Portrayal of caesarean section in Brazilian women’s magazines: 20 year review

Maria Regina Torloni, medical doctor12, Silvia Daher, medical doctor2, Ana Pilar Betrán, medical officer3, Mariana Widmer, technical officer3, Pilar Montilla, technical officer4, Joao Paulo Souza, medical officer3, Mario Merialdi, unit coordinator3


+ Author Affiliations

1Brazilian Cochrane Centre, Rua Pedro de Toledo 598, São Paulo, Brazil, CEP 04039-001

2Department of Obstetrics, São Paulo Federal University, Rua Napoleão de Barros 875, São Paulo, CEP 040024-002

3Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland

4Osservatorio Nazionale sulla salute della Donna (O.N.Da), Milan, Italy

Correspondence to: M Torloni ginecologia@terra.com.br

Accepted 29 October 2010


Abstract

Objective To assess the quality and comprehensiveness of the information on caesarean section provided in Brazilian women’s magazines.



Design Review of articles published during 1988-2008 in top selling women’s magazines.



Setting Brazil, one of the countries with the highest caesarean section rates in the world.



Data sources Women’s magazines with the largest distribution during the study period, identified through the official national media indexing organisations.



Selection criteria Articles with objective scientific information or advice, comments, opinions, or the experience of ordinary women or celebrities on delivery by caesarean section.



Main outcome measures Sources of information mentioned by the author of the article, the accuracy and completeness of data presented on caesarean section, and alleged reasons why women would prefer to deliver though caesarean section.



Results 118 articles were included. The main cited sources of information were health professionals (78% (n=92) of the articles). 71% (n=84) of the articles reported at least one benefit of caesarean section, and 82% (n=97) reported at least one short term maternal risk of caesarean section. The benefits most often attributed to delivery by caesarean section were reduction of pain and convenience for family or health professionals. The most frequently reported short term maternal risks of caesarean section were increased time to recover and that it is a less natural way of giving birth. Only one third of the articles mentioned any long term maternal risks or perinatal complications associated with caesarean section. Fear of pain was the main reported reason why women would prefer to deliver by caesarean section.



Conclusions Most of the articles published in Brazilian women’s magazines do not use optimal sources of information. The portrayal of caesarean section is mostly balanced, not explicitly in favour of one or another route of delivery, but incomplete and may be leading women to underestimate the maternal/perinatal risks associated with this route of delivery.



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Introduction

A caesarean section is a surgical procedure that was developed to prevent or treat life threatening maternal or fetal complications. The proportion of births using caesarean delivery has been steadily increasing in most high income and middle income countries, despite the lack of sound scientific evidence indicating any substantial maternal or perinatal benefits from increasing rates of caesarean section and consistent reports of increased risks for the mother and baby.1 2 3 4 5 In many developed nations and in Latin America, approximately a third of all deliveries occur by caesarean section.6 In the past few decades, Brazil has been one of the countries with highest proportion of deliveries by caesarean section in the world.2 6 According to data from a national health survey, the overall caesarean section rate in Brazil in 2006 was 43.6%,7 but in the private sector it can be more than 80%.8 More than 850 000 unnecessary caesarean sections are being done each year in Latin America, and almost half of them occur in Brazil.2



Despite worldwide concern, debate, and research on this subject, the modifiable causes of rising caesarean section rates remain unclear. Without a better understanding of the possible causes and contributing factors for this tendency, developing and implementing effective strategies to help curb this upward trend and reduce the number of unnecessary caesarean sections will be difficult. This is important, as high rates of non-medically indicated caesarean section have financial implications and unnecessarily expose mothers and children to risks and consequences that are not yet fully understood.



Contemporary women are exposed to and have access to a wide range of information on health topics, including their options for childbirth. This exposure can influence their opinions and affect the decision making process.9 10 11 Additionally, women’s views and preferences on type of delivery are, for different reasons, being increasingly respected by practising obstetricians.12 13 Women’s magazines are one of the most ubiquitous sources of information and can play a critical role in shaping women’s opinions and influencing the decisions they make.9 However, to the best of our knowledge, the accuracy and comprehensiveness of the information on caesarean section compared with vaginal delivery presented in these magazines has not been evaluated.



In this context, we set out to review the top selling women’s magazines published in the past 20 years in Brazil, one of the countries with the highest rates of caesarean section in the world, to analyse the content of the articles that presented information or expressed views related to caesarean section. This is part of a larger worldwide multi-country investigation covering women’s magazines from countries in Europe, Latin America, and North America, where caesarean section rates are increasing in an unprecedented manner. Our hypothesis was that the information transmitted to women through this media was incomplete, biased in favour of caesarean section (possibly presenting it as a more beneficial route of delivery), or both.



The specific objectives of the review were to assess the sources of information that the magazine authors reported to have consulted for writing their articles; the accuracy and comprehensiveness of the information presented on caesarean section versus vaginal delivery; and the views, opinions, or preferences of ordinary women and celebrities about route of delivery and the alleged reasons or motives why they would prefer a caesarean section to a vaginal delivery.

Click here to read the rest

BMJ 2011; 342:d276 doi: 10.1136/bmj.d276 (Published 25 January 2011)


Cite this as: BMJ 2011; 342:d276

Study Details Causes of High Maternal Death Rates

This is just an expert from the full article.....please click here to read the full article

By Sharon Johnson
WeNews senior correspondent
Tuesday, April 26, 2011

In the United States 1 out of every 7 maternal deaths occurs six weeks after delivery, so some deaths might have been prevented if the woman received more follow-up care.


"On the other hand, some women may have received too many interventions," Bingham said. "Surgical interventions may have reached a level of overuse in the United States. Although there has been a 50 percent increase in the number of Cesarean sections since the 1990s, we have not seen any data to show that this leads to improvements in outcomes for the mother or baby. C-sections carry all the risks of abdominal surgery, such as infection and hemorrhage and life-long complications, such as adhesions."


The city's report found that 79 percent of all mothers who died from pregnancy-related causes gave birth via C-section. Although the report did not break the C-section data down by race or ethnicity, it did note that C-sections were the most common method of delivery among women who died from hemorrhage, infections and embolism.

Experts Discuss Art of Adhesion Prevention, Fixation Methods

Many Choices for the General Surgeon, Few Clear Answers


by Gabriel Miller

New York—Adhesions, particularly those following common procedures like appendectomy or hernia repair, are among the oldest and most common surgical complications encountered. Despite more than 150 years of published clinical insight into adhesions, they remain one of the most troublesome aspects of modern surgery.


“Preventing postsurgical adhesions remains truly an art rather than a science,” said Charles E. Miller, MD, clinical associate professor of obstetrics and gynecology at the University of Illinois College of Medicine, in Chicago.



“I second that,” said Stephen Kavic, MD, assistant professor of surgery at the University of Maryland School of Medicine, in Baltimore. “This is the one area where I find my colleagues wax poetic. There was a ‘forest of adhesions’; ‘I was wading through a sea of adhesions’; ‘the adhesions looked bad but they were mere cobwebs.’ You don’t get descriptive terms like this when you talk about the colon, but you find it often with adhesions.”



Drs. Miller and Kavic were two members of a panel of experts tackling the issue of adhesions and hernia mesh, during a plenary session at the 2010 annual meeting of the Society of Laparoendoscopic Surgeons.



“Healing Gone Awry”



Every surgeon is familiar with adhesions—fibrous bands connecting tissues and organs, typically bound to the peritoneum.



The key to understanding adhesions, and the newest approaches in preventing them, said Dr. Kavic, is that they are “an abnormal variant of a normal healing process initiated by trauma.” In other words, adhesions result from healing gone slightly awry.



“When tissue is traumatized the first thing that happens is the mast cells degranulate, causing an edema and the release of histamine and a variety of cytokines that initiate an inflammatory response,” said Kathleen Rodgers, PhD, director of research in obstetrics and gynecology at the University of Southern California, Los Angeles.



After this inflammatory phase, tissue formation begins with the recruitment of fibroblasts to create an extracellular matrix at the wound site.



“With the addition of these cellular elements—fibrinogen and thrombin onto the viscera—what can happen over time is the migration of myofibroblasts that can lead to fibrin deposition and a permanent adhesion,” said Dr. Kavic.



Because adhesions are a natural process, they may be instigated by any one of many postoperative conditions. “You have a number of issues, including infection, inflammation, a foreign body, tissue injury, necrosis—all of these contribute to postoperative adhesion formation. So the point is that it’s not a one-size-fits-all or simple mechanism,” said Ray Lanzafame, MD, MBA, associate professor of surgery at the University of Rochester School of Medicine in Rochester, N.Y.



