Friday, February 27, 2009
Scarring caused by surgical gel spray
Monday, 11 February 2008
Surgical treatment hurts women but is allowed to continue
ANDREW GORRIE/ Dominion Post ANGRY AND AMAZED: Hanifa Koya has stopped using SprayGel after her patients required further surgery to remove scars. She says the product should be put on hold till surgeons and patients can be assured of its safety.
A surgical gel - containing a drug untested on humans - has caused excruciating internal scarring in dozens of women that could lead to infertility, claims a leading gynaecologist.
Many of the endometriosis patients have already forked out thousands of dollars for repeat surgery. Some are now pursuing compensation from ACC.
Endometriosis is a condition where abnormal growths develop in pelvic organs, causing inflammatory reactions leading to scarring and pain. It affects millions of women worldwide.
Though some gynaecologists have stopped using the anti-scarring gel because of concerns about its safety and effectiveness, others still use the treatment, Wellington specialist Hanifa Koya said.
Medsafe, the Government agency that approves medicines, has told the American manufacturer to add additional precautions to the instruction pamphlet.
But it maintains the product is safe, and refuses to ban its sale without conclusive evidence of harm - even though the gel is considered high risk under proposed legislation.
Dr Koya - who first raised concerns in December 2005 - was disillusioned at the response of health agencies, which she claimed had let Confluent SprayGel be used internally on thousands of Kiwi women since about 2002 without adequate clinical testing or ongoing monitoring of its effects.
She had spoken out because of concern for her patients and to highlight the need for immediate law changes to protect people.
"Confluent SprayGel is a product sprayed inside human beings and contains a section 29 drug (methylene blue) which has not been tested on human beings, and this product was allowed to be used ... [with] no quality assurance in terms of monitoring," she wrote to Medsafe in December.
"It's quite amazing - we're using it inside human beings," she told The Dominion Post. "I would have expected ... that they would have said, `Let's put this product on hold or start asking some questions', but that didn't happen."
Dr Koya began using the gel in October 2002, but stopped in April 2006 after her rate of repeat laparoscopies - keyhole operations - jumped from less than 2 per cent to around 10 per cent.
Women who would usually have made swift recoveries developed severe pain or discomfort after their initial operations.
Dozens of the many hundred women she treated with the gel needed repeat surgery to remove scarring - which could cause infertility - even though their endometriosis had not returned. "It's only where I've sprayed the SprayGel. It's like sheets of scarring which I've never seen in my practice."
Dr Koya said she had not repeated any laparoscopies since using an alternative product.
She complained to American manufacturer Confluent Surgical and has written repeatedly to MedSafe and the Health Ministry asking them to investigate, but felt her concerns had been ignored.
New Zealand distributor Covidien Tyco did not return calls.
Medsafe interim manager Stewart Jessamine said SprayGel was classed as a device under the Medicines Act, not a medicine.
No clinical assessment was required before its sale, though manufacturers had to ensure the device was safe. Medical practitioners had the ultimate responsibility for its use on patients.
After a review, it it concluded the gel was safe "when used as intended".
There had been no other complaints and there were no plans to restrict its supply, it said.
Source: LANE NICHOLS - The Dominion Post
Adhesion Barrier return on investment
As IHRT contemplates the desperation of consumers to have adhesion barriers provided in their surgeries and industries willingness to provide them, we are disheartened.
Patients aware of adhesion barriers or indeed adhesions are a slim minority.
Adhesion Barrier Market to Skyrocket to Over $550 Million by 2013PR Newswire (press release), NY - Feb 2, 20092 /PRNewswire/ -- According to Millennium Research Group's (MRG's) US Markets for Surgical Hemostats, Internal Tissue Sealants, and Adhesion Barriers 2009 ...
As we reflect on this headline, one wonders where this number comes from?
IHRT then looks at the source of this press release.
IRONICALLY, Millennium Research Group is based in Waltham, MA, home of Confluent SprayGel!
If an effective adhesion barrier were found and put into use….the number would be enormous!Here is an example of a guess on what that number might truly be.
Some facts about cesarean sections from Childbirth.org. ... The latest statistics indicate that 967000 cesareans were performed in the US in 1989. ...www.childbirth.org/section/CSFact.html - 16k - Cached - Similar pages
Lets say each of these c-sections had and adhesion barrier applied at the cost of $200.00 per procedure. We feel that this would be a very conservative estimate. The cost would be $193,400,000 for just one procedure in which the number of c-section has increased dramatically since this statistic was reported…
Take the history of Spraygel to it’s current incarnation as SprayShield TM.
