The vaginal mesh complications in U.S have hurt 100's of women. This may be the largest mass dangrous product to date. Women call the helpline with hoorific stories on a daily basis. The FDA must not accelorate the approval process of Medical devices. The latest recall of breast implantas in Europe is a message that should be listened to.

New York, NY (PRWEB) January 24, 2012 Over the past year, proponents of an accelerated process for procuring FDA approval of high-risk medical devices have been citing the European Union’s process for approving medical devices as a model plan, aJanuary 19 Bloomberg Article states. The EU’s approval process–which allows complex medical devices to reach the European market an average of two years sooner than they reach the U.S. market–is luring device manufacturers away and is consequently contributing to the country’s high unemployment rate, medical device industry supporters argue.

The breast implant debacle in Europe, which involves the removal of thousands of potentially faulty implants manufactured by the now-defunct French company Poly Implants Protheses SA, has heightened scrutiny of the EU’s medical device approval process, however. The European breast implant problem therefore should make U.S. regulators realize that it would be unwise to adopt an accelerated medical device approval process similar to the one in place in Europe, according Carl Heneghan, an Oxford University teacher who has studied device recalls and is cited in the Bloomberg article.

“All the industry guys in the U.S. say, ‘we should have access to these products much sooner, like in Europe,’” the Bloomberg article quotes Heneghan as saying. “The flip side is, the European people are being used as guinea pigs.”

The importance of subjecting medical devices to comprehensive FDA reviews before those devices are approved for sale has been highlighted in recent months by the thousands of U.S. women who have suffered injuries as a result of vaginal mesh implants. Categorized by the FDA as medical devices that the agency can clear for sale based on similarity to medical devices already on the market and without the benefit of human testing, the implants have so far spawned more than 650 lawsuits filed by patients alleging that they have been significantly injured as a result of having mesh products implanted transvaginally. Articles on abc news and on local news explain the FDA approval process that cleared vaginal mesh for sale, and the tribulations of women who are suffering injuries as a result of vaginal mesh and are filing lawsuits to recover for those injuries. Women must be protected for these drugs and medical devices

About Pelvic Prolapse, Vaginal Mesh Helpline

The uterus is held in position by pelvic muscles, ligaments and other tissues. If the uterus drops out of its normal position, this is called prolapse. Prolapse is defined as a body part falling or slipping out of position. Prolapse happens when the pelvic muscles and connective tissues weaken. The uterus can slip to the extent that it drops partially into the vagina and creates a noticeable lump or bulge. This is called incomplete prolapse. Complete prolapse occurs when the uterus slips to such a degree that some uterine tissue is outside the vagina.

Pelvic prolapse is usually accompanied by some degree of vaginal vault prolapse. Vaginal vault prolapse occurs when the upper part of the vagina loses its shape and sags into the vaginal canal or outside the vagina. Pelvic prolapse may also involve sagging or slipping of other pelvic organs, including the bladder, the urethra which is the tube next to the vagina that allows urine to leave your body, and rectum.

Normanat and Proluterus
Anatomy of the Vagina

The vaginal vault is the “ceiling” or the inner, upper end of the vagina. The vaginal vault has four “compartments”: an anterior compartment, closest to the front of the body; the vaginal wall; a middle compartment consisting of the cervix; and a posterior compartment consisting of the vaginal wall at the back of the body.
Signs & Symptoms1

Women with mild cases of pelvic prolapse may have no noticeable symptoms. However, as the uterus falls further out of position, it can place pressure on other pelvic organs—such as the bladder or bowel — causing a variety of symptoms, including:

•     Sensation of sitting on a small ball
•     Heaviness or pulling in the pelvis
•     Pelvic or abdominal pain 
•     Pain during intercourse
•     Protrusion of tissue from the opening of the vagina
•     Repeated bladder infections
•     Vaginal bleeding or an unusual or excessive discharge
•     Constipation
•     Frequent urination or an urgent need to empty your bladder 

Symptoms may worsen with prolonged standing or walking due to added pressure placed on the pelvic muscles by gravity.
Causes and Risk Factors1

Pelvic prolapse is fairly common and the risk of developing the condition increases with age. It can occur in women who have had one or more vaginal births. Normal aging and lack of estrogen after menopause may also cause pelvic prolapse. Chronic coughing, heavy lifting and obesity increase the pressure on the pelvic floor and may contribute to the condition. Although rare, pelvic prolapse can also be caused by a pelvic tumor. Chronic constipation and the pushing associated with it can worsen pelvic prolapse.
Screening & Diagnosis1

Diagnosing pelvic prolapse requires a pelvic examination usually performed by a gynecologist. The doctor will ask about your medical history and perform a complete pelvic examination to check for signs of pelvic prolapse. You may be examined while lying down and standing. Imaging tests, such as ultrasound or magnetic resonance imaging (MRI), may be performed to further evaluate the pelvic prolapse.
Treatment1

Treatment is not necessary unless the symptoms are bothersome. Most women seek treatment by the time the uterus drops to the opening of the vagina. Losing weight, stopping smoking and getting proper treatment for contributing medical problems, such as lung disease, may slow the progression of pelvic prolapse.

If you have very mild pelvic prolapse – without any symptoms – or very mild symptoms, treatment is usually unnecessary. However, keep in mind that without treatment, you may continue to lose uterine support, which could cause more severe symptoms.