Fibrinous adhesions are temporary and disappear over time, usually without incident. However, if inflammation is continuous—which is typical in the presence of a foreign body like mesh—fibrinous material is converted to fibrous material that forms permanent adhesions of the variety that “plague us and cause a terrific amount of grief,” Dr. Kavic said.



A Common Problem



Equally familiar to the surgical community is the variety of complications that can occur as a result of permanent adhesions, most notably small bowel obstruction, chronic pain and increased operative times in subsequent procedures.



Adhesions are so common, in fact, that they are not perceived as a legitimate complication worthy of informed consent, but instead as natural sequelae that occur in more than 90% of patients following major abdominal surgery, according to one review of peritoneal adhesions (Colorectal Dis 2007;Suppl 2:35-38).



However, a recent study found that 11% of patients are hospitalized within five years of an appendectomy for suspected adhesions, Dr. Kavic said. “That’s an alarmingly high number for a common clinical condition,” he added.



For the hernia patient, there is, perhaps not surprisingly, disagreement among surgeons about the best approach to prevent adhesions. “Generally speaking, it’s still felt that the incidence of adhesions after laparoscopy is lower than [after] open procedures, and certainly is least when the mesh surface is covered in some way,” said Dr. Lanzafame. “Adhesions are more likely with TAPP [transabdominal preperitoneal] and IPOM [intraperitoneal onlay mesh] repairs as opposed to a TEP [totally extraperitoneal] type of laparoscopic herniorrhaphy,” he added.



Nevertheless, adhesions can result from any type of hernia operation. “When we take a look at any mesh and any fixation method, we can find adhesions if we look at it hard enough; so adhesions are ubiquitous when it comes to mesh placement,” said Dr. Kavic.



Strategies and Products for Adhesion Prevention



Absorbable Tacks



Currently, there are three main approaches to prevent adhesions, and in particular, mesh and point-fixation adhesions in hernia patients:





•new approaches to affixing mesh to tissue





•composite materials that combine traditional mesh with a nonadhering surface





•resorbable liquid barriers that dissolve after the risk for adhesions has passed.



Recognizing that many current meshes allow aggressive tissue ingrowth in the first weeks after hernia repair such that permanent fixation is no longer necessary in some cases, companies introduced absorbable fixation tacks. These products, which are made from polylactic acids, show significant absorption within six months and nearly complete absorption within a year.



Although several studies have shown that absorbable tacks generally reduce postoperative pain, there are fewer data on adhesion formation using absorbable tacks. One early study of laparoscopic ventral hernia repair in a pig model found no difference in tack adhesions between metal and absorbable devices (Hernia 2004;8:358-364); in contrast, a much more recent study comparing Covidien’s metal and absorbable tacks in a rat model of laparoscopic incisional hernia repair found that adhesions were significantly reduced with absorbable tacks (Surg Endosc 2010;24:1318-1324).



Biologic Glues



Lately, hernia surgeons have eschewed point fixation altogether. The most well studied of these techniques involves fixation with resorbable biologic “glues,” most of which are tissue sealants first approved for use in thoracic or cardiovascular settings.



Much of the early research with biodegradable glues was done in inguinal hernia patients, where mesh placement within tissue planes provided a more favorable environment for glue fixation. However in the past year, three studies compared glues with other fixation methods in porcine models of laparoscopic ventral or incisional hernia repair.



The first study, conducted at the University of Southern California, found no difference in tensile strength or adhesions between four fixation methods: fibrin glue alone, transfascial sutures with tacks, fibrin glue with tacks and tacks alone (Surg Endosc 2010; July 31:Epub ahead of print).



More recently, a group at Washington University School of Medicine, in St. Louis, found that three absorbable tacking devices (PermaSorb, SorbaFix and I-Clip) were significantly stronger than fibrin glue (Surg Innov 2010;17:285-290).



Finally, in a study published in January, surgeons in Vienna demonstrated that fibrin glue fixation did not differ significantly from absorbable tacks provided that specific open-porous meshes were used. Fibrin glue did not work as well with polyester mesh coated with a resorbable collagen or condensed PTFE mesh (J Am Coll Surg 2011;212:80-86).



Covidien has introduced a self-affixing mesh that uses resorbable polylactic acid “microgrips” and adheres evenly to tissue within 60 seconds, according to the company.



