15 Januari 2012

Native Evergreen Conifers in North Georgia

As a companion piece to my posts last year on Winter Twigs and Leaf Identification, this post gives some tips for learning how to identify some of the more common native evergreen conifers that grow in north Georgia.  As you may know, not all evergreens are conifers (think of hollies and rhododendrons), and not all conifers are evergreen (think of bald cypress). But since most conifers ARE evergreen, we've got a few things to work with here.

Blue-green foliage of white pine



Tsuga, hemlock










In the great kingdom of Plantae, conifers in Georgia are found in the Division Coniferophyta, in the Class Pinopsida, and in the Order Pinales, which has five families.  And within the Pinales Order, only two families are represented in Georgia: Cupressaceae and Pinaceae.  That is to say, there aren’t many conifer families in Georgia!  Of note: we are just outside the natural range of Abies (fir) and Thuja (arborvitae).




Tsuga canadensis foliage
The Pinaceae family is where most of Georgia’s evergreen conifers reside yet it is represented by just 2 out of the nine genera here: Pinus and TsugaTsuga, known as hemlock, has two species: Tsuga canadensis is more prevalent than Tsuga caroliniana.  Hemlock is very shade tolerant and is generally found in mountain communities, but it does fairly well in gardens as well.

Hemlock is easily noted by its flattened, short needles; it's graceful, drooping form; and by the tiny, flexible cones it produces. The needles are single and are two-ranked along the stem, meaning they reside in a horizontal plane.



Pines have round needles that surround the stem (not two-ranked), often lose their lower branches over time, and have stiff cones that sometimes have prickles.  The needles are arranged in bundles along the stem.

With the common pines of north Georgia I find that looking at the needles is the quickest way to make an identification.  If you were to look at a list of the pines (Pinus spp.) that are native to Georgia, this might seem a little daunting. But if you live in north Georgia like I do, there are really only four and, with just a little help, I think you can learn to tell them apart.  If you live elsewhere, perhaps you can pick some tips on how to identify them in general.

The four pines that you are likely to find in north Georgia are: Pinus echinata (shortleaf pine), Pinus strobus (eastern white pine), Pinus taeda (loblolly pine), and Pinus virginiana (Virginia pine).  The needles are arranged in bundles within a fascicle at the base of a bundle, so you need to examine how many there are, how long they are, and if they are straight or twisted.

From top to bottom, the picture above shows:

loblolly (usually 3 needles per bundle, length is 5-8 inches); 
eastern white pine (5 needles per bundle, color is bluish-green); 
shortleaf pine (2-3 needles per bundle, length is 3-4 inches); 
Virginia pine (2 needles per bundle, needles are short and twisted).



Below are some pictures of the cones:
Pinus taeda: large cones with prickles

Pinus strobus: long cones, no prickles

Pinus echinata, short cones stay on
tree; small prickle

Pinus virginiana, short cones stay on
tree but prickle is long and sharp























White pine branches




White pine does have one interesting growth characteristic - the branches tend to encircle the tree, like spokes on a wheel. So, if the branches are intact, you might be able to confirm it by looking at the trunk.

By the way, pines do lose their leaves (that is, their needles), just not all at once.  The loblolly pines in my yard drop some needles in the fall, about the same time that deciduous trees are dropping theirs too.






The Cupressaceae family is represented by 3 genera in Georgia: Chamaecyparis, Juniperus, and TaxodiumTaxodium, a genus perhaps most familiar to people by the species Taxodium distichum (bald cypress), will not be covered here because it is deciduous (a trivia question for your family: "Name a deciduous conifer"). Chamaecyparis is represented in Georgia by Chamaecyparis thyoides (Atlantic white cedar) but that is not indigenous to north Georgia (although people do grow it here). That leaves us with Juniperus virginiana which is found throughout Georgia; however, it is best known by its common name, eastern redcedar.  People are often surprised when you tell them it is a juniper.

I learned something when I was researching Juniperus virginiana for this article.  I was certainly familiar with the plant - it grows everywhere around here, and I've dug up many a small one. However, I had not seen one with fruit so I decided to try and find one.  I looked at a lot of trees before I found one, but I was puzzled when I did.  The foliage didn't look right.  As I dug into my references a little deeper, I found the answer.  The mature foliage is different!  Juvenile foliage is needle-like and prickly - what I was used to seeing; the mature foliage is "awl-like" and scaly with overlapping sections - not prickly.

Berries and mature foliage, Juniperus virginiana
Juvenile foliage, Juniperus virginiana


It is also curious to think that junipers have berries - why would a conifer have berries instead of cones?  Well, the "berries" are actually cones with fleshy scales that have fused together, creating the appearance of a berry.









So now that you know a little bit more about identifying these plants, spend some time outside practicing your identification skills.  Those fragrant green trees with needles are not all alike; the differences are there for you to discover.





Good tree identification references for the southeastern U.S.:

Native Trees of the Southeast: An Identification Guide by Kirkman, Brown and Leopold
Woody Plants of the Southeastern United States by Ron Lance
Guide to Southern Trees by Harrar and Harrar (Dover publication) – you can get this used on Amazon for as little as $1.50 plus shipping; it’s a great starter for young people and the line drawings are excellent.

