Ohio State University Press Release's 2005
Dr. Schlanger has been invited to answer these questions, but has elected not to. These
questions are easy ones for any surgeon to answer, IF they are acclimated to a high
quality adhesiolysis procedure….
I suspect Dr. Schalnger has not responded to my questions regarding his adhesiolysis
procedure because he cannot answer them in any effective way, and in his silence alone,
he posses a risk to any surgical patient he lures into his operating room!
http://columbus.bizjournals.com/columbus/stories/1998/11/09/story1.html?page=1
http://columbus.bizjournals.com/columbus/stories/2002/06/03/story1.html?page=2
“Wolves in Sheep’s Clothing”
Persons afflicted with ARD
BEWARE
There does exist in just about every medical facility in the world, those who make
claims of cures for “ARD”
and your doomed for failure if in fact you simply take a medical care
providers word for things without asking for validation, proof, and statistics
to back them up!!
How can you save yourself from the bad surgeons?
“Be informed about ARD enough to know what questions to
ask and be familiar with what the answers should be
and
“Be Your Own Best Dr!”
I would be remiss in my quest for the truth regarding medical intervention for
victims of ARD if I did not question this article and the claims made in it. One thing
rings true in the world of ARD and that is that the PATIENT is a whole lot more
educated today then they were in the past! If a Dr. wants to make a claim, they
better be able to follow it up and in a public manner as with ARD issues,
NO MORE SECRETS!!
My concerns are NOT regarding “Adhesion Barriers” being used by
Dr. Richard Schlanger, a general surgeon and director of the
Center of Advanced Wound Management at University Hospital East at the
Ohio State University Medical Center, MY concerns are far greater then that!
It is not my intention to impress upon others what medical intervention to pursue or not pursue,
however, for those who are looking to further their education regarding ARD, then let this be part
of it! Do as you please with your walk with ARD, but understand that I am doing what I see fit in
MY walk with ARD, as I speak for me and for no one else!
(And stand by as I take apart this article that just came out! Again, highlighting this Dr. Schalnger, “Surgeons' Multiple Techniques Prevent Pain of Adhesions Posted 2/22/2005” in which he appears to be making a claim to have found the cure for ARD, however it REALLY opens Dr. Schlanger up for scrutiny as it has more holes in it the Swiss cheese! And we all know what “cheese” does to an ARD patient!)This article leave me with more questions then answers as Dr. Schlanger’s comments
leave him open to questions needing answers before I can accept his words as truth. What anyone else thinks or does with it is up to them, but I want more answers!
I would be thrilled if in fact he steps up to the plate here and comes up with what I would like to hear, and if Dr. Schlanger produces, then we just might have a leader in this area. The door is wide open in the area of adhesion cures, in fact, every door is wide open when it comes to any issue in the ARD arena, worldwide!
I want to give Dr. Schlanger a chance to clarify and expound on some of his comments in this article as, in my opinion, it leaves much to be questioned before ARD patient’s head to Ohio!
Many of us know where medical intervention got us when we simply took a surgeons word for things and put him up on a pedestal, without questioning one single word, if you don’t know where that “trusting” attitude will get you, well, so be it, but I know where it got me and not very far either!
(And stand by, as another article just surfaced regarding this Dr. Schlanger in which he appears to be making a claim to have found the cure for ARD, however it REALLY opens Dr. Schlanger up for scrutiny as it has more holes in it the Swiss cheese! And we all know what “cheese” does to an ARD patient!)
Healthy 4 Life: Pain After Surgery
This interview aired Feb. 9, 2005, on Channel 4 Action News at 5 p.m.
Sincerely yours, Donna Headlee, RN, BSN, CCRPPress Release
Schlanger> “Surgeons are trying a different approach.”
Bev’s 2 questions> A.) Surgeons at the University Hospital East at the Ohio State University Medical Center, or surgeons in general?
B.) What is the basis for this comment please?
Schlanger> "Anything we can use that can coat the bowel and allow it from either sticking together or sticking to other surfaces will give us the upper hand on adhesion formation." Schlanger is using a material called seprafilm to coat the inside of his patient.
Bev’s 2 questions> A.) Is it fair to assume that all your surgical procedures using the sheets of the adhesion barrier “Seprafilm” are open surgeries or laporotomies involving the abdomen, being that this is how the Seprafilm is indicated for use in an abdominal procedure?
B.) Do you have an opinion on the fact that a laporotomy increases the patient’s chance of abdominal herniation and chronic painful neuropahy due to excessive tissue damage from the laporotomy, not to mention that is also increases a greater chance of forming adhesions along the incision site internally?
Schlanger:> Before closing the patient, he wraps the area with the film to see if it prevents the development of scar tissue. Then he watches for results.
