Massachusetts cannot ban FDA-approved painkiller, judge rules

By Brady Dennis, Published: April 15 E-mail the writer

A federal judge on Tuesday blocked an effort by Massachusetts Gov. Deval L. Patrick to ban sales of a controversial new painkiller in the state, saying the governor’s move was preempted by federal law and could harm people who need the drug for pain relief.

In a five-page order, U.S. District Judge Rya W. Zobel sided with the drug’s California-based manufacturer, Zogenix, which had argued that Patrick had no right to bar a medication that the Food and Drug Administration has deemed safe and effective.

More: http://www.washingtonpost.com/national/health-science/massachusetts-cannot-ban-fda-approved-painkiller-judge-rules/2014/04/15/91436946-c4db-11e3-b574-f8748871856a_story.html

FDA: Use Sicker Patients in Clinical Trials

By  David Pittman , Washington Correspondent, MedPage Today

WASHINGTON -- The FDA is taking steps to include more patients with multiple chronic conditions in clinical trials of new drugs, believing such patients are too frequently excluded from new drug studies.

Pharmaceutical companies routinely exclude the sickest patients from studies, fearing complications they may suffer from the drug candidates, but, as a result, the studies don't provide a glimpse of the treatment's "real world" effect.

To counter this, the FDA recently issued a memo to its new drug reviewers asking them to work with drug manufacturers to include a broader population in trials more regularly.

"The whole point of this is that if there really are differences in response -- either favorable or unfavorable -- among subsets of the population, what clinicians need is to know about it, so they can either watch for them or use a different drug," Bob Temple, MD, deputy director for clinical science at the FDA's Center for Drug Evaluation and Research, told reporters Friday. "This adds to the information available."

The internal memo, which effectively changes FDA policy, will force those conducting trials to focus more on their inclusion criteria and avoid unnecessary exclusions.

More: http://www.medpagetoday.com/PublicHealthPolicy/ClinicalTrials/44088?xid=nl_mpt_DHE_2014-02-03&utm_content=&utm_medium=email&utm_campaign=DailyHeadlines&utm_source=WC&eun=g691559d0r&userid=691559&email=tbarnes@coalitionforpf.org&mu_id=5770751

Benefits and harms of adhesion barriers for abdominal surgery: a systematic review and meta-analysis

Richard P G ten Broek MD a , Martijn W J Stommel MD a, Chema Strik MD a, Prof Cornelis J H M van Laarhoven MD a,Fred
erik Keus MD b, Prof Harry van Goor FRCS a

Summary

Background

Formation of adhesions after peritoneal surgery results in high morbidity. Barriers to prevent adhesion are seldom applied, despite their ability to reduce the severity of adhesion formation. We evaluated the benefits and harms of four adhesion barriers that have been approved for clinical use.

Methods

In this systematic review and meta-analysis, we searched PubMed, CENTRAL, and Embase for randomised clinical trials assessing use of oxidised regenerated cellulose, hyaluronate carboxymethylcellulose, icodextrin, or polyethylene glycol in abdominal surgery. Two researchers independently identified reports and extracted data. We compared use of a barrier with no barrier for nine predefined outcomes, graded for clinical relevance. The primary outcome was reoperation for adhesive small bowel obstruction. We assessed systematic error, random error, and design error with the error matrix approach. This study is registered with PROSPERO, number CRD42012003321.

Findings

Our search returned 1840 results, from which 28 trials (5191 patients) were included in our meta-analysis. The risks of systematic and random errors were low. No trials reported data for the effect of oxidised regenerated cellulose or polyethylene glycol on reoperations for adhesive small bowel obstruction. Oxidised regenerated cellulose reduced the incidence of adhesions (relative risk [RR] 0·51, 95% CI 0·31—0·86). Some evidence suggests that hyaluronate carboxymethylcellulose reduces the incidence of reoperations for adhesive small bowel obstruction (RR 0·49, 95% CI 0·28—0·88). For icodextrin, reoperation for adhesive small bowel obstruction did not differ significantly between groups (RR 0·33, 95% CI 0·03—3·11). No barriers were associated with an increase in serious adverse events.