All IHRT can think to say is, “return on investment”.
Here is an example to see.
Tuesday, October 28, 2008Falling apart over OmrixWhen I added Omrix Biopharmaceuticals Ltd. (Nasdaq:OMRI) to my portfolio, tracked by "Globes", I noted that it was a profitable biotechnological company in a most interesting niche - biosurgical sealants for the prevention of hemostasis in surgery - and that it was not an all or nothing company, like Pharmos Corp. (Nasdaq: PARSD), for example, where one failed trial can wipe almost an entire investment.
The founder of Confluent Surgical knew his product would not pass FDA standards so the product was taken out of clinical trials….Somehow, with fraudulent information SprayGel got it’s CE mark and was used throughout the world as an anti-adhesion barrier. Those in the United States remained safe.
IHRT was founded by the victims of ongoing study of Spraygel until we realized we were being experimented on and paying for the pleasure. In of all places Germany!
The gig was up and Confluent was sold to Tyco which was then sold to Covidien.
As IHRT continues to watch Covidiens stocks fall we become more concerned about them seeking a quick return on their investment!
Top of FormCOV (Common Stock)ExchangeNYSE(US Dollar)Price$34.46Change (%)0.69 (1.96%)Volume1,019,293As of 02/26/09 11:23 a.m. ETMinimum 20 minute delayBottom of Formhttp://investor.covidien.com/preview/phoenix.zhtml?c=207592&p=irol-alerts
It looks like Covidien may have learned to save money by moving it all offshore just as Confluent did.
Is it the old lets see if it works ON THEM and then go to the FDA?
The same scenario is happening again with of all people, Kruschinski and Mettler. In of all places Germany!
Kruschinski D, Homburg S, D’Souza F, Campbell P, Reich H.Adhesiolysis in severe and reccurent cases of adhesions relateddisorder (ARD) - a novel approach utilizing lift (gasless)laparoscopy and SprayGel™ adhesion barrier. Surg Technol Int.2006;15:131-9.
Mettler L, Audebert A, Lehmann-Willenbrock E, Schive-PeterhanslK, Jacobs VR. A randomized, prospective, controlled,multicenter clinical trial of a sprayable, site-specific adhesionbarrier system in patients undergoing
Somehow the bogus science in the above studies are being used once again to tout a product and way after the fact are we learning how the bogus studies of SprayGel made thing worse for us for all of us. Victims of this fraud would tell you there are things worse than death....
It is IHRT’s opinion that until there are actually surgeons learned enough to perform an adhesiolysis that needs no barrier, these products are just a panacea…Skill is what’s needed and compensation for the time it takes to perform a successful adhesiolyis. Until then we fell everyone’s just kidding themselves and no product can compensate for, quick or ultra conservative surgery.
So think hard and do your research, be careful of patients who claim this is the best or only way.
How many doctors (surgeons) encourage those who are sick to contact his former patients? No doubt, Dr. Kruschinski has raised the bar of excellence when it comes to "treating" a patient. See: Patient ListThanks Dr. Kruschinski. Our daughter has regained her life due to your brilliance, commitment and compassion for those who suffer from this dread disorder.
This is what IHRT calls “Harvesting” a dreadful practice that can lead a person to an unwanted intervention.
Remember that these biomedical companies and surgeons are expecting a return on their investments and patients are a dime a dozen. We must remember always “people are willing to profit from others pain”. Our capitulation to the adhesion barrier craze just seems to make us “a return on investment”
Posted by IHRT at 2/27/2009 07:47:00 AM 0 comments Links to this post
Labels: adhesion barrier, adhesion prevention, adhesions, Confluent Surgical, Covidien, SprayGel, Sprayshield, Tyco
Saturday, February 21, 2009
COVIDIEN EXPOSES DR. DANIEL KRUSCHINSKI - GERMANY - OF PERFORMING EXPERIMENTAL SURGICAL PROCEDURES ON UNSUSPECTING HUMANS - MANY PATIENTS WERE FROM THE UNITED STATES!
COVIDIEN is an International provider of medical devices, supplies and pharmaceuticals.
Dr. Daniel Marian Kruschinski - a Polish surgeon was performing experimental operations in Germany on patients from the United States......has stated on numourouse occasions that his father was in Auschwitz concentration camp during WWII and he learned his methods from him! "These adhesion patients are sufferring no matter what I do to them, so I do operations on them to see what outcomes will be!" said Kruschiski!
Self proclaimed: Head of the Endoscopic Gynecology Centers in Germany. EndoGyn pursues the idea of Novel and progressive treatment modalities of gynecological endoscopy. 18 years experience and more than 5000 operations behind him and with the greatest experience worldwide and, at international level.
Based on information found in the "Covidien" web site relating to the study of
"Spraygel Adhesion Barrier".........
(No abstract on this "study" is shown in the Covidien web site, as none exist!)
"Kruschinski et al. (2006) evaluated the efficacy of SprayGel™ in preventing adhesion reformation during adhesiolysis procedures in patients with adhesion related disorder.
Following gas less laparoscopic adhesiolysis, 35 patients received SprayGel™ application, followed by a second-look laparoscopy at Day 7 and, in cases of continued pain, a third-look laparoscopy within 6 months after the initial surgery".........more:
Learn More About the SprayShield™Adhesion Barrier:
Bottom Right On This Page
ALL of the patients from the United States were unsuspecting "human experiments" and were charged for their surgeries, paying Dr. Kruschinski thousands of US dollars.
A number of these patients returned for multiple operations by Dr. Kruschinski, and again paid thousands of dollars for what is now recognized as unauthorized medical experiments.
* Patients from the United States listed below in this post!
Not only did Dr. Kruschinski perform these operations without the knowledge of the German Medical Board, he violated the German Laws & Ethics governing "clinical trials" in that country, which parallels the "Ethics and Laws" of clinical studies in the USA! * See reports below in this post!
Kruschinski never related to his patients that his "Adhesiolysis procedures with Spraygel" was of an "experimental basis!"
Information in the "Covidein" web site also exposed that Dr. Kruschinski misrepresented the surgical results of his "gas less adhesiolysis procedure" to his patients, and the world by use of his Endogyn web site...........
Dr. Kruschnsi made claims that no re-formed or Denovo adhesion formation was found at second look procedures! He claimed over and over that patients undergoing his "gas less adhesiolysis procedure" were 100% adhesion free at SLL, he even validated those claims by posting pictures of the SLL results of these patients!"
(Never did Dr. Kruschinski offer to do video taping of his surgical procedures, though he claimed he had "state of the art" surgical equipment in his operating room! Desperate vulnerable adhesion patients from the USA bought that lie without question, and more then once for some of them!)
Per the Covidien web site, Dr. Kruschinski makes the following claims...
(Again, no abstracts associated with these claims is avaiable, anywhere!)
"The reduction in the adhesion score at Day 7 was 89.8% (90.1% reduction in extent,
89.3% reduction in severity, and 89.9% reduction in grade).
Five patients (14.3%) had a third-look laparoscopy within 6months of the initial surgery, in which four cases of adhesion reformation were confirmed."
If YOU had an "Adhesiolysis with Spraygel" in Germany under the scalpel of Dr. Daniel Kruschinski, you were a human experiment, and if you are currently presenting with abdominal/pelvic pain, it is more then probable that your pain and suffering is from adhesions!
(Patients undergoing adhesiolysis in Germany with Kruschinski have been given every excuse in the book for recurring pain following his procedure, and many are once again buying his lies!)
Contacts for the "Germany Agencies" governing clinical trials in Germany, and "Government Agencies" currently involved with investigations of Dr. Daniel M. Kruschinski will be Posted Soon on IHRT!
Contact these agencies to report you experience with Dr. Kruschinski and to seek monetary compensation! YES! It is possible to recoup your money through the German courts by submitting your claim against Daniel Kruschinski's bankruptcy (insolvency) actions!!)
*See "Bankruptcy Report" on Dr. Kruschinski at this link....
IHRT encourages all patients to Dr. Kruschinski to also contact "Covidien" and request the "Abstracts" from the "Endogyn SprayGel Adhesiolysis" clinical studies performed by Dr. Daniel Kruschinski as represented in the Covidien web site!
* See contacts below in this post!
(Keep in mind that the following clinical study, also found in the Covidein web site, was deemed invalid due to Mettler frauding a "mirror" report of this same study where she inflated numbers on her fraudulant report and attempted to submit that for fact! Mettler got caught, but at the same time, she rendered this real Abstract useless!! Shameful indeed Mettler! )
Mettler L, Audebert A, Lehmann-Willenbrock E, Schive-Peterhansl
K, Jacobs VR. A randomized, prospective, controlled,
multicenter clinical trial of a sprayable, site-specific adhesion
barrier system in patients undergoing myomectomy. Fertil
Steril. 2004 Aug;82(2):398-404.
