Dr Augustin Betz (Neunkirchen, Germany) The Betz Institute 2015 Update

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Quote from: Limbfan2020 on June 02, 2021, 10:58:57 AMThe 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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Quote from: DonBones on June 02, 2021, 03:10:08 PMIt 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They have withdrawn precice's CE mark but Betzbone still has it?

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Quote from: Want-3-inches on June 02, 2021, 03:14:50 PMThey have withdrawn precice's CE mark but Betzbone still has it?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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Quote from: DonBones on June 02, 2021, 03:20:57 PMOf 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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Quote from: DonBones on June 03, 2021, 09:14:59 AMWithout 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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Quote from: DonBones on June 04, 2021, 07:56:42 AMAgain, 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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Quote from: SirStretchAlot on June 05, 2021, 06:25:18 AMThe 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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Quote from: DonBones on June 04, 2021, 07:56:42 AMAgain, 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.