“They’ve actually designed it to stick, so you’ve got these polylactic acid prongs in polypropylene, where sooner or later, the polylactic acid is resorbed and you have the underlying matrix,” said Dr. Lanzafame. “It’s the surgical equivalent of Velcro.” But currently, this mesh is not configured for laparoscopic use, he said.



Laser Tissue Welding



At the forefront of fixation is laser tissue welding or soldering, a technique that Dr. Lanzafame pioneered as a result of research funded by a National Institutes of Health (NIH) grant in collaboration with Conversion Energy Enterprises at the Laser Research Laboratory at Rochester General Hospital, in Rochester, N.Y. In this approach, mesh is welded to tissue using a collagen-based solder, which is then spread completely over the mesh material. In animal models, Dr. Lanzafame demonstrated that laser soldering can be used without increasing inflammation or adhesions compared with staples.



There are several obstacles that will need to be surmounted before surgeons can use laser-welding prosthetics intraperitoneally. “There are a couple of different issues, not the least of which is getting the [collagen-derived solder] where you want it, holding it in position and having minimal trauma to the tissue,” said Dr. Lanzafame. “This process is no small trick.”



Barrier Meshes



Even if point fixation is abandoned in favor of fibrin glues or tissue welding, surgeons still will have to deal with adhesions forming on the mesh itself, or more commonly, around the perimeter of the mesh.



The current chapter in the long-running battle to reduce adhesions began 30 years ago with the work of Scott Jenkins, MD, who performed seminal comparisons of different mesh products. In 1983, Dr. Jenkins sought to characterize adhesion formation among five different materials, most of which still are used today.



The most recent leap forward involves the creation of barrier meshes, usually comprised of a solid anti-adhesive surface bound to a standard macroporous mesh. Dr. Jenkins’ original ideal of finding a material so chemically inert that adhesions would never form is probably unrealistic, but the practical difference between placing a standard macroporous mesh and a barrier mesh intraperitoneally is the difference between bluntly dissecting thin, flimsy adhesions that are easily swept off a mesh and getting bogged down in dense, vascularized fibrotic bands that require a half-hour or longer to clear.



With the introduction of microporous mesh in the early 1980s, the market for barrier meshes exploded and at least 11 barrier meshes are being manufactured for use in the United States.



As an extension of the barrier concept, more recently liquid barrier coatings have been recommended for use in hernia repairs. Last fall, a multinational, interdisciplinary consensus conference published recommendations for adhesion prevention that included advocating use of FDA-approved adhesion barriers when appropriate.



Currently, there are three FDA-approved adhesion barriers: Seprafilm (Genzyme), Adept (Baxter) and Interceed (Gynecare), each of which has benefits and drawbacks, according to the surgeons interviewed for this article.



Seprafilm, a sodium hyaluronate/carboxymethylcellulose, was the first approved by the FDA to prevent adhesions in patients undergoing laparotomy.



“It has been shown to decrease severity of adhesions—incidence has been a little bit more questionable—and adhesion reduction seems to be what it is marketed for and what it delivers,” said Dr. Kavic.



However, in a Cochrane review of published studies, reviewers found that even though adhesions were reduced, there may have been an increased risk for leaks when Seprafilm was wrapped around anastomoses, and furthermore it did not ultimately affect rates of small bowel obstruction or morbidity and mortality.



With Seprafilm, Dr. Kavic said, “we may be preventing adhesions, but at a bit of a price.”



Less well studied are the two other adhesion barriers, Adept and Interceed.



Interceed is an oxidized, regenerated cellulose barrier approved by the FDA in 1998 for reducing adhesions in open gynecologic pelvic surgery. However, Interceed has a black box warning against use in laparoscopic surgery and is specifically contraindicated as a hemostatic agent.



“It has been shown to reduce adhesions, but it doesn’t work well when there is blood,” said Dr. Kavic. “There are very few operations that I do that involve zero blood loss; most are minimal, but there is some present.”



Finally, there is Adept, a 4% icodextrin solution approved in 2006 to reduce adhesions in patients undergoing laparoscopic gynecologic surgery. The most significant point about Adept is that it carries more contraindications than the other adhesion barriers, including infection, laparotomy incision, bowel resection, appendectomy, and uniquely, allergy to cornstarch.



Although adhesion barriers represent a step forward, by no means are they the ideal agent, said Dr. Kavic.



“We have properties of the ideal anti-adhesive—it eliminates adhesions, it’s inert, it’s cheap, it’s pliable, it’s easy to apply, but we really don’t have that agent as of yet,” he said. “Seprafilm probably comes closest to the mark for general surgery, but we do not have this for the laparoscopic setting.”



Drug Therapies: The Future?



At the farthest reaches of the adhesion prevention spectrum lie systemic or medical treatments that support normal healing while limiting adhesion formation.



Drug therapies under investigation work in one of three ways, said Dr. Rodgers, the research scientist at the University of Southern California: They reduce fibrin deposition, accelerate fibrin removal or decrease the anti-inflammatory process.



“They accelerate the healing process by reducing the inflammatory response or they reduce the scaffold that adhesions are built upon,” she said. However, many of these agents affect clotting and Dr. Rodgers said there is some risk for bleeding at a time when clotting is paramount.



Dr. Rodgers said that several other agents have shown promise, including recombinant human activated protein C, a polysaccharide similar to heparin, and a recombinant tissue plasminogen activator. But like earlier medical therapies, these agents can affect blood clotting and wound healing.



“I’ve worked with most of these kinds of drugs, and again, what I’ve noticed in my animal models when I’ve given them is there is bruising and bleeding at the incision site, and there is a very low therapeutic index between efficacy and some toxicity with their use,” Dr. Rodgers said.



The problem is that these drugs are largely systemic, rather than localized, and when they are given locally, they are diluted in a wash that’s quickly removed from the wound site.



Ultimately, Dr. Rodgers believes the future of adhesion prevention is a combination of adhesion barriers and pharmacologic therapies.



“This is where the research is going,” she said. “It’s still at very early stages, and clinically no drug yet has been shown to reduce adhesions. There are barriers that are being used clinically to prevent adhesions, and they can be effective, but they are minimally effective and they have complications. We have to find something that steps up the ability of these barriers to be effective, and my recommendation would be a drug that is safe and prevents the inflammatory events that lead to the adhesion formation.”



Currently, the general surgeon, particularly for hernia repair, has an incredible armamentarium when it to comes to preventing adhesions. Despite this, adhesions continue to proliferate.



“There is a terrific volume of research that is going into the study of preventing adhesions, but there is nothing that has really been elevated above the rest as of yet,” Dr. Kavic said.





--------------------------------------------------------------------------------



Disclosure Statements



Kathleen Rodgers, PhD, is a consultant for FzioMed and has been a consultant for Atrium Medical.



Ray Lanzafame, MD, MBA, reports grant funding from the National Institutes of Health Small Business Innovation Research (SBIR) program and research equipment from Conversion Energy Enterprises, Inc. Dr. Lanzafame also is or has been a consultant for General and Plastic Surgery Devices and other panels of the Medical Devices Advisory Committee of the FDA’s Center for Devices and Radiological Health; he has done medicolegal consulting for various law firms and entities; and he has served as a consultant for various biomedical technology companies including Carestream Health, Conversion Energy Enterprises (CEE), Eastman Kodak, Lucid, Surgicon and business and venture capital groups.



Stephen Kavic, MD, reports no disclosures and no business or financial relationships that apply to hernia fixation or to adhesion prevention.



Charles Miller, MD, reports grant/research funding from Covidien and Femasys; he has served as a consultant for Ferring Pharmaceuticals, Ethicon Endo-Surgery, Ethicon Women’s Health and Urology, Boston Scientific, Care Fusion Interlace Medical, Covidien and Femasys; he serves on the speaker’s bureau for Ferring Pharmaceuticals, Ethicon Endo-Surgery, Ethicon Women’s Health and Urology, Merck and Femasys.



http://www.generalsurgerynews.com/ViewArticle.aspx?d=In%2Bthe%2BNews&d_id=69&i=March%2B2011&i_id=711&a_id=16775

Liz Taylor Suffered terribly from Adhesions

Elizabeth Taylor Suffered terribly from Adhesions and  had approximently 30 surgeries by the time this article was written in 1973! A hysterectomy, 2 c-sections to boot.
http://news.google.com/newspapers?id=JmUtAAAAIBAJ&sjid=AYkFAAAAIBAJ&pg=2394,3022218&dq=liz+taylor+adhesions&hl=en

and another article;
http://news.google.com/newspapers?id=lVJRAAAAIBAJ&sjid=WzMNAAAAIBAJ&pg=3945,4530201&dq=adhesions&hl=en

AlloDerm® Regenerative Tissue Matrix ~ Mesh alternative for hernia repair

LifeCell Tissue Matrices: new alternatives for soft-tissue repair




There are many reasons patients may need an operation to repair weak or damaged tissue. Hernia surgery, breast reconstruction after mastectomy, revision procedures after breast augmentation surgery, and other diseases and degenerative conditions can all require tissue repair.



