New Challenge for Nobel Reps





All this childish, Implant Direct produced propaganda is entertaining, and sheds a light on what misinformed people work at Implant Direct. The one thing none of you geniuses has touched on, and it maybe just a little bit important, is the fact that over the last 30 years (10 times longer than ID has even existed) there has never been nor is there currently any abnormally high failure rates with Nobel Implants. Maybe one of you Rhode Scholars want to explain how millions of leaky, contaminated vials have been on the market, containing bacteria laden implants, and Nobel's failure rate is less than or equal to every other implant company. You can split hairs about failure rate, 97.3 vs. 98.1, but in reality and practice Nobel falls well within the industry standard. Pretty God Damn good for having all that bacteria and leaky vials. Maybe you can explain these facts for us.

Is that the validated test that Nobel has to offer to the FDA during an investigation?
Are all failures reported to Nobel or are the published studies based on procedures performed in a limited number of selected practices? Can a leaky vial be the cause of cross contamination?

Some questionable published percentages may not be the answer to all questions.
 




All this childish, Implant Direct produced propaganda is entertaining, and sheds a light on what misinformed people work at Implant Direct. The one thing none of you geniuses has touched on, and it maybe just a little bit important, is the fact that over the last 30 years (10 times longer than ID has even existed) there has never been nor is there currently any abnormally high failure rates with Nobel Implants. Maybe one of you Rhode Scholars want to explain how millions of leaky, contaminated vials have been on the market, containing bacteria laden implants, and Nobel's failure rate is less than or equal to every other implant company. You can split hairs about failure rate, 97.3 vs. 98.1, but in reality and practice Nobel falls well within the industry standard. Pretty God Damn good for having all that bacteria and leaky vials. Maybe you can explain these facts for us.

Have you thought that it is Nobel who is spreading propaganda about its high implant success? Here is a study reported at the EAO meeting only 3 weeks ago comparing Implant Direct's RePlant to Nobel Biocare's Replace implants. 5 clinicians, upper jaws only all with Nobelguide placement in the maxilla with Nobel and Implant Direct implants placed by the same clinician in the same upper jaw for a control. How do you explain the results with only1% failures for Implant Direct compared to 13% with Nobel's implants. Not bad for a "cheap knock-off". Maybe it was the lack of sterility of the Nobel Implants that made the difference - that is the only variable I can see other than the RePlant is self-tapping and went in with possibly more stability. As for Nobel being around for 30 years which you claim is 10X longer than Implant Direct, Niznick has been in the implant industry for 27 years dating back before Nobel started selling implants in North America. Where would Nobel be today if it had not bought Steri-Oss in 1999 - gone and long forgotten, that's where. Niznick was making internal bevel and hex implants since 1986 (Screw-Vent still on market) while Nobel did not introduce the NobelActive with an internal bevel and hex in 2008 and called it the implant of the future. They had to buy it from an Israeli "cheap knock-off" company called Alpha Bio that intelligently knocked off Niznick's Screw-Vent fro years. They were smart enough not to copy Nobel's external hex and it paid off when Nobel bought them for $95M.

http://www.implantdirect.com/pdf/EAO_ImplGuidSurg_Final.pdf
 




Game set match Nitzick. Where is this going to end?

I think it has to end with Nobel having a global recall. If you think lack of seal of sterile packaging is not critical, ask Boston Scientific that had a Health Canada Recall
2009-08-07 just because the "Sterile barrier in the packaging may be commpromised."

THERE IS NO QUESTION THAT NOBEL'S Sterile barrier in their packaging IS compromised as proven by repeated failure of independent dye leak tests.