Interpretation

Oxidised regenerated cellulose and hyaluronate carboxymethylcellulose can safely reduce clinically relevant consequences of adhesions.

Funding

None.

You must log in or pay to read the full paper http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(13)61687-6/abstract

Dr Mario Malzoni Italy

Dott. Mario Malzoni 
Head physician of the  Department of Advanced Gynaecological Endoscopy 
Nursing Home - Avellino 
Dott. Mario Malzoni, born in Avellino on June 06 1969 

STUDIES: 
High School Diploma  “Liceo Scientifico” at the  "PS Mancini " high school in Avellino in 1987; 
He graduated on 29/07/93 in Medicine at the University of Naples (Federico II) with 110 cum laude. 
Specialization in Obstetrics and Gynecology at the University of Naples (50/50) in October 1997;
6 month internship at the Division of Advanced Laparoscopic Surgery at Columbia University (New York).

PROFESSIONAL EXPERIENCE:. 
Head of the Gynecologic Endoscopy Division at the Casa di Cura Malzoni of Avellino. (CIP Laparoscopic LT03899 IP hysteroscopy L100101) 

Consultant of endoscopic surgery at: 
1.Casa di Cura Villa Del Rosario Rome 
2.Casa di Cura Ruesch Napoli 
3.Casa di Cura "Malzoni" Spa Agropoli;

Read the rest of his impressive Vitae here http://www.endoscopicamalzoni.it/index.php?option=com_content&task=view&id=193&Itemid=280&lang=english

The ETCA-ARD solutions Antwerp

How those afflicted with ARD can have hope

What are adhesions? 
Adhesions are fibrous bands which connect tissues and organs that are normally separated. Generally, they occur within a week after surgery as a part of the normal healing process. 
  
Why are they a problem? 
They often reduce movement and distort internal organs. Adhesions can cause a variety of complications including infertility, pelvic pain and bowel obstruction.  In a short way: they can greatly affect your daily activities. 
   
Where do adhesions form? 
As they form on tissue surface following surgery: these can be found anywhere. But there are some organs where they are more likely to form, namely: ovaries, pelvic sidewalls, fallopian tubes and bowel. These are potentially affected during gynaecological and other procedures. 
    
What can be done? 
You have to understand that you as a patient can neither cause, nor eliminate your own adhesions. 
Microsurgical techniques were developed so the primary causes of trauma and inflammation are minimized and the formation of adhesions reduced. 
Fortunately, the use of new adhesion barriers during the medical intervention offers great hope to prevent the formation of adhesions.  It actively prevents the tissues of forming a whole during the critical week following the surgery. 
    
How does it function? 
During the abdominal, pelvic, surgery, the surgeon would apply the adhesion barrier on the surfaces who poses the biggest risk for the formation of adhesions, such as uterus, ovary, etc….  The coating prevents the tissues from gluing together and forming adhesions.  When the healing process is complete, this synthetic, absorbable, adhesion barrier dissolves and is carried away from the body by the urine. 
   
Important for yourself 
The doctors you will meet understand and acknowledge that adhesions do cause pain along with a host of associated illnesses, disorders and medical problems that arise because adhesions are present.
   
They will do their utmost to improve your quality of life.
  
Why at the ETCA in Antwerp?
  
Here many internationally renowned Gynaecologic surgeons have formed world famous endoscopic units.
  
In Antwerp professor van Herendael has been involved in endoscopic surgery for more than 25 years.  On a yearly basis over 200 major endoscopic surgeries are performed by professor van Herendael and his staff, all highly trained in endoscopic surgery.
 
He founded an endoscopic school, the ETCA, the Endoscopic Training Centre Antwerp. Over 250 endoscopic surgeons have been trained at the ETCA and some of them are now leaders in the field on their own merit.
 
Professor van Herendael’s accomplishments in the field of endoscopic surgery have been recognized all over the world and the Università degli studi dell’ Insubria at Varese in Italy has bestowed him the honour of a professorship in endoscopic surgery.
 
