Showing posts with label adhesiogenic. Show all posts
Showing posts with label adhesiogenic. Show all posts

Sunday, April 20, 2014

Mirena Lawsuits Move Forward in New Jersey Litigation, As Court Schedules May Conference, Bernstein Liebhard LLP Reports

The Firm is representing clients who filed Mirena IUD lawsuits in this proceeding after allegedly suffering serious Mirena complications that followed spontaneous migration of the device.


New York, New York (PRWEB) April 18, 2014
More than 700 Mirena lawsuits (http://www.themirenalawsuitcenter.com) filed on behalf of women who were allegedly injured due to spontaneous migration of the IUD continue to move forward in a consolidated litigation underway in New Jersey’s Bergen County Superior Court, Bernstein Liebhard LLP reports. Court documents indicate that the proceeding’s next Case Management Conference has been scheduled for May 13, 2014, at 2:00 p.m. According to an Order dated April 1, 2014, the parties have been directed to submit a proposed agenda to the Court at least seven days prior to the conference. (In Re: Mirena Litigation; Case No. 297)
“Our Firm is representing numerous women in this proceeding who allegedly suffered serious Mirena complications after their IUD spontaneously migrated from its proper position in the uterus. We are pleased to see this litigation moving forward,” says Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is currently offering free Mirena lawsuit evaluations to women who may have been injured due to the spontaneous migration of their IUD.
Mirena IUD Lawsuits
The Mirena IUD is a long-acting contraceptive device that is manufactured by Bayer Healthcare Pharmaceuticals. The product was initially approved as a method of birth control in 2000 by the U.S. Food & Drug Administration (FDA), which in 2009 expanded its approved uses to include the treatment of heavy menstrual bleeding in women who wish to use an IUD as their method of contraception. According to a report that aired on 7 Action News this past summer, the U.S. Food & Drug Administration (FDA) has received more than 70,000 complaints involving Mirena, including thousands that detail cases of device dislocation and uterine perforation, since the IUD was first launched.*
In December 2009, the FDA issued a Warning Letter to Bayer Healthcare Pharmaceuticals after finding that one of the company’s Mirena promotions made misleading claims about the safety and efficacy of the IUD.
According to court documents, all of the Mirena lawsuits pending in the New Jersey litigation allege that plaintiffs sustained uterine perforations, adhesions, infections, and other serious Mirena complications due to spontaneous migration of the IUD, even though the device had been properly inserted by a healthcare provider. The lawsuits further allege that Bayer has a history of overstating the IUD’s benefits and downplaying its risks. Finally, plaintiffs claim that the company has not provided adequate warnings regarding its propensity to spontaneous migrate from its proper position in the uterus, and point out that the Mirena label only states that migration may occur if the uterus is punctured during insertion.
Court records indicate that more than 1,000 lawsuits involving alleged Mirena complications are now pending in courts throughout the country. In addition to the New Jersey litigation, nearly 500 additional lawsuits have been consolidated for pretrial proceedings in the U.S. District Court, Southern District of New York. (In re: Mirena IUD Products Liability Litigation, MDL No. 2434)
Women who have allegedly experienced serious Mirena complications related to spontaneous migration of the IUD may be entitled to financial compensation for their injury-related damages. Learn more about potential Mirena complications at Bernstein Liebhard LLP’s website, or visit the Firm’s Facebook page:https://www.facebook.com/mirenalawsuithelp. For a free legal consultation, please call 800-511-5092.
*wxyz.com/dpp/news/local_news/investigations/thousands-of-women-complain-about-dangerous-complications-from-mirena-iud-birth-control, 7 Action News, August 27, 2013
About Bernstein Liebhard LLP
Bernstein Liebhard LLP is a New York-based law firm exclusively representing injured persons in complex individual and class action lawsuits nationwide since 1993, including those who have been harmed by dangerous drugs, defective medical devices and consumer products. The firm has been named by The National Law Journal to the Plaintiffs’ Hot List, recognizing the top plaintiffs firms in the country, for the past 12 consecutive years. Bernstein Liebhard LLP is the only firm in the country to be named to this prestigious list every year since the list was first published in 2003.
Bernstein Liebhard LLP
10 East 40th Street
New York, New York 10016
800-511-5092
ATTORNEY ADVERTISING. © 2014 Bernstein Liebhard LLP. The law firm responsible for this advertisement is Bernstein Liebhard LLP, 10 East 40th Street, New York, New York 10016, 800-511-5092. Prior results do not guarantee or predict a similar outcome with respect to any future matter.
Contact Information:
Felecia L. Stern, Esq.
Bernstein Liebhard LLP
info (at) consumerinjurylawyers (dot) com
http://www.themirenalawsuitcenter.com 
https://plus.google.com/115936073311125306742?rel=author