Trade Name A) Expo Angiographic Catheters, amplatz
B) Impulse Angiographic Catheter, amplatz
C) Impulse Angiographic Catheter, brachial
D) Impulse Angiographic Catheters,femoral
E) Impulse Angiographic Catheters,internal
F) Impulse Angiographic Catheters,left
G) Impulse Angiographic Catheters, multi
H) Impulse Angiographic Catheters, radial
I) Impulse Angiographic Catheters, ventri.
J) Impulse Angiographic Catheters, kimny
K) Impulse Angiographic Catheters, cummings
L) Expo Angiographic Catheters, brachial
M) Expo Aangiographic Catheters, femoral
N) Expo Angiographic Catheters, femoral r.
O) Expo Angiographic Catheters intermal
P) Expo Angiographic Catheters L/R coronar
Q) Expo Angiographic Catheters, multipurpose
R) Expo Angiographic Catheters, ventricular
S) Expo Angiographic Catheters, multipack
T) Expo Angiographic Catheters, kimny famil
U) Expo ANgiographic Catheters, cummings FA
V) Wiseguide Guide Catheters, femoral
W) Wiseguide Guide Catheters, allright
X) Wiseguide Guide Catheters, voda
Y) Wiseguide Guide Catheters, amplatz
Recall Posting Date 2009-09-14
Manufacturer Boston Scientific Corporation
Recall Start Date 2009-08-07
Recall Number 50383
Hazard Classification Type II
Model or Catalog # A) 08526-01
B) 16391-100
C) 16391-11
D) 16391-02
E) 16391-201
F) 16391-190
G) 16391-117
H) 16391-174
I) 16391-40
J) 16391-180
K) 16391-203
L) 08526-150
M) 08526-21
N) 08526-01
O) 08526-201
P) 08526-190
Q) 08526-146
R) 08526-40
S) H749085263002
T) 08526-180
U) H749085263031
V) 16320-01
W) 16320-496
X) 16320-230
Y) 16320-103
Lot or Serial # A) N/A
B) N/A
C) N/A
D) N/A
E) N/A
F) N/A
G) N/A
H) N/A
I) N/A
J) N/A
K) N/A
L) N/A
M) N/A
N) N/A
O) N/A
P) N/A
Q) N/A
R) N/A
S) N/A
T) N/A
U) N/A
V) N/A
W) N/A
X) N/A
Y) N/A
Reason for Recall Sterile barrier in the packaging may be compromised.
 




A lot of talk about this issue on a childish, moronic rep board. No talk, discussion, or recall by FDA, and that is all that matters. Now you ID morons go out and sell on merit instead of waiting for the sky to fall on Nobel. Boston Scientific is still in business, and thriving by the way.
 








A lot of talk about this issue on a childish, moronic rep board. No talk, discussion, or recall by FDA, and that is all that matters. Now you ID morons go out and sell on merit instead of waiting for the sky to fall on Nobel. Boston Scientific is still in business, and thriving by the way.

Not a good analogy - Boston Scientific is still in business because the recall only effected a small fraction of its product line. Nobel's potential recall effects all of its Implants. I guess its "sterile" abutment and drill packaging also needs testing.
 




A lot of talk about this issue on a childish, moronic rep board. No talk, discussion, or recall by FDA, and that is all that matters. Now you ID morons go out and sell on merit instead of waiting for the sky to fall on Nobel. Boston Scientific is still in business, and thriving by the way.

This is weekend update by Saturday Night Live, the "Really" Segment:

Really, before you post a dumb reply, take a moment and think how extensive Boston Scientific's product line is compared to Nobel Biocare. Really! Here, let me help. For starters, they are in Endo, Cardiac, Urology, and god knows what else. Really, so, if they have a recall, it won't be as bad as say Nobel's only product line being recalled... Really, then Nobel gets rid of Mosher and the COO and you want the implant world to believe that this is not related to what is going on...REALLY??? It's like saying that Michael Jackson doctor didn't kill him, he only administered the drug...REALLY!
You are right, nothing has come down from the FDA, but all indications are that something will happen, it's just a matter of time. What a stupid moronic post that was....REALLY!
 