Bev’s questions> A.) Will you please explain what the protocol is for “watching” results and what those “results” would be?
B.) Are you using the protocol for “watching” for these surgical results, as stipulated by the FDA for collecting and recording data of this sort? (You wouldn’t be doing a study with human test subjects without FDA regulations in affect, would you!!)
C.)What is the time frame for “watching” these post surgical patient(s) and collecting and recording of this data?
D .) Where is this data posted and when and how will it be made pubic?
E.) Do the “results” your watching for differ in each patient depending on how extensive or involved the patient was with adhesions? (Given that ARD patients present with many different case scenarios and many with multiple past surgeries for adhesions among other things.)
F.) Do these patients know they are test subjects for data being collected on the effectiveness of the Seprafilm?
G.) Are you charging these test patients for these surgeries?Schlanger:> He found that the film made a dramatic difference. "We coated them all with seprafilm on the inside, and when we've taken them back for surgery, we found either stage one or no adhesions, so this stuff works."
Bev’s questions>
A.) What method of approach was used to determine the effectiveness of the Seprafilm for you to make this comment please? A “second look” procedure perhaps? (Though I am surmising that your performing second look surgeries for research means only as I cannot think of any other approach to a second surgery on these patients for you to being able to discover such a “dramatic difference.”)
B.) I know that second look procedures are not allowed in the USA, other then being sanctioned by the FDA and under strict guidelines for research purposes only. Are you performing these second surgeries under FDA guidelines for research?
C.) Insurance companies will not pay for second look procedures for research, are you doing the second look procedures under another type of diagnostic code, such a” Diagnostic Procedure” Abdominal Pain…anything like that?
D.) Do you perform these second look procedures at no cost to the test subject?Dr. Schlanger,
Have you completed or been involved in any type of animal studies using the Seprafilm Powder?
Has this powdered Seprafilm been tested previously by the Genzyme Corp where Seprafilm is manufactured?
Do you have any abstracts available on these testing results that you can post?
Now here is great timing, one would have thought that the Ohio State University and Nama Bev worked this out hand in hand…and you, Mr. Milosovich, said asking questions was a nuisance, well, you do what you want to do, but the rest of those who suffer ARD, I agree with Dr. Young when he says: “ASK QUESTIONS!”
The Ohio State University Comprehensive Cancer Center.
How to Make Sense of Medical Studies Posted 2/2/2005Michelle Gailiun Dr. Donn Young, a biostatistician and senior research scientist there had this to say:
Well, for starters, Young suggests asking a few questions. The answers will help you tell
the good ones from the bad ones.
Medical Center Communications
You will find the associated issues in this web site: My commments in the attached post are in response to a public post on the ARDchat wen site blog dated Tuesday, February 22nd 2005.
http://adhesion.bravejournal.com/entry/10943
From Pittsburg Channel 4
Healthy 4 Life: Pain After SurgeryIt is my intention to make a public comment on the ARDchat web site blog regarding "Multiple Techniques Prevent Pain of Adhesions" Posted 2/22/2005.
Here is a sampling of my question to Dr. Schlanger:
Schlanger said. “So we wash the abdomen and dry it carefully so there is no fluid left over.How might this surgeon accomplish this task he describes as "dry it carefully so there is no fluid left over" and is this wise to do to the internal organs?( I do have a notice out of the Genzyme company making reference to "drying" of internal peritoneal surfaceses prior to using Seprafilm, but it does NOT mention anything about drying of the internal organs.)
Schalnger states that Stage 2 adhesion are the ones that cause pain verses a stage 1 adhesions?
“Type 2 adhesions are the progenitors of pain because they can pull on sensor receptors and cause discomfort,” Schlanger said."
Is he saying that "Stage 1" adhesion do not cause pain, and how would he know this to be true?Schlanger states that: "Patients with inflammatory bowel conditions, for example, have adhesions that are much worse and usually will create other problems.”
Why would these patients present any worse off then patients who had never had inflammatory bowel conditions, but HAVE had numerous surgeries that increased adhesion formation with each surgery?
Why would those patients with " inflammatory bowel conditions" be worse off then patients who underwent gynecological surgery and developed adhesions?
( Such as I did.)
Is Schlanger saying because I did not present with an inflammatory bowel condition, I was less likely to have real medical problems and pain? This is not good for all those ARD victims looking for medical intervention or disability benefits that ARE justified in receiving them...regardless of what stage adhesions this surgeon thinks causes problems or not..he hasn't a clue about this!
And I can prove that he hasn't any validation for his comments in this article..in fact I will prove it, but in a public manner!I do not have an email address for Dr. Schlanger, and if I would have been able to secure one, I would address my issues directly with him, however, scanning the OSU - East web site, I was not able to produce an email address for him, so maybe you will be kind enough to alert him as to my plans of addressing his recent public press release's as it is only responsible of me to offer him the opportunity to address my issues in a personal manner. However, I am not willing to wait for any response from him prior to making my comments publicly, but I would post any comments he had in response to my questions and issues with him.