IMPORTANT NOTICE ABOUT COVIDIEN and the SPRAYSHIELD.........
It appears that Covidien is currently involved in a similar scam with Dr. Kruschinski as he makes claims in his web site that he is currently doing the clinical trials for Covidien and the SprayShield, though there is no record of these clinical trials being authorized by the German Government for Kruschinski to be involved in them.
Once again we see that Kruschinski is using unethical and "novel" means of sharing the "Covidien SprayShield" clinical trials results by using his web site "message board!"
It is all to apparent to IHRT that Daniel Kruschinski is once again perpetrating crimes against humanity as he performs "experimental" operations with the "Covidien SprayShield Adhesion Barrier" on unsuspecting vulnerable patients once again! Covidien appears to be sanctioning these studies by not denying their association with Endogyn and Dr. Daniel Kruschinski when contacted by IHRT representatives.
Endogyn aka Covidien.....
(A bit of gossip, but we all know that with any gossip, there is a bit of truth!: It has been brought to IHRT's attention that "Covidien" has a reputation of being rather "unscrupulous" and not above dealing in unethical and "novel" means to get the end means of their product on the world wide market!)
Vice President Investor Relations - Covidien
> Eric Kraus
Contacts Eric Kraus
Coleman Lannum, CFA
Senior Vice President
Vice President Investor Relations
Tele: 508-261-8305 or 508-452-4343
Clinical Trials: The Growing Business Of Medical Experimentations ...
Differences between clinical trials according to the German law on pharmaceuticals (Arzneimittelgesetz) and trials according to the German law on medical products (Medizinproduktegesetz)]
Institut für Medizinische Biometrie, Epidemiologie und Informatik der Universität Mainz. email@example.com
PURPOSE: Similar to the registration process for pharmaceutical agents, medical devices have to undergo standardized clinical evaluation before being marketed and used in routine therapy or diagnostics. However, conduction, submission, and reporting of such clinical evaluations to authorities has to follow the German law on medical products(Medizinproduktegesetz,MPG), which in some central aspects differs remarkably from the German law on pharmaceuticals (Arzneimittelgesetz,AMG).
METHODS: Relevant deviations of MPG requirements from those of the AMG are reviewed with particular emphasis on submission, conduction, and reporting of trials to the authorities in charge.
RESULTS: Whereas AMG-based trials focus on the proof of efficacy of pharmaceutical agents, the MPG demands instead proof of functionality of the medical devices; the MPG therefore concentrates more on technically satisfactory results in the context of function and patient safety. The aim of MPG trials is thus CE marking instead of AMG-based registration. However, this focus on functionality implies that medical devices need not necessarily be tested in a clinical trial--in some settings evidence-based evaluation alone will be sufficient. The decision on the necessity of a clinical trial is based mainly on the risk profile and invasive character of the device at hand.
CONCLUSIONS: The early consideration of differences between AMG and MPG concerning the role and conduction of clinical trials will remarkably increase the (CE) certification process's outcome quality and juridical validity.Publication Types:
· Comparative Study
· English Abstract
Responsibilities of ethics committees]
Med Klin (Munich). 2000 May;95(1 Spec No):15-7.
von Bergmann K.
Abteilung für Klinische Pharmakologie der Medizinischen Fakultät, Rheinische Friedrich-Wilhelms-Universität Bonn.
Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing.
The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure.
Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.
PMID: 10851843 [PubMed - indexed for MEDLINE]
· [Responsibilities of ethics committees] [Med Klin (Munich). 1999]
· [Recording and reporting adverse reactions in clinical trials. New legal provisions according to the 12th Law Amending the German Drug Law (AMG) and the Ordinance on GCP (GCP-V)] [Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2005]
· [Therapeutic trial, clinical research and therapeutic freedom--legal boundaries] [Z Arztl Fortbild Qualitatssich. 1997]
· ReviewEthics committees and achievement of good clinical practice. [Therapie. 1996]
· ReviewEthical considerations. [Epilepsy Res Suppl. 1993]
National Institiute of Health - USA
Comparison of German and American law concerning clinical trials.