To accomplish as high a surgical standard as possible a partnership with industry has been made. Karl Storz Gmbh & Co (Tuttlingen Germany), one of the world leaders in manufacturing endoscopic equipment, provides the theatres with their newest instruments, video and computer equipment.
 
We invite you to open the PDF file for a fully documented overview of the possibility for you to have your surgery carried out in Antwerp.
Please feel free to contact us directly by mail for more information.
 
The information about the ETCA itself shall not be used for other purposes whatsoever, nor for any commercial action.
If you want to know more about the ETCA, please contact us directly.

Burden of adhesions in abdominal and pelvic surgery: systematic review and met-analysis

Me & My Adhesions

Eloquently spoken.
Thank you.
See her other video too. 

Vaginal rejuvenation, and Adhesions

Q Considering Cosmetic Gynecology?
What can you tell me about so-called vaginal rejuvenation? A friend is planning to have a procedure. Is it safe? What are the risks?

A Answer (Published 2/22/2008)

Vaginal rejuvenation, also called "designer vaginoplasty," refers to any of several new cosmetic surgical procedures being promoted as ways to enhance appearance in the genital area or to tighten tissues that have lost tone due to childbirth or aging. It has been popularized on television and in other media, often reflecting insecurities some women have about their bodies and, perhaps, the fantasies their male partners have about women. It might be far less appealing if more women understood that they don't all look alike in the genital area. Gynecologists repeatedly make the point that there's a wide variation of what constitutes "normal."

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The American College of Obstetricians and Gynecologists (ACOG), a professional association of medical specialists in these fields, has warned women against the new cosmetic genital surgery. In a strongly worded statement published in the September 2007 issue of Obstetrics & Gynecology, ACOG said that it is deceptive to give women the impression that any of the procedures is medically accepted or routine. They are neither. ACOG also warned of serious risks including infection, nerve damage, pain, adhesions and scarring and noted that there is no scientific data attesting to the effectiveness of this kind of surgery.

The new procedures are represented as variations on surgery performed to repair vaginal or uterine prolapse or the damage caused by female circumcision (which is still performed ritually in some parts of the world, such as Africa).

I'm not a fan of any type of cosmetic surgery, but this new variation seems even more unnecessarily risky than face lifts and nose jobs. Vaginal rejuvenation is costly (between $3,000 and $9,000), is not covered by health insurance, and, contrary to what some women believe, won't affect sexual satisfaction.

Andrew Weil, M.D.
http://www.drweil.com/drw/u/QAA400358/Considering-Cosmetic-Gynecology.html
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Gastroparesis

Gastroparesis diabeticorum; Delayed gastric emptying

Last reviewed: November 11, 2010.



Gastroparesis is a condition that reduces the ability of the stomach to empty its contents, but there is no blockage (obstruction).



Causes, incidence, and risk factors

The cause of gastroparesis is unknown, but it may be caused by a disruption of nerve signals to the stomach. The condition is a common complication of diabetes and can be a complication of some surgeries.



Risk factors for gastroparesis include:



•Diabetes



•Gastrectomy (surgery to remove part of the stomach)



•Systemic sclerosis



•Use of medication that blocks certain nerve signals (anticholinergic medication)



Symptoms

•Abdominal distention



•Hypoglycemia (in people with diabetes)



•Nausea



•Premature abdominal fullness after meals



•Weight loss without trying



•Vomiting



Signs and tests

•Esophagogastroduodenoscopy (EGD)



•Gastric emptying study (using isotope labeling)



•Upper GI series



Treatment

People with diabetes should always control their blood sugar levels. Better control of blood sugar levels may improve symptoms of gastroparesis. Eating small meals and soft (well-cooked) foods may also help relieve some symptoms.



Medications that may help include:



•Cholinergic drugs, which act on acetylcholine nerve receptors



•Erythromycin



•Metoclopramide, a medicine that helps empty the stomach



•Serotonin antagonist drugs, which act on serotonin receptors



Other treatments may include:



•Botulinum toxin (Botox) injected into the outlet of the stomach (pylorus)



•Surgical procedure that creates an opening between the stomach and small intestine to allow food to move through the digestive tract more easily (gastroenterostomy)



Expectations (prognosis)

Many treatments seem to provide only temporary benefit.