While clinical studies support the effectiveness of the da Vinci Surgical System when used in minimally invasive surgery, individual results may vary. There are no guarantees of outcome. All surgeries involve the risk of major complications. Before you decide on surgery, discuss treatment options with your doctor. Understanding the risks of each treatment can help you make the best decision for your individual situation. Surgery with the da Vinci Surgical System may not be appropriate for every individual; it may not be applicable to your condition. Always ask your doctor about all treatment options, as well as their risks and benefits. Only your doctor can determine whether da Vinci Surgery is appropriate for your situation. The clinical information and opinions, including any inaccuracies expressed in this material by patients or doctors about da Vinci Surgery, are not necessarily those of Intuitive Surgical, Inc. and should not be considered as substitute for medical advice provided by your doctor. © 2010 Intuitive Surgical. All rights reserved.

    Uterine Prolapse; A service of the U.S. National Library of Medicine – National Institutes of Health. Available from: http://www.nlm.nih.gov/medlineplus/ency/article/001508.htm

Content provided by Intuitive Surgical. For more information, please visit www.davincisurgery.com

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The Vaginal Mesh Helpline receives calls daily from women with Vaginal mesh complications. If you are having complications with your mesh device see a Urogyneciologist or your Doctor. Lawsuits are underway against the manufacturers of the vaginal mesh devices. The Vaginal Mesh Helpline can help you locate a Transvaginal Mesh lawyer who will take your case on an individual basis. These cases are contingency cases.

What is Vaginal Mesh?
Vaginal mesh, which is often called  a “hammock” or a “sling,” is a device which is used after surgery to treat POP and stress urinary incontinence (SUI) in women. Many woman suffer these types of medical issues as a result of weakened pelvic muscles that stretch and weaken to the point where they can no longer completely support nearby organs.  As the pelvic floor muscles lose their retaining power, the bladder, urethra, bowel, and even uterus can “drop” downward, bulging into the vagina.  While there are several causes of this condition it normally occurs because of age, childbirth, hysterectomy, or menopause
While incontinence is not uncommon, normally when woman begin to experience symptoms like pressure, pain, SUI, constipation, and sexual problems, woman seek the advice of a doctor.  In another example of corporations putting profits over people, several medical device manufacturers began selling vaginal mesh as a cure all for these types of issues and told doctors and the world that these devices were safe for use.  Because of this sales job done by these medical device manufactures, vaginal mesh repair became very common as one of several surgical options.
The concept of the surgery is simple.  The doctor uses a surgical mesh to help reinforce the vaginal wall and provide an additional supporting layer to organs like the bladder or urethra which should ease the pain and permit woman to go to the bathroom easier.  However, it became apparent after several years after this product was used, many women began to experience complications like pain, infection, bleeding, extrusion, and urinary problems

The FDA’s Investigation into Transvaginal Mesh
In 2006, a type of vaginal mesh called the “bladder sling”, was removed from the market after studies found a high rate of vaginal extrusion where the sling started to rub against the  top of the vaginal wall the sling ripped through the wall causing major complications.
Then in October 2008, the FDA warned healthcare professionals about serious complications associated with vaginal mesh. By that time, the FDA had received over 1,000 reports about complications associated with other types of vaginal mesh.  Included in these complications were:
    •    Mesh erosion through vaginal wall or other body parts
    •    Infection
    •    Pain
    •    Urinary problems
    •    Recurrence of prolapse and/or incontinence
    •    Bladder, bowel or vessel perforation
    •    Vaginal scarring
    •    Pain during sexual intercourse
    •    Other problems that led to a significant decrease in patient quality of life due
to discomfort and pain.

Now, after receiving over 3000 complaints from women who suffered serious injuries caused by polypropylene transvaginal device/mesh, the FDA issued a very detailed and comprehensive statement to warn doctors that they should consider no longer using mesh to treat their patients.  The reason for the warning was that, in most instances, the risk of serious injury outweighed all benefits from the transvaginal mesh.  In short, the FDA found that use of transvaginal mesh should only be used a matter of last resort.  
Recent Research Indicates Serious Risks and Complications
In a recent article in the Journal of Obstetrics and Gynecology, the journal found that patients would have been better off with traditional treatment rather than being implanted with vaginal mesh.  There has also been a recent clinical study which has shown that more than 15 percent of women who had surgery which used vaginal mesh are experiencing dangerous and painful condition known as “erosion,” in which the skin splits and the mesh protrudes.  The results of this mesh being exposed to your internal organs can be catastrophic.  If you feel any pain or suffer any symptoms or just don’t feel right, you need to go to a doctor right away so the doctor can determine whether your problems are a result of vaginal mesh.
Four Transvaginal Device Manufacturers Implicated in this problem
The manufacturers of the mesh and the products are as follows:
Johnson & Johnson®
    •    Ethicon® TVT
    •    Gynecare® TVT
    •    Gynecare® Prosima
    •    Gynecare® Prolift
    •    Gynemesh® PS

Boston Scientific®
    •    Advantage™ Sling System
    •    Obtryx® Curved Single
    •    Obtryx® Mesh Sling
    •    Prefyx Mid U™ Mesh Sling System
    •    Prefyx PPS™ System
    •    Arise®
    •    Pinnacle®
    •    Lynx®
    •    Solyx®

C.R. Bard®
    •    Avaulta Plus™ BioSynthetic Support
    •    Avaