Thursday, September 14, 2006

Surprise! You were an experiment

One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted...................

Kruschinski's paper ( this means YOU!)


Applications of the general principles to the conduct of research leads to consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects of research.

1. Informed Consent. -- Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.

While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.

Information. Most codes of research establish specific items for disclosure intended to assure that subjects are given sufficient information. These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc.

However, a simple listing of items does not answer the question of what the standard should be for judging how much and what sort of information should be provided. One standard frequently invoked in medical practice, namely the information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place precisely when a common understanding does not exist. Another standard, currently popular in malpractice law, requires the practitioner to reveal the information that reasonable persons would wish to know in order to make a decision regarding their care. This, too, seems insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care. It may be that a standard of "the reasonable volunteer" should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation.

A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.

Comprehension. The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.

Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.

Special provision may need to be made when comprehension is severely limited -- for example, by conditions of immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these subjects to involvement should be honored, unless the research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by acknowledging their own wishes and by the use of third parties to protect them from harm.

The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to act in that person's best interest. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject's best interest.

Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.

Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially where possible sanctions are involved -- urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins. But undue influence would include actions such as manipulating a person's choice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwise be entitled.

2. Assessment of Risks and Benefits. -- The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified. For prospective subjects, the assessment will assist the determination whether or not to participate.

The Nature and Scope of Risks and Benefits. The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons. The term "risk" refers to a possibility that harm may occur. However, when expressions such as "small risk" or "high risk" are used, they usually refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned harm.

The term "benefit" is used in the research context to refer to something of positive value related to health or welfare. Unlike, "risk," "benefit" is not a term that expresses probabilities. Risk is properly contrasted to probability of benefits, and benefits are properly contrasted with harms rather than risks of harm. Accordingly, so-called risk/benefit assessments are concerned with the probabilities and magnitudes of possible harm and anticipated benefits. Many kinds of possible harms and benefits need to be taken into account. There are, for example, risks of psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits. While the most likely types of harms to research subjects are those of psychological or physical pain or injury, other possible kinds should not be overlooked.

Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society). Previous codes and Federal regulations have required that risks to subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research. In balancing these different elements, the risks and benefits affecting the immediate research subject will normally carry special weight. On the other hand, interests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects' rights have been protected. Beneficence thus requires that we protect against risk of harm to subjects and also that we be concerned about the loss of the substantial benefits that might be gained from research.

The Systematic Assessment of Risks and Benefits. It is commonly said that benefits and risks must be "balanced" and shown to be "in a favorable ratio." The metaphorical character of these terms draws attention to the difficulty of making precise judgments. Only on rare occasions will quantitative techniques be available for the scrutiny of research protocols. However, the idea of systematic, nonarbitrary analysis of risks and benefits should be emulated insofar as possible. This ideal requires those making decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. This procedure renders the assessment of research more rigorous and precise, while making communication between review board members and investigators less subject to misinterpretation, misinformation and conflicting judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the nature, probability and magnitude of risk should be distinguished with as much clarity as possible. The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk. It should also be determined whether an investigator's estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.

Finally, assessment of the justifiability of research should reflect at least the following considerations: (i) Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures. (iii) When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject -- or, in some rare cases, to the manifest voluntariness of the participation). (iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits. (v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

3. Selection of Subjects. -- Just as the principle of respect for persons finds expression in the requirements for consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects.

Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions.

Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although individual institutions or investigators may not be able to resolve a problem that is pervasive in their social setting, they can consider distributive justice in selecting research subjects.

Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and environments. When research is proposed that involves risks and does not include a therapeutic component, other less burdened classes of persons should be called upon first to accept these risks of research, except where the research is directly related to the specific conditions of the class involved. Also, even though public funds for research may often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the recipients of the benefits.

One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.

Monday, September 11, 2006

Breaking News: Endogyn folds as a medical service

Endogyn is now listed as a "Small Business LTD "

IHRT brought you the breaking news that "Endogyn" had never been, and will never be an "Institute," and TODAY we bring to you the validation that Endogyn is no longer considered a medical practice or medical organization!

"Ohhhhh" "Ahhhhhhh"

IHRT shares that Endogyn has now dropped another level in it's "business" practices that can only equate to it being a "bottom feeder" in a fish tank!
(Perhaps more like a "Sea Cucumber!! Look THAT one up!!)

Endogyn is now listed on it's web site as being a "limited" business for profit, as in sales of a product, etc. Nothing medical about an LTD business's, trust us on that one! Next Kru will be selling "hot dogs" through his "telemarketing business" with Michi. (Which is a good thing as Michi can add to her CV that she has "retail sales," and "hot dog" expertise through Endogyn. Now, THAT could be helpful to her...somehow, someway, sort of...)

"Daniel, do you like my "Hot Dog vending" outfit??

"Oh, Michi, I just love the hat!
Do you like MY new "franchising outfit?"

"I can't find my "Mercedes," I think someone stole it back from me! No problem though, I picked up this little "Pimp Mobile" that matches my hat and you can ride in the basket!"

"Kru says, " My Endogyn "Hot Dog" franchise will soon be in a number of countries, but better then any other "Hot Dog" vendor in the world, not like the usual one found here:

MY "Endogyn Hot Dog" vending infrastructure will be different, as seen below!

With the Endogyn vending infrastructure, you "carry" everything with you as you approach customers to sell the hot dogs! This is brillant of me as usual! As I said before, great minds think alike, and at times I find it hard to seperate myself from Einstein!

We have sold over 3000 hot dogs to date, and I will be publishing a report on this as well!

"Yes, I work for Dr. Kru! He sent me to pick you up for your surgery, sweety babe! Hop into my "Mercedes," and I will take you to him! Wanna drive, we're all family you know!"

Dr. med. Daniel Kruschinski
Managing Director EndoGyn® Ltd.
Endoskopische Gynäkologie
Passauer Str. 22 94094

Adresse in England:
Suite F 1st floor,
New City Chambers,
36 Wood Street,
Wakefield, West Yorkshire,
WF 1 2HB, Great Britain

It is against the law in Germany to refer to a medical organization as an "LTD" business. What is most interesting about this information as posted by Kruscniknski is that the address he lists for "Endogyn" in England, is the same address used by thousands of less then desirable "businesses", including pornography sites, and only costs about $1.89 a year for each business to purchase and use the mailing address.

Talk about "cheesy" business practices, just when one thought that "Kru" could not go any lower then he has in the recent past, he buys a sleezy mail box to use as his Endogyn "business" adddress, and then lists Endogyn as an "LTD" business.

So much for the "recent claims of patients from other countries" having surgeries by Kru, let alone getting quality services, and interesting as well, since he has no hospital to perform a surgery in, but maybe he and Michi ARE performing basement adhesiolysis and ob/gyn procedures with the Abdolift!!!

"What do you mean your suyrprised I work out of a motel? I told you that Endogyn was where ever I am, as I am Endogyn! What didn't you understand? I am still a surgeon, you know! It doesn't matter where you have your surgery, only who performs it!"

IHRT would not put it past Kru to do something like that....IHRT must point out that after this was posted on the Endogyn web site by "Kru" he removed it the next day! Kru probably posted it in a drunken stupor, and once he was partially sober, he removed it, realizing that it really was not information he should share in a public way!
What this booze bag's sloshed brain didn't remember though, was that Google grabs everything posted in the Internet and caches it for IHRT'S use. (So we like to think!!)
Don't take IHRT's word for this, check it out for yourself! Type in google search: "Endogyn England"

(For those "Kru" groupies who are afraid to know the truth, DO NOT TYPE THIS IN GOOGLE, this way you can remain in the dark about "Kru" doings!

I miss something? Was it about my wonderful frog post in Endogyn? Did you say that "Kru" translated that for his German board? Posted Saturday, August 19, 2006 @ 02:32 PM THE POWER OF THE TONGUE / THE POWER OF WORDS

If the frog was deaf, how did it know what the others where saying when he got out of the pit, Helen?

Helen posted: "It is a paradox of our time that those with power are too comfortable to notice those who suffer, and those who suffer have no power. To break out of this trap requires... the courage to speak truth to power."
IHRT asks Helen when she is going to stand behind her own words here, as HER words brought so many to harm, and she has yet to speak the truth about her multiple trips to Kru! She remained silent about her mutiple trips, and kept silent even though she knew he was scamming other patients who trusted HER word. You are a nasty lady in IHRT's opinion and most deserving to fall with Endogyn!