To help reduce the risk of potential problems in repairing or replacing weak or damaged tissue, your surgeon may choose to use an alternative: AlloDerm® Regenerative Tissue Matrix or Strattice™ Reconstructive Tissue Matrix from LifeCell. AlloDerm® Tissue Matrix and Strattice™ Tissue Matrix support regeneration (growth of new tissue) and they actually become part of your own body.


Every patient is different and results may vary. Only a physician can determine the best treatment for you. Please ask your doctor to explain the benefits and risks to see if LifeCell products are right for you.
From the manufacturer:

AlloDerm® Regenerative Tissue Matrix provides a strong, intact repair for challenging hernia repair and breast reconstruction postmastectomy procedures. Unlike other acellular human dermis products, AlloDerm® Tissue Matrix is produced through a unique non-damaging process that allows the body to mount its own tissue regeneration process.


Donated human skin tissue supplied by US AATB-compliant tissue banks is aseptically processed using LifeCell’s proprietary technique to remove the epidermis and cells that can lead to tissue rejection and graft failure. The result is an intact acellular matrix of natural biological components that promotes rapid revascularization, white cell migration and cell repopulation.



AlloDerm® Tissue Matrix provides excellent handling properties, exhibits a remarkable versatility to convert into functional tissues that provide structural support (e.g., gingiva and fascia), and is screened and tested according to FDA regulations, AATB standards and appropriate state regulations.



Used in challenging hernia and abdominal wall repair and breast reconstruction postmastectomy procedures, AlloDerm® Tissue Matrix transforms into host tissue for a natural repair and a safe and clinically optimal outcome. Its benefits include:

Abdominal wall reconstruction

Breast reconstruction postmastectomy

LifeCell Corporation Instructions for use:
http://www.lifecell.com/downloads/LC_Alloderm114_IFU_B_T4.pdf

Please review all information with your doctor to see if this is an option for you.

Maude Adverse Event Data on AlloDerm:
MAUDE Adverse Event Report


Results for 'AlloDerm® Regenerative Tissue Matrix' in All of FDA


... LIFECELL CORPORATION ALLODERM REGENERATIVE TISSUE MATRIX MESH, Back to Search Results.

Event Date 04/04/2008. ... Brand Name, ALLODERM REGENERATIVE TISSUE MATRIX. ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1045000 - 23k - Cached



Enforcement Report for April 16, 2008



... Recall # B-0911-08; d) AlloDerm, Oral Plastic ... B-0912-08; e) Graftjacket Regenerative

Tissue Matrix 5x5cm, .89 ... B-0913-08; f) Repliform Tissue Regeneration Matrix ...

www.fda.gov/Safety/Recalls/EnforcementReports/2008/ucm120502.htm - 67k - Cached



MedSun Reports



... Manufacturer response for Regenerative Tissue Matrix, AlloDerm

===== LifeCell was notified and will reveiw. ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=%25%22-_%3E%25_%3C%20%0A - 16k - Cached





TPLC - Total Product Life Cycle



... Injury, 1. MDR Distribution by Brand. STRATTICE, 15. ALLODERM, 1. ALLODERM REGENERATIVE

TISSUE MATRIX, 1. ALLODERM TISSUE, 1. LTM, 1. Device Problems. Device emits ...

www.accessdata.fda.gov/.../cfdocs/cftplc/tplc.cfm?id=FTL&min_report_year=2007&long_name=LIFECELL%20CORP. - 20k - Cached



MedSun Reports



... Device brand name: Straight Plate Self Drilling Screws AlloDerm Regenerative

Tissue Matrix. Device manufacturer's name: Medtronic ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?id=%25%22-_%3C%26_%5C%20%0A - 16k - Cached



MedSun Reports



... Device brand name: Straight Plate Self Drilling Screws AlloDerm Regenerative

Tissue Matrix. Device manufacturer's name: Medtronic ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/medsun_details.cfm?ID=%25%22-_%3C%26_%5C%20%0A - 16k - Cached



Medsun: Newsletter #36, May 2009



... LifeCell Corporation, AlloDerm Regenerative Tissue Matrix Other: 402025, Patient

underwent resection of pilocytic astrocytoma in the posterior fossa. ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/printer.cfm?id=994 - 19k - Cached



