Surgical Mesh: The Ten Year Window

The Ten Year Window

I have spent many years in the health care industry. The outcome of the observations I have made tells me that most often it takes about 10 years for facts to catch up with drug, treatments, and device approvals.

Approvals in this arena come from the Food and Drug Administration (FDA). Commonly, because of the faster fast track system instituted now for a couple of decades, money buys the ticket to the train. When first instituted Fast Track cost a manufacturer about $330,000; now it is at least double.

This doesn’t end up doing too much for safety because, if you follow the news, you too frequently hear about a drug recall, an ineffective treatment, or medical device failures along with product liability law suits.

Surgical mesh offers no different scenario.

The FDA orders Johnson & Johnson, C.R. Bard and 31 other companies to take another look at complication rates associated with their transvaginal mesh implants.

Retropubic urethral suspension was first used in 1910. Since that time over 100 different surgical techniques for the treatment of genuine stress urinary incontinence (GSUI) have been described.

Procedures done through the abdomen have been referred to as "bladder lifts". These include procedures known as the Burch repair and Marshall-Marchetti (1949) procedure. Although these are very "old" surgical procedures, the results have proven durable over time.

Some surgeons believe that the sling surgery should be used only in certain special cases because of its higher rate of complications and because they have found the older surgery techniques to be effective.

Pubovaginal Sling Procedures 

In instances where mesh may be contraindicated the procedures can be done with natural products such as bovine, or cadaver grafts.

Your physician should discuss all options with you for your situation to help you to decide which procedure is the correct one for you.

In the early 1990s, at the time use of surgical mesh began becoming popular there were no long term studies available on the differing types of products, and few long term studies of the surgical techniques.

Vaginal mesh repair has become popular, because of access to the areas involved in surgery, ease of application using the manufacturers' needles, variable mesh sizes that can be cut to size during surgery, laparotomy is not required, the option of achieving permanent tissue replacement after failure of tissue reconstruction, and experience with similar materials.

According to Dr. Saralyn Mark, a spokesperson for COOK in the capacity of Senior Scientific Policy Advisor, surgical mesh has been used for over a decade. COOK has provided biologically-derived grafts that are not cross-linked, including grafts for pelvic organ prolapse, for about 13 years. Dr. Mark’s statement was part of her presentation in September 2011 at the FDA conference covering the problems with this product.

There are several types of mesh or similar products and they are most often used in surgery involving hernia, uterine prolapse, bladder prolapse, rectocele, cystocele, and other applications.

Synthetic mesh is found in absorbable and non-absorbable forms. Biologically derived graft material is offered in cross-linked and non-crosslinked forms.

The type of material selected and the outcome of surgery is, according to Marks, best determined by “(1) assuring that the patient is a suitable candidate, (2) performing the procedure correctly, and (3) choosing the appropriate product”.

Based on the three criteria, Marks went on to state that she reviewed numerous articles where the studies referenced one of the four types of material for implant.

COOK’s findings show that most non-absorbable synthetic mesh is made of Type I polypropylene. Outcomes for this type material suggest that there is a strong bond with mesh and surrounding tissue encapsulation. In some cases the long term tissue response is more like a foreign body reactions that may include granulation tissue, limited neovascularization, eventual fibrosis, and encapsulation.

Foreign body reactions are similar to transplant surgeries where anti-rejection drugs are commonly prescribed in an effort to reduce risk of rejection.

Absorbable synthetic mesh can rapidly degrade and does not provide long term tissue support. For this reason this type of product is rarely used.

Cross-linked biologic grafts are made with chemical agents to bond or “cross-link” collagen fibers together in an effort to reduce degradation. The material seems not to support normal movement of body cells into the graft is significantly. Because of this inflammation occurs and over time leads to a foreign body reaction and encapsulation. The tissue response of chemically cross-linked graft material has been found to be very similar to the synthetic products.

Non-crosslinked biologic grafts are minimally processed to remove cells and leave no cross-linked collagen.

