? For someone to maintain a decent reputation for a decent period of time and be highly regarded whilst lengthening ungodly amounts, means they must have had some successful outcomes, no?
Seems there were even stories from Sarin where people lengthened 9cm and were "fine" although there were no logs.
He just has a billion of cases. He does LL in the richest country in Europe.
If he didn't have success stories, no one would go to him. Regardless, 9-10cm is too much for the vast majority of people who want CLL.
To exemplify: one figure I've seen for femur size in this forum was 43cm (don't remember from which poster). 15% of that is 6.45cm. This falls in line with what is "folk knowledge" here: lengthening up to 6.5cm being the safer limit for femurs. The medical literature I've read on LL associates higher risks and complications from and above 20% of your initial bone length.
Someone would need to have 60cm femurs for 9cm to be equivalent (15% of their initial bone length), and 66.67cm femurs for 10cm to be the 15% equivalence. Even then, we don't really know if that is all there is to it - if the soft tissues would really behave/feel relatively the same after having been lengthened relatively the same with higher absolute numbers in one taller person, when compared to the equivalent in a shorter person (those values being lower in absolute numbers).
I know some people don't give a shxt about what I post because they collected all that money "and saw other people being fine", but I just try stating what I read in the medical literature those surgeons themselves wrote after operating on people like us.
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Betz has new material since about 4-5 years and he seemed to have no more broken or bent nails. His new nail can do full weight bearing and up to 12 cm (4-5 inches)
Also he has got new you tube videos:
https://www.youtube.com/watch?v=aaOYSUDyYgg
https://www.youtube.com/watch?v=4oYq5JWAY8s&t=74s
Who has got some experience?
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I had a consultation with Dr. Betz and he was excellent:
* He really answers every question
* He is open to different opinions (i.e. if you question the Betzbone he is willing to discuss - even with people like me who don't have any medical education)
* He did not push me in any directions
Beside the facts already mentioned I have been quiet late at his office (18:30) because of a train delay. Even during these late hours he had a very positive attitude.
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Are u kiddin me 20-22cm??I guess no one can go through Betz's death trap
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Do more people get away with 9cm-10cm on femur than we may have originally thought? Or are alot of the procedures fabricated and there is very little evidence of 9cm-10cm ever being successful?
I know this comment is old but I want to put my history here for other readers. I did 10cm with Betz back in 2012 (9cm in the left femur, 10cm in the right one) and I'm great. 100% recovery.
I spent months in Germany for this and during that time I met tons of Betz patients. Most did around 7cm to 8cm, but there was a good amount of people doing around 9cm to 10cm like. Betz himself usually would not recommend more than 8. He actually asked me to stop at 8.
My recovery was so good that I actually regret not doing 10cm to 11cm, but hindsight is always 20/20 .
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Why should anyone trust you? 100% recovery is impossible
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Why should anyone trust you? 100% recovery is impossible
Well, you trust whatever you want. I'm just telling my story.
I was very fit and flexible before the surgery (weight lifting since 16 plus Yoga) and one year after I took the nails out I became as fit as before
And who said 100% recovery is impossible?
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Fyi: Constantine is Fine. Im a fellow Gerrman, interested in Surgery with Betz, which is why a reached out to Constantine recently, in order to hear his opinion on Betz. Constantine is fine and has no regrets, even spoke to him on the phone for 30min. The only thing is his walk/ gait (minor hip issue), which is still not at 100% after 1,5y.
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Well, you trust whatever you want. I'm just telling my story.
I was very fit and flexible before the surgery (weight lifting since 16 plus Yoga) and one year after I took the nails out I became as fit as before
And who said 100% recovery is impossible?
100% recovery, at least in terms of potential athletic performance, is impossible with current LL technology. Soft tissue will inevitably weaken and lose its original strength after 1.5 cm of lengthening or so.
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100% recovery, at least in terms of potential athletic performance, is impossible with current LL technology. Soft tissue will inevitably weaken and lose its original strength after 1.5 cm of lengthening or so.
Says the guy who never did LL against the guy that did 10cm :P
I was a much better shape than the average and I continue to do so after my LL.
As i said to the other guy, believe whatever you want.
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Says the guy who never did LL against the guy that did 10cm :P
I was a much better shape than the average and I continue to do so after my LL.
As i said to the other guy, believe whatever you want.
Multiple people who have done LL have also said so.
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Says the guy who never did LL against the guy that did 10cm :P
I was a much better shape than the average and I continue to do so after my LL.
As i said to the other guy, believe whatever you want.
Do you play soccer, basketball, handball, rugby etc., any sports which require high agility?
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Fyi: Constantine is Fine. Im a fellow Gerrman, interested in Surgery with Betz, which is why a reached out to Constantine recently, in order to hear his opinion on Betz. Constantine is fine and has no regrets, even spoke to him on the phone for 30min. The only thing is his walk/ gait (minor hip issue), which is still not at 100% after 1,5y.
If his walking gait is not normal, swaying hip still after 1 and a half year, it may stay that way for a long time
Walking is the easiest thing in our movements
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Do you play soccer, basketball, handball, rugby etc., any sports which require high agility?
I didn't play any of those before LL and I still don't after. But I've been seriously weightlifting since I was a teenager, as well practicing Yoga. I also do HIIT for the cardio portion of my weightlifting training. I also do a lot of hiking and dancing (which requires high agility).
My performance in all of those went back to normal around 2 years after the operation (I only fully recovered after I took my nails out).
The main difference is that is harder to do squats than before due to the femur/tibia ratio (one of the reasons I'm considering doing LL on my tibias). On the other hand I can lift more than before (I assume it's because of the bigger leg muscles now).
So I consider my recovery 100%.
But you do have a point. Maybe if I did play some sports that need more explosiveness I would have a different opinion. But as I didn't practice those before I won't ever be able to compare.
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Multiple people who have done LL have also said so.
And why are their opinions more valid than mine?
It seems you only want to read what validates your already formed opinion.
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Hi, there are currently several lawsuits from former patients against Dr. Betz going on. If you or somebody you know is a former patient of Dr. Betz who would like to initiate legal action against him please send me a personal message.
I can help with lots of information on how to go about this.
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Hi, there are currently several lawsuits from former patients against Dr. Betz going on. If you or somebody you know is a former patient of Dr. Betz who would like to initiate legal action against him please send me a personal message.
I can help with lots of information on how to go about this.
If there was any genuine lawsuit against him that was actually proved true that he was responsible then they would have stripped him of his license a long time ago.
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If there was any genuine lawsuit against him that was actually proved true that he was responsible then they would have stripped him of his license a long time ago.
You have no idea what you are writing about. There's a difference between civil lawsuits and criminal lawsuits.
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You have no idea what you are writing about. There's a difference between civil lawsuits and criminal lawsuits.
No one is suing Betz. Youre the only one frustrating trying to sue him for 6 years without any success while he’s out there still operating every week.
Get on with life youre wasting so many years of your life trying to stop him from his profession. Hes been a surgeon for 30-40 years.
How frustrated do you have to be I just dont get it
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Does Dr. Betz have the right to call himself Professor? It is true that he has held lectures at Munich University some 20 years ago. However, that doesn't automatically give him the right to keep the title Professor after he stopped his lectures there.
Normally this right is only bestowed upon established officials after their retirement. In some cases the University can bestow this right directly if certain conditions were met. However with Dr. Betz it is questionable that this was the case.
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Why should anyone trust you? 100% recovery is impossible
Well, we shouldn't. We should be taking what that guy says with a grain of salt. His username and posts are a bit suspicious tbh.
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Does Dr. Betz have the right to call himself Professor? It is true that he has held lectures at Munich University some 20 years ago. However, that doesn't automatically give him the right to keep the title Professor after he stopped his lectures there.
Normally this right is only bestowed upon established officials after their retirement. In some cases the University can bestow this right directly if certain conditions were met. However with Dr. Betz it is questionable that this was the case.
What is the lawsuit about?
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What is the lawsuit about?
There are several lawsuits, not just one. They are about medical malpractice and defect Betzbone nails.
