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Saturday, January 28, 2012

Rapid Aging and EMF Exposure

Selections from Natural Health News

Jul 15, 2010
Real EMF Danger. Vatican radio waves blamed for high cancer risk ... Posted by herbalYODA at 15:49 · Email ThisBlogThis!Share to TwitterShare to Facebook. Labels: cancer and EMF, EMF. 1 comments: West Coast Family ...
Jun 05, 2010
(CNN) -- San Francisco, California, likely will become the first U.S. city to require cell phone companies to disclose how much radiation their gadgets emit. The city's board of supervisors voted 10-1 on Tuesday in favor of a law ...
May 01, 2010
MAY IS ELECTROSENSITIVITY MONTH, many states are promoting this as a health education event. Cell Phone Radiation Levels · FCC Consumer Resources: Wireless Devices Even though some people who submit ...
Feb 14, 2009
Quite a few years ago I presented a program to some nurses in Lewiston, Idaho focused on the health impact of EMF and a coming storm of health problems that would be - more likely than not - unable to be diagnosed by ...

Wednesday, January 18, 2012

Money: Who Gets Healthcare at What Cost

5% of Americans Made Up 50% of U.S. Healthcare Spending

And the top 1%? They made up one fifth of medical expenditures.

from The Atlantic

"When it comes to America's spiraling health care costs, the country's problems begin with the 5%. In 2008 and 2009, 5% of Americans were responsible for nearly half of the country's medical spending.

Of course, healthcare has its own 1% crisis. In 2009, the top 1% of patients accounted for 21.8% of expenditures.

The figures are from a new study by the Department of Health and Human Services, which examined how different U.S. demographics contributed to medical costs. It looked at the $1.26 trillion spent by civilian, non-institutionalized Americans each year on health care.
The top 5% of spenders paid an annual average of $35,829 in doctors' bills. By comparison, the bottom half paid an average $232 and made up about 3% of total costs.
Aside from the fact that such a tiny fraction of the country was responsible for so much of our expenses, it also found that high spenders often repeated from year to year. Those chronically ill patients skewed white and old and were twice as likely to be on public healtcare as the general population.
The graph below looks at how many people remained in each tranche of healthcare spending in both 2008 and 2009. One fifth of the top 1% of healthcare spenders in 2008 also were in the top 1% a year later. More than a third of those in the top 5% stayed there both years.
According to this follow-up chart, elderly patients, aged 65 or older, made up 13.2% of the population in 2009. But they were 42.9 of the patients among the top 10% of spenders in both 2008 and 2009. Middle-aged Americans made up another 40.1% of that category.
America's healthcare spending crisis is a concentrated phenomenon. The challenge isn't just about making everybody's insurance cheaper (although that would be nice). It's about figuring out how to cut costs, wisely and fairly, for the disastrously ill and preventing diseases before they become chronic. This is America's 5% problem."

My view is that we have moved so far from prevention that it will take years before this urgently needed philosophy returns to US health care process.

Doctors Required to Report Payments from Drug and Device Firms

UPDATE: 26 January
Dialing for Doctors - 

18 January
To head off medical conflicts of interest, the Obama administration is poised to require drug companies to disclose the payments they make to doctors for research, consulting, speaking, travel and entertainment.
Many researchers have found evidence that such payments can influence doctors’ treatment decisions and contribute to higher costs by encouraging the use of more expensive drugs and medical devices.
Consumer advocates and members of Congress say patients may benefit from the new standards, being issued by the government under the new health care law. Officials said the disclosures increased the likelihood that doctors would make decisions in the best interests of patients, without regard to the doctors’ financial interests.  

Tuesday, January 17, 2012

Energy Drinks

UPDATE:15 January 2012

Once again energy drinks are in the news and it appears that it isn't good (no surprise!).
Agence France-Presse reports that "Australia experts call for energy drink warnings".

We encourage you to check out the almost two dozen articles we have posted on Natural Health News about this subject .  We also invite you to consider our organic natural herbal blend, herbalYODA's sportZtea, in place of these drinks over loaded with caffeine, artificial flavoring, artificial coloring, and worst of all artificial sweeteners like aspartame, acesulfame K, and Splenda.  The sports food bars are not far off with too much sugar and too many GMO ingredients.
Learn more here and here.

Researchers in Australia called for health warnings on caffeine-loaded energy drinks following a spike in the number of people reporting medical problems after drinking them.
Health professionals from the University of Sydney's Medical School and the New South Wales Poisons Information Centre said reports of adverse reactions to drinks like Red Bull and V jumped from just 12 in 2004 to 65 in 2010.
Over the seven years to 2010, 297 calls for assistance were recorded with at least 128 people hospitalised with symptoms including heart palpitations, agitation and stomach upsets.
Of these, 20 people had more serious issues, such as seizures and hallucinations.
The study, published in the Medical Journal of Australia on Monday, said the average person affected was 17 years old and that they often mixed energy drinks with alcohol.
"Our study demonstrates the extent of the growing problem in Australia with energy drink consumption and toxicity, particularly among adolescents," the study's authors wrote.
"Given the clear evidence of toxicity and the growing number of hospitalisations associated with consumption of energy drinks... health authorities should increase awareness of the problem, improve package labelling and regulate caffeine content."
They recommended that "labelling and any marketing of these products should include appropriate health warnings and the national poisons hotline number". A can of energy drink may contain up to 300 milligrams of caffeine -- compared to an average 65-120mg for a cup of drip coffee -- and Poisons Centre medical director Naren Gunja called for more thorough regulation.
"Things to look at would be... how much caffeine do these drinks contain, how many can you buy at once, what age should you be when you buy them, should there be an age limit to being sold the drinks," he said.

Originally posted September 2008

Five years ago I released one of my long used herbal formulas on two college campuses to try to provide help to reduce college binge drinking. My formula makes it so you just don't drink too much, and certainly not enough to get drunk.

Learning that many people mix energy drinks with alcohol is also a concern to me.

In addition to the herbs to help stem the tide of drinking, and in relation to developing my sports enhancement formula (ADVENTURX), I revived the sports drink herbal blend I used to mix up for my kids and others years ago.

You can use my organic, herbal 'sportZtea' blend as the basis for your sports drinks while saving money and avoiding stimulants and caffeine. Using the 'tea' with ADVENTURX makes a lot more sense.

Energy drinks: What you need to know
By David Liu, Ph.D.
Sep 28, 2008
Editor's note: Please note that the statement "Energy drinks are soft drinks (meaning with alcohol) that ---" is incorrect. The author meant to say "Energy drinks are soft drinks (meaning without alcohol) that ---." By definition, soft drinks are non-alcoholic beverages! We apologize for the error.
Common Questions and Answers about energy drinks

What are energy drinks?

Energy drinks are soft drinks (meaning without alcohol) that contain caffeine and other stimulants such as ephedrine, guarana, and ginseng. The beverages may not contain more calories than normal soft drinks, but they are often believed to help enhance performance and boost alertness as some studies showed. Energy drinks are often marketed to people under 30, particularly to college students.

Is it true that energy drinks boost alertness and enhance performance?

At least two studies showed significantly improvements in mental and cognitive performance and increase subjective alertness in those who drank an energy drink. In repeated cycling tests in young healthy adults, an energy drink drastically increased upper body muscle endurance.

Are there any dangers to drinking energy drinks?

High doses of caffeine are known to pose a range of short-term side effects. The problem with energy drinks is probably that there is no regulation in the US about caffeine, which is a natural stimulant. Energy drinks may contain caffeine at a level anywhere between from 50 mg to 505 mg per can or bottle, according to a recent Johns Hopkins study. Without paying attention, people may over-ingest caffeine leading to unintentional caffeine intoxication. Normal adverse reactions induced by high doses of caffeine, particularly in those who are sensitive to the compound, include increased heart rate and blood pressure, in severe cases dehydration, and inability of falling into sleep.

One study showed side effects associated with caffeine in energy drinks include insomnia, nervousness, headache, and tachycardia. Four caffeine-related deaths and four seizures have been reported.

When should energy drinks not be used?

Energy drinks should not be used when exercising as fluid loss from sweating and the diuretic activity of caffeine can cause severe dehydration. Energy drinks should not be used in an attempt to offset the effect of alcohol on one's capability of operating a vehicle.

What would happen when energy drinks are combined with alcoholic drinks?

The real danger of caffeine to someone who is drinking is that caffeine could mislead him to believe that he is drinking the right amount of alcohol without realizing that actually he could have been drinking too much.

It is true that caffeine provide alertness. But it does not change the level of alcohol in the blood. Once the stimulant disappears, the depressant effect of the blood alcohol at high concentration would manifest leading to vomiting in one's sleep or respiratory depression.