Monday, April 14, 2014

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.

Sunday, April 13, 2014

Adhesion Incidence and Severity Vary by Surgical Procedure

By Jeannette Wick |
 MExperts estimate approximately 93% of patients who have undergone laparoscopic surgery develop abnormal fibroid bands that bind organ surfaces to the abdominal wall after a second surgery. Many adhesions are asymptomatic, but in some patients, they can cause pain, small bowel obstruction and other postoperative issues, as well as increase cost and complicate surgical suite workload. As surgeons underestimate the rate of adhesion development given that up to 93% of consent forms don’t address them, the March 2014 issue of Surgery Today contained a systematic review estimating the formation rate, distribution, and severity of postoperative adhesions in abdominal surgery patient.
Full article  http://www.hcplive.com/publications/surgical-rounds/2014/March-2014/Adhesion-Incidence-and-Severity-Vary-by-Surgical-Procedure

Thursday, April 10, 2014

Harry Reich, M.D Aquadiscetion and more.

This is the technique that spared me from most of the ravages of ARD. No barrier used just meticulous surgical technique.



  1. [PDF]

    LAPAROSCOPIC SURGERY FOR ADHESIOLYSIS Harry ...

    by H Reich - ‎Cited by 2 - ‎Related articles
    Harry Reich, M.D., F.A.C.O.G., FACS. 1. 1. Attending .... Aquadissection is the use of hydraulic energy from pressurized fluid to aid in the performance of surgical.
  2. Can your surgeon do this?

Substance P is an early mediator of peritoneal fibrinolytic pathway genes and promotes intra-abdominal adhesion formation.

 2013 May 1;181(1):25-31. doi: 10.1016/j.jss.2012.05.056. Epub 2012 Jun 6.

Substance P is an early mediator of peritoneal fibrinolytic pathway genes and promotes intra-abdominal adhesion formation.

Abstract

BACKGROUND:

The substance P (SP) or neurokinin-1 receptor pathway has been implicated in intra-abdominal adhesion formation, in large part through its effects on peritoneal fibrinolysis. This study investigates the role of SP as an early mediator of the messenger RNA (mRNA) expression of key components of the peritoneal fibrinolytic system and other fundamental adhesiogenic pathways.

MATERIALS AND METHODS:

Intra-abdominal adhesions were surgically induced in 28 rats using the ischemic button model. mRNA levels of tissue plasminogen activator (tPA), plasminogen activator inhibitor 1 (PAI-1), hypoxia-inducible factors (HIFs) 1α and 2α, and vascular endothelial growth factor A (VEGF-A) were measured in adhesive button tissue taken at time 0 and 1, 3, 6, 12, and 24h after surgery in rats receiving an intraoperative peritoneal bolus (25mg/kg) of a neurokinin-1 receptor antagonist (NK-1RA) or saline. Peritoneal fluid fibrinolytic activity was measured in peritoneal lavages taken at the same time points.