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Where can you read about these lawsuits? Any sources? How did you find about it?
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There are several lawsuits, not just one. They are about medical malpractice and defect Betzbone nails.
No there arent any lawsuits. Stop bull ting him.
You were one of those patients who did LL with Prof. Betz and had non-union. This procedure is full of risks complications that you have to keep in mind.
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No there arent any lawsuits. Stop bull ting him.
You were one of those patients who did LL with Prof. Betz and had non-union. This procedure is full of risks complications that you have to keep in mind.
You've just outed yourself as a shill. There are currently at least 5 lawsuits from former patients going on.
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You've just outed yourself as a shill. There are currently at least 5 lawsuits from former patients going on.
Boy you’re delusional. Every of your post are against Betz. Youve been lurking since 2014 fighting against Betz. Youre doing it for 7 years now but whats your point? Get on with life
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Boy you’re delusional. Every of your post are against Betz. Youve been lurking since 2014 fighting against Betz. Youre doing it for 7 years now but whats your point? Get on with life
I am interested, what are the main problems that come with non-union? Shouldn't it have been fixed by now? You can't run around for 7 years with an unhealed bone.
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I am interested, what are the main problems that come with non-union? Shouldn't it have been fixed by now? You can't run around for 7 years with an unhealed bone.
Why not? It's not ideal but it can be done as far as I know.
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Boy you’re delusional. Every of your post are against Betz. Youve been lurking since 2014 fighting against Betz. Youre doing it for 7 years now but whats your point? Get on with life
Looks like your a sock puppet account of wanttaller. The mods should check your IP number.
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Looks like your a sock puppet account of wanttaller. The mods should check your IP number.
I know wanttaller personally and we‘ve all been talking about you and Betz and all
the other people know you, trying to sue Betz for 7 years.
How can someone be so desperate trying to spend an almost whole decade to blame someone for your own mistake.
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Looks like your a sock puppet account of wanttaller. The mods should check your IP number.
Can you provide any links to the lawsuits? He is one of the doctors I am considering but if there are indeed lawsuits against him, then I will of course have to look elsewhere.
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Wow, .... 52000 euros !!!!!!!!!
My height is 186 cm But my wife's height is 157,
I liked his LL surgery but 52000 euros ?????? I do not have 52000 euros.
Why do you need LL surgery? You are 186cm! Are you crazy in the head? ::)
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He's properly looking to increase his height in order to get more distance to his wife ;D
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He's properly looking to increase his height in order to get more distance to his wife ;D
:P ;D
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Is he terrible? I’ve heard his nail issues with bending and breaking are fixed, and have seen good diaries on him. Plus fully weight bearing. By the way I want 6cm femur and 4 on tibias. Let me know if I should consult with him. Thanks
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Do and consult with him and see for yourself. Modern cases have all been good and I was told, from someone who does it rn with him, a lot of people are happy with betz. But of course you can never rule out the risk of being a bad case with complications.
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Is he terrible? I’ve heard his nail issues with bending and breaking are fixed, and have seen good diaries on him. Plus fully weight bearing. By the way I want 6cm femur and 4 on tibias. Let me know if I should consult with him. Thanks
I spent 1.5 hours talking to him on the phone yesterday and he seemed anything but terrible. He spent all that time explaining in a rather enthusiastic manner what can be done, what cases he had, why he is using Betzbone and of course also what can go wrong. My first impression was rather good. I suggest that you should consult with him :)
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Betzbone is weight bearing as was stryde. What differentiates the two? Does betzbone rust also?
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Betzbone is weight bearing as was stryde. What differentiates the two? Does betzbone rust also?
The difference is it's a mechanical nail, you extend it by ratcheting/clicking, usually this is more painfull.
It doesn't rust though.
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Betzbone is weight bearing as was stryde. What differentiates the two? Does betzbone rust also?
1. Betzbone is mechanical, you extend it by rotating your leg. For some people this is very painful, others do it effortlessly, see video at 8:30:
https://www.youtube.com/watch?v=q0t9XIfoBN4
Stryde is extended via a magnet, which many people will find less daunting.