Both energy drinks and alcohol can be very dehydrating and thus inhibiting the body's ability to metabolize alcohol and boosting the toxicity of alcohol and the hangover.

How safe is it to use energy drinks?

Energy drinks in itself are relatively safe. Most ingredients including ginseng, maltodextrin, inositol, carnitine, creatine, ginkgo biloba, taurine, vitamins and herbs appear to be safe. The only concern is probably caffeine, which varies in its content greatly from brand to brand.

A recent report authored by Reissig CJ, Strain EC, and Griffiths RR at the Johns Hopkins University School of Medicine and published in the Sep 20, 2008 issue of Drug and Alcohol Dependence calls for warning labels for energy drinks.

Tuesday, January 10, 2012

OJ? No Way

In the past few months there has been more flurry over commercially prepared orange juice on the tails of Dr Oz raising the arsenic flag for apple juice.

In this article by Alyssa Hamilton from 2009 she makes the case against OJ in the box.

It’s orange juice season. More precisely, it’s the season of the Florida Valencia, considered the “Cadillac of oranges” within the orange juice industry for its deep orange color, high juice content and rich orange flavor.
We’re so used to getting orange juice 365 days of the year that it may come as news that even Tropicana Pure Premium has a season. But it does.From March until June the Valencia is in its prime in Florida, and even Californians will admit that Florida grows a superior Valencia. The state produces a few other varieties for juicing. The Hamlin, which peaks in late fall, is the most heavily planted. But anyone who has anything to do with the manufacture of commercial orange juice knows that nothing compares to Florida Valencia juice.
The leading orange juice companies such as Tropicana (owned by PepsiCo), Minute Maid and Simply Orange (owned by Coca-Cola), and Florida’s Natural tell us many stories about orange juice: it’s natural, it’s pure and simple, it’s squeezed from oranges grown on pristine looking trees in Florida. But they leave out the details about how most commercial orange juice is produced and processed. SOURCE

Now we have the FDA ringing in on this issue over their 'concern' for fungicide in OJ coming from Mexico, Central and South America. (We warned you years ago about the problems with CAFTA.)

FDA steps up testing for fungicide in orange juice
By Mary Clare Jalonick
WASHINGTON - The Food and Drug Administration says it will step up testing for a fungicide that has been found in low levels in orange juice.
FDA officials said they aren't concerned about the safety of the juice but will increase testing to make sure the contamination isn't a problem. In a letter to the juice industry Monday, the agency said that an unnamed juice company contacted FDA in late December and said it had detected low levels of the fungicide carbendazim in the company's own orange juice and also in its competitors' juice. Fungicides are used to control fungi or fungal spores in agriculture.
Carbendazim is not currently approved for use on citrus in the United States, but is used in Brazil, which exports orange juice to the United States. An FDA spokeswoman said the company's testing found levels up to 35 parts per billion of the fungicide, far below the European Union's maximum residue level of 200 parts per billion. The United States has not established a maximum residue level for carbendazim in oranges.
In the letter to the Juice Products Association, FDA official Nega Beru said the agency will begin testing shipments of orange juice at the border and will detain any that contain traces of the chemical. Because it is not approved for use in the United States, any amount found in food is illegal.
Beru said that because the FDA doesn't believe the levels of residue are harmful, the agency won't remove any juice currently on store shelves. But he asked the industry to ensure that suppliers in Brazil and elsewhere stop using the fungicide.
"If the agency identifies orange juice with carbendazim at levels that present a public health risk, it will alert the public and take the necessary action to ensure that the product is removed from the market," he said.
The discovery comes after the agency said it would also step up testing for arsenic in apple juice. FDA officials said last year that the agency is considering tightening restrictions for the levels of arsenic allowed in the juice after consumer groups pushed the agency to crack down on the contaminant.
Studies show that apple juice has generally low levels of arsenic, and the government says it is safe to drink. But consumer advocates say the FDA is allowing too much of the chemical, which is sometimes natural, sometimes man made, into apple juices favored by thirsty kids.
Patty Lovera of the consumer group Food and Water Watch said the federal government needs to rely on its own testing, not that of the companies.
"The federal government needs to set consistent, meaningful, enforceable standards for all toxins," she said.

Read more:
If you go in the archives at, you'll note that we reported on fungicides in agriculture along with food wax and related topics well over a decade ago.

Little seems to change. 

Just better to juice your own, my dears.

Selections from Natural Health News

Natural Health News: GMO Coming to your Liquid Sunshine: OJ Alert
Dec 04, 2010
As former beauty queen Anita Bryant chirped more than four decades ago, in what remains a fondly remembered tagline: "A day without orange juice is like a day without sunshine." She wasn't talking about green oranges or ...
Dec 13, 2008
And I am just lucky enough to have some fresh squeezed organic Valencia orange juice that makes it much more delightful, as are the strawberries, lecithin and hemp, et al. I hope you enjoy yours! And now if you'd like to try ...
Apr 28, 2010
Carrots were the most common source of beta-carotene, oranges and orange juice the most common source of beta-cryptoxanthin, spinach the most common source of lutein/zeaxanthin, strawberries the most common source ...
Aug 16, 2010
Vitamin D fortifies a lot of foods, including milk, cereal and orange juice. And it's naturally found in wild-caught oily fish such as salmon and tuna. That suggests that most people get plenty of Vitamin D. But that's wrong. ...

Study links statins to higher diabetes again

For years, more than a dozen at least, I have been covering the statin drug issue. My focus has been to educate people about the serious risks of this drug class and to help them realize that what they are being told is not always correct.

Now, again, we have a new report on the fact that statins can raise your risk of getting diabetes.

In light of all the serious risks from this drug class perhaps you might wish to consider natural care approaches to the cholesterol conundrum.

An increased risk of diabetes among statin users was first seen in 2008, in a randomized controlled trial of the drug Crestor, says Vivian Fonseca, the American Diabetes' Association's president for medicine and science. A 2011 analysis in the Journal of the American Medical Association and a 2010 analysis in The Lancet also found an increased risk of diabetes among statin users.Complete article
Related Article and good interview

Find over 20 articles on this topic here at Natural Health News

In a related Atlantic article the writer says: "Long prescribed to reduce levels of cholesterol in the blood, high doses of statins might even end plaque build-up, according to researchers."  

Why would you want the risk and expense of a drug when natural health approaches will do the job for you.  Remember that arteriosclerosis did not appear on the scene until the beginning of the use of homogenization of milk in the 1950s.

Selections from Natural Health News

Nov 11, 2011
In the past, statins have said to help prevent pneumonia (infection in the lung) on the basis of epidemiological studies. However, it is generally the case that frail, elderly individuals, with perhaps complicated health histories ...
Sep 30, 2011
If you want to balance out your cholesterol, first check your thyroid, then evaluate triglycerides that are the real danger to your health, and get nutritional and lifestyle support. Health Forensics can help. Posted by herbalYODA ...
Mar 28, 2011
Now more studies shoe increased risk of diabetes among other health problems from statins. And the cookie cutter medicine machine wants YOU to take this drug if you have diabetes. Its doing the same as aspartame. ...
Nov 21, 2010
Again: Statins Not Effective. Statin drugs may be over-prescribed. So tell me what is new! Not only are they over-prescribed, they have heart-risky side effects and many more problems like kidney failure secondary to ...

Saturday, January 07, 2012

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, 

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.

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.

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.

Friday, January 06, 2012

FDA slow to take action on vaginal mesh

UPDATE: 24 January 2012
If you are experiencing problems because of mesh please consider
looking  to our colleague, Linda Kilpatrick, for more information and support, 

Dems call for Lap-Band, mesh probes ahead of MDUFMA re-authorization

Democrats in the U.S. House of Representatives are calling for a congressional probe into a pair of high-profile medical device products – Lap-Bands and vaginal mesh – as Congress gears up for hearings and a vote on re-authorizing the Medical Device User Fee & Modernization Act.
Capitol Hill
Democrats in the U.S. House, concerned about a pair of high-profile medical devices, want the Energy & Commerce Committee to open a probe into gastric band and vaginal mesh products. SOURCE

US House of Representatives recently has been visiting my series of articles on surgical mesh.  Find them all using our search window.
5 January 2012
FDA wants new studies on surgical mesh