Thank-you,
Beverly J. Doucette
Members of the ARD “International Human Rights Team” (IHRT) made contacts with OSU to secure an email contact for Dr. Schlanger as it is very difficult to secure in the OSU web site!
I, Beverly J. Doucette, will send this “analysis” to Dr. Schlanger, along with ALL her contact information and invites him to discuss her opinions about him and his practice at OSU. And all communications will be publically!
Dr. Schlanger, schlanger.4@osu.edu.What you are about to read are Beverly Doucette personal opinions on the comments and claims of one, Dr. Richard Schlanger out of Ohio State University-East. And though I would like to have addressed my concerns directly with this person, he does not avail himself to email contact, but non the less, I would have gone public with my comments anyway!
I will risk everything for the truth, thus I cannot be stopped from expressing my opinions on what is or is not TRUTH!My concerns and suspicions of this surgeons comments come from my varied and extensive background of not only setting the pace for education and awareness of adhesion issues world wide, but having had the wonderful opportunity to attend a number of “International Medical and Scientific Congress’s” regarding adhesions, having been invited to observe a number of adhesiolysis procedures both with and without the use of adhesion barriers, and from what I believe is my best weapons to challenge the comments of not only this surgeon, but ANY person who I think is making claims that cannot and are not being produced on, is that I have a medical background AND I AM one of the unfortunate people afflicted with “Iatrogenic ARD!”
(Iatrogenic: reactions caused by drugs, operations, and invasive procedures)
MORE: http://www.simillimum.com/FirstAid/TheFirstResponder/FirstAidin/Latrogenesis.html
As an advocate for persons afflicted with “Adhesion Related Disorder”(ARD)
I would like nothing better then to think that someone within the medical community has really found the successes as claimed in Dr. R. Schlanger’s comments in his recent public announcements, however, these comments are not validated with any statistics, abstracts of research, and cannot be accepted as anything but a surgeon baiting desperate and vulnerable patients to his scalpel! In the world of ARD we see this all the time, but have become wiser to the scam when it surfaces time and again. Had Dr. Schlanger offered validation of his comments he wouldn’t have left himself open to questions, criticism and challenge, but he can still produce on that, as I have laid out a format for easy answering of my questions with validations of his claims.
I tend to think that is not going to happen though! Why not?
Mark my words here!
“Because he can’t!”Things that you need to be aware of when seeking surgery for adhesions!
Ask to see documentation of how many times this surgeon has performed the procedure your questioning and what the results were in those procedures he performed.
Ask for references of persons who have secured improvements from his procedure and have remained well for over a year or so! Ask for more then ONE reference too!
Ask HOW the surgeons procedure will benefit you and WHY would it benefit you!
DO NOT accept a surgery unless it is performed by an “endoscopic” procedure known as a laporoscopy.. Very seldom does a skilled surgeon have to resort to an “open” procedure known as
a laporotomy
Make sure your surgeons will video tape the entire procedure, and rinse the cavity with ringer solution thoroughly at the close of the surgery AFTER performing a “clot” evacuation (removing un-oxygenated blood and debris left by the procedure!)Make sure you secure your operative reports and ALL associated prior diagnostic reports, and pathology/cytologyreports associated with the procedure just completed.
Make sure you discuss with your surgeon when your “surgery pain” should start to resolve it self, and what to look for in recognizing that you are healing.
Discuss what steps the surgeon will take to help you IF your adhesion pain and symptoms return after 4-6 months!
Remember that when you go to a shoe store, the salesperson will try to sell you a pair of shoes. When you seek counsel with a surgeon, they will try to sell you a surgery!COLUMBUS, Ohio – Surgeons at The Ohio State University Medical Center are getting positive results from the use of a special substance and other techniques designed to prevent disorders caused by a common but sometimes painful leftover from abdominal surgeries.
Bev> This paragraph makes a case for more then one surgeon finding success with the use of adhesion barriers at OSU.
A.) Who are the other surgeons please?
B.) Are they all general surgeons
C.) Are they all using Seprafilm with these successes?
I noticed that Dr. Schlanger did not mention what type of surgical procedure he uses in his adhesiolysis procedures. To the best of my knowledge regarding his procedure, it is via a lapororotmy! Seprafilm is only indicated for use in open surgery! It has been understood as far back as 1932 that an “open” incision is NOT conducive to an adhesion patient’s recovery with improvements! Today, there IS no reason a surgeon practices an adhesiolysis via an open surgery, absolutely no reason other then being unskilled in performing an adhesiolysis!Vick RM. Statistics of acute intestinal obstruction. Br Med J 1932; 2 : 546-8.