2. Stryde rusts and it can cause lesions (irregularities / cavities in your bone), which is claimed to result in pain many months post surgery. Betzbone has no such problems.
3. Stryde can be retracted, which it claims can help with non-union. Betzbone extends in only one direction.
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You commented the consultation was terrible yet you said you were impressed??
Sorry I was confused
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how much was the consult
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how much was the consult
€350 - That's because it was over the phone. The other €150 you pay when you're there before the surgery.
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Hey nice to see you here DonBones
1) I had the opporunity to talk to 4 other patients during my 2 week hospital stay. Only 1 had no problems clicking. 2 had severe pain clicking (had to come back for anesthasia). 2 (including myself had moderate pain clicking). Out of a sample size of 5, I would say 80% of patients have had some problems clicking in at least one leg. Luckily for me, the pain becomes more manageable after 2.2cm.
2) Dr Betz loves to advertise the point that his nail has no iron in it, thus can't rust. It seems the rust causes pain for 5% of patients according to Dr Giotikas. Failures for Betzbone is at least double that. Still, it is severe enough of a % for Nuasive to voluntarily recall Stryde. That's usually what you get with American medical device suppliers. Extremely expensive, but reliable.
3) I posed that to Dr Betz too, and he claimed that non-union is extremely rare. I have received PMs from former patients who got non-union from Dr Betz. It seems this happens much more frequently in tibias and there is always some level of patient non-cooporation. For femurs, the retraction mechanism isn't a deal breaker, though for tibias, I would not consider Betzbone.
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Hey nice to see you here DonBones
1) I had the opporunity to talk to 4 other patients during my 2 week hospital stay. Only 1 had no problems clicking. 2 had severe pain clicking (had to come back for anesthasia). 2 (including myself had moderate pain clicking). Out of a sample size of 5, I would say 80% of patients have had some problems clicking in at least one leg. Luckily for me, the pain becomes more manageable after 2.2cm.
2) Dr Betz loves to advertise the point that his nail has no iron in it, thus can't rust. It seems the rust causes pain for 5% of patients according to Dr Giotikas. Failures for Betzbone is at least double that. Still, it is severe enough of a % for Nuasive to voluntarily recall Stryde. That's usually what you get with American medical device suppliers. Extremely expensive, but reliable.
3) I posed that to Dr Betz too, and he claimed that non-union is extremely rare. I have received PMs from former patients who got non-union from Dr Betz. It seems this happens much more frequently in tibias and there is always some level of patient non-cooporation. For femurs, the retraction mechanism isn't a deal breaker, though for tibias, I would not consider Betzbone.
Oh cheers for that, some interesting insights.
Do you have any sources for "Failures for Betzbone is at least double that."? I would like to read more about it.
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If you read earlier posts on this thread, they've compiled a list of complications and came to rates of near 30%. Giotikas told me he has seen estimates of 10%, which I think is likely closer to the truth. If it means anything, one of the patients I met who had his nail removed, had a broken screw. Luckily for him it happened during consolidation so it didn't lead to complications. But had it happened a few weeks earlier, things would be very different. I personally don't doubt Betz' surgical skills given that he has over 2000 surgeries under his belt. You will find that few if any complications are surgically related. He's a career surgeon and medical professor. However his nails don't have nearly the same reputation. No other doctors use his nails, even though they are cheaper than Stryde, for a reason. When asked about nail or screw breakages, Betz' doesn't even deny it. He just says it's the patients fault for weight bearing too early or not using crutches.
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Thank for letting us know about it. So regarding the nail breakages, Betz just blames all on the patients' faults, but why did he advertise the nail to be "full weight bearing" in the first place? I am carefully considering Betzbone nail since it is the only option for loading full weight at the moment
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So the thing is both Stryde and Betzbone are full weight bearing in lab testing. I've seen xrays of both nails or their screws bending resulting in losing height gains or other complications. They are both a huge step up from Precise 2, but not perfect. Stryde has much more objective data from third party surgeons but only Betz' uses Betzbone, so we have to be skeptical about his claims. Stryde surgeons will ask that you walk with crutches during lengthening also. At the end of the day, it's just safer to use crutches and not test the limit of "full weight bearing" feature of any nail.
