Is Adhibit and Sprayshield compomised due to false information submitted by it's principal investigator, Professor Dr. Liselotte Mettler - Kiel Germany ?
Just as Spraygel was dubunked?
Wednesday, December 26, 2007
Professor Dr. Liselotte Mettler - Declaration of Guilt
Is this the face of someone you can trust?
Introducing Professor Dr. Liselotte Mettler - Kiel Germany
( An ol Granny the ilk of "Ma Barker")
IHRT would still like to know how these products are getting European CE marks?
http://www.endogyn.de/index.php?seite=endogyn&sprache=en&a=EndoGyn&b=Physicians&c=ProfMettler
Is she responsible for sending ARD patients to Endogyn for EXPERIMENTAL surgeries by
Daniel Kruschinski?
IHRT presents indisputable evidence that Mettler and Kruschinski, and others, KNEW that every adhesiolysis procedure performed as a gas-less laparoscopy by him, and "HIS" Abdolift at "The Institute of Endoscopic Surgery aka Endogyn" were in fact EXPERIMENTS!
Gas-less procedures that were performed on ALL ARD patients to Endogyn were NEVER a part of any bonifide organized clinical studies under the auspices of authorized standards or medical authorities, statistics and material coming out of Endogyn were NEVER considered studies let alone "clinical studies," anything at Endogyn was NEVER monitored by any medical organizations or authorities, any procedures done via Endogyn were NEVER performed using organized, authorized protocol, any and all "statistics" coming out of Endogyn were NEVER based on true and factual information, there was NEVER any consistent, useful or productive follow-up information regarding any surgeries coming out of Endogyn, let alone any honest information or material, and last, but not least, proof that these two, and others were 100% guilty of unethical behaviors at Endogyn also lies in the fact that...ALL patients were charged for their surgeries, which is against "clinical study" protocol, in Germany no different then in any other civilized country.... the end means of all this is that ALL adhesiolysis gas-less procedures performed with the Abdolift at Endogyn were nothing more then HUMAN EXPERIMENTS!
It appears that Mettler and Kruschinski, and others, did not care what happened to patients undergoing surgery at "Endogyn," as they KNEW they were performing operations that were not considered as anything but useless crap, and this we can prove as fact!
What is easy for IHRT to surmise about Mettler and Kruschinski, this being based on the number of operations performed by them and the means by which they harvested patients to those surgeries, is that they were more interested in seeing what they might be able to come up with during those surgeries rather then what was best for the patients having those surgeries! When one considers that they had no clue as to what the "might" discover in these surgeries is nothing short of mind boggling!
IHRT would be hard pressed to think that their focus was simply to stumble upon "something" that might etch their names in medical history, or perhaps find a "cure" for "something" before someone else did, even if it meant NOT taking into consideration ethical, compassionate, honest, moral and heaven forbid, human rights!
In all honesty, IHRT thinks it was for monetary gain and for no other reason!
The deplorable physical conditions MOST patients were left in when they came out of an Endogyn operating room leaves one with the impression that the patients were the least interest of these two surgeons...not only did they get your money, they threw you away, fudged their "statistics" and moved on to others to butcher for their gain and pressuring patients to help them accomplish that gain! And that gain was for only one thing...MONEY! YOU’RE MONEY!
What is really interesting is that any "statistics" presented anywhere, paid magazines or otherwise, were so poorly "fudged" that they were good for nothing! Most adhesion statistics "researched or gathered" by Endogyn were found ONLY within the Endogyn web site itself, or in papers created by someone associated with Endogyn and put out on the Internet.
ISGE & OB/GYN.net......
Interesting enough is that 99% of International ARD research, as well as many OB/GYN Congress's and organizations can be traced back to, YUP.... Mettler and Kruschinski! The ISGE, OB/GYN.net, etc...and all claims of ARD issues coming out of Mexico, Russia and throughout Europe and most certainly out of India can be traced back to these two! Are we then to assume that 99% of what is read on the ISGE and OB/GYN web sites is 99% bogus?
Are we to assume that 99% of what we hear from the surgeons and companies that have aligned themselves with Endogyn, aka Mettler and Kruschinski, are as aware of these facts as IHRT is? Are we to assume that they too are 99% "guilty" of being party to harvesting innocent, vulnerable ARD patients to EXPERIMENTAL surgeries at Endogyn?
Of course we are! No Dr. is THAT stupid! (Well, IHRT admits that they could stand corrected on that after all, a priest is only considered "saintly" before they get caught!)
Why do they continue to sponsor organizations like the ISGE who remain tight with surgeons associated with Endogyn, even after Endogyn, Kruschinski, Homberg and others were proven to have taken part in fraud and patient abuse!Perhaps it is all about money and profit as when it comes to anything even remotely related to the issues of adhesions, ARD and those afflicted with it, as little help has come to us from any medical, business or social arena associated with ARD.