They offer both mechanical strength and a platform to promote “cellular infiltration, proliferation, and remodeling of the patient’s tissue”. Long term outcome with this type product aids repair and reinforcement as the graft is replaced by connective tissue and normal blood supply.

Review of 15 years of reports using different types of graft material evaluated these studies for incidence of “(1) erosion, (2) pain including dyspareunia, (3) graft-related infection, (4) persistence or recurrence of prolapse based on objective measures (such as the POP-Q score), and (5) symptomatic recurrence.”

Of these five parameters the final evaluation specifically looked at three objective measures for each type of material: (1) erosion, (2) infection, and (3) objective measurement of recurrence. Pain and other symptomatic complaints were excluded.

Overall findings with non-absorbable synthetic mesh products had a 10% erosion rate, while crosslinked biologics had 6.2% rate. Repairs with non-crosslinked biologic grafts had the lowest erosion rate at 1.2%.

Infection rates associated with material types were approximately 4.0%.

Of course and of great concern to patients are pain and other complaints, including but not limited to forced lifestyle change and quality of life concerns.

There is great consideration given to the need for follow-up sonography to evaluate the anterior and posterior mesh positions after prolapse surgery. Reported frequently is a considerable discrepancy between the implanted mesh size and its length measured after six weeks by postoperative ultrasound.

In consideration of economic cost, the recently reported direct cost of pelvic organ prolapse surgeries were between $1012 million and $1251 million dollars. Of this $494 million (49%) covered costs for vaginal hysterectomy; $279 million (28%) were costs for both cystocele and rectocele repair; and $135 million dollars (13%) were allocated for abdominal hysterectomy.

Physician services accounted for 29% ($298 million) of total costs, and hospitalization accounted for 71% ($714 million). Twenty-one percent of all reported pelvic organ prolapse operations included urinary incontinence procedures ($218 million). If all of the reported surgeries were reimbursed by non-Medicare sources, the annual estimated cost would increase by 52% to $1543 million.

Procedures using surgical mesh are permanent. There may be benefit in first understanding long term complications as these may include mesh erosion into the vagina, bladder or rectum; painful intercourse; infection or bleeding.

The FDA has received thousands of complaints about surgical mesh. Examples follow of manufacturer and complaints filed as of 2009 -

Manufacturer Product names and Number of MAUDE* reports

American Medical Systems SPARC 65

Bard Pelvicol, Pelvisoft 64, 1

Boston Scientific Scimed Prefyx PPS, Obtryx Curved Single, Obtryx Mesh Sling, Advantage Sling System, Prefyx System Mid U, Mesh Sling System23, 1, 62, 29, 23, 78

Caldera T-Sling 2

Ethicon Gynemesh PS (K013718) a/k/a/ Prolift Pelvic Floor, Prolene Polypropylene Mesh 123, 72

Gynecare Secur, Tension Free Vaginal Tape 1, 4

Johnson & Johnson – Switzerland K974098 495

Mentor ObTape (K031767) 236

Sofradim Uretex TO, Avaulta Biosynthetic, Uretex Pubovaginal Sling/support kit, Bard Posterior Biosynthetic Support System, Pelvetex Polypropylene Mesh 64, 0, 27, 3, 0

*MAUDE (Manufacturer and User Facility Device Experience) data represents reports of adverse events involving medical devices received by the FDA.

Cases involving Kugel Mesh Hernia Patches involving hernia repair are also on the increase. Davol, Inc., a division of the C. R. Bard, Inc., in December 2005 issued a recall following reports that the patch memory recoil ring may not withstand stresses associated with specific surgical placement techniques. The recall extended into 2006 and a law suit was filed against this product in December 2006.

Expanded recalls into 2007 were related to memory recoil ring breaks that had caused bowel perforation, bowel obstruction, internal pain, internal fistulas, migration through the abdominal wall, and additional surgery for repair or removal of mesh, blood clots, and death caused by septic shock. A case of acute heart attack secondary to surgery for bowel fistula repair was caused by perforation from the broken memory recoil ring.