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So the thing is both Stryde and Betzbone are full weight bearing in lab testing. I've seen xrays of both nails or their screws bending resulting in losing height gains or other complications. They are both a huge step up from Precise 2, but not perfect. Stryde has much more objective data from third party surgeons but only Betz' uses Betzbone, so we have to be skeptical about his claims. Stryde surgeons will ask that you walk with crutches during lengthening also. At the end of the day, it's just safer to use crutches and not test the limit of "full weight bearing" feature of any nail.
The main problem is that Betzbone doesn't have any regulatory approval from the FDA or EMA and Dr Betz is the only doctor who uses it. He doesn't have to report any complications (non-union, loose screws, corrosion etc.) to a regulatory authority. That means, he can say anything he wants and there will be no serious consequences when it's a lie.
Stryde is very different. It's an FDA approved device. Any complication has to be reported to the FDA! And if there is a slightest doubt about safety the device will be banned until further notice.
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The main problem is that Betzbone doesn't have any regulatory approval from the FDA or EMA and Dr Betz is the only doctor who uses it. He doesn't have to report any complications (non-union, loose screws, corrosion etc.) to a regulatory authority. That means, he can say anything he wants and there will be no serious consequences when it's a lie.
Stryde is very different. It's an FDA approved device. Any complication has to be reported to the FDA! And if there is a slightest doubt about safety the device will be banned until further notice.
It has the CE mark and is reviewed every year.
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It has the CE mark and is reviewed every year.
They have withdrawn precice's CE mark but Betzbone still has it?
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They have withdrawn precice's CE mark but Betzbone still has it?
Of course. He wouldn't be operating without it. This is Germany we are talking about. The bar to bring anything to the market is fairly high. If anyone thinks Betz has been able to operate on thousands of people with a rogue nail for over 20 years then that is borderline ridiculous.
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Of course. He wouldn't be operating without it. This is Germany we are talking about. The bar to bring anything to the market is fairly high. If anyone thinks Betz has been able to operate on thousands of people with a rogue nail for over 20 years then that is borderline ridiculous.
It has to be noted that CE Marks only tell you that something is built to a certain "standard" and is often self-declared. It does not go through nearly the same thorough third-party audits that FDA does when it approves a medical device. In fact CE themselves say "...is not a quality indicator or a certification mark."
For example, I can say that my phone charger is built to provide 5000 mAh of battery life. The product then only has to be able to perform this out of the factory (standard), not after a year of rigorous use at home (quality). So we can be relatively certain that Betzbone does what it says it does in factory testing (CE Mark), but that has no bearing on whether this thing will live on in our bodies for months without any complication (FDA Approval).
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Without going into depth on any particular comment here, here is an excerpt from the EMA:
"Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level. The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device.
Medical devices in the EU have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. EU Member States can designate accredited notified bodies to conduct conformity assessments.
The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment."
Source: https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
Whether this is as rigorous as the FDA I do not know, but having lived in Germany for 20 years I have no doubts that German standards of quality assurance are as good as anyones, in particular in medicine where entry requirements are extremely high. By that I mean top 1% of your graduation (Numerus Clausus) class and 13 years of studies before you can even call yourself a specialised doctor (i.e. Facharzt).
It would be inconceivable to me that someone makes it through this system, earns a professor title and works as one of the most senior surgeons in Munich to then produce a nail that is of low quality and sort of goes under the radar of the German or European quality assurance agencies.
I am of course not an expert in legal matters, but if safety and regulatory conformity are a concern, then I feel confident that Germany is one of the best, if not the best, place to go to.
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Without going into depth on any particular comment here, here is an excerpt from the EMA:
"Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level. The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the European Medicines Agency (EMA) and national competent authorities in the assessment of certain categories of medical device.
Medical devices in the EU have to undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. EU Member States can designate accredited notified bodies to conduct conformity assessments.
The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
Manufacturers can place a CE (Conformité Européenne) mark on a medical device once it has passed a conformity assessment."