In German and American law, clinical trials require a positive benefit-risk evaluation, free and informed consent, medical and scientific qualification of the doctor, and a written research protocol. American law requires a written consent, which is free of undue influence, the subject being instructed that he is free to withdraw from the trial.
In German law, an orally given consent is sufficient for therapeutic trials. With minor or incompetent research subjects, informed consent to therapeutic clinical experimentation has to be given by their parents or guardians, the permissibility of which, in other trials, is controversial.
In non-therapeutic trials, blind studies, double-bind studies, and trials involving placebos, special attention has to be paid to the risk-benefit analysis and to informed consent, which in these cases, even in Germany, must be written.
The most outstanding feature of American law of clinical trial is that the experimentation is subject to previous control and approval by institutional review boards.
The most interesting difference in German law is the investigator's duty to effect an insurance against the risks of the research subject's death or invalidity.
Germany Clinical Trials
Information presented on Clinical Trials Search isn't designed to be a substitute for proven medical advice, travels to or treatment with a real mD.
We are not doctors. Always consult your local Germany physician on conditions.
Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Germany Clinical research trials and Germany health trials occur in hundreds of Germany localities. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The purpose of the studies / undertakings is to figure out particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate remedies for all kinds of conditions.
Germany Clinical Trials and other clinical trials permit volunteers to access medical treatment options before they are available to the masses.
Most times the human subjects receive treatment for without cost, and every now and again they are compensated for their time.
Test subjects oftentimes obtain the best healthcare available for their condition. Risks are a reality, nonetheless, and can include extra or frequent physician calls, health hazards (potentially life-threatening), and/or the treatment being ineffective.
Trials are federally regulated with rigorous guidelines to protect clinical trials patients.
Endoscopic Gynecology Centers Ltd.
Registered at Companies House for England and Wales
Company No. 5914561
Regional office: Wolfenbütteler Str. 41 D-38124 Braunschweig
Registered at district court Braunschweig HRB-Nr. 201524
Info - Phone: +49 180 /
Fax: +49 7000 /
USA Patients contacts Endogyn
(This list is in part as many patients to Endogyn refused to have thier names made public. All the patients listed here gave permission for their contact information to be accessed via the Internet.
IHRT does have the most conprehgensive list of patient who went to Europe for adhesiolysis procedures with SprayGel, as well as patients in the USA! )
Name ** eMail ** Telephone ** Location ** Which operation? ** Mulptiple trips to Endogyn for Surgery
+1 (419) 782-3944
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 01.11.2003
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 11.02.2005
+1 (847) 918 - 1470
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 11.03.2005
+1 (503) 316-0575
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 22.04.2005
+1 972 394 9061
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 23.01.2004
Dawson Kay Belinda
+1 (409) 579-4000
Adhesiolysis via gasless lift-laparoscopy with SprayGel, AdhesionsDate: 13.08.2007
** Dynda Helen - Multiple trips
+1 (320) 986-2898
Adhesiolysis via gasless laparoscopy with SprayGelDate: 18.07.2003
+1 (419) 822 9283
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 03.12.2004
+1 (503) &"(-"=)=
Adhesiolysis via gasless Lift-Laparoscopy with SprayGel AdhesionsDate: 21.02.2007
Foster, Terry and Kevin
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 07.02.2003
Froelich, Barb and Leon
Gasless laparoscopic adhesiolysis Date: 07.11.2003
Fuller, Barbara (Mother of an ARD sufferer)
+1 (209) 368-5536
Adhesiolysis via gasless laparosocpyDate: 04.05.2005
+1 (580) 263 0270
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 27.02.2006
** Graven, Lisa - Multple trips
+1 (419) 893 5645 (home)+1 (419) 346 7547 (cell phone)
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 19.07.2002
** Grigg, Sally Multiple trips
+1 (707) 964-6725
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 25.10.2002
+1 (732) 870-8775+1 (732) 996-3900
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 08.08.2003
(419) 782-3944(508) 580-1592
Gasless laparoscopic hysterectomyDate: 07.11.2003
+1 (908) 236-9859
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 06.06.2003
Hiltz-Scerbo, Leiza Ann
+1 (207) 778 2331
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 11.02.2005
+1 (979) 733-8041
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 03.06.2005
Kessler, Claudia and Rick