RESULTS:

SP levels increased (P≤0.05) within 1h postoperatively followed by an increase (P≤0.05) in tPA mRNA expression from 3 to 6h after surgery along with a striking increase (P≤0.05) in PAI-1 mRNA expression from 3 to 12h. NK-1RA administration further increased (P≤0.05) tPA mRNA expression and significantly blunted the increase in PAI-1 mRNA levels. The NK-1RA increased (P≤0.05) fitbrinolytic activity in peritoneal fluid at 3, 12, and 24h after surgery. HIF-1α and VEGF-A mRNA expressions increased from 3 to 12h (P≤0.05) and from 1 to 3h (P≤0.05) after surgery, respectively, whereas HIF-2α mRNA expression steadily decreased. NK-1RA delayed the rise in HIF-1α mRNA and ablated the changes in HIF-2α and VEGF-A mRNAs.

CONCLUSIONS:

SP is a pleiotropic early regulator of mRNA levels of key adhesiogenic mediators after surgery, suggesting that it may be a viable therapeutic target.
Copyright © 2013 Elsevier Inc. All rights reserved.
PMID:
 
22765994
 
[PubMed - indexed for MEDLINE]

Wednesday, April 09, 2014

Adhesion Barrier Not Helpful for Cesarean Delivery ~ Seprafilm

Laurie Barclay, MD
April 08, 2014
"Use of a commercially available carboxymethylcellulose adhesion barrier at primary cesarean delivery did not reduce time to delivery, total operative time, or complications during repeat cesareans, according to findings of a retrospective cohort study published in the May issue of Obstetrics & Gynecology.
"Adhesions that occur as a result of a prior cesarean delivery have been implicated as one cause of delayed delivery of the neonate during repeat cesarean deliveries," write Rodney K. Edwards, MD, associate professor, Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama Birmingham School of Medicine, and colleagues. "Seprafilm (sodium hyaluronate and carboxymethylcellulose absorbable adhesion barrier) is a commercially available product that is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct that is intended to reduce the incidence, extent, and severity of adhesion formation between the abdominal wall and the intraabdominal viscera.... However, data regarding use of this product for adhesion prevention at the time of caesarean delivery are limited to a single study of 52 patients."

Sunday, April 06, 2014

Adhesiolysis in Germany Dr. Matthias Korell and Dr. Jens Pagel

Adhesiolysis in Germany Dr. Matthias Korell and Dr. Jens Pagel

Dr. Matthias Korell
Johanna-Etienne Hospital Neuss
On Hasenbergstraße 46 
41462 Neuss 
North Rhine-Westphalia
Germany
Phone : 02131/5295-5002 
Fax: 02131/5295-5003 

PD Dr. Matthias Korell practiced as:
  • Specialist in Obstetrics u.Geburtshilfe
  • PD Dr. Matthias Korell speaks: German.Vocational group is senior consultant or senior doctor. 
  • ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
 Dr. Jens Pagel
St. Joseph's Hospital Department of Obstetrics and Gynecology
Asberger Strasse 4 
47441 Moers 
North Rhine-Westphalia
Germany
Phone : 02841/107-2430 
Fax: 02841/107-2000 
Dr. Jens Pagels practiced as:

Histone deacetylase inhibitors decrease intra-abdominal adhesions with one intraoperative dose by reducing peritoneal fibrin deposition pathways.

 2014 Feb;155(2):234-44. doi: 10.1016/j.surg.2013.08.018. Epub 2013 Nov 14.

Histone deacetylase inhibitors decrease intra-abdominal adhesions with one intraoperative dose by reducing peritoneal fibrin deposition pathways.

Abstract

BACKGROUND:

We previously demonstrated that postoperative peritoneal injury and inflammation contribute to adhesiogenesis. Recent evidence suggests that in addition to their role of interfering with the acetylation status of nuclear histone proteins, histone deacetylase inhibitors (HDACIs) including valproic acid (VPA) can target nonhistone proteins to resolve inflammation and modulate immune cells. We hypothesized that HDACIs could reduce adhesions.