Find the truth here > Google search..." Endogyn England"

endoskopische Gynäkologie - [ Translate this page ]
EndoGyn® Ltd. Endoskopische Gynäkologie Passauer Str. 22 94094 Rotthalmünster Adresse in England: Suite F 1st floor, New City Chambers, 36 Wood Street, - 23k - Cached - Similar pages

EndoGyn® Endoskopische Gynäkologie
Dr. med. Daniel Kruschinski Managing Director EndoGyn® Ltd.
Endoskopische Gynäkologie
Passauer Str. 22 94094

Adresse in England:
Suite F 1st floor, New City Chambers,
36 Wood Street,
Wakefield, West Yorkshire,
WF 1 2HB, Great Britain
Info-Telefon: 0180 / ENDOGYN (3636496)
Fax: 07000 / ENDOGYN (3636496)

Gewinnspiele auf · Gewinnen mit System! ist eine kostenpflichtige Dienstleistung der Firma Fast
Win Limited Suite F 1st Floor,
New City Chambers,
36 Wood Street,
Wakefield, ... - 33k - Im Cache - Ähnliche Seiten


Suite C4 1st Floor,

New City Chambers,
36 Wood Street
Wakefield West Yorkshire WF1 2HB
United Kingdom
Company Number: 04987454 ...
Anbieter im Sinne des § 10 Abs. 1 Nr.1 MDStV:CASHLOAD Internet Services LTDCompany No. 4985843

Suite C4, 1st Floor
New City Chambers
36 Wood Street
Wakefield WF1 2HB
West YorkshireGreat Britain
Suite C4 1st Floor,
New City Chambers,
36 Wood Street,
Wakefield, West Yorkshire,

© Copyright CASHLOAD Internet Services LTD
Anbieter im Sinne des § 10 Abs. 1 Nr.1 MDStV:
CASHLOAD Internet Services LTD

Company No. 4985843Suite C4,
1st FloorNew City Chambers
36 Wood StreetWakefield WF1 2HB
West Yorkshire Great Britain

Deutschland-Vertretung:GewinnIdee e-solutions GmbHSportallee 4122335 HamburgTelefon 040-631282-0

EndoGyn - Institut für endoskopische Gynäkologie - [ Translate this page ] EndoGyn® Ltd. Endoskopische Gynäkologie Passauer Str. 22 94094 Rotthalmünster Adresse in England: Suite F 1st floor, New City Chambers, 36 Wood Street, - 23k -

Posted Monday, September 11, 2006 @ 00:33 AM
by Doc Kru ONLY on Endogyn English message board!
"The lady from US will have her 2nd look tomorrow. Yesterday in the late summer weather, she and her husband had a trip to Bad Füssing.
Today, we have 2 cases of hysterectomies and one case of adhesions on a man.
Adhesiolysis surgery increases in man. Some are telling me that we need also a website for man... I think we should do one, as they are right."

Doc. Kru as
Lets see if "Kru" will answer a few questions about this post..
1.) How did the lady from the USA contact you as your "telecommunication" states it is for Germans only?
2.) Where did she send her $10,000.00?
3.) Where did you perform these surgeries?
4.) Who assisted you with the male patient's surgery?
5.) Did you perform these adhesiuolysis procedures with the " Abdolift," knowing that it is NOT recommended for intestinal adhesion surgery?
6.) Did you perform any experiments on these patients?
7.) Why didn't you post this on the German message board?
8.) Why aren't you posting the patients' names on your web site?
9.) Why aren't you posting surgical photos of them anymore?
10.) Who is "We?"

IHRT recalls the following issues:
*You posted that IHRT would soon be sued and silenced, where you lying about that after involving so many with your whining about IHRT?
*You mentioned that you could do surgery at the "Emma" at any time, do you perform operations there at all?
* If you do, how do you get there from Passau, drive a Mercedes?
*Are you performing surgeries at "Passau" as you stated a few months ago?
*Where IS your Endogyn office these days?
*Do you have a business phone anymore?

IHRT invites all interested readers to try to call this number. When you reach it, no business name is given, only the offer to leave a message! Perhaps your personal message will be heard by everyone, so much for your OB/GYN!
+49800 / E N D O G Y N (+49800 / 3 6 3 6 4 9 6)

IHRT is watching for "Kru's" demonstration at the upcoming
"Pax Meeting " later this month! We will most certainly share this with our viewers!

Until next time,
Chow! Caio! Hasta la vista! Auf Viderseine, So Long, and REGARDS

Friday, September 08, 2006


It sounds like the stuff of Star Trek, but a California-based medical device company – Minos Medical Inc – believes that this futuristic idea will soon be a reality.