This is weekend update by Saturday Night Live, the "Really" Segment:

Really, before you post a dumb reply, take a moment and think how extensive Boston Scientific's product line is compared to Nobel Biocare. Really! Here, let me help. For starters, they are in Endo, Cardiac, Urology, and god knows what else. Really, so, if they have a recall, it won't be as bad as say Nobel's only product line being recalled... Really, then Nobel gets rid of Mosher and the COO and you want the implant world to believe that this is not related to what is going on...REALLY??? It's like saying that Michael Jackson doctor didn't kill him, he only administered the drug...REALLY!
You are right, nothing has come down from the FDA, but all indications are that something will happen, it's just a matter of time. What a stupid moronic post that was....REALLY!

It is amazing that you idiot ID reps can compare the Michael Jackson death to a non existent recall of every single implant Nobel has ever made. Conspiracy theorists are alive and well at Implant Direct. Your desperate CEO, hires a company to perform a test on their competitors product then promotes it on CF, and that means the FDA is all over the case? For your information, Nobel has several manufacturing facilities, 3 different implant brands, so for you to say that all of Nobel's products will be effected illustrates your ignorance of the situation. No matter what you or your wacko boss has to say about anything, the reality is there is no recall of Nobel products. Now go and get us some information about the Kennedy Assasination or Princess Dianna's death. ID will hire anyone these days, as long as they play with Star Wars figures and believe there is a conspiracy theories.
 




It is amazing that you idiot ID reps can compare the Michael Jackson death to a non existent recall of every single implant Nobel has ever made. Conspiracy theorists are alive and well at Implant Direct. Your desperate CEO, hires a company to perform a test on their competitors product then promotes it on CF, and that means the FDA is all over the case? For your information, Nobel has several manufacturing facilities, 3 different implant brands, so for you to say that all of Nobel's products will be effected illustrates your ignorance of the situation. No matter what you or your wacko boss has to say about anything, the reality is there is no recall of Nobel products. Now go and get us some information about the Kennedy Assasination or Princess Dianna's death. ID will hire anyone these days, as long as they play with Star Wars figures and believe there is a conspiracy theories.

Get ready, I'm about to get mid-evil on yo ass! BTW, I'm not an ID rep, I have some dignity.

Here, let's break it down, I only do it for your benefit, so please don't cry to Donato or who ever else is feeding you these lines.

"For your information, Nobel has several manufacturing facilities, 3 different implant brands, so for you to say that all of Nobel's products will be effected illustrates your ignorance of the situation."

Now, even if the manufacturing facilities portion is correct, from what I can tell from the switch out I did today, the packaging all look the same to me. Even if they were different, that means that your packaging process must be faultier than we have thought!!! Don't forget that the implant lines in question here are the Replace and the Active.

Now, the combined sales of those two together conservatively must make up at least 60% of your total sales. So in REALITY, and think before you respond, you will suffer more than Boston Scientific, right???

Geez, responding to your posts is similar to when Joe Pesci was cross examining the witness regarding the shooting and robbery at the sac-o-suds. You are now Mr. Ernie Crane!!! Going forward, I will call you Ernie Crane!

Mr. Crane, what are these pictures of?
Ernie Crane: My house and stuff.
Vinny Gambini: House and stuff. And what is this brown stuff on your window.
Ernie Crane: Dirt.
Vinny Gambini: Dirt. And what is this rusty, dusty, dirty looking thing that's covering your window?
Ernie Crane: That's a screen.
Vinny Gambini: A screen! It's a screen. And what are these really big things that are right in the middle of your view of the Sac-o-Suds and your kitchen window, what do we call these big things?
Ernie Crane: Trees?
Vinny Gambini: Trees, that's right, don't be afraid just shout 'em right out when you know 'em. And what are these thousands of little things that are on trees?
Ernie Crane: Leaves.
Vinny Gambini: And these big bushy things between the trees.
Ernie Crane: Bushes.
Vinny Gambini: Bushes. So, Mr. Crane, you can positively identify the defendants, for a moment of 2 seconds, looking through this dirty window, this crud covered screen, all of these trees, with all of these leaves on them, and I don't know how many bushes.
Ernie Crane: Looks like five.
Vinny Gambini: Uh, uh, uh, don't forget, this one and this one.
Ernie Crane: Seven bushes!
Vinny Gambini: Seven bushes. So, what do you think? Isn't possible you just saw two guys in a green convertable and not necessarily these two particular guys?
Ernie Crane: I suppose.
Vinny Gambini: I'm finished with this guy.

I can't help myself, it's too easy!
 




It is amazing that you idiot ID reps can compare the Michael Jackson death to a non existent recall of every single implant Nobel has ever made. Conspiracy theorists are alive and well at Implant Direct. Your desperate CEO, hires a company to perform a test on their competitors product then promotes it on CF, and that means the FDA is all over the case? For your information, Nobel has several manufacturing facilities, 3 different implant brands, so for you to say that all of Nobel's products will be effected illustrates your ignorance of the situation. No matter what you or your wacko boss has to say about anything, the reality is there is no recall of Nobel products. Now go and get us some information about the Kennedy Assasination or Princess Dianna's death. ID will hire anyone these days, as long as they play with Star Wars figures and believe there is a conspiracy theories.

Nobel may have 3 different manufacturing facilites but they only have one design of implant vial and they all leak. The FDA is involved, not because Niznick posted it on cafepharma... but because he submitted a medwatch report to the FDA when Mosher did not the leaking vial warning seriously. Yes, unless the FDA takes some action, this will probably blow over but it is yet another nail in Nobel's coffin.
 




It is amazing that you idiot ID reps can compare the Michael Jackson death to a non existent recall of every single implant Nobel has ever made. Conspiracy theorists are alive and well at Implant Direct. Your desperate CEO, hires a company to perform a test on their competitors product then promotes it on CF, and that means the FDA is all over the case? For your information, Nobel has several manufacturing facilities, 3 different implant brands, so for you to say that all of Nobel's products will be effected illustrates your ignorance of the situation. No matter what you or your wacko boss has to say about anything, the reality is there is no recall of Nobel products. Now go and get us some information about the Kennedy Assasination or Princess Dianna's death. ID will hire anyone these days, as long as they play with Star Wars figures and believe there is a conspiracy theories.

Here is my "Cousin Vinny" parody rendition of the FDA investigator and Mosher arguing the objection of the validity of the leaky dye test testimony by Niznick:

Mosher: I object to this witness being called at this time. We've been given no prior notice he would testify. No discovery of any tests he's conducted or reports he's prepared. And as the court is aware, the defense is entitled to advance notice of all witness who will testify, particularly those who will give scientific evidence, so that we can properly prepare for cross-examination, as well as give the defense an opportunity to have his reports reviewed by a defense expert, who might then be in a position to contradict the veracity of his conclusions.
Judge Chamberlain Haller: Mr. Mosher?
Mosher: Yes, sir?
Judge Chamberlain Haller: That is a lucid, intelligent, well thought-out objection.
Mosher: Thank you, sir.
Judge Chamberlain Haller: Overruled.

Next day:

Scala: Mosher, step into my office.
Mosher: Why?
Scala: Because you *%&!'n fired!
 








Nail in Nobel's coffin? I suppose that is a $1 billion coffin since that is what sales have been trending this year. Yea, Nobel is just about DOA. What a fucking dreamer.

Geez, don't you Nobel reps get it? Yes, you have a success rate that is within industry standard (but lets not bring up the buccal resorption yet, that's another topic for another day that may not come). But, that is not the arguement here!