METHODS:

Seventy-two rats underwent laparotomy with creation of 6 peritoneal ischemic buttons to induce adhesions. A single intraperitoneal (IP) dose of 50 mg/kg VPA was administered intraoperatively, whereas controls received vehicle. To evaluate the timing, 25 rats underwent ischemic button creation with either an intraoperative or a delayed IP dose of VPA at 1, 3, or 6 hours postoperatively. On postoperative day 7, adhesions were quantified. To investigate mechanisms, ischemic buttons were created in 24 rats and either VPA or saline was administered in 1 intraoperative dose. At 3 or 24 hours later, peritoneal fluid was collected and fibrinolytic activity measured. Alternatively, button tissue was collected 30 minutes postoperatively to measure tissue factor, fibrinogen, and vascular endothelial growth factor (VEGF) by real-time polymerase chain reaction or Western blot.

RESULTS:

A single intraoperative dose of VPA reduced adhesions by 50% relative to controls (P < .001). Delayed dosing did not reduce adhesions. In operated animals, peritoneal fibrinolytic activity was not different between groups. Tissue factor mRNA was downregulated by 50% (P = .02) and protein by 34% (P < .01) in animals administered VPA versus saline. VPA decreased fibrinogen protein by 56% and VEGF protein by 25% compared with saline (P = .03).

CONCLUSION:

These findings suggest that VPA rapidly reduces the extravasation of key adhesiogenic substrates into the peritoneum. A single, intraoperative intervention provides an ideal dosing strategy and indicates an exciting new role for HDACIs in adhesion prevention.
Copyright © 2014 Mosby, Inc. All rights reserved.
PMID:
 
24239397
 
[PubMed - indexed for MEDLINE]

Friday, April 04, 2014

Great article in Trials, on why regulators should stop withholding trial info from doctors and patients

October 18th, 2012 by Ben Goldacre in bad science, big pharma | 5 Comments »

One thing in Bad Pharma has shocked readers more than anything else: the way that vitally important information about trials is withheld from doctors and patients, not just by drug companies, but also by government bodies such NICE and the European Medicines Agency (the body that approves and regulates medicines for the UK).
Great site BAD SCIENCE http://www.badscience.net/

Monday, March 31, 2014

Mobilisation viscérale : lyse et prévention des adhésions péritonéales

Thérapie manuelle

 Mobilisation viscérale : lyse et prévention des adhésions péritonéales



Cet article pubié en 2011 ( Bove, G.M., Chapelle, S.L., Visceral mobilization can lyse and prevent peritoneal adhesions in a rat model, Journal of Bodywork & Movement Therapies (2011), doi:10.1016/j.jbmt.2011.02.004)  a pour but de vérifier par des thérapies manuelles, la prévention et le traitement des adhésions péritonéales, sources de divers problemes tels que des dysfonctions digestives, des douleurs du pelvis, des syndromes d'infertilité... Leur hypothèse, en s'aidant de rats pour modèles, était que la mobilisation viscérale, reposant sur l'anatomie, peut faciliter la mobilité physiologique abdominale, et traiter des adhésion induites par exemple après un geste chirurgical. 

3 groupes de 10 rats, 1 contrôle, 1 préventif et 1 lyse. 
Tous les rats ont été évalués après le 7ème jour chirurgical. 

 Lyse group: traitement avec  mobilisation viscérale, palpation digitale, action ciblée de défibrosage manuel, et mobilisation des murs abdominaux et viscéraux. Evaluation des adhésions après chaque séance. 
 
 Preventive group:  Traiter de la même manière mais dès le jour suivant la chirurgie. 

Control group: Evaluation 7 jours après la chirurgie sans aucune mobilisation viscérale.   


Résultats : 

Le degré de sévérité des adhésions ainsi que leur nombre étaient significativement inférieurs dans le groupe  Preventiv en comparaison aux autres groupes .   


Conclusions: 

Ces observations  initiales montrent que la mobilisation viscérale peut avoir un rôle important dans la prévention et le traitement des adhésions post-opératoires. 

 

 

  

bove_chapelle_11_adhesions.pdf Bove_Chapelle_11_Adhesions.pdf  (651.18 Ko) 

Saturday, March 29, 2014

Adhesions Adhesion Related Disorder Wiki

Adhesions are fibrous bands[1] that form between tissues and organs, often as a result of injury during surgery. They may be thought of as internal scar tissue that connect tissues not normally connected.