Complications

Persistent nausea and vomiting may cause:



•Dehydration



•Electrolyte imbalances



•Malnutrition



People with diabetes may have serious complications from poor blood sugar control.



Calling your health care provider

Apply home treatment such as managing your diet. Call your health care provider if symptoms continue or if you have new symptoms.



References

1.Koch KL. Gastric neuromuscular function and neuromuscular disorders. In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease. 9th ed. Philadelphia, Pa: Saunders Elsevier;2010:chap 48.

Review Date: 11/11/2010.



Reviewed by: David C. Dugdale, III, MD, Professor of Medicine, Division of General Medicine, Department of Medicine, University of Washington School of Medicine; and George F. Longstreth, MD, Department of Gastroenterology, Kaiser Permanente Medical Care Program, San Diego, California. Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.

http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001342/

A reliable way to predict intraabdominal adhesions at repeat cesarean delivery: scar characteristics

NASUH U. DOGAN1, SEVAL A. HAKTANKACMAZ1, SELEN DOGAN2, OZLENEN OZKAN3, HATICE CELIK1, OZLEM G. ERYILMAZ1, MELIKE DOGANAY1, CAVIDAN GULERMAN1Article first published online: 16 MAR 2011Keywords: Intraabdominal adhesion; repeat cesarean delivery; hypertrophic scar



DOI: 10.1111/j.1600-0412.2011.01080.x
© 2011 The Authors Acta Obstetricia et Gynecologica Scandinavica © 2011 Nordic Federation of Societies of Obstetrics and Gynecology





Abstract


Objective. To evaluate association between scar characteristics and intraabdominal adhesions at repeat cesarean delivery. Design. A prospective, cross-sectional study. Setting. Tertiary Government Maternity Training Hospital in Ankara, Turkey. Population. 295 pregnant women with at least one prior cesarean delivery. Methods. All women were at least 36 weeks pregnant. Appearance of previous cesarean delivery scars was categorized into three groups – flat, depressed and elevated. Pigmentation status was also noted (non-pigmented or pigmented). Main Outcome Measures. Intraoperatively detected adhesions, evaluated and classified into three groups (no adhesion, filmy adhesion and dense adhesion groups) by a modified Nair's classification. Results. Elevated scars had significantly more dense adhesion formation than depressed ones (31.4 vs. 12.7%, p=0.02). No difference was found for dense adhesions when depressed and flat scars were compared (12.7 vs. 6.8%, p=0.124). Of flat scars, 93.2% were free of dense adhesions. Pigmented scars had more dense adhesions than non-pigmented (26.6 vs. 9.3%, p<0.01). Using logistic regression analysis scar length, scar width and appearance of scar (flat or non-flat) were directly related to adhesion formation. Conclusion. There is an association between scar type and adhesions, particularly for hypertrophic scars and dense adhesions.

Adherencias

Adherencias Dirección de esta página: http://www.nlm.nih.gov/medlineplus/spanish/ency/article/001493.htm
.Son bandas de tejido similar al cicatricial que se forman entre dos superficies dentro del organismo y hacen que éstas se peguen.

A medida que el cuerpo se mueve, los tejidos u órganos en su interior normalmente pueden desplazarse a su alrededor entre sí, lo cual se debe a que dichos tejidos tienen superficies resbaladizas.

Causas, incidencia y factores de riesgoLa inflamación (hinchazón), una cirugía o una lesión pueden provocar que se formen adherencias casi en cualquier parte en el cuerpo, incluyendo:

•En articulaciones como el hombro
•En los ojos
•En el interior del abdomen o la pelvis
Una vez que se forman, las adherencias pueden volverse más grandes o más firmes con el tiempo. Se pueden presentar síntomas u otros problemas si las adherencias llevan a que un órgano o parte del cuerpo se retuerza, se salga de su posición o que tampoco pueda moverse.

El riesgo de formación de adherencias es alto después de cirugías intestinales o cirugías de los órganos femeninos. La cirugía en donde se usa un laparascopio tiene menor probabilidad de causar adherencias que la cirugía abierta.