11 Januari 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: http://www.philly.com/philly/wires/ap/news/nation/washington/20120109_ap_fdastepsuptestingforfungicideinorangejuice.html?c=r#ixzz1j4wTMrqo
If you go in the archives at www.leaflady.org, 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. ...

10 Januari 2012

Why I Will Not Buy a Keurig Machine

I promise never to write a post urging you to give up your morning coffee. I don't much care about calcium or Vitamin C depletion, adrenal stress or whatever else is said about the effects of coffee. We all have limits and that's mine. And no, decaf doesn't cut it. I have no intention of giving up coffee-EVER. For sure, too much coffee makes me jittery and way too much coffee makes me paranoid. But one to two cups (read 8-16 ounces) is fine for my system to handle. The gurgling of my coffee pot at 5 am when the rest of the lights are off in my house, it is as comforting a sound as 'I love you'.

Recently though it seems that everyone I know has been throwing away their traditional coffee pots for the new-fangled brew-one-cup-at-a-time Keurig machines. My office invested in it. All of my family has switched. I heard of so many folks at work who have them at home and they all love them. Then this past weekend my husband turned to me and said he just HAD to have one. Last straw, people.

If you don't know about Keurig, they produce coffee machines that brew coffee one cup at a time. Their sell-in is no carafe, no parts to clean and each cup is perfectly fresh brewed. But I can't do it. I won't buy one. Besides being expensive, there is nothing actually wrong with my current machine. And replacing a perfectly good machine with another more expensive one that doesn't produce anything different doesn't make sense to me.

When I asked DH why he wanted to get the machine he said it was because we waste too much coffee. I do make too much. I throw away 2-3 cups of coffee most days. I make it because some days we DO drink it all. And I am a girl of routine, I make the same amount everyday, weekday or not. But the waste argument got me. Coffee grinds are one of the most biodegradable things out there. They'll mush up into soil in a few weeks. And you can even include them in your compost. But Keurig coffee comes in these little K-Cups or plastic capsules containing coffee grinds. The machine punches holes in the top and bottom of the K-Cup and your coffee is brewed right in there before passing through a filter and into your cup. So now instead of flimsy paper filters and compostable coffee grinds going in the garbage every morning, we have more bits of plastic that will be with us in 1000 years. Awesome. Which machine is more wasteful? Why are we worried about wasting coffee that you just pour down the drain when the Keurig creates plastic garbage that won't break down?

I told my DH that under no circumstances would we buy a Keurig machine. I told him I would make less coffee every morning if he had an issue with our coffee waste.

But also I have other issues eith the machine. I can't find the country of origin on the K-Cups. I don't know the quality of the coffee. I can't grind my own beans. I don't know how fresh the coffee is. And although they offer organic, can I guarantee that it is fair trade? And lastly, when I brew coffee with near boiling water inside a small plastic cup designed for disposibility (and cheapness), well I would imagine that some of that plastic ends up my cup of coffee. Does Keurig use BPA or other dangerous chemicals in the plastic of their K-Cups? Do you know? Yummy goodness.

Late adapters unite!! What was really wrong with our old coffee pots? Don't waste your money. Keep your old machine.

**FYI, Thank you toall the great commentors. YES-Keurig does make a refillable K-Cup. And all K-Cups have been BPA free since mid 2010. However....that doesn't really solve problem that Keurig machines are expensive and my current machine ain't broken. Thanks everyone for contributing! Keep the comments coming!

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 ...

8 Januari 2012

Frost Flowers

I had a chance this week to find something quite unusual in my yard - frost flowers.  They are not true flowers, and it takes a special event in Georgia to produce them: good moisture in the ground and it's got to get COLD.  I like the explanation in Wikipedia so much that I will paste it here verbatim:

"The formation of frost flowers, also known as "ice flowers," is dependent on a freezing weather condition occurring when the ground is not already frozen. The sap in the stem of the plants will expand (water expands when frozen), causing long, thin cracks to form along the length of the stem. Water is then drawn through these cracks via capillary action and freezes upon contact with the air. As more water is drawn through the cracks it pushes the thin ice layers further from the stem, causing a thin "petal" to form."

Late summer flowers, Cunila origanoides


I learned about this condition only recently by way of a friend in the Georgia Native Plant Society.  She called it "crystallofolia" and provided some pictures of dittany (Cunila origanoides) in her yard exhibiting the condition.  Another friend used those pictures to write an article about it for the January newsletter.  Still - I didn't expect to see it myself.  We've had some warm weather lately but earlier this week it got very cold - below 20 overnight!

After a tip from my friend Jane that she found some in her yard, I went outside to look. Bingo!  My dittany had frost flowers too!

While this oozing, freezing, "flowering" event is very exciting, photographing it is so not easy!  Here is a picture of the frost flowers in my yard:

Cunila origanoides

A much better picture belongs to my friend Jane - she sent me this picture of the frost flowers on her Joe-Pye weed (Eupatorium sp.):

Eupatorium sp.

This subject is a popular topic this week due to the cold snap throughout the eastern U.S. Gail over at the blog Clay and Limestone also has a post on this with some very excellent pictures of Verbesina virginica from Tennessee.

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.


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.


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

7 Januari 2012

FDA slow to take action on vaginal mesh

UPDATE: 24 January 2012



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

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


How FDA Approved Mesh 


Graphic Courtesy of Patrick

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

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