Source: https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
Whether this is as rigorous as the FDA I do not know, but having lived in Germany for 20 years I have no doubts that German standards of quality assurance are as good as anyones, in particular in medicine where entry requirements are extremely high. By that I mean top 1% of your graduation (Numerus Clausus) class and 13 years of studies before you can even call yourself a specialised doctor (i.e. Facharzt).
It would be inconceivable to me that someone makes it through this system, earns a professor title and works as one of the most senior surgeons in Munich to then produce a nail that is of low quality and sort of goes under the radar of the German or European quality assurance agencies.
I am of course not an expert in legal matters, but if safety and regulatory conformity are a concern, then I feel confident that Germany is one of the best, if not the best, place to go to.
You don't know what you're talking about. Since in the case of Betz the surgeon is identical with the manufacturer there is no effective control process whatsoever. The declaration of conformity simply means that the manufacturer promises that his product is conform the the EU regulation. But this is not verified. The regulation in question here is called 93/42/EWG and can be found online.
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Again, to reiterate:
1. Betzbone is definitely audited and approved by an independent body. Those bodies are commonly referred to as the "Bennante Stelle". This happens yearly and is mandatory to be able to keep the CE mark. Betz actually has to pay a fair amount of money for it. The audit will be by one of those: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=276
2. Betz definitely does have to report complications to the so-called BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte / Federal Institute for Drugs and Medical devices). This is the english version of their website for more info: https://www.bfarm.de/EN/Home/home_node.html
3. In general, surgeons in Germany hold a license which can be revoked should there be actual evidence of malpractice.
This is Germany and this is the EU we are talking about, and I am not sure how someone might think that a surgeon there can self-approve themselves. Having said that, I don't mean to get into meaningless merry-go-round discussions on those topics. My advice to anyone reading is:
a) Always have an actual consultation with a doctor such as Betz himself and never draw premature conclusions. If after the consultation you have major doubts it's likely best to look elsewhere or to avoid the surgery altogether.
b) Be vigilant when you read defamatory comments about doctors online. I think sometimes sentiments against particular doctors may be personal or competitive in nature.
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Again, to reiterate:
1. Betzbone is definitely audited and approved by an independent body. Those bodies are commonly referred to as the "Bennante Stelle". This happens yearly and is mandatory to be able to keep the CE mark. Betz actually has to pay a fair amount of money for it. The audit will be by one of those: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=276
2. Betz definitely does have to report complications to the so-called BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte / Federal Institute for Drugs and Medical devices). This is the english version of their website for more info: https://www.bfarm.de/EN/Home/home_node.html
3. In general, surgeons in Germany hold a license which can be revoked should there be actual evidence of malpractice.
This is Germany and this is the EU we are talking about, and I am not sure how someone might think that a surgeon there can self-approve themselves. Having said that, I don't mean to get into meaningless merry-go-round discussions on those topics. My advice to anyone reading is:
a) Always have an actual consultation with a doctor such as Betz himself and never draw premature conclusions. If after the consultation you have major doubts it's likely best to look elsewhere or to avoid the surgery altogether.
b) Be vigilant when you read defamatory comments about doctors online. I think sometimes sentiments against particular doctors may be personal or competitive in nature.
The problem with CE is that, it is in fact largely self-declared. "Notified Bodies" do not independently test the devices themselves. They audit your company's compliance to regulations. The manufacturer would issue a Declaration of Conformity and the independent "Notified Bodies" would review the documentation provided to justify the declaration (quality management system, technical files, etc...). I understand that you have faith in Germany, but in the area of medical devices, the EU audits its manufacturers much less rigorously than the US, where Nuasive, perhaps Betzbone's largest competitor is based.
Hanshi may have come down a bit hard, but I think his main point was that since Betz is the only user of Betzbone, there cannot exist an independent audit. Normally, it is in the customer's interest to report on defective products to benefit from refunds and other remuneration. However, since Betz is the customer and manufacturer, he has a financial incentive to under report complications so he can keep Betzbone on the market, hence a clear conflict of interest. He controls the data and what complications to report. Stryde on the other hand has independent data reported from different doctors globally. Nuasive cannot control what complications are reported.