MORE: http://www.adhesionrelateddisorder.com/adhesion4.htmlIncreased systemic inflammation after laparotomy vs laparoscopy in an animal model of peritonitis.
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9517736&dopt=Abstract
CONCLUSIONS: Laparotomy and laparoscopy increased the incidence of bacteremia and systemic inflammation in this peritonitis model. The inflammatory response was significantly higher in the laparotomy group compared with the laparoscopy group.Genzym: Important safety information
Seprafilm Adhesion Barrier is indicated for the reduction of post-surgical adhesions in patients undergoing abdominal or pelvic laparotomy. The most common adverse events in clinical trials, which were not different from untreated controls, were ileus, anastomotic leak, and abdominal abscess. Seprafilm should not be wrapped around an anastomosis as such usage may result in increased anastomotic leak related events. Seprafilm has not been studied prospectively in pregnancies, in the presence of frank infections, or in malignancies.Adhesions can rarely be prevented in open abdominal or pelvic surgery, even at the hands of well-trained surgeons using modern techniques. As internal wounds related to abdominal surgeries heal, scar tissue is formed – a hallmark of the wound-healing process. In some cases, adhesions formed by the scarring and inflammation that accompany wound healing can cause tissue to stick together or to organs in the abdominal cavity. Though everybody’s body makes adhesions, in rare cases, the adhesions are associated with painful twisting or cramping of the bowel or internal hernias, sometimes requiring additional surgery to repair.
Bev> A.) “Rare?” Do you mean in numbers of ARD patients presenting to the “general” surgeons at OSU?
B.) In making claims that post surgical problematic adhesions are rare, are you taking into consideration every area of surgery?
C.) What validation do you have to support your claim of ARD being “rare?”
Just based on the figure listed below, problematic adhesions are far from being rare! Note that I am not even addressing the numbers for re-operations due to general surgery to men, women and children alike! Dr. Schlanger, you stated that OSU has one of the largest presentations of ARD patients, so it should be easy for you to present figures on this group as to why you refer to ARD as being a rare occurrence.Approximately 600,000 hysterectomies are performed each year in the United States More than one-fourth of U.S. women will have this procedure by the time they are 60 years of age. Hysterectomy is the second most frequent major surgical procedure among reproductive-aged women.
More: August 8, 1997, Special Focus: Surveillance for Reproductive Health surveillance summary, Hysterectomy Surveillance--United States, 1980–1993 (796KB PDF)
Hospital readmission due to complications after hospital discharge was the factor most strongly and consistently associated with women's reports of negative outcomes from hysterectomy. For example, women who were readmitted to the hospital during the first year after hysterectomy were 23 times more likely to report that the results of the surgery were worse than they had expected, after adjustment for all other factors. About 5.4 percent of women were readmitted at least once to the hospital during the 2 years of follow up, and 4 percent were readmitted during the first year. The most common reasons for readmission were incision problems, surgery for adhesions, intestinal blockage, and urinary tract problems.
For more information, see "Patient satisfaction with results of hysterectomy," by Kristen H. Kjerulff, Ph.D., Julia C. Rhodes, Ph.D., Patricia W. Langenberg, Ph.D., and Lynn A. Harvey, in the December 2000American Journal of Obstetrics & Gynecology183, pp. 1440-1447.
Adhesion disorders are most common after gynecological and abdominal surgeries because scar tissue can disrupt more organs there. Published research on various procedures has found post-operative adhesions in 80 percent to 85 percent of those patients, although fewer than 1 in 3 have symptoms. Adhesions also can result from infection, radiation therapy, endometriosis and injuries, Nesbitt said. (Anthea Nesbitt of Columbus, Ohio From the Dayton Daily News: 09.30.2003)Efforts to eliminate the need for adhesion-related repairs led to OSU’s implementation of a series of preventive surgical techniques and the use of Seprafilm barrier material, says Dr. Richard Schlanger, a general surgeon and director of the Center of Advanced Wound Management at University Hospital East
Bev> A.) Can you supply your adhesiolysis procedure and technique in written form when requested?
B.) Is OSU currently researching any other types of adhesion barriers?
C.) If so, which ones are they?
D.) Is Dr. Schlanger the ONLY researcher at OSU?
E.) What roll do the laporoscopic surgeons play in the OSU adhesion research, F.)
F.) Is this general surgeon doing this adhesion research alone at OSU?