Otras causas de adherencias en el abdomen o la pelvis:

•Apendicitis, con mayor frecuencia cuando el apéndice se abre (presenta ruptura)
•Cáncer
•Endometriosis
•Infecciones en el abdomen y la pelvis
•Radioterapia
Las adherencias se pueden formar alrededor de articulaciones como el hombro (ver: capsulitis adhesiva) o los tobillos, o en los ligamentos y tendones. Este problema puede suceder:

•Después de cirugía o traumatismo
•Con ciertos tipos de artritis
•Con sobrecarga de una articulación o tendón
SíntomasLas adherencias en las articulaciones, los tendones o ligamentos dificultan el movimiento de la articulación y pueden causar dolor.

Las adherencias en el vientre (abdomen) que causan un retorcijón, contorsión o tirón pueden provocar un bloqueo de los intestinos. Los síntomas abarcan:

•Distensión o hinchazón abdominal
•Estreñimiento
•Náuseas y vómitos
•Ya no poder evacuar los gases
•Dolor en el abdomen que es intenso y con cólicos
Las adherencias en la pelvis pueden causar dolor pélvico crónico o prolongado.

Signos y exámenesLa mayoría de las veces, las adherencias no se pueden ver usando radiografías o exámenes imagenológicos.

•Una histerosalpingografía puede ayudar a diagnosticar adherencias dentro del útero o las trompas de Falopio.
•Las radiografías del abdomen, los estudios de contraste con bario y las tomografías computarizadas pueden ayudar a diagnosticar un bloqueo de los intestinos causado por adherencias.
Una endoscopia (una forma de observar el interior del cuerpo usando una sonda flexible que tiene una pequeña cámara en el extremo) puede ayudar a diagnosticar adherencias:

•La histeroscopia examina el interior del útero
•La laparoscopia examina el interior del abdomen y la pelvis
TratamientoSe puede realizar una cirugía para separar las adherencias. Esto a menudo permite el movimiento normal del órgano y reduce los síntomas causados por las adherencias; sin embargo, el riesgo de presentarse más adherencias aumenta, a medida que se incrementa el número de cirugías.

Dependiendo de la localización de las adherencias, al momento de la cirugía, se puede colocar una barrera para tratar de reducir la posibilidad de que éstas reaparezcan.

Ver también: reparación de obstrucción intestinal

Expectativas (pronóstico)El pronóstico generalmente es bueno.

ComplicacionesDependiendo de los tejidos comprometidos, las adherencias pueden ocasionar diversos trastornos.

•En el ojo, la adherencia del iris al cristalino puede llevar al desarrollo de un glaucoma.
•En los intestinos, las adherencias pueden producir una obstrucción intestinal completa o parcial.
•Las adherencias dentro de la cavidad uterina, llamadas síndrome de Asherman, pueden hacer que una mujer tenga ciclos menstruales irregulares y que sea incapaz de quedar en embarazo.
•Las adherencias pélvicas que involucran cicatrización de las trompas de Falopio pueden llevar a que se presente esterilidad y problemas reproductivos.
•Las adherencias pélvicas y abdominales pueden causar dolor crónico
Situaciones que requieren asistencia médicaConsulte con el médico si presenta:

•Dolor abdominal
•Incapacidad para evacuar los gases
•Náuseas y vómitos que no desaparecen
•Dolor en el vientre intenso y con cólicos
Nombres alternativosAdherencia intrauterina; Adherencia pélvica; Adherencia intraperitoneal

Actualizado: 3/30/2010Versión en inglés revisada por: Susan Storck, MD, FACOG, Chief, Eastside Department of Obstetrics and Gynecology, Group Health Cooperative of Puget Sound, Redmond, Washington. Clinical Teaching Faculty, Department of Obstetrics and Gynecology, Unviersity of Washington School of Medicine. Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.

Traducción y localización realizada por: DrTango, Inc.

Hojee la enciclopedia
http://www.nlm.nih.gov/medlineplus/spanish/ency/article/001493.htm