I really don't think anyone is trying to defame Dr Betz. As a patient, I think he's a legit and experienced surgeon. Betzbone on the hand, may not be a reliable device and because he's the only user, we can never know.
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The problem with CE is that, it is in fact largely self-declared. "Notified Bodies" do not independently test the devices themselves. They audit your company's compliance to regulations. The manufacturer would issue a Declaration of Conformity and the independent "Notified Bodies" would review the documentation provided to justify the declaration (quality management system, technical files, etc...). I understand that you have faith in Germany, but in the area of medical devices, the EU audits its manufacturers much less rigorously than the US, where Nuasive, perhaps Betzbone's largest competitor is based.
Hanshi may have come down a bit hard, but I think his main point was that since Betz is the only user of Betzbone, there cannot exist an independent audit. Normally, it is in the customer's interest to report on defective products to benefit from refunds and other remuneration. However, since Betz is the customer and manufacturer, he has a financial incentive to under report complications so he can keep Betzbone on the market, hence a clear conflict of interest. He controls the data and what complications to report. Stryde on the other hand has independent data reported from different doctors globally. Nuasive cannot control what complications are reported.
I really don't think anyone is trying to defame Dr Betz. As a patient, I think he's a legit and experienced surgeon. Betzbone on the hand, may not be a reliable device and because he's the only user, we can never know.
Great points. In fact, the problems with Stryde were first reported by a UK surgeon.
The only way the authorities can audit Betz's data is by forcing him to submit all his patient medical information so that they can verify that there are no gaps. But that would be a massive privacy violation and I doubt Betz would be allowed to give away any patient medical information except if there is a lawsuit.
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Again, to reiterate:
1. Betzbone is definitely audited and approved by an independent body. Those bodies are commonly referred to as the "Bennante Stelle". This happens yearly and is mandatory to be able to keep the CE mark. Betz actually has to pay a fair amount of money for it. The audit will be by one of those: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=country.notifiedbody&cou_id=276
2. Betz definitely does have to report complications to the so-called BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte / Federal Institute for Drugs and Medical devices). This is the english version of their website for more info: https://www.bfarm.de/EN/Home/home_node.html
3. In general, surgeons in Germany hold a license which can be revoked should there be actual evidence of malpractice.
This is Germany and this is the EU we are talking about, and I am not sure how someone might think that a surgeon there can self-approve themselves. Having said that, I don't mean to get into meaningless merry-go-round discussions on those topics. My advice to anyone reading is:
a) Always have an actual consultation with a doctor such as Betz himself and never draw premature conclusions. If after the consultation you have major doubts it's likely best to look elsewhere or to avoid the surgery altogether.
b) Be vigilant when you read defamatory comments about doctors online. I think sometimes sentiments against particular doctors may be personal or competitive in nature.
You are spreading misinformation. The notified body (in this case a small company from Aachen which already stopped doing certifications) did only certify the quality system of Betz's company, on paper only. And the certification is valid for 5 years. Not just 1 as you wrote.
It is true that doctors and manufacturers have the obligation to report "dangerous events" in connection with medical devices. However, Betz and his company have never done this(the problem is that there are no consequences if they don't report). This is a fact which has been brought up in a current lawsuit.
A doctor's license could be revoked however this normally only occurs after he has been sentenced for criminal charges.
Betz resides in the 2nd smallest federal state of Germany and the institutions there are very reluctant to go after him. He seems to be well connected locally.
I know many more details about this "Betzbone business" , but I'll leave it at that here.
If you choose Dr. Betz you will be at his mercy.
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I’ve seen plenty of the recent diaries for betz, and it seems like he’s pretty good. From what you all have gathered, does he seem like a very good choice? I see the benefits being the weight-bearing nail, however the downside is that clicking can be painful for some. Thoughts on choosing him?
Thanks
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The downsides are that clicking is a nightmare and follow-up care is minimal. But he is a good surgeon and do your own research and become VERY well-informed about anatomy and PT, it can be good. I am a former Betz patient.