(PRWEB) September 5, 2006 -- Today the appendix is removed (appendectomy) by either traditional open surgery or by keyhole techniques known as laparoscopy. Both of these methods have one major disadvantage; they both invade the abdomen of the patient. According to Minos Medical Inc’s medical director Prof. Christoph Gasche, this can increase the risks of infections, adhesions and other serious complications.

Minos Medical Inc hopes to avoid entering the abdomen with an innovative new procedure called APPENDOECTOMY(TM) that approaches the appendix via the colon.

“By approaching the appendix from inside the colon, we avoid the need to incise the abdominal wall and pass near critical structures inside the abdomen,” says Prof Gasche. “This should bring major benefits to both patients and clinicians. Hopefully we will be able to avoid the need for general anaesthesia and should see faster recovery with much less pain.”

With an estimated 800,000 appendix procedures performed each year in the western world, the proposed APPENDOECTOMY system would be able to help a lot of patients and potentially reduce a lot of health care dollars.

“We hope to revolutionize first the appendix procedure, and then a host of other procedures,” says Brad Sharp, CEO of Minos Medical Inc. “So far we have tested our system in the lab and demonstrated that our unique appendix inverting procedure seems to be feasible. Our first results were presented at DDW in May last year and we have had a lot of interest since then. There’s a long way to go, but we really do believe that soon we could be taking out the first appendix with no incisions using the APPENDOECTOMY system.”

Natural Orifice surgery (or NOTES) is seen as a next major frontier in the world of medicine, offering the hope of eliminating incisions from many procedures. This will not only offer cosmetic benefits, through the elimination of unsightly scars, but also clinical benefits that are associated with such incisions.

As new medical frontiers are passed, it really seems that the fantasy world of Dr McCoy and Star Trek could soon be a reality.

For more information on Minos Medical Inc visit

APPENDOECTOMY is a trade mark of Minos Medical Inc.
STAR TREK is a trademark of CBS Studios Inc.


Tyco International Signs Agreement to Acquire Confluent Surgical

Press Release

PEMBROKE, Bermuda – July 18, 2006 – Tyco International Ltd. (NYSE: TYC, BSX: TYC) today announced that U.S. Surgical, a subsidiary of Tyco’s Healthcare segment, entered into a definitive agreement to acquire Confluent Surgical, Inc., a leading developer and supplier of polymer-based technology used in sprayable surgical sealants and anti-adhesion products. The transaction is priced at $245 million. The Boards of Tyco International and Confluent Surgical have approved the transaction, which is expected to close by the end of August. Tyco expects to incur a charge in its fiscal fourth quarter to write off in-process research and development.

Confluent Surgical, located in Waltham, Mass., markets a neurosurgical sealant that was the first product to receive Food & Drug Administration (FDA) approval for use in cranial dural repair. This sealant, along with several other products in the company’s pipeline, is intended to improve patient outcomes by reducing leaks or adhesions across various surgical specialties. Over the next six years, the biosurgery market—which is estimated at $900 million—is expected to double in size. This acquisition helps position Tyco Healthcare and U.S. Surgical to compete effectively in that growing market.

Source: International Adhesion Society

Thursday, September 07, 2006

In situ cross-linkable hyaluronic acid hydrogels prevent post-operative abdominal adhesions in a rabbit model.

Biomaterials. 2006 Sep;27(27):4698-705. Epub 2006 Jun 5. Related Articles, Links
Yeo Y, Highley CB, Bellas E, Ito T, Marini R, Langer R, Kohane DS.
Department of Chemical Engineering, 77 Massachusetts Avenue, Massachusetts Institute of Technology, Cambridge, 02139, USA.
We studied the efficacy of an in situ cross-linked hyaluronic acid hydrogel (HAX) in preventing post-surgical peritoneal adhesions, using a rabbit sidewall defect-cecum abrasion model. Two cross-linkable precursors were prepared by modifying hyaluronic acid with adipic dihydrazide and aldehyde, respectively. The hydrogel precursors cross-linked to form a flexible hydrogel upon mixing. The hydrogel was biodegradable and provided a durable physical barrier, which was highly effective in reducing the formation of post-operative adhesions. Ten out of 12 animals in the untreated control group developed fibrous adhesions requiring sharp dissection, while only 2 out of 8 animals treated with HAX gels showed such adhesions, and those occurred in locations that were not covered by the hydrogel. We also studied means by which gel degradation time can be modulated by varying the precursor concentration and molecular weight.
Grant Support:
* GM073626/GM/NIGMS