G.) Is Dr. Schlanger part of the “Endoscopic Services at OSU-East” that appears to offer laporoscopic surgery for gastro-intestinal conditions!Endoscopic Services at OSU-East:
OSU Medical Center has a variety of hospital and community-based endoscopic services available that focus on the diagnosis and treatment of a wide range of gastroenterology conditions. Inpatient and outpatient services are available and can be sought by obtaining a referral from your primary care physician."The presence of bowel content, the presence of blood, the fact that tissue has to be handled – all of those things can set up adhesions," Schlanger said. "So we wash the abdomen and dry it carefully so there is no fluid left over. We also meticulously control bleeding in the abdominal cavity and limit the handling of tissue, which will limit the inflammatory response."
Bev> A.) What validation do you have to support your claim that your procedure IS limiting the inflammatory response post surgically?”
B.)What IS your procedure for “drying” the organs in a manner that will reduce serosal trauma to the organs.
C.) Isn’t it true that when you change the composition of the external serosal tissue of the intestines your opening the patient up for pathogen invasion?
D.) Do you perform a “clot” evacuation? (Adequate excision of ischaemic or infected debris within the peritoneum.)Vick RM. Statistics of acute intestinal obstruction. Br Med J 1932; 2 : 546-8. E.) Is your “wash” done with ringers?
MORE: http://www.adhesionrelateddisorder.com/adhesion4.html
F.) How do you dry all the areas needing the adhesion barrier without excessive manipulation the organs?
G.) What type of instrument do you use to control bleeding during the procedure? Harmonic Scalpel?
H.) Do you have this technique in written form upon request?These techniques, combined with the addition of barrier material to prevent adhesions, have provided benefits to numerous patients, he said.
Bev> A.) How do you gage the “benefits” to your adhesiolysis patients in relationship to your adhesiolysis procedure?
B.) Do you perform second look procedure on your adhesiolysis patients?
C.) How long to you follow the recovery status of your adhesiolyusis patients?
D.) What is your protocol for the following and determining the results of your adhesiolysis procedures?"OSU has been at the forefront of adhesion research and clinical efforts. We’ve been eager to put barrier materials to use and have one of the larger populations of patients with adhesions who have been treated with these barriers," Schlanger said.
Genzym: Surgeons know the risks associated with adhesions--that’s why many of them rely on Seprafilm. They have applied more than 800,000 sheets since its introduction.3 Seprafilm is a proven adhesion barrier.1,2 With clinical trials in both the abdomen and pelvis, no adhesion barrier has been studied more broadly than Seprafilm.http://www.seprafilm.com/home.asp Bev> A.) Exactly what is it in “adhesion research” you are researching?
B.) What are you researching that has not been researched regarding adhesions or internal adhesion pathology and biophysical adhesion formation?
C.) Is OSU participating in any Genzym Clinical trials for Seprafilm Gel research?
D.) It doesn’t appear to me that Dr. Schlanger is qualified to do adhesion research ON HUMAN TEST SUBJECTS AS HE HAS BEEN WORKING IN THE AREA OF TOPICAL WOUND CARE while at OSU!
E.) I do not find any indication on the OSU web site of any “adhesion Research” or “adhesion Clinical trials?” Why is that if Dr. Schlanger is doing research on adhesions?
http://www.cmis.ohio-state.edu/publications.htm
Gordillo GM, Kalliainen L, Roy S, Atalay M, Schlanger R, Kelch J, Lambert L, Sen CK. Topical oxygen in wound healing. International Conference on Wound Healing: Oxygen and Emerging Therapeutics, Columbus, Ohio, September 12-15, 2002.White LM, Roy S, Atalay M, Gordillo GM, Schlanger RE, Sen CK. Method Development for the Extraction and Simultaneous Quantification of Hydrophilic and Lipophilic Antioxidants from a Small Human Wound Tissue Biopsy. 2002 Health Science Graduate & Postgraduate Research Day (Landacre Society), Ohio State University, College of Medicine, April 4, 2002.
Adhesion research using human test subjects can be granted to an institution under FDA guidelines, or adhesion research using human test subjects can be granted by an institution such as OSU and in it’s own facility, however, this research must still be done with strict guidelines and record keeping and presented to the FDA that research is taking place at the institution. More on the subject or human research:
Being that OSU is in the forefront of “Adhesion Research” under the direction of Dr. Richard Schlanger, then I am certain that abstracts and records are available upon request. It is also necessary to inform any patients undergoing an adhesion surgery with adhesion barriers being researched to be informed of this PRIOR to the procedure! The patient must also be informed and sign a consent that they understand the procedure is a research project thus subjecting them to risks and outcomes not yet known!
It is also important for any of Dr. Schlanger’s “adhesion research patients” to contact OSU or the FDA or the Ohio Attorney Generals office to inquire if a patient being used in a clinical research project is subject to paying for that surgery, as I am certain that human research subjects are not to be charged for being part of a research project! Schlanger makes similar claims of performing adhesion research on patients at OSU back in 2003!
Hopefully one of the persons listed below will come forward with explanations of just how Dr. Schlanger’s adhesion research projects are being instituted.
Richard Schlanger MD –Chief of Staff OSU schlanger.4@osu.edu.
Joel G. Lucas, MD – Medical Director
Karen Mlawsky – Executive Director
or the writer of this article: Emily Caldwell Medical Center Communications caldwell-6@medctr.osu.eduJim Petro
www.ag.state.oh.us
State Office Tower
30 E. Broad St., 17th Floor
Columbus, OH 43215-3428
Telephone - 614-466-4320
Toll Free Number - 800-282-0515
(Attorney General Office, Public Action Line, Provides Consumer Protection Against Fradulent Business Practices)FDA info at www.FDA.gov
Cincinnati District Office (Serves Kentucky and Ohio)
Food and Drug Administration
6751 Steger Dr.
Cincinnati, OH 45237-3097
Telephone - 513-679-2700
Schlanger > Sheets or a powder form of Seprafilm are placed in the abdomen just before surgery is completed, coating parts of the cavity during healing as the methyl cellulose-based material is absorbed by the body. The coating prevents tissue from sticking together or to the abdominal wall.
Bev > A.) What is your surgical procedure and technique for placing Seprafilm Sheets into the peritoneal cavity?
B.) For the Seprafilm Sheets, is this placement site specific?
C.) For the Seprafilm Podwer, you create a moist gel from it for application as indicated in the “US Patient of the Seprafilm gel?”
D.) How many of your surgical patients get the Seprafilm Sheets compared to the Seprafilm gel?
E.) Being that these surgeries are for research purposes, are you basing your results of the efficiency of the Seprafilm SHEETS verses the efficiency of the Seprafilm GEL as you calibrate success of the adhesion procedures?
Seprafilm Adhesion Barrier Sheets
United States Patent 6,693,089
Calias , et al. February 17, 2004
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2Fsearch-
bool.html&r=0&f=S&l=50&TERM1=seprafilm&FIELD1=&co1=AND&TERM2=&FIELD2=&d=ptxt
Seprafilm Adhesion Barrier Gel
United States Patent 6,521,223
Calias , et al. February 18, 2003
http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=/netahtml/search-
bool.html&r=7&f=G&l=50&co1=AND&d=ptxt&s1=seprafilm&OS=seprafilm&RS=seprafilm
For the record: The Seprafilm gel is then precipitated with ethanol as a solid. Preferably, the gel is pulverized to form a powder, which can be stored until it is needed for medical use. The powder can be easily reconstituted by rehydration, and optionally subjected to heat treatment to adjust the rheological properties to achieve the desired physical characteristics.In a semi-controlled study of the material, Schlanger has found that the barrier’s use in patients with diverticular disease undergoing temporary colostomy placement – who are definite candidates for follow-up surgery to remove the colostomy – have experienced fewer and less-troublesome adhesions.
Seprafilm is not warranted to be used on ANY anastomosis type bowel wounds... (this is how people died with the Integral, it seeped into the wound areas at the anastomosis sites leading toseptic shock from blood contamination.) Genzym: Important safety information
Seprafilm Adhesion Barrier is indicated for the reduction of post-surgical adhesions in patients undergoing abdominal or pelvic laparotomy. The most common adverse events in clinical trials, which were not different from untreated controls, were ileus, anastomotic leak, and abdominal abscess. Seprafilm should not be wrapped around an anastomosis as such usage may result in increased anastomotic leak related events. Seprafilm has not been studied prospectively in pregnancies, in the presence of frank infections, or in malignancies.Bev > A.) What is “semi-controlled” study? Please see the Package
B.) With human beings as the test subjects, how can you do a “semi-controlled study!?
C.) With the magnitude and seriousness of adhesions, your doing a SEMI-CONTROLLED STUDY?
D.) How can you trivialize such a thing as ARD?
E.) It is no wonder that you’re the only one involved here…it is bogus study!
F.) Dr. Schlanger, I was under the impression that Seprafilm Sheets were already researched, and had passed clinical FDA studies and regulations and was on the market for surgical use, why are YOU researching Seprafilm?
G.) Why isn’t this “Adhesion Research” or “Seprafilm Clinical trial” not listed in the OSU web site?
H.) How can you use Seprafilm in these bowel resection cases and then use them as a test subjectin re-operations?
I.) Why did you use Seprafilm if you didn’t know what it would do for the patient?
J.) What did you tell the patient it would do for them prior to performing the surgery?"Patients in the past that we did not use Seprafilm in had adhesions that were significant and added about an hour to the follow-up operation," Schlanger said. "But for those on whom we had used Seprafilm, re-entering the abdomen was basically a breeze. The adhesions, if present, were very filmy and easy to take down. In some patients, we found no adhesions."