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Could you further describe how clicking was a nightmare? It seems that for many the only downside to betz is the clicking.
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The leg has to move in a very unnatural position, and it's very painful. Read the diaries. Once it's over, it's a big relief and for most it gets easier one day and then easier and easier thereafter. The first few weeks are hell, though, and scary.
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I would never give so much money for an obsolete nail which is a torture to use and a very old and controversial doctor.
I really can't understand how some people are thinking.
There are people who even consider ridiculously expensive butchers like Guichet for their doctors and end up crippled or mistreated and come here searching for other doctors to fix them while yhey would have gone to these doctors from the begining.
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Could you further describe how clicking was a nightmare? It seems that for many the only downside to betz is the clicking.
It's not a nightmare for everyone. For me clicking was super easy. During the 8 months I stayed in Germany for my LL, II'd say clicking was painless for most patients (let's say 95% or more of them). The problem is that when is NOT, it's really bad - you may need anesthesia to click.
But this is very rare. I only remember two cases in my 8 months there (and I met every single Betz patient there during this time).
And I'm taking about the old Betzbone. With the current one the clicking is much easier.
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I needed clicking under anasthesia and when I was in the hospital I saw another person who needed it. Its not at all rare. Some people can never click at all. It has happened. Even body builders cry when they click. I know of one such case. And a friend of mine cried and screamed while
Clicking. This lasts for weeks and then disappears like magic.
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Disappears like “magic” however sounds excruciatingly terrible before, was that worth it inchesmatter?
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I think so. For most, it is worth it. I haven't met or spoken with anyone who didn't think so. All the Betz patients I know are very happy.
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I needed clicking under anasthesia and when I was in the hospital I saw another person who needed it. Its not at all rare. Some people can never click at all. It has happened. Even body builders cry when they click. I know of one such case. And a friend of mine cried and screamed while
Clicking. This lasts for weeks and then disappears like magic.
It is still rare. It happens but not often. Thus, it's rare (check the meaning of the word rare in the dictionary...)
As I said, I knew two cases of patients who needed clicking under anesthesia, but only two cases in 8 months meeting EVERY Betz patient in Germany.
For the most Betz patients clicking is either painless or very little pain (more of a soreness than real pain).
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Hi! Any previous patients of Dr Betz? Can you share your thoughts on him?
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Hi, my former posts on this forum will tell you pretty well my thoughts on him. I know much more about him than probably anybody else on this forum.
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The cost of surgery does not inlude nail removal. Cost 7000 Euro extra.
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Hey man, I'm going with him on January 2024. Can we talk about your experience ? Thanks !
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Hey man, I'm going with him on January 2024. Can we talk about your experience ? Thanks !
Are you sure it is Dr.Betz?
He has retired and taking over by Dr.Becker!
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Hi there,
I'm also looking at doing LL with Becker-Betz. What's the maximum you can have on the femur and tibias? I know the nail allows up to 12.5cm but are there any records of people doing this?
When I emailed some time ago they seemed to indicated 12.5 on femurs was doable but were advising not beyond 10 on the tibias.
I'm also looking at maybe doing LON elsewhere because of the price at Betz.
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thread too old
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Any update ?
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yes it will be with Becker !
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Hi there,
I'm also looking at doing LL with Becker-Betz. What's the maximum you can have on the femur and tibias? I know the nail allows up to 12.5cm but are there any records of people doing this?
When I emailed some time ago they seemed to indicated 12.5 on femurs was doable but were advising not beyond 10 on the tibias.
I'm also looking at maybe doing LON elsewhere because of the price at Betz.
I did 12.36cm with betzbone.
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Anyone did Tibias with him?
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I would never give so much money for an obsolete nail which is a torture to use and a very old and controversial doctor.
I really can't understand how some people are thinking.
There are people who even consider ridiculously expensive butchers like Guichet for their doctors and end up crippled or mistreated and come here searching for other doctors to fix them while yhey would have gone to these doctors from the begining.
Why do you think the nail is obsolete? Do you know what are the main differences between more new nails like Precice, Stryde and Betzbone?