PMID: 16750564 [PubMed - in process]

Wednesday, September 06, 2006

2006 Seprafilm Adverse Event Reports (FDA)


Event Description

Female, underwent a right salpingo-oophorectomyby the gynecology service for a fibroma. The pt was found to have adhesionsin the small bowel area and adhesiolysis was performed by a general surgeon.Three sheets of seprafilm were utilized around the small bowel. One sheetof seprafilm was placed between the retroperitoneum and the small bowel.Two sheets were placed between the small bowel and the intra abdominal wall.The pt did well with her postoperative recovery and was subsequently dischargedfour days later. Within 24 hrs of discharge, the pt was experiencing nauseaand vomiting. She was unable to tolerate any oral intake. She was not experiencingabdominal bloating or distension. She presented to the emergency dept ontwo occasions. First on the evening of the next day and then again at theearly evening the following day. She was hydrated with intravenous fluidson both occasions. Her symptoms persisted, however, and she re-presentedto the emergency dept 3 days later. She was found to have a benign abdominalexamination. Her while blood cell count, however, was elevated at 14. 95.She was clinically dehydrated with hyponatremia, hypokalemia and hypochloremia.She was admitted to the hosp for further evaluation and management. A nasogastrictube was placed. She had greater than two liters of output. A ct scan ofabdomen and pelvis was obtained revealing dilatation of the stomach and proximalsmall bowel. There was a transition point with distal decompression. Thiswas consistent with a mechanical small bowel obstruction. The next day, thept was taken to the o. R. And re-opened. The pt was found to have a veryintense inflammatory reaction of her small bowel and small bowel mesenterywere clumped together into a few areas of indurated masses. Her entire smallbowel was basically one large conglomerate that was matted together. Thetissues appeared somewhat melted together, without any identificable planes.The tissues were friable, and upon opening the abdomen, injuries were sustained.An area of "deserosalization" was oversewn. Two enterotomies were repaired.A distal ilieal longitudinal tear was not repairable. The pt basically hada "concrete abdomen" and this was inoperable. A resection was impossible,as was exteriorization. The proximal and distal portions of the tear weredecompressed with tube ileostomies. The inflammatory process was limitedto the distribution of where the seprafilm was placed. This was around thesmall bowel and small bowel mesentery. The pelvis was spared from this process,as was the upper abdomen. She was kept on bowel rest/decompression and totalparenteral nutrition. Over the next few days, the pt developed progressiveconfusion and delirium. Her oxygen requirements increased. A chest x-rayrevealed patchy infiltrates. The pt was subsequently transferred to icu 2days later. The next day, she was diagnosed with severe sepsis and begantreatment using xigris. The pt's respiratory status worsened and she eventuallyrequired intubation and ventilatory support. The pt appeared to develop asystemic inflammatory response and ards. The pt continued on high ventilatorysupport and intermittent vasopressors. It was felt that she had worsening fibroproliferative ards. Twenty days later, active measures were withdrawn and the pt subsequently passed away.

Event Date 03/23/2006 Event Type Injury Event Description

Severe adhesive intestinal obstruction. Underwent synechiotomy due to severe adhesive intestinal obstruction. In mar-2006 with placement of one sheet of seprafilm under the wounded area. No post-operative complications were noted. On 23-mar-2006 the patient developed severe adhesive intestinal obstruction under the wounded area where the seprafilm had been placed. Two days earlier the patient was getting better and considered recovered without sequelae. The physician assessed the relationship between the event and seprafilm as "definite".

Device Problem Device, incorrect care/use of Event Date 01/31/2006 Event Type Injury Event Description

Vaginal bleeding; hydrosalpinx of the right (fallopian) tube; multiple degenerating cysts of the right ovary; multiple adhesion between right ovary, omentum, and the top of the vaginal cuff; piece of plastic found in vaginal. A female pt (age and initials unk) who underwent a hysterectomy in 2003 during which seprafilm was placed (number of sheets and location unk). Two years status post hysterectomy, the pt was brought in with vaginal bleeding. Granulation tissue at the top of the vaginal felt to be a stitch granuloma was initially tried to be removed vaginally in 2004 but the to continued to have vaginal bleeding. On 31-jan-2006, the pt was brought in for a combined approach laparscopy and found to have hydrosalpinx of the right (fallopian) tube with multiple degenerating cysts of the right ovary and multiple adhesion between that, the omentum, and top of the vaginal cuff. Additionally during the procedure, a piece of plastic measuring 8. 5 x 3. 7 x 0. 1 cm was found in the area around the vaginal cuff. The plastic was removed and the area repaired. The pt tolerated the procedure well. The reporter stated that a review of ths physican properties of the plastic removed from the pt was found to be similar to a portion of the holder that is used to apply and protect the adhesion barrier (seprafilm) in the packaging. The reporter felt that in the case, it was possible that the holder was left in the pt rather than removing it per manufacturer instructions. No further details regarding the surgery or pt outcome were provided. The reporting health care professional did not ptovide an assessment of the relationship of the events to the use of seprafilm. Manufacturer's comment: no lot number was provided by the user facility. Genzyme quality assurance is unable to perform an evaluation or lot history review. Additional information was received april-2006 from the hosp risk manager who provided the initial report to fda. The risk manager stated that she believes that same surgeon had performed both the original hysterectomy procedure as well as the re-operative procedure which revealed the piece of plastic in the vaginal cuff area and led to its removal. The risk manager stated that "they were absolutely certain seprafilm had been used in the initial procedure. " she also stated that there were originally plans to do testing on the retained piece of plastic however; once it had been removed from the pt it had been placed in formaldehyde for a perios of plastic however; once it had been removed from the ot it had been placed in formaldehyde for a period of time and therefore no testing was performed. She confimred that only a physical examination of the pice of plastic was completed and it was concluded from that, that the plastic in the pt was similar to the plastic holder used in seprafilm placement.

Event Date 01/22/2006 Event Type Injury Event Description

Small bowel obstruction, small bowel matted together, inflammatory reaction of the small bowel. Information was received from a physician in 2006 concerning a patient with a pas t surgical history of an unspecified operation to correct a previous bowel obstruction, who in 2006 underwent removal of a right ovarian mass and lysis of adhesion. One sheet of seprafilm was placed between the retroperitoneum and the small bowel, and two sheets were placed between the small bowel and the entry abdominal wall. During the surgery, saline was the only fluid used for intraperitoneal irrigation, gloves were non-powdered, no products were left behind in the abdominal cavity, and sutures were silk. The reporting physician thought that the patient had no known allergies, but he was not completely sure. Three to four days post-operation, the patient developed nausea and vomiting and was unable to keep anything down. A white blood cell count was elevated at 16,000 mm3. 6 days later, a computed tomography scan showed a transition point small bowel obstruction. That same day, the patient underwent a re-operation to repair the obstruction. At re-operation, the physician discovered that the patient was experiencing an "inflammatory reaction of the small bowel" in the area of seprafilm placement. The bowel was noted to be inflamed and "matted together," which was causing her obstruction. No further details regarding the surgery or patient outcome were provided. The reporting physician felt that the events were "between highly probably and definite" related to the use of seprafilm.

Event Description

After placement of seprafilm, pt developed early postop small bowel obstruction and leukocytosis. Re-exploration-significant edema, induration, adherence, friability to tissues where seprafilm was placed (small bowel and mesentery). Abdomen was inoperable.

Friday, September 01, 2006

Rondell Office re-opening as Rondell Swimming Pool!


We are pleased to announce the opening of the new Rondell Warm-Water Swimming Pool.
This unique facility is located in the former EndoRondell Office in Seligenstadt, now under new management!
Open daily from 6 am till midnite!

The upstairs area of the former Rondell Office now includes a juice bar, separate Women and Men's changing rooms, and a boutique featuring the latest in swim wear, goggles, swim fins, and flip flops.

Walk down the gracefully curving staircase to the bottom level, and step directly into our crystal clear, warm water swimming pool.

This fantastic facility was designed by "Dan the Man who Can", who is not only a surgeon but also a civil engineer, and an architect.

Water was piped in straight from the River Mainz, using a complicated series of tunnels, aquaducts, and re-tooled abdolift levers. The water was then filtered, purified, and all traces of carbon dioxide were removed. The water is kept at a consistent comfortable temperature of 98.6 degrees. Water purity is checked hourly by Dr. Dan himself.

Visit us today for a free introductory swim session. Reasonable membership fees, on a sliding scale.
Swimwear is required.
For those more adventurous swimmers who prefer a swimsuit-optional experience, our franchise is planning another location, opening soon.

Management and Maintainence by Don- Bevel Associates.