Bev> A.) What was the reason these patients had re-operations for you to make this determination?
B.) Did you secure informed consents from your adhesion patients explaining that they were test subjects for your adhesion research project?
FOR PATIENTS of Schlangers: It is also necessary to inform any patients undergoing an adhesion surgery with adhesion barriers being researched to be informed of this PRIOR to the procedure! The patient must also be informed and sign a consent that they understand the procedure is a research project thus subjecting them to risks and outcomes not yet known!
It is also important for any of Dr. Schlanger’s “adhesion research patients” to contact OSU or the FDA or the Ohio Attorney Generals office to inquire if a patient being used in a clinical research project is subject to paying for that surgery, as I am certain that human research subjects are not to be charged for being part of a research project!There are two types of adhesions: Dr. Schlanger, you missed the boat here, adhesions have already been defined, classified and are commonly recognized as they are listed below no need to start to create your own stages as your simply wrong here! There are THREE types!
Definitions
Several definitions of adhesions exist. De novo or new adhesions may form at a site where none existed before but a surgical procedure was performed.
Three general types of adhesions exist - filmy, vascular, and cohesive. The underlying pathophysiology of all three, however, is similar. The American Fertility Society has attempted to classify adhesive disease according to the location and type of adhesions
http://www.womenssurgerygroup.com/conditions/Adhesions/overview.asp
C.) How much do you or have you corresponded or worked in cooperation with other surgeons who posses exceptional skill and experience in laparoscopic surgery for ARD patients?Type 1 adhesions are filmy and web-like and break up easily.
Bev> A.) Please provide data as to how you drew the conclusion your type “A” adhesions do not cause pain?
B.) Have you been involved with any pain mapping procedures to validate this claim?
( Larry Demco, Alberta Canada has performed pain mapping on ARD patients.)Type 2 adhesions are more significant and usually result from infection, internal bleeding or traumatic injury in which scarring is severe enough to be supported by nerves and blood vessels.
Bev> A.) Please provide data as to how you drew the conclusion your type “2” adhesions are the result of infection, internal bleeding or traumatic injury?
B.) How much do you or have you corresponded or worked in cooperation with other surgeons who posses exceptional skill and experience in laparoscopic surgery for ARD patients?
C.) Have you ever attended an International Congress on surgical adhesions?Scientific or medical, either one? D.) Being that I have attended a number of International Medical and Scientific Congress’s for Adhesions, I have never heard your name or OSU mentioned as being part of any issues regarding ARD, can you explain that?"Type 2 adhesions are the progenitors of pain because they can pull on sensor receptors and cause discomfort," Schlanger said. "And really, adhesions themselves aren’t so much the culprit as much as what they can cause, which are bowel obstructions, internal hernias or fistulas between the inside of the bowel and the abdominal wall.
Bev > A.) Why is it that as a general surgeon you are performing and researching these adhesion surgeries verses the surgeon listed below who is also interested in peritoneal surgery out of OSU?
B.) Dr. Schlanger, are you working on this adhesion research alone?According to the Society of Laparoendoscopic Surgeons, there is no acceptable nonsurgical medical treatment for a hernia and if the repair is delayed, it can result in incarceration or strangulation.
Author: Chuck Cook,MD Jeff Hazey, MD
http://ccme.osu.edu/cmeactivities/onlineeducation/webcast/
"Everybody makes adhesions and every surgery will produce adhesions. But it just depends on what the associated symptomatology is with it. Patients with inflammatory bowel conditions, for example, have adhesions that are much worse and usually will create other problems."
Bev> A.) Why would these patients present any worse off then patients who had never had inflammatory bowel conditions, but HAVE had numerous surgeries that increased adhesion formation with each surgery?
B.) Why would those patients with " inflammatory bowel conditions" be worse off then patients who underwent gynecological surgery and developed adhesions?
( Such as I did.)
C.) Dr. Schlanger, are you saying because I did not present with an inflammatory bowel condition, I was less likely to be compromised with real medical problems and pain? Do you realize that you have just excluded a major portion of those who DO suffer terrible excruciating pain and massive medical symptoms from adhesions regardless of what “stage adhesions” YOU thinks causes problems or not..Dr. Schalnger, you don’t have a clue as to what your saying here as it is impossible to make such a determination as to what adhesions do what in a human beings body, and you know I am correct!This is nothing more then “uneducated gibberish” with NO FACTUAL BASIS existing anywhere in the world about “type A and type B adhesions” If you or anyone thinks that I am not correct in that assessment of my knowledge on ARD, ask us both the same question, and they will get the answer!
Other then your own silly comments here and back in 2003 when you also made a “profound”
comment like this!
I am appalled at OSU for not only allowing you to make such idiotic comments that indicate your
about as educated on adhesions as an ass is!