WASHINGTON (Reuters) - U.S. health regulators ordered new safety studies for surgical mesh implants that are used to hold pelvic organs in place, citing a spike in the number of complications seen for female patients, including erosion and infection.The Food and Drug Administration also said it may reclassify the devices in a higher-risk category that would require manufacturers, such as Boston Scientific and a unit of Johnson & Johnson, to conduct clinical trials in people before receiving approval for sale.
The companies could not be immediately reached for comment.
The devices, made of synthetic or biological material, are commonly implanted in women to repair weakened or damaged tissue and provide support in cases of pelvic organ prolapse (POP). They are also used to help those with a severe overactive bladder known as stress urinary incontinence.
The FDA said it received more than 1,500 reports of complications related to the repairs with mesh from 2008 to 2010, including cases in which the mesh eroded into the vagina or caused bleeding and infection. The rate of problems was five times the rate reported from 2005 to 2007.
The FDA sent letters this week to 35 manufacturers of transvaginal surgical mesh, requesting three-year studies of several hundred women each to study side effects, as well as the women's overall quality of life.
In July, the agency warned that complications with the mesh were "not rare" and that transvaginal organ repair using mesh may put patients at greater risk than other surgeries and treatments.
The FDA also said it was concerned about scientific studies that show a lack of clinical benefit from surgical mesh, compared to non-mesh repair.
About 75,000 women received mesh repairs for pelvic organ prolapse in 2010 and about 200,000 women received transvaginal repairs for stress urinary incontinence.
The agency is asking for more studies from companies that sell the mesh for POP surgery. In the case of mesh used to correct an overactive bladder, the FDA is seeking further study of use of a so-called "mini-sling," when strips of material are used around the bladder neck and the urethra.
During their lifetime, 30 percent to 50 percent of women may experience POP, with two percent developing symptoms. The condition happens when tissue that holds the pelvic organs in place becomes weak or stretched and bulges into the vagina.
Surgery to support prolapsing organs can be done through the abdomen or the vagina, either with stitches or also with surgical mesh for reinforcement.
Surgical mesh has been used since the 1950s to repair abdominal hernias, but doctors only started using the mesh for POP and stress urinary incontinence in the 1990s, a procedure that has grown in popularity.
Companies that wanted to make the mesh specifically for POP or urinary incontinence could submit their application under a 510(k) accelerated review application that did not require them to do clinical trials in people, as long as they could show their implants were similar to devices already on the market.
But during a panel meeting in September, outside advisers to the FDA recommended that the agency reclassify the devices for POP to require companies to submit additional studies. The FDA said it is considering their advice.
Jeffrey Grand, a lawyer at Bernstein Liebhard in New York, is representing women who are suing companies that make the transvaginal mesh, with a case going to trial later this year.
"These things were basically put on the market without any significant safety testing," Grand said. "I'm hoping that all of this brings about some regulatory changes."

In September 2011 the FDA convened a conference on the use of TV mesh and the consideration for changing its device classification to a more stringent one.

Now the FDA is calling for comments regarding its process of classifying its own process.  You can read more about this here... 

FDA Public Health Notification: Official 2008 warning from the FDA

Serious Complications Associated with Placement of Surgical Mesh 

in Repair of Pelvic Organ Prolapse and Stress Urinary Incontinence 

What to consider before choosing surgery -

Alternatives to the laparoscopic Burch and/or paravaginal repair procedures include the following:

  • do nothing and continue to experience the loss of urine
  • medical (non-surgical) treatment
  • lifestyle modification: quit smoking, lose weight, allergy treatment
  • Kegel’s exercise: regular contraction of the muscles that allow you to stop urine in mid-stream may reduce or eliminate incontinence
  • pessary use: usually a donut-shaped rubber or plastic device inserted into the vagina to support the bladder
  • hormonal (estrogen) replacement therapy
  • treatment with medication helps certain types of incontinence
  • other surgical procedures including
    • the so-called anterior repair (performed from a vaginal approach),
    • other procedures performed in the space between the bladder and pubic bone (may be done at laparoscopy or through a large incision at laparotomy),
    • sling procedures usually done with an incision in the vagina and a 1-2" incision at the pubic hairline,
    • collagen injection (injection of a natural glue-like substance into the bladder neck), and
    • InterStim® - a nerve stimulator is surgically placed to reduce bladder irritability

Many times using a combination of several forms of treatment results in the best treatment for incontinence and paravaginal defects (such as losing weight, stopping smoking, taking estrogen replacement, performing Kegel’s exercise, and having the Burch procedure). If you have any questions regarding the above or any aspect of the proposed surgery, be sure to discuss them with your physician. SOURCE

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Latest News on Device Approval from Congress, 13 December, 2011