Infertility has been reported secondary to a fibrotic reaction to mesh used in surgery for repair of inguinal hernia.

Some studies report that there can be a systemic allergic reaction to polypropylene mesh used in surgical treatment. These studies found too that Polytetrafluoroethylene (PTFE - fluoride) coated mesh, DuPont’s synthetic fluoropolymer of tetrafluoroethylene, may cause a greater risk.

Many researchers determined that skin patch tests should be conducted on patients in a timely manner before undergoing any surgery using polypropylene materials.

Davol and Bard were later involved in an FDA criminal investigation related to the sale of counterfeit surgical mesh kits containing flat sheets of polypropylene.

Between 2002 and 2006 Davol sold approximately 32,000 kits worldwide. In 2005 mesh kit sales generated $11 million for this firm.

In September 2011 the FDA called for the Obstetrics & Gynecology Devices Advisory Committee to discuss the issues related to the use of surgical mesh for treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

The panel discussed the use of surgical mesh and its risks and benefits based on the literature and adverse reporting data (MAUDE).

Comments were taken about proposed FDA premarket and post market regulatory strategies for surgical mesh use in POP and SUI, and reclassification from Class II into Class III.

The goal of the panel is to assist FDA in determining whether there is need for additional clinical studies (premarket and/or post market) on surgical mesh use, based on data from the published literature and the MAUDE database. 

Perhaps as we move in to the future more careful consideration will be given to evaluation based on other than journal articles and adverse reporting data.

This article is part of a consumer health education series written by Gayle Eversole, DHom, PhD, MH, NP, ND, of Creating Health Institute, in collaboration with Chaffin Luhana LLP

The views expressed in this article are solely those of the author, Gayle Eversole.

Transvaginal Mesh 1

http://naturalhealthnews.blogspot.com/2011/10/fda-slow-to-take-action-on-vaginal-mesh.html


http://naturalhealthnews.blogspot.com/2009/03/transvaginal-mesh-and-womens-health.html


http://naturalhealthnews.blogspot.com/p/womens-health-transvaginal-mesh.html


http://leaflady.org/mesh2.htm

Chickenpox (Varicella-zoster) Virus Information

What is chickenpox?
Chickenpox is a common illness that causes an itchy rash and red spots or blisters (pox) all over the body. It is most common in children, but most people will get chickenpox at some point in their lives. Even if they have been vaccinated.

Chickenpox usually isn't serious in healthy children. But it can cause problems for pregnant women, newborns, teens and adults, and people who have immune system problems that make it hard for the body to fight infection.

After you have had chickenpox, you are not likely to get it again. But the virus stays in your body long after you get over the illness creating a natural immunity to further infections.

What causes chickenpox, and how is it spread?
Chickenpox is caused by the varicella-zoster virus. It can spread easily. You can get it from an infected person who sneezes, coughs, or shares food or drinks. You can also get it if you touch the fluid from a chickenpox blister.

A person who has chickenpox can spread the virus even before he or she has any symptoms. Chickenpox is most easily spread from 2 to 3 days before the rash appears until all the blisters have crusted over.

You are at risk for chickenpox if you have never had the illness.  If someone you live with gets chickenpox, your risk is even higher because of the close contact. Even if you have had the vaccine, you should treat chickenpox with caution as the vaccine does not protect 100% and weakens over time.

What are the symptoms?
The first symptoms of chickenpox often are a fever, a headache, and a sore throat. You or your child may feel sick, tired, and not very hungry. The chickenpox rash usually appears about 1 or 2 days after the first symptoms start. Some children get the chickenpox rash without having a fever or other early symptoms.

It usually takes 14 to 16 days to get the symptoms of chickenpox after you have been around someone with the virus. This is called the incubation period.

After a chickenpox red spot appears, it usually takes about 1 or 2 days for the spot to go through all its stages. This includes blistering, bursting, drying, and crusting over. New red spots will appear every day for up to 5 to 7 days.