I, as a lay person, posses more knowledge about “Adhesion Related Disorder” in my little finger
then you posses overall!Schlanger said demand for adhesion-prevention barrier use is growing as awareness increases about surgical adhesions.
Bev> Education and awareness of adhesions is growing as well, and those afflicted with ARD are much wiser today then they were just a year ago, thus we will not tolerate such “crap” as Schlanger is trying to pass off here in these articles! OSU and Schlanger are about as far off of the “cutting edge” of adhesion research and surgery as one can get…let alone make claims as to the outcomes of his adhesion surgeries!NOW I WILL TELL IT LIKE IT IS! “Schlanger said. "But for those on whom we had used Seprafilm, re-entering the abdomen was basically a breeze. The adhesions, if present, were very filmy and easy to take down. In some patients, we found no adhesions."
Bev > these patients were NOT those who presented with post-surgical adhesions from numerous procedures! These are patients who are having surgery for diseased intestines, and this does not mean they had adhesions prior to this procedure, and with using an adhesions barrier, one would think Schlanger would EXPECT decent results for using it…he is supposed to be working for the betterment of his patients, what did he think he was doing when he used an adhesion barrier??
Schlanger very intentionally slides the results from these colostomy patients by leading one to think he is getting results like this in ALL his surgical adhesion patients, which is not the case at all! (We will see this in future articles that “ARDchat” has asked me to critique that Schlanger is quoted in)The only way that Schlanger could perform re-operations on an adhesion patient is if they “In a semi-controlled study of the material, Schlanger has found that the barrier’s use in patients with diverticular disease undergoing temporary colostomy placement – who are definite candidates for follow-up surgery to remove the colostomy – have experienced fewer and less-troublesome adhesions.”
present with post operative symptoms indicating surgical intervention, or if he were deliberating
changing the prior surgical diagnosis for a re-operation, or if he is practicing under clinical trials
that call for a second look procedure…in his comments in these past two articles, he very
conveniently fuses the results from the colostomy patients to represent adhesion patients, and that
is a rotten trick, and a dirty shame!
See for yourself….Schlanger "If we can stop the adhesions, we may be able to stop this cycle that some patients tend to have with chronic pain, who undergo surgeries but don’t feel any better," he said.
Investment pays off
http://columbus.bizjournals.com/columbus/stories/2002/06/03/story1.html?page=2
OSU has also invested $20 million to improve East's physical plant, including extensive upgrades of several operating rooms. Surgeons are responding by bringing more of their patients to East, said Dr. Richard Schlanger, the hospital's chief of staff.The number of surgeries had dwindled to as few as eight a day just before Ohio State acquired the hospital. Now 25 to 30 procedures are done on a typical day.
"This place is busting out at the seams," Schlanger said. "We're booming."
2002 American City Business Journals Inc.
I do want to tell Dr. Schlanger that right now that in my opinion he has NO credibility as an expert or even as a skilled or knowledgeable surgeon when dealing with adhesions!
Everything I have read in these articles, and in other articles involving him, that you WILL see here in future, he is deliberating taking advantage of a very suffering and vulnerable group of people afflicted with
”Adhesion Related Disorder”
And other victims of ARD will be able to draw their own conclusions
after reviewing this post and be better for it!I will not tolerate such nasty behavior from anyone within the medical community
or otherwise!
Know this, I will be all over him like a bad rash from now on!Good thing Mr. Milosovich opened this door or this might not have been brought to my attention!
I tip my hat to you, Sir!_________________________________________________
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
_____________________________________________________________________________________________
Food and Drug Administration
Center for Devices and
Radiological Health
2098 Gaither Road
Rockville, MD 20850
Beverly Doucette March 30, 2005
2314 Carney Avenue
Marinette, WI 54143Dear Mrs. Doucette:
This letter is in response to your concerns expressed to the FDA regarding Dr. Richard Schlanger of the Ohio State University Medical Center and his use of Seprafilm™ Adhesion Barrier. Seprafilm™ Adhesion Barrier is indicated for use in patients undergoing abdominal or pelvic laporotomy as an adjunct intended to reduce the incidence, extent and severity of post operative adhesions between the abdominal wall and underlying viscera such as omentum small bowel, bladder, and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel and bladder.
You have expressed concern with an Ohio State Medical Center press release posted February 22, 2005, which describes “a powder form of Seprafilm™ “ that is used “in patients with diverticular disease undergoing temporary colostomy placement – who are candidates for follow-up surgery to remove the colostomy – have experienced fewer and less troublesome adhesions.”
Seprafilm™ is currently not available in a powder form. It has been clarified that this device is being used in its approved indication.
Thank you for bringing this matter to our attention.
Special Investigating Branch
Bioresearch Monitoring
Office of Compliance
Center for Devices and Radiological Health
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