Pathophysiology[edit]

Adhesions form as a natural part of the body’s healing process after surgery in the same way that a scar forms. The term "adhesion" is applied when the scar extends from within one tissue across to another, usually across a virtual space such as the peritoneal cavity. As part of the process, the body deposits fibrin onto injured tissues. The fibrin acts like a glue to seal the injury and builds the fledgling adhesion, said at this point to be "fibrinous." In body cavities such as the peritoneal, pericardial and synovial cavities, a family of fibrinolytic enzymes may act to limit the extent of the initial fibrinous adhesion, and may even dissolve it. In many cases however the production or activity of these enzymes are compromised because of injury, and the fibrinous adhesion persists. If this is allowed to happen, tissue repair cells such as macrophages, fibroblasts and blood vessel cells, penetrate into the fibrinous adhesion, and lay down collagen and other matrix substances to form a permanent fibrous adhesion. In 2002, Giuseppe Martucciello's research group showed a possible role could be played by microscopic foreign bodies (FB) accidentally contaminating the operative field during surgery.[2] These data suggested that two different stimuli are necessary for adhesion formation: a direct lesion of the mesothelial layers and a solid substrate (FB).
While some adhesions do not cause problems, others can prevent muscle and other tissues and organs from moving freely, sometimes causing organs to become twisted or pulled from their normal positions.

Regions affected[edit]

Adhesive capsulitis[edit]

In the case of adhesive capsulitis of the shoulder (also known as frozen shoulder), adhesions grow between the shoulder joint surfaces, restricting motion.

Abdominal adhesions[edit]

Abdominal adhesions (or intra-abdominal adhesions) are most commonly caused by abdominal surgical procedures. The adhesions start to form within hours after surgery and may cause internal organs to attach to the surgical site or to other organs in the abdominal cavity. Adhesion-related twisting and pulling of internal organs can result in complications such as abdominal pain or intestinal obstruction. Small bowel obstruction (SBO) is a significant consequence of post-surgical adhesions. A SBO may be caused when an adhesion pulls or kinks the small intestine and prevents the flow of content through the digestive tract. It can occur 20 years or more after the initial surgical procedure, if a previously benign adhesion allows the small bowel to spontaneously twist around itself and obstruct. SBO is an emergent, possibly fatal condition without immediate medical attention. According to statistics provided by the National Hospital Discharge Survey approximately 2,000 people die every year in the USA from obstruction due to adhesions.[3] Depending on the severity of the obstruction, a partial obstruction may relieve itself with conservative medical intervention. However, many obstructive events require surgery to lyse the offending adhesion(s) or resect the affected small intestine.

Pelvic adhesions[edit]

Pelvic adhesions are a form of abdominal adhesions in the pelvis, typically in women affecting reproductive organs and thus of concern in reproduction or as a cause of chronic pelvic pain. Other than surgery, endometriosis, and pelvic inflammatory disease are typical causes.
Surgery inside the uterine cavity (e.g., suction D&C, myomectomy, endometrial ablation) can result in Asherman's Syndrome (also known as intrauterine adhesions), a cause of infertility.
A meta-analysis in 2012 came to the conclusion that there is only little evidence for the surgical principle that using less invasive techniques, introducing less foreign bodies or causing less ischemia reduces the extent and severity of adhesions in pelvic surgery.[4]

Pericardial adhesions[edit]

Adhesions forming after cardiac surgery between the heart and the sternum place the heart at risk of catastrophic injury during re-entry for a subsequent procedure.

Peridural adhesions[edit]

Adhesions and scarring as epidural fibrosis may occur after spinal surgery that restricts the free movement of nerve roots, causing tethering and leading to pain.

Peritendinous adhesions[edit]

Adhesions and scarring occurring around tendons after hand surgery restrict the gliding of tendons in their sheaths and compromise digital mobility.