Is the ISGE really a functional organization or is it a "front" for physicians to take trips all over the world to party and stroke each others egos and performing surgeries that they can no longer perform in their own countries? A smoozing bunch of lying and non productive Ob/Gyn's all tied to Mettler and Kruschinski, who will "tattle" on them at a drop of a scalpel!! Oh well, what's a kidney lost here and there, after all we do have two of them!
The Storz Company..... Did the Storz Co. look the other way and take part in this cover-up so that the Abdolift would be seen as something more then a "butchering" hook that caused adhesions? IHRT knows for a fact that the Storz Co. in CA was contacted well prior to 2006 and these concerns were discussed with them, to no avail! Perhaps they thought that if the world did not find out about the injuries resulting from the Abdolift they would sell more of them? Perhaps they didn't care who found out anything about anything regarding the Abdolift, as when Kruschinski and Mettler cornered the market in India, who would care what happened to the poor destitute people there.
Perhaps Mrs. Storz was taken advantage by those wanting her sponsorship, as well as some leading employees, perhaps!
IHRT knew the Abdolift was being abused by Kruschinski and Mettler as it was not being used as stipulated by their company, yet the Storz Co. stood by and kept quiet! Why?
Why do they continue to sponsor organizations like the ISGE who remain tight with surgeons associated with Endogyn, even after Endogyn, Kruschinski, Homberg and others were proven to have taken part in fraud and patient abuse!
Perhaps it is all about money and profit as when it comes to anything even remotely related to the issues of adhesions, ARD and those afflcited with it, as little help has come to us from any medical, bussiness or social arena associated with ARD.
What has any ARD patient throughout the world reaped from the ISGE other then it's promotion of EXPERIMENTAL surgeries by Mettler and Kruschinski? The answer: NOTHING!
Not one medical organization in the world considers anything coming out of Endogyn, or surgeons and facilities associated with it to be anything but a joke!
Total garbage!
Something to be "ashamed" of!
Despicable!
Unimaginable!
Criminal!
Endogyn, an "Institute" created in the mind of a psychotic nut and filled with false, unusable crap and presented to the world through a website filled with people boasting "titles" before their names when in reality they could not hold a candle to those who have earned such titles.
(Remember when Kruschinski put the title "Professor" before his name in the Zuckerberg web site, but pulled it as soon as that scam was discovered and exposed by Endogyn "spys, and when Shirli Homberg "created," falsified and lied about an "Adhesion" lab in which SHE was making more discoveries about adhesion intervention faster then all the researchers combined throughout the world wide! (Patients even bought that crap!) Wow, do these people KNOW what group of patients to target or what!
The good news is that surgeons associated with Endogyn will forever be associated with a place where it is common, rather expected, to see the following come out of it...
False documents,
Fake studies,
Fake facilities,
Phantom staff,
Bogus research being done in bogus labs,
Fake statistics,
False claims,
Lies & cover-ups,
A helter-skelter of "medical" material poorly presented and always presented in the midst of a chaotic mess of name calling, drunken outbursts and postings by Kruschinski,
Emotional outbursts from a cult like following of people and patients, who fall away one by one and are not well either!
Price fixing and over charges,
Patients pictures being presented as "validation" of surgeries performed in 4 star facilities without telephones, computers and in which patients have to bring their own DVD's and then donate them to the facility!!
This list can go on and on and on, however.....
What a way for some of these surgeons to retire!
Way to go Docs, you've been trashed by Endogyn and you deserve it!
(Who loves you now, Kruschinski? Perhaps Peter - down under?????)
Endogyn LTD is nothing more then an elaborate website built to reflect what is not real, and never was..Endogyn's boasting of being an "Institute" was quickly removed when it was exposed as anything but!
Numbers and more numbers of patients rushing to get to this "miracle worker and his staff," had their private lives smeared all over the Internet in what was nothing more then a bogus website! These things, and more, appear to be in direct defiance of the ethics and moral characteristic of your trusted physician, as patients were called names and harassed as being Internet" trolls if they so much as mentioned not being well following surgery with "King Kru!" Patients were told that as "women" they will just have to suffer, and this profound message was delivered to them by the 17 year old son of Kruschinski - who posted over and over again medical advice under the name Gucci.
This whole web of deceit was spun by a crazy "physician" and his mentor, perpetrated through his mistress's "Internet" site, and "created" to give the illusion of medical care rendered in the highest of standard and quality! And through it all, surgeons in the ISGE stood by and continued to support Kruschinski to the bitter end, even electing him to their board in 2007! http://www.isge.org/nshowp.php?pid=95
List after list of "physician associates," to Endogyn along with a continual stream of NEW infrastructures world wide were always popping up in the Endogyn web site, yet both physicians and facilities alike fell like dominoes tumbling one another! Over and over again names and places appeared in Endogyn and were soon found out to be from an endless pool of "unsuspecting people and facilities" who had no knowledge that they were now tagged as being part of "Endogyn" Everyone and everything that even came close to the words "Endogyn, Kruschinski or Mettler" became entwined in a snare created to scam the world and it did, for a while that is!
