Surgical Mesh: The Ten Year Window

The Ten Year Window

 

If you are experiencing problems because of mesh please consider

looking  to our colleague, Linda Kilpatrick, for more information and support, 

Bladder Sling Surgery Blog

Mesh Medical Device News Desk

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

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."

###

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.

Merck vaccine trail increased infection risk

This article points out vaccine failure. I reported on this blog at the time this report was first made. Now there is room for an update.

This experimental HIV vaccine was a Merck product, not unlike the Gardasil vaccine that is known to have caused death and higher risk of disease, without real promise of effectiveness, and no long term studies.

With advertising and marketing Merck and the FDA have made a killing of sorts, at the bank. This might be a good analogy for those of us that keep trying to explain that vaccines aren't all they are built up to be. They do make people sick.

And here's my opportunity to make another plug for the trial I'd like to run with supplements to show they can stop the conversion of HIV to AIDS.

If Bill Gates won't give me a grant perhaps Merck will. Just wish Sir Elton would read this, I'd like his money better. William and Harry might come through so we can dedicate this to their Mum.

Experimental HIV vaccine may have increased infection risk
Mon Nov 3, 2008
WASHINGTON (AFP) – Trials of a once-promising experimental HIV vaccine were cut short in 2007 because the drug may have increased the likelihood of HIV infection rather than preventing it, according to a new study.

The HIV-1 vaccine, which raised hopes in the fight against AIDS as it was being developed by US pharmaceutical giant Merck and Co., was undergoing second stage trials when the problem was discovered in September 2007, said researchers at the Montpellier Institute of Molecular Genetics in France.

The vaccine relied on a modified form of a common cold virus -- Adenovirus 5 (Ad5) -- to carry elements of HIV (Human immunodeficiency virus) into the body.

The smaller HIV parts, the Merck trials contended, would trigger the human immune system to start fighting off later infection with the virus.

One of main worries about the approach was that widespread immunity to the vaccine might cause the drug to be rejected by the body before an effective anti-HIV response could develop.

But three years after the first trial, researchers discovered that more of the vaccine recipients who had prior immunity to the Ad5 virus had been infected with HIV than those not exposed to the vaccine, according to the study, published online in the Journal of Experimental Medicine.

The presence of long-lasting antibodies specifically catering to the Ad5 virus, generated during natural infections with the common cold, could have altered the response to the HIV vaccine, the study said.

HIV infection spread through cell cultures three times faster in the presence of antibodies from individuals immune to the Ad5 virus, because the HIV virus came in contact with more of its preferred "T" cells -- prompted to grow by the vaccine -- to infect.

The study said the vaccine reached the second phase of its trials because primates, used in the first phase, do not naturally come into contact with the human common cold, so the problem went unrecognized.

The vaccine prototype was tested on 700 HIV-negative persons in five hospitals in South Africa between February and September 2007, in the first clinical HIV trial of its magnitude ever conducted in Africa.

Meanwhile, tests had been conducted since 2004 in the United States, Australia, Peru, Brazil and Puerto Rico.

HIV can lead to acquired immunodeficiency syndrome (AIDS).

According to the World Health Organization, 33 million people around the world are infected with the AIDS virus, mostly in the sub-Sahara Africa.

Some two million people died worldwide of AIDS in 2007.

Copyright © 2008 Agence France Presse.

Flu deaths? Now really

The argument proferred here makes little sense.

Flu is caused by a virus. Pneumonia is more likely than not bacterial in origin. Staph aureus is a bacteria.

The "hard-to-treat complications" are not eneumerated so we cannot determine what might connect these to flu virus. I also don't quite follow the connection from flu to staph infection. Perhaps this is from wrongly administered antibiotics that do not treat a virus.

There are many serious problems with flu vaccines and this is a poor argument to convince you to take this jab.

You should be asking many more questions rather than follow blindly.

More vitamin C, vitamin A and home made chicken soup with garlic, onions, and carrots just might give you more of a healthy boost than a drug. Years ago it was proven that chicken soup did fight colds and flu because of the amino acid cysteine found in goodly amounts in the soup.

The idea of chicken soup must be a good one because its being given to some young pandas in china to help them boost their immune systems.

Jump seen in staph-linked flu deaths in kids
By LINDSEY TANNER, AP Medical Writer, Mon Oct 6, 2008

More children have died from flu because they also had staph infections, according to a new government report that urges parents to have their kids get the flu shot.

The number of deaths wasn't high — 73 during the 2006-07 flu season — but there was more than a fivefold increase in hard-to-treat complications. And preliminary figures indicate deaths rose again during this past winter's flu season.

Public health officials say the numbers underscore the importance of a brand new recommendation that all children, from 6 months through 18 years, get routine flu shots. Before this year, shots were recommended for kids under 5 years.

More than half the children who died were between ages 5 and 17 and had been healthy until they got the flu.

Parents shouldn't panic, "but it's an important message to say even healthy children develop complications and die almost before anything much can be done for them," said Dr. Gregory Poland, a Mayo Clinic infectious disease specialist. He was not involved in the federal study, but has worked with a federal vaccine advisory committee and has consulted for vaccine makers.

Flu season is just beginning, and this year's vaccine should be widely available this month.

While few children die from the flu virus, it puts about 20,000 U.S. kids in the hospital each year.

Only 6 percent of the children studied who died had been fully vaccinated against the flu. Two doses are recommended each flu season for children ages 6 months to 8 years who have not been vaccinated previously; for older kids, just one dose a year is needed.

The study, appearing in the October edition of Pediatrics for release Monday, is based on an analysis of reported flu deaths from the 2004-05 through 2006-07 seasons. Flu deaths in children during those seasons totaled 47, 46 and 73, respectively.

The percentage of those who also had bacterial infections jumped from 6 percent to almost 36 percent. Most had staph infections, and 60 percent of those involved the dangerous MRSA bug, which is resistant to antibiotics.

More recent data suggest flu deaths among children have continued to rise, with 86 tallied for the 2007-08 season in a preliminary report last month, said Lyn Finelli, the study's lead author, who is a researcher for the Centers for Disease Control and Prevention.

Preliminary information also suggests there has been no drop in fatal flu-staph cases in children, and those could still be on the rise too, she said.

Staph germs commonly live in the nose or skin without causing illness; more than one-fourth of U.S. children and adults carry them.

These bugs can become deadly when they get into the bloodstream, sometimes through wounds. The flu is thought to make people more susceptible to bacterial infections like staph, Finelli said.

Details on how children in the study died were not available, but some developed bacterial pneumonia, seizures and shock.

Finelli said parents should take children to the doctor when they have flu symptoms and signs of other complications. These could include extreme fatigue, no thirst, or in older children complaints about feeling very ill.
___

On the Net: American Academy of Pediatrics: http://www.aap.org
CDC: http://www.cdc.gov
Copyright © 2008 The Associated Press.