You or your child can go back to work, school, or day care when all blisters have crusted over. This is usually about 10 days after the first symptoms start.

Other illnesses can have symptoms like those of chickenpox. For this reason, you may think you have had chickenpox twice when instead you have had two different infections.

How is chickenpox diagnosed?
Your doctor will ask you about your symptoms and will examine you. This usually gives your doctor enough information to make a proper diagnosis.

Healthy children with chickenpox symptoms may not need to visit a doctor. You may be able to describe your child’s symptoms to the doctor over the phone. Then your child won't have to leave the house and risk spreading the virus to others. But it is important to check with your doctor to find out if he or she wants to see your child.

Teenagers, adults, pregnant women, and people with health problems need to see a doctor for chickenpox. This is especially important for pregnant women, since chickenpox during early pregnancy can cause birth defects. Call first to make an appointment and to discuss whether you need to take any steps to avoid spreading the virus when you arrive.

Battling Bacteria or Boosting Superbugs

Once again we learn that another bacteria is on the rise and its leading to resistant infection.

I've asked the Infectious Disease Society to apprise me of status regarding using novel method to halt this before it becomes another base for death reports a la Morbidity & Mortality reports.

Be observant for fluroquinolone Rx, these fluoride based antibiotics have some severe side effects.

Bad Bugs Don't Need Drugs - They need courageous pratitioners who are willing to try my protocol and who dare to think outside the box.

I'll keep you posted.

Public release date: 30-Jul-2010
http://www.idsociety.org/Content.aspx?id=16864

Contact: John Heys
jheys@idsociety.org
703-299-0412
Infectious Diseases Society of America

Emerging E. coli strain causes many antimicrobial-resistant infections in US

The new strain, ST131, was a major cause of serious antimicrobial-resistant E. coli infections in the United States in 2007, researchers found. This strain has been reported in multiple countries and encountered all over the United States. In the study, researchers analyzed resistant E. coli isolates collected during 2007 from hospitalized patients across the country. They identified 54 ST131 isolates, which accounted for 67 percent to 69 percent of E. coli isolates exhibiting fluoroquinolone or extended-spectrum cephalosporin resistance.
"If we could discover the sources of this strain, the transmission pathways that allow it to spread so effectively, and the factors that have led to its rapid emergence, we could find ways to intervene and possibly slow or halt this strain's emergence," said study author James Johnson, MD, of the VA Medical Center in Minneapolis.
In the past, highly virulent E. coli strains usually have been susceptible to antibiotics, while highly resistant strains have been fairly weak in terms of their ability to cause disease. The susceptible strains were easily treated even though they caused serious infections, while the resistant ones tended mostly to affect only weakened or vulnerable individuals. Now, the study's findings suggest, the ST131 strain has appeared with a high level of virulence and antimicrobial resistance.
"If this strain gains one additional resistance gene," Dr. Johnson added, "it will become almost untreatable and will be a true superbug, which is a very concerning scenario."

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Founded in 1979, Clinical Infectious Diseases publishes clinical articles twice monthly in a variety of areas of infectious disease, and is one of the most highly regarded journals in this specialty. It is published under the auspices of the Infectious Diseases Society of America (IDSA). Based in Arlington, Va., IDSA is a professional society representing more than 9,000 physicians and scientists who specialize in infectious diseases. For more information, visit www.idsociety.org.

The Lymphatic System - Offers Protection from Infection and More

The lymphatic system is primarily known for its ability to protect the body from infection. However, it has other functions, from maintaining fluid balance to the absorption of fat.

Diseases and problems with the lymphatic system can impede the body's ability to protect against infection. Moreover, one of the worst prognoses to receive, is that cancer cells have migrated and spread into the lymphatic system.

To read the entire article:

http://generalmedicine.suite101.com/article.cfm/the_lymphatic_system#ixzz0nsMlLR7P

The copyright of the article The Lymphatic System in General Medicine is owned by Linda Mundorff. Permission to republish The Lymphatic System in print or online must be granted by the author in writing.