Association with surgery[edit]

A study in Digestive Surgery showed that more than 90% of patients develop adhesions following open abdominal surgery and 55–100% of women develop adhesions following pelvic surgery.[5] Adhesions from prior abdominal or pelvic surgery can obscure visibility and access at subsequent abdominal or pelvic surgery. In a very large study (29,790 participants) published in British medical journal The Lancet, 35% of patients who underwent open abdominal or pelvic surgery were readmitted to the hospital an average of two times after their surgery due to adhesion-related or adhesion-suspected complications.[6] Over 22% of all readmissions occurred in the first year after the initial surgery.[6]Adhesion-related complexity at reoperation adds significant risk to subsequent surgical procedures.[7]
Applying adhesion barriers during surgery can help to prevent the formation of adhesions.[8] Surgical humidification therapy may also minimise the incidence of adhesion formation.[9] Laparoscopic surgery has a reduced risk for creating adhesions.[10] Steps can be taken during surgery to help prevent adhesions such as handling tissues and organs gently, using starch- and latex-free gloves, not allowing tissues to dry out, and shortening surgery time.[11]

Types[edit]

Types of adhesions:
  1. Fibrinous adhesions. These are causes of early postoperative obstruction which settles down within 3–5 days. The majority of fibrinous adhesions will disappear in due course of time[citation needed].
  2. Fibrous adhesions. If the infection is continuous or if foreign[clarification needed] is present, the fibrinous material is converted into fibrous material[citation needed].

References[edit]

  1. Jump up^ "adhesion" at Dorland's Medical Dictionary
  2. Jump up^ Torre M, Favre A, Pini Prato A, Brizzolara A, Martucciello G (December 2002). "Histologic study of peritoneal adhesions in children and in a rat model". Pediatr. Surg. Int. 18 (8): 673–6. doi:10.1007/s00383-002-0872-6. PMID 12598961.
  3. Jump up^ See article at: www.adhesions.org/ardnewsrelease092303.pdf
  4. Jump up^ Ten Broek, R. P. G.; Kok- Krant, N.; Bakkum, E. A.; Bleichrodt, R. P.; Van Goor, H. (2012). "Different surgical techniques to reduce post-operative adhesion formation: A systematic review and meta-analysis". Human Reproduction Update 19 (1): 12–25.doi:10.1093/humupd/dms032. PMID 22899657. edit
  5. Jump up^ Liakakos, T; Thomakos, N; Fine, PM; Dervenis, C; Young, RL (2001). "Peritoneal adhesions: etiology, pathophysiology, and clinical significance. Recent advances in prevention and management". Digestive surgery 18 (4): 260–73.doi:10.1159/000050149. PMID 11528133.
  6. ^ Jump up to:a b Ellis, H.; Moran, B.; Thompson, J.; Parker, M.; Wilson, M.; Menzies, D.; McGuire, A.; Lower, A.; Hawthorn, R.; Obrien, F. (1999). "Adhesion-related hospital readmissions after abdominal and pelvic surgery: A retrospective cohort study". The Lancet 353 (9163): 1476. doi:10.1016/S0140-6736(98)09337-4. edit
  7. Jump up^ Van Der Krabben, AA; Dijkstra, FR; Nieuwenhuijzen, M; Reijnen, MM; Schaapveld, M; Van Goor, H (2000). "Morbidity and mortality of inadvertent enterotomy during adhesiotomy". The British journal of surgery 87 (4): 467–71. doi:10.1046/j.1365-2168.2000.01394.x. PMID 10759744.
  8. Jump up^ "Adhesion prevention: a standard of care". Medical Association Communications. American Society of Reproductive Medicine. February 2002.
  9. Jump up^ Peng, Y; Zheng M; Ye Q; Chen X; Yu B; Liu B (2009). "Heated and humidified CO2 prevents hypothermia, peritoneal injury, and intra-abdominal adhesions during prolonged laparoscopic insufflations". J Surg Res. 151(1): 40–47.
  10. Jump up^ "Adhesions". Better Health Channel. Retrieved 20 February 2014.
  11. Jump up^ "Abdominal Adhesions (Scar Tissue)". Medicinenet. Retrieved 20 February 2014.