One of many responsibilities of the FDA is to protect the public interest and to protect the public from "possible" harm. Meaning, the harm may not happen, but the fact that the possibility exist is enough to warrant action. They accomplish this by making certain any medical device that must be sterile within a certain amount of time have the packaging capability to remain sterile. So, although the implant may not have caused harm; which has yet to be determined; the arguement is that improper packaging techniques can open the possibility of harm to the public and that is a LIABILITY! A word that ALL surgeons know too well. Because of this, it's the responsibility of the FDA to respond by at least looking into this situation. Forget that ID called you out, or some wall street firm backed up the testing by sending their nobel implants to a seperate fda approved lab. The fact is that Niznick was smart enough to have an FDA approved lab to verify the seal. I can't stand the guy, he hurts what us hard working high end implant sales reps do for a living. But i have to hand it to the guy, he was smart enough to send it to a FDA approved lab rather than a non-approved lab. Had he done the latter, then Nobel reps have an argument to hang their hats on.

But he didn't and you don't so, se la ve. Go get your shoe shine box and shine my shoes before I get on that plane to my club trip because I've converted your accounts. Thanks Niz!
 




Nail in Nobel's coffin? I suppose that is a $1 billion coffin since that is what sales have been trending this year. Yea, Nobel is just about DOA. What a fucking dreamer.

Nobel's stock value has dropped 15.38% in the last month while Straumann's has stayed flat so concern over Nobel's leaky packaging may have cost Nobel's shareholders $600,000,000 in value. A rather expensive price to pay for Nobel's decision to take a cheap shot at Implant Direct's packaging. Mosher lost his job over this and the COO was demoted to parking cars at the corporate headquarters or some other minor role.
 




Nobel's stock value has dropped 15.38% in the last month while Straumann's has stayed flat so concern over Nobel's leaky packaging may have cost Nobel's shareholders $600,000,000 in value. A rather expensive price to pay for Nobel's decision to take a cheap shot at Implant Direct's packaging. Mosher lost his job over this and the COO was demoted to parking cars at the corporate headquarters or some other minor role.

Here is Niznick's latest shot accross Nobel's bow... actually I think this one hit the side of the boat and now it is leaking like their packaging.

http://www.implantdirect.com/newsletter_0/newsletter_18/canada.htm
 




Niznick fails to mention that Nobel's stock took a larger dive 2 years ago, and there was no fraudulent reports of leaky vials, then. For Niznick to take credit for the latest stock drop is similar to a bomb going off and ten different terrorist groups call the the newspapers to say they are responsible. Management changes all the time at Nobel. Before Mosher's departure Canepa left, again, normal transition, nothing to do with Niznick or ID. Niznick seems to want to take credit for everything that happens at Nobel, instead of realizing his failure in the market, his own recall of Implant Direct products, and the upcoming lawsuits, which as in the past will probably once again end in failure for Niznick. In the early 1990's Niznick paid Nobel millions in a lawsuit. Since then he has had a huge hard on for Nobel. Last market conditions show Nobel has 36% market share in the US, ID less than 1%. hardly a worthy competitor, or a market player.
 




If Implant Direct is such a small player why are you Nobel guys so worried about them. Less than 1% market share? Why did a disgruntled ex ID employee get a personal audience with Mosher and Scala. ID are selling an equal or better product at a better price Dr's aren't stupid they see thru the BS. Anyone still placing Nobel Biocare is doing it because of the "brandname" with patients not because they don't know ID implants are an equal or better product. This won't last once ID has been around for a little longer!
Nobel is going to have to compete on price!
Which they are already doing --see the abutment price for the new milled abutments if you own a scanner. Nobels price to the lab is close to ID's abutment prices and about half what it used to be!
How do you keep a business afloat if you have to cut price?--cut overheads=cut reps
No wonder there is so much vitriol on here against Niznick personally!
The facts of this case as presented in the above link seem to show that in this case at least, Niznick has the ethical high ground.
So from us Dr's who are enjoying opening our implant inventory invoices and no longer feeling ripped! All the best to Niznick! His courage and intelligence has been rewarded in the past by our capitalist democracy and I am sure it will continue to be!