MedSun: Newsletter #36, May 2009



... LifeCell Corporation, AlloDerm Regenerative Tissue Matrix Other: 402025, Patient

underwent resection of pilocytic astrocytoma in the posterior fossa. ...

www.accessdata.fda.gov/scripts/cdrh/cfdocs/medsun/news/newsletter.cfm?news=36 - 91k - Cached



Enforcement Report for June 18, 2008



... PRODUCT Human Cornea Tissues, Recall # B ... Tissue Matrix, 2x4 cm, .33-76 mm; AlloDerm

GBR; 2x2 cm, .46-86 mm; Graft Jacket, Regenerative Tissue Matrix Ulcer Repair ...

www.fda.gov/Safety/Recalls/EnforcementReports/2008/ucm120511.htm - 193k - 2009-05-28 - Cached

Asherman syndrome
Uterine synechiae
Last reviewed: September 12, 2010.

Asherman syndrome is the formation of intrauterine adhesions (scar tissue), which typically develop after uterine surgery.

Causes, incidence, and risk factors
Asherman syndrome is a rare condition. In most cases, it occurs in women who have had several dilatation and curettage (D&C) procedures.

A severe pelvic infection unrelated to surgery may also lead to Asherman syndrome.

Intrauterine adhesions can also form after infection with tuberculosis or schistosomiasis. These infections are rare in the United States, and uterine complications such as Asherman syndrome related to these infections are even less common.

Symptoms
The adhesions may cause amenorrhea (lack of menstrual periods), repeated miscarriages, and infertility.

However, such symptoms could be related to several conditions. They are more likely to indicate Asherman syndrome if they occur suddenly after a D&C or other uterine surgery.

Signs and tests
A pelvic exam is usually normal.

Tests may include:

•Blood tests to detect tuberculosis or schistosomiasis

•Hysteroscopy

•Hysterosonogram

•Infertility evaluation

•Transvaginal ultrasound examination

Treatment
Treatment involves surgery to cut and remove the adhesions or scar tissue. This can usually be done with hysteroscopy, which uses small instruments and a camera placed into the uterus through the cervix.

After scar tissue is removed, the uterine cavity must be kept open while it heals to prevent adhesions from returning. Your health care provider may place a small balloon inside the uterus for several days and prescribe estrogen therapy while the uterine lining heals.

Antibiotic treatment may be necessary if there is an infection.

Support Groups
The stress of illness can often be helped by joining a support group where members share common experiences and problems. See www.ashermans.org for information about an online Asherman syndrome support group.

Expectations (prognosis)
Asherman syndrome can be cured in most women with surgery, although sometimes more than one procedure will be necessary.

Women who are infertile because of Asherman syndrome may have a successful pregnancy after treatment Successful pregnancy depends on the severity of Asherman syndrome and the difficulty of the treatment, as well as other factors that affect fertility and pregnancy.

Complications
Complications of hysteroscopic surgery are uncommon and include bleeding, perforation of the uterus, and pelvic infection.

In some cases, treatment of Asherman syndrome will not cure infertility.

Calling your health care provider
Call your health care provider if your menstrual periods do not resume after a gynecologic or obstetrical procedure. An evaluation for infertility is also warranted if you are unable to achieve a pregnancy after 6 to 12 months of trying.

Prevention
Most cases of Asherman syndrome cannot be predicted or prevented.

References
1.Lobo RA. Primary and secondary amenorrhea and precocious puberty: etiology, diagnostic evaluation, management. In: Katz VL, Lentz GM, Lobo RA, Gershenson DM, eds. Comprehensive Gynecology. 5th ed. Philadelphia, Pa: Mosby Elsevier; 2007:chap 38.
2.Simpson JL, Jauniaux ERM. Pregnancy loss. In: Gabbe SG, Niebyl JR, Simpson JL, eds. Obstetrics: Normal and Problem Pregnancies. 5th ed. Philadelphia, Pa: Elsevier Churchill Livingstone; 2007:chap 24.
Review Date: 9/12/2010.

Reviewed by: Linda J. Vorvick, MD, Medical Director, MEDEX Northwest Division of Physician Assistant Studies, University of Washington, School of Medicine; 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, University of Washington School of Medicine. Also reviewed by David Zieve, MD, MHA, Medical Director, A.D.A.M., Inc.