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 29.07.2003
+1 (580) 497-2610
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 14.01.2005
+1 (814) 371-5821
Dubois, PA 15801
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 07.09.2006
+1 (972) 542 1117
Gasless laparoscopic adhesiolysisDate: 22.04.2005
Lyn Joyce and Raymond
+1 (863) 852-3625
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 28.01.2005
+1 (253) 630-2088
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 06.06.2003
+1 (207) 433-5819
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 06.12.2006
+1 (815) 230 5253
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 05.07.2006
Purcel Jaimie and Joe
+1 (520) 876-4205
Casa Grande, AZ 85222
Adhesioloyis via gasless laparoscopyDate: 08.04.2005
+1 (951) 694-5219
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 17.06.2005
+1 (817) 423-1170
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 23.04.2004
+1 (972) 442-7730
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 06.10.2003
+1 (918) 448-4088
Adhesiolysis via gasless Lift-Laparoscopy with SprayGel AdhesionsDate: 17.01.2007
+1 (732) 851-5643
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 02.07.2004
+1 (407) 443-2897
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 13.01.2006
+1 (419) 596-3345
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 26.03.2004
+1 (508) 580-1592
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 05.03.2004
Sowers Lyn Dell
+1 (717) 343-0131
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 02.12.2005
Adhesiolysis via gasless laparoscopy with SprayGel, AdhesionsDate: 10.04.2003
Steward, Karen (Mother of Melissa)
Gasless laparoscopic adhesiolysis
+1 (732) 774 1158
Adhesiolysis via gasless laparoscopy with SprayGelDate: 02.12.2005
STAY TUNED FOR THE LINKS TO GERMAN AGENCIES WHERE YOU CAN SEEK FACTUAL INFORMATION ABOUT THE CURRENT STATE OF AFFAIRS (FIASCOS)
- DR. DANIEL M. KRUSCHINSKI -
Friday, February 13, 2009
IHRT has been assured that the Karl Storz Co. has stopped manufacturing and sales of the AbdoLift long ago.
Besides, IHRT tipped off a klinik that Kruschinsi and gasless was a con and he hi tailed it out of there so quick he left his abdolift there with a bunch of unopened mail! Bills we believe.
I Need Help Paying for Much Needed Adhesiolysis Surgery
Hello, I appreciate you reading my post. I am a 35 year old female in need of surgery to remove pelvic adhesions. Adhesions are scar tissue, or bands of fibrous tissues that bind your organs together (bowel to ovary or stomach to intestine, for example) so that your organs cannot move independently as they are designed to do. My adhesions cause pain- everyday. We suspect they are causing infertility (based on findings during prior surgery) and we are scheduled to do a dye test to confirm this. I have been married for 3 years, so this was a particularly sad piece of news. My adhesions are pulling on my organs causing a constant spasm cycle that is extremely difficult, if not impossible to break as long as adhesions are present. Plain and simple-I hurt. Every day.
Pick up the phone and spend as much time as you did on this site to see if Kruschinski is legit.
He has conned greater minds than yours.
Wednesday, February 11, 2009
Please check back!
( no IHRT can't get translations this fast!)
Too al vitim of Dr. Daniel Kruschinski! An alle Opfer von Dr. Daniel Kruschinski!Ich habe mir lange überlegt diesen Schritt in die Öffentlichkeit zu tun, aber ichsehe keine andere Möglichkeit. Dr. Kruschinski hat meinen Mann um seineTätigkeit im Krankenhaus in Rottal-Münster gebracht, und meine Gesundheitgeschadet. Die Klinik hat Dr. Kruschinski rausgeworfen, weil er schlimme Dinge gemachthat. Die Gründe die er auf seinem Messageboard angegeben hat sind unwahr. WennSie mehr erfahren wollen, rate ich Ihnen die Klinik anzurufen. Das schlimmeist, dass mein Mann diesen schlechten Menschen auch noch empfohlen hat.Kruschinski behauptet immer dass er allen nur helfen will, dabei sind das nurTricks um das Vertrauen zu erschleichen, und dann die Menschen auszubeuten. Erhat keine Skrupel, noch nicht einmalseiner eigenen Familie gegenüber, die er ausnützt.Ich wurde selbst von Ihm operiert, und werde das mein Lebenlang bereuen. Er redet immer von Studien, aber er hat überhaupt keine Beweisedass er Verwachsungen heilen kann. Und das Gel wirkt nicht. Ich habe auchseinen Versprechungen geglaubt jedoch wie so viele andere wurde ich auchenttäuscht, und es hat alles nur viel Geld gekostet. Er ist halt sehr geübt imAusnutzen von Menschen.Als er endlich meinem Mann das Honorar bezahlen sollte, ist er ekelhaft vulgär geworden.Ich habe noch nie solche schlimmen Sachen gehört. Er war vollkommen betrunkenund widerlich. Ich weiß dass Dr. Kruschinski mich jetzt als geisteskrank darstellt,wie er es mit vielen anderen Menschen auch schon getan hat, aber nachdem ich gelesenhabe, dass er jetzt sogar, Selbsthilfegruppen aufsucht um Patienten zubekommen, habe ich mich entschlossen mit meiner Geschichte an die Öffentlichkeitzu gehen.Ich kann nur jeden warnen Dr. Kruschinski zu vertrauen,und auch nicht auf Frau Miltenberger zu hören, die völlig besessen ist. Siemerkt selbst nicht wie sie ausgenutzt wird, lässt sich von Dr. Kruschinskilenken wie ich und mein sich früher auch einspannen ließen. Mein Mann hat über1 Jahr mit Dr. Kruschinski gearbeitet, nein für Ihn geschuftet, und als Danknichts bekommen. Endogyn ist eine einzige Lüge es ist nichts als ein Trick um chronischkranke Menschen um ihren letzten Groschen zu bringen. Um zu beweisen, dass ichnicht Lüge und auch keine Geisteskranke bin, habe ich hier das Dokument veröffentlicht.Ich kann nur jeden Menschen vor Dr. Kruschinski warnen. Er wird alles tun, umauch Sie um Geld und Gesundheit zu bringen.Ich weiß, dass Dr. Kruschinski gerne ausländischePatienten hat, da er viel mehr Geld von Ihnen nehmen kann, als von Kassenpatienten.Daher habe ich eine automatische Übersetzung gemacht.Too al vitimof Dr. Daniel Kruschinski!Ha
( This document can be clearly viewed at this blogs location!)
have longthink abot doing this. No no oter possibility for mee. Dr. Kruschinski hasdestroied husband job and my health harmed. He lied Klinik Rottal Munster fierdDr. Kruschinski because of horrible mess, and not what he wrote onmessageboard. If want to learn more please make call to Klinik.Horrible myhusband recommended Dr. Kruschinski, and this why my husband lost job. Dr.Kruschinski says he only wants to help, but this is ly he only wants money anddoes many harm. He not has scrouples and is no god to his family.I underwentsurgical to, and regred it for ever. No studies exist, just trick for monneytaking. Gel does not help. I trusted promises and got lied. Only expensive Heis very good in tricking people out, long much experience. My men wanted his salarybut Dr. Kruschinski was very lubricious. Veery drunken and so mean. I know thathe says I am sick and lie, now he was at help your self group, wit other sickpeople. After red this on this I choosen to make my stori official.I onli canwarn and do not trust Dr. Kruschinski and not to woman Mrs. Miltenberger. Sheblind is and not know that she is instrument like I was. She used by him to.Man work 1 year for Dr. Kruschinski, only drudgeand got nothing thank you. Endogyn trick only to get bugs and health ruined. Toprov I not sick mental I document public made.Dr. Kruschinski doing everything healthruin and money from you.I know Dr.Kruschinski love patient foreigner from while pay more as German people. Have madebecause automatic translation.
Posted by STOP Dr. Daniel M. Kruschinski at 8:13 AM
IHRT applaudes your bravery and hope you join the many involved in his lawsuits to get your money back.....a small consolation for your life of suffering.
Is Adhibit and Sprayshield compomised due to false information submitted by it's principal investigator, Professor Dr. Liselotte Mettler - Kiel German
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?
Is she responsible for sending ARD patients to Endogyn for EXPERIMENTAL surgeries by
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!
Something to be "ashamed" of!
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...
Bogus research being done in bogus labs,
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 (firstname.lastname@example.org)
"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.
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
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
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
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
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
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
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"
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!)
© Commonwealth of Australia 
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
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Electronic copies can be obtained from http://www.horizonscanning.gov.au
Enquiries about the content of the report should be directed to:
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GPO Box 9848
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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).
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 but changed indication or modification of technique
Should be taken out of use
AUSTRALIAN THERAPEUTIC GOODS ADMINISTRATION APPROVAL
Yes ARTG number 122805
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
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.
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).
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.
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.
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)
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.
No issues were identified from the retrieved material.
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
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~~~~~~~~~~~~~
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.”
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.