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
As we close out the year 2007 and four years of IHRT bringing the facts to light surrounding Endogyn, Kruschinski, Mettler and many, many more names you can find in IHRT, in the end, everything Endogyn tried to "accomplish" was for naught!
You, the reader, draw your own conclusions from the FACTUAL information shared below as IHRT presents for your consideration, and well being, the harvesting of innocent patients by Mettler as she begs them to have operations at an already defunct and desperate Endogyn!
Ask yourselves if Mettler's words to these desperate patients were out of compassion for them, or maybe out of fear of her being blackmailed by Kru if she didn't get patients to him, or for money, as it most certainly was not because she really thought that they might get well, not at all, as where she was sending them was straight to a living Hell!
Also recognize how the fraudulent material on ARD as presented by Mettler and her bunch, was "considered" by the Australian government and caused them to lose interest in a most promising adhesion barrier, - Confluent Spraygel!
Thanks to the likes of "Kruschinski and Mettler" and their bunch, IHRT suspects how this barrier will be judged by the world! Let’s see if the "New ISGE President Peter Maher" (the 'ol douche bag of Australia) has any influence over this decision....and IHRT is already monitoring this!
President, International Society of Gynecological Endoscopy (peterm2@tpg.com.au)
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"Happy New Year" to ALL....
And may all who are so deserving find IHRT to be their worst nightmare in the coming year and may you be as poor and in ill health as the patients you sent to Endogyn.
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May 2008 be as productive for IHRT as these past years have been! We have just begun to fight this war against Endogyn, and will continue to bring to you the truth of "Endogyn" happenings!
"German Endometriosis" forum run by no other then, drum roll pleeeease....... "Mettler and Tinnenberg" harvesting patients to an already defunct Endogyn! http://www.endometriose-liga.eu/forum/1
Page 1
Question archives
Topic: Pain therapy date: 05/05/2006
question hello, after two BS, a Gestagentherapie and a therapy over 4 months with Enantone Gyn is my gynecologist at the end and me to the pain therapist transferred. This meant that a implantierte pain pump for me was the correct. So far I take Durogesic plaster 100. It to be counted by such a pump on the fact is that I would get along with a lower morphine dose? Did you have female patients with those only such a drastic pain therapy already helped? I am 20 years and had myself hoped for not mine to live to be long dependent on such strong medicines. Cordial thanks, Andrea petrol
Answer Hello Andrea I hopes we can you help. Please you submit your operation reports of the Voroperationen to us and we discuss then details of the therapy, with 20 years must one you definitely to help be able. Probably must still once endoscopic operationally in detail rangegangen to become. Please you turn to the EndoGyn hospital in the proximity from Frankfurt and discuss yourselves everything with my colleague, Dr. Kruschinski, it inform me then and we operate you with indication together. 4 eyes do not see letting hang more than two - the head. Write please to Dr. Kruschinski that you by me to be operiiert want. Love of greetings Dr.Lilo Mettler http://www.endometriose-liga.eu/node/4347
Pg. 2
Topic: Operational treatment date: 04/05/2006
question good day, I lives in Rhineland-Palatinate and is on the search for a specialized clinic/special hospital. It surprises me much that no university University of (e.g. Mainz) was designated. Are there particularly certified hospitals for the clear Erkenung of the illness and/or for the OI? For your answer I would like to thank you in advance already cordially. Yours sincerely
Answer Contact nevertheless please Dr. Kruschinski of the EndoKlinik in blessed city with Frankfurt: email Dr.Kruschinski@t online.de parts you it with that I send you, if necessary, I would operate you there. Yours sincerely I remain their Dr. Liselotte Mettler http://www.endometriose-liga.eu/node/4340
Pg. 3
Topic: Hypogastric region pain date: 05/05/2006
question very honoured expert team, I set the pill off in March and more frequently since then abdomen cramps (feels, like if one would have taken exhausting means and chair course before stands). Last night were so bad the cramps that I had sweats, me speiuebel became and I had the feeling to become equivalent ohnmaechtig. I have this Kraepfe already for years (however maximally 1-2 times in the year). Lately they come more frequently. Schwanger am not I and signs on intestine problems gives it also not. Could the Endometriose be or have you otherwise an idea? Thank you for your answer already in advance. Greeting, Susanne
Answer Lioebe Susanne for clarification need you a belly reflection. We can accomplish these by the EndoGyn hospital gladly for you. Turn please by email on mean yourselves colleague Dr. Kruschinski under Dr.Kruschinski@t online.de and divide it with that you by me to be operated want. The details discusses he with you friendly ones of greetings Dr. Lilo Mettler http://www.endometriose-liga.eu/node/4346
Pg. 4
Topic: Operational treatment date: 25/05/2006
question Katharina, 27 years dear expert team, forwards approx.. me the blind intestine was removed for 2.5 years. The operating surgeon communicated to me after the OI, he additionally two Endometrioseherde would have removed. To my question, which that was, it did not answer with "anything bad". I did not receive further information. In the meantime I am the OI not really well smart unfortunately ran, a scar caught fire. Nevertheless I became with large pain to dismiss. I became four days later then (in another hospital!) again operates. The entire peritoneum had caught fire. The scar had to zuheilen from the inside out. Since that time I have strong pain, as soon as I harness belly muscles. Since I suffer from recovery weakness, that would be the only way to come again into my trousers. In addition it is extreme bloed to be able to drive no sport. I am tried to let me operate again white in addition, that the danger of renewed growing together is large. My question would now be, how you think of it? And thereby are the earlier cuts used? Does it have to zuheilen again from the inside out? Already times a belly reflection had, with all this problem-free ran and had thereafter never complaints with the scars before mentioned OI. Could you recommend a hospital to me? I live at present in Emden.
Answer An operational revision of the wound with evtl. Growing together solution without everything from internal ago heal must is surely with you indicated. With the EndoGyn hospital we operate at 3 Sttellen in Germany and you gladly would help. I can operate you also. Please you turn to the organization at Dr, Daniel Kruschinski of the EndoGyn hospital and divide it with that you by me to be operated want www.EndoGyn.com email address Info@EndoGyn.com letter you nevertheless times there Love of greetings Professor Dr. Lilo Mettler http://www.endometriose-liga.eu/node/4421
Pg.5
Date: 12/05/2006
question good day, is 27 years old and has a 20 mm large Endometriosezyste in the left. Ovar, by which the Ovar fixed itself in the Douglas space at the Peritoneum. At the same time to it still another second Herd(ca. 10 piece of cent largely) in the rear separate-tightness-curves, me more concerns prepared, because it is so near because of the Rektum. I have fear that this in-grows also there sometime with further growth. Both things prepare during the Menstruation and with the sexual intercourse strong pain for me. In addition are my man and I at present because of unerf. Child desire in treatment, a whose cause however before-weigh the bad sperm cells quality of my man is. An attempt ICSI unfortunately failed. Now my question, due to my complaints is recommended to me an immediate operational therapy. On the other hand one says also, is a pregnancy the best therapy against the Endometriose. On the one hand I am afraid the complications of the operation, on the other hand a further growth of the herd by the hormoneal stimulation. Operation or child desire treatment with hope for success? Thank you for its advice Claudia tap
Answer Dear Claudia the Endometriose also the Einnistung of the embryos after IVF or ICSI ET negatively affected solten you first the Endometrioseherde operationally by belly reflection to remove there leaves. Please you turn to it, if not already organizes, at us over mean yourselves colleagues, Dr Daniel Kruschinski under DrKruschinski@t online.de gladly I you will then operate. With the best greetings I remain her Dr. Liselotte Mettler http://www.endometriose-liga.eu/node/4381
Pg.6
Date: 09/05/2006
question very honoured expert team, today I am 36 years and am childless - I do not have a child desire not and take for 10 years hormone preparations to preventing or the like. Before scarcely 2 years deplored I strengthens irregular pain in the hypogastric region and blister range. This reported I my Gyn., which determined 1 approx. 4cm large Myom by means of ultrasonic investigation. She guessed/advised me approx.. to wait 1/2 year and to let then a total operation accomplish. I did not wait, a second opinion did not catch up - still two further Myome of the size were found, I had let which remove by means of Laperaskopie (dec. 2004). With the OI coincidentally a Endometrioseherd was found and removed. A further treatment did not take place for the time being. After approx.. strengthened and ever more regularly (at first mainly at night) abdomen cramps and blister problems arose to 5 months, which none could explain itself. An ultrasonic investigation broke the result "free liquid in the abdominal cavity" and easily increased leukocytes. An intestine reflection without findings as well as a further belly reflection followed. Here it was stated that in a OI place of the Gebaehrmutter(Myome) the intestine wall festgewachsen was. The organs were separated and the free liquid was sucked off and returned. Further remarkablenesses was not found. After 10 days the cramps were and the Gyn again there were helpless. The Histologie had communicated to the liquid the fact that she was not inflammatory but with blood shifts. I asked then the Gyn whether it which with the Endometriose from the first OI to do have could. It was surprised something that I knew and meant the OI report that my disease picture would fit rather exactly. He suggested a six month's treatment with Zoladex (?). The side effects were genuinly hard, but I was pain-free after 3 weeks. Since the side effects were so violent however after 4 Moanten, I had gotten additionally the preparation Liviella. After approx. 3 weeks were the first cramps again there. - now I got and take the 6th and last syringe 2 weeks ago ago for 6 weeks the tablets. My questions: Was that the best therapy? What happens, if the effect of Zoladex is used up in 14 days, if now already by the additional income of Liviella already the pain is again there (usually approx. 24 hours last and are with Ibuprofen 600 only moderately into the grasp zubekommen)? The hormones change mean bodies, the mental load are very large, I increase strongly, although I drive 5-6 days the week sport and me after Dr. Strunz very consciously and healthier nourish. Is there a possibility to live here without hormones? Thank you for your trouble in advance and with best greeting Daniela Pohle
Answer ielleicht a renewed Lparoskopie could help through in expert team please to turn you to it at Dr, Daniel Kruschinski my Operatiuon with you organizes itself. Dr.Kruschinski@t online.de love gruepsse Dr. liselotte Mettler http://www.endometriose-liga.eu/node/4370
Here comes the laugh of 2007! ~~~~~~~~~~~~~~~~~~ So much for Karen Steward's book about "Kruschinski, Endogyn, the Abdolift and Confluent Spraygel!" Capitalizing on others misfortunes isn't what you thought it would be, right Karen! Your book just got crapped on, BIG TIME! Now ya'al just giddy up there you little filly and read! Lets hear it for Karen AND Helen, the two most deserving people to be flushed down the toilet by King Kru!!"
"HAPPY NEW YEAR"
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You will find that Mettler's material was not good enough to validate the effectiveness of Spraygel, so the recommendation was to "shelf " the Spraygel, however, You will find validation of Dr. Lilo Mettler jumping ship when Endogyn sunk in 2006 and promoting the ADHIBIT™ adhesion barrier instead! (Boy is this company going to hear it now!)
Coincidence??
© Commonwealth of Australia [2007]
This work is copyright. You may download, display, print and reproduce this material in unaltered form only (retaining this notice) for your personal, non-commercial use or use within your organisation. Apart from any use as permitted under the Copyright Act 1968, all other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to Commonwealth Copyright Administration, Attorney General’s Department, Robert Garran
Offices, National Circuit, Canberra ACT 2600 or posted at http://www.ag.gov.au/cca
Electronic copies can be obtained from http://www.horizonscanning.gov.au
Enquiries about the content of the report should be directed to:
HealthPACT Secretariat
Department of Health and Ageing
MDP 106
GPO Box 9848
Canberra ACT 2606
AUSTRALIA
DISCLAIMER: This report is based on information available at the time of research and cannot be expected to cover any developments arising from subsequent improvements to health technologies. This report is based on a limited literature search and is not a definitive statement on the safety, effectiveness or cost-effectiveness of the health technology covered.
The Commonwealth does not guarantee the accuracy, currency or completeness of the information in this report. This report is not intended to be used as medical advice and it is not intended to be used to diagnose, treat, cure or prevent any disease, nor should it be used for therapeutic purposes or as a substitute for a health professional's advice. The Commonwealth does not accept any liability for any injury, loss or damage incurred by use of or reliance on the information.
The production of this Horizon scanning prioritising summary was overseen by the Health Policy Advisory Committee on Technology (HealthPACT), a sub-committee of the Medical Services Advisory Committee (MSAC). HealthPACT comprises representatives from health departments in all states and territories, the Australia and New Zealand governments; MSAC and ASERNIP-S. The Australian Health Ministers’ Advisory Council (AHMAC) supports HealthPACT through funding.
This Horizon scanning prioritising summary was prepared by Mr. Luis Zamora from the Australian Safety and Efficacy Register of New Interventional Procedures – Surgical (ASERNIP-S).
PRIORITISING SUMMARY
REGISTER ID: S000030
NAME OF TECHNOLOGY: SPRAYGEL ADHESION BARRIER SYSTEM (CONFLUENT SURGICAL INC., WALTHAM, MA, UNITED STATES)
PURPOSE AND TARGET GROUP: FOR THE PREVENTION OF ADHESION FORMATION FOLLOWING GYNECOLOGICAL SURGERY
STAGE OF DEVELOPMENT (IN AUSTRALIA):
Yet to emerge
Established
Experimental
Established but changed indication or modification of technique
Investigational
Should be taken out of use
Nearly established
AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION APPROVAL
Yes ARTG number 122805
No
Not applicable
COUNTRY LEVEL OF USE
Trials Underway or Completed Limited Use Widely Diffused
Australia Bahrain Europe Israel Lebanon New Zealand Oman Qatar Saudi Arabia
South Africa UAE United States
IMPACT SUMMARY:
SprayGel® is a new adhesion prevention system developed for use intra-operatively. SprayGel has shown to provide some prevention in adhesion formation in ovarian surgery patients without major adverse events. The system is currently available in Australia and New Zealand.
Background
Adhesions (also called pelvic adhesions, intraperitoneal adhesions) are abnormal scar-like bands that form between two surfaces inside the body. Their formation can be a result of peritoneal damage, intra-abdominal ischemia or the presence of foreign materials in the abdominal cavity (e.g. surgical glove powder, micro-organisms, gauze lint, sutures and prosthetic mesh) (Mettler et al. 2002). Adhesions can range in severity from, thin film-like bands to thick fibrous bands. Although adhesions are not associated with specific symptoms, people with adhesions may experience pain (resulting from the pulling of nerves at the site of adhesions), intestinal obstruction, infertility and increased rate of complications during subsequent surgeries (Ellis et al. 1999).
Adhesions can occur anywhere within the peritoneal cavities. There are several causes of adhesion formation including endometriosis, attacks of appendicitis and pelvic inflammatory disease. However the most common cause of adhesion formation is surgery (Johns et al. 2003).
Treatment of adhesions involves the cutting or releasing of the adhesions through a process called adhesiolysis, a procedure which can be performed via laparoscopy or laparotomy (Szomstein et al. 2006). The surgery is performed to allow normal movement of the affected organs. Unfortunately, even after adhesiolysis has been performed up to two-thirds of patients will experience recurrence (Mettler et al. 2002).
Given that even adhesiolysis surgery can cause adhesion formation, surgeons use various surgical techniques in an attempt to prevent adhesion formation. These include: avoidance of the introduction of foreign bodies into the cavity (e.g. surgical glove powder), limiting unnecessary handling of organs, avoiding the use of dry sponges and irrigating the cavity during the surgical procedure, avoiding unnecessary damage to organs, tissues and blood vessels, and using the finest size suture thread appropriate to the surgery.
The SprayGel adhesion barrier system is designed to minimise adhesion formation and consists of two separate polyethylene glycol (PEG) based liquids that when mixed together (upon application) quickly cross-link to form a biocompatible flexible, absorbable hydrogel in situ. The SprayGel component liquids are sprayed onto the target tissue(s) with an air-assisted sprayer which can be used in either endoscopic or open procedures. SprayGel remains intact for five to seven days preventing fibrin deposition and fibrinolysis and after which it breaks down into water-soluble PEG components that undergo renal clearance.
CLINICAL NEED AND BURDEN OF DISEASE
It has been reported that adhesions occur in 68% to 100% of patients who have undergone one or more laparotomies (Ellis 1997, Luijendijk et al. 1996, Menzies and Ellis 1990). Previous abdominal surgery has been described as the single most important predictive factor of adhesion formation (Szomstein et al. 2006).
Adhesions can have severe implications for sufferers. Sufferers of abdominal adhesions can suffer chronic abdominal pain as well as develop small bowel obstructions. Female sufferers of pelvic adhesions (involving the uterus, ovaries, fallopian tubes or bladder) may develop reproductive complications including infertility and ectopic pregnancy. Finally, sufferers of heart adhesions may suffer from decreased heart efficiency.
Unfortunately, the majority of adhesion barriers and agents used for prevention of adhesion formation are difficult to use in open surgery settings and even more difficult under laparoscopic surgery settings (Mettler et al. 2002).
DIFFUSION
The SprayGel adhesion barrier is currently not approved for sale in the United States. The barrier has received CE Mark and is available in the European community. The system is also available in Australia, New Zealand, South Africa, UAE, Oman, Qatar, Bahrain, Israel, Saudi Arabia and Lebanon.
The extent of diffusion of the SprayGel adhesion barrier in Australia was not revealed in the searches conducted.
COMPARATORS
Various barriers have been evaluated to reduce or prevent adhesion formation. However, many are difficult apply under laparoscopic conditions, have unsuitable absorption times or are associated with increased adverse events (Mettler et al. 2004).
Other adhesion barriers suitable for abdominal and ovarian surgery include:
• Gynecare Interceed (TC7) Absorbable Adhesion Barrier (Ethicon, Inc.)
• Seprafilm Adhesion Barrier (Genzyme Corporation)
• ADEPT (ML Laboratories)
SAFETY AND EFFECTIVENESS ISSUES
The first clinical evaluation of SprayGel was conducted as a multi-centre study investigating the safety and effectiveness of the barrier in women undergoing open or laparoscopic myomectomy procedures. Three publications reporting results from the same study were retrieved in the literature search (Mettler et al. 2003a, Mettler et al. 2003b, Mettler et al. 2004). Only results from the most recent, detailed study are presented (Mettler et al. 2004).
In this prospective, randomised, controlled phase III study, patients undergoing open or laparoscopic surgery for leiomyoma or leimyomatous uteri were assigned to receive the SprayGel adhesion barrier plus optimal surgical technique (treatment group) or optimal surgical technique alone (control group). Following myomectomy, patients were randomly allocated to either the treatment or control group. At each site, the first eligible patient was not randomised but instead received treatment with SprayGel to familiarise the investigators with its use (these patients were followed-up for safety analysis only). All patients who received application of the SprayGel barrier had suture lines and all potentially adhesiogenic surfaces on the uterus and adjacent structures coated to a thickness of approximately 0.5 mm to 1.0 mm.
Of the 69 women enrolled, five did not proceed to randomisation (two training patients and three study withdrawals). Therefore, 64 were included in the efficacy evaluation (34 treatment and 30 control group patients) and 66 in the safety evaluation (including the two training patients). The uterine myomectomy procedure and thus application of the SprayGel barrier was performed laparoscopically in 28 (82.4%) of treatment and 23 (76.7%) of control patients. The authors noted that application of the SprayGel barrier was easy in both laparoscopic and open procedures with mean time of application of 3.7 minutes and average requirement of 1.9 kits per treatment patient. There were no adverse events related to the use of the SprayGel barrier.
The primary efficacy outcomes were incidence1, severity2 and extent3 of adhesions measured at the second look laparoscopy (SLL), which was performed between three and 16 weeks after surgery. Twenty-two (64.7%) treatment and 18 (60%) control group patients returned for SLL. Despite the high attrition rates, no significant differences between patients who returned and those who did not were found. Prior to surgery, patients in both groups had similar incidence, severity and extent of adhesions. At the SLL there were no significant differences between groups in regards to extent of adhesions with both groups having similar median areas of the uterus covered with adhesions (p > 0.1). Although treatment patients experienced lower incidence than control patients (31.8% versus 11.1% adhesion free, respectively), no statistically significant difference was observed. Treatment group patients experienced significantly lower severity as shown by a lower mean tenacity score than the control group (1.0 versus 1.9, p = 0.002). In terms of recurrent adhesions, no statistical difference between the two groups was reported.
Comparison of SLL to initial myomectomy values revealed patients who did not receive SprayGel were at an increased risk of forming adhesions compared to patients in the treatment group, demonstrated by increased incidence of adhesions (0.64 for treatment versus 1.22 for control, p = 0.035). Similarly, severity at the SLL was significantly lower for treatment group patients than at the initial surgery compared to control group patients (0.6 for treatment versus 1.7 for control, p = 0.001). No statistically significant difference in the extent of adhesion was noted with both groups having similar increase in the adhesion area from initial surgery to SLL (4.5 cm2 for treatment versus 7.2 cm2 for control, p > 0.1).
Johns and colleagues conducted another randomised controlled trial of the SprayGel adhesion barrier to investigate its impact on frequency of adhesion formation and reformation after ovarian surgery (Johns et al. 2003). In this study 14 women undergoing laparoscopic ovarian surgery were randomised to have one ovary treated with SprayGel and the other with good surgical technique only. Patients who received the SprayGel treatment had the barrier applied to the entire surface of the relevant ovary and immediately adjacent structures with the air-assisted applicator. No SprayGel was applied to any contralateral structures.
At the SLL treated ovaries demonstrated a reduction in adhesion formation of 21.4% (p value not reported) and a significantly lower extent of adhesion cover over the treated ovary (control mean extent surface are 52.0%, treated mean extent surface area 29.6% , p = 0.0298). Additionally the mean severity score was lower for the treated ovaries (mean 2.1) than for the control (mean 2.7) ovaries although statistical significance was not reported. The frequency and extent of adhesion formation on ovaries, fallopian tubes and pelvic side walls were also evaluated by an independent reviewer who determined that the change in both frequency and extent between the initial surgery and the SLL were significantly lower in the treated ovary side compared to the control side (p = 0.0488 for frequency and p = 0.0494 for extent). The frequency in the treated sides increased from 3.21 (initial surgery) to 4.21 (SLL) compared to 2.57 (initial surgery) and 6.07 (SLL) for the control side. Similarly extent of adhesions increased from 5.46 cm2 at the initial surgery to 10.97 cm2 at the SLL.
No adverse events related to the use of the SprayGel barrier were reported.
COST IMPACT
A search of the published literature and website of the manufacturer of SprayGel (Confluent Surgical Inc., Massachusetts, United States) did not reveal the cost of SprayGel.
1 Incidence: defined as mean number of sites adherent to the uterus
2 Severity: defined as mean adhesion tenacity score, ranging from 0 to 3: 0 = no adhesions, 1 = filmy or vascular adhesions, 2 = vascular and/or dense adhesions, 3 = cohesive adhesions
3 Extent: defined as mean area of uterus covered by adhesions, cm2
The Medicare Benefits Schedule reimbursement fees for procedures related to the treatment of adhesions are listed in Table 1:
Table 1: Medical Benefits Schedule of fees for procedures related to the treatment of adhesions (Department of Health and Ageing 2007)
Category
Item Number Benefit (AUD) Number of Claims (July 2005 to June 2006)
Laparotomy for the division of peritoneal adhesions
30376 $460.55 456
Laparotomy involving division of adhesions in conjunction with another intra-abdominal procedure where time to divide adhesions is between 45 minutes and 2 hours
30378 $462.70 4,381
Laparotomy with division of extensive adhesions (duration greater than 2 hours)
30379 $820.15 1,195
Laparoscopic division of adhesions in association with another intra-abdominal procedure where time taken to divide adhesions exceeds 45 minutes
30393 $462.70 4,686
Laparoscopic division of adhesions, as independent procedure lasting 1 hour or less
31450 $359.35 284
Laparoscopic division if adhesions, as an independent procedure lasting more than 1 hour
31452 $628.70 248
Thoracotomy or sternotomy involving division of adhesions where time taken exceeds 45 minutes
38643 $943.15 559
Thoracotomy or sternotomy involving division of adhesions where time taken exceeds 2 hours
38647 $1,886.15 489
ETHICAL, CULTURAL OR RELIGIOUS CONSIDERATIONS
No issues were identified from the retrieved material.
OTHER ISSUES
No issues were identified from the retrieved material.
HEALTHPACT CONCLUSION
Adhesions present major complications for sufferers. Although adhesiolysis is performed to divide any adhesions present, the technique itself can lead to further adhesion formation. Various surgical techniques and adhesion barriers are available to reduce adhesion formation. Though the evidence suggests that SprayGel is somewhat effective in reducing adhesion formation, there is a lack of studies comparing SprayGel to other adhesion barriers as well as documenting the long term effects of this adhesion barrier. It is recommended that SprayGel be archived in view of the limited evidence and the alternative barriers currently available.
SOURCES OF FURTHER INFORMATION
Abbott J, Thomson A, Vancaillie T. SprayGel following surgery for Asherman’s syndrome may improve pregnancy outcome. Journal of Obstetrics and Gynaecology 2004; 24(6): 710-711.
Kruschinski D, Homburg S, D’Souza F, Campbell P, Reich H. Adhesiolysis in severe and recurrent cases of adhesions related disorder (ARD) – A novel approach utilizing lift (gasless) laparoscopy and SprayGel adhesion barrier. Surgical Technology International 2006; 15:131-139.
Mettler L, Audebert A, Lehmann-Willenbrock E, Jacobs V, Schive K. New adhesion prevention concept in gynaecological surgery. Journal of the Society of Laparoendoscopic Surgeons 2003 (a); 7(3): 207-209.
Mettler L, Audebert A, Lehmann-Willenbrock E, Schive K, Jacobs V. Prospective clinical trial of SprayGel as a barrier to adhesion formation: An interim analysis. The Journal of the American Association of Gynecologic Laparoscopists 2003 (b); 10(3): 339-344.
LIST OF STUDIES INCLUDED
Total number of studies 2
Level II intervention evidence
SEARCH CRITERIA TO BE USED
Adhesion
Barrier
SprayGel
Hydrogel
Pelvic adhesion
Abdominal adhesion
Mettler always appears where there is ARD "research and money," so is it a wonder why Harry Reich is always saddled to her back? Can anyone trust Mettler's statistics and research?
IHRT says, "NO," and proof of that comes with the stench of Endogyn that she carries around as well! `````````````
~~~~~~~~FOR IMMEDIATE RELEASE~~~~~~~~~~~~~
ADHIBIT™
ANGIOTECH PRESENTS POSITIVE ADHIBIT™ DATA AT THE 19TH ANNUAL EUROPEAN CONGRESS OF OBSTETRICS AND GYNECOLOGY
Surgical adhesion scores were threefold less in patients treated with Adhibit™
Friday, April 7, 2006
ANGIOTECH PRESENTS POSITIVE ADHIBIT™ DATA AT THE 19TH ANNUAL EUROPEAN CONGRESS OF OBSTETRICS AND GYNECOLOGY
Surgical adhesion scores were threefold less in patients treated with Adhibit™
VANCOUVER, BC and TORINO, ITALY, April 7, 2006 – Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced positive results from its Adhibit™ Adhesion Prevention Gel Myomectomy Study.
The final data set was presented today by Dr. Lilo Mettler, the study’s principal investigator, at the 19th Annual European Congress of Obstetrics and Gynecology in Torino, Italy.
About the Study
This randomized, controlled, single-blind, clinical study was designed to evaluate the safety and efficacy of Adhibit in reducing the incidence and severity of post-operative adhesions when applied immediately after the removal of uterine fibroids (myomectomy surgery). The study was conducted at six investigational sites in Europe, Canada, and the Netherlands Antilles.
The trial randomized 71 patients, with 48 patients receiving the Adhibit treatment and 23 patients receiving no post-operative adhesion treatment (the Control group). Patients were surgically re-examined eight to ten weeks post-procedure to determine the incidence and severity of adhesions.
Adhibit was shown to reduce post-operative adhesion formation as measured by the modified American Fertility Society (mAFS) score, a scoring system that factors in both the extent and tenacity of adhesions. Patients in the group that were treated with Adhibit experienced a statistically significant reduction in their mAFS score when compared with those in the Control group (0.8 ± 2.0 Adhibit group versus 2.6 ± 2.2 Control group; p=0.010).
“Consistent with preliminary results, we’re encouraged and pleased that this data indicates Adhibit is safe and effective,” said Dr. Rui Avelar, Chief Medical Officer for Angiotech. “Adhibit also proved itself to be easily delivered through a laparoscope, and has the potential to further advance minimally-invasive surgery in women.”
About Adhibit™
Adhibit is a fully-synthetic, sprayable hydrogel that is safely resorbed by the body over 30 days and is designed to reduce or prevent the formation of post-operative surgical adhesions. Currently approved in Europe to prevent or reduce post-surgical adhesion formation in pediatric patients undergoing cardiac surgery, Adhibit is an Angiotech product that is sold and marketed by Baxter Healthcare Corporation worldwide, excluding the U.S. Baxter has an option to license Adhibit in the U.S.; however, Adhibit is not currently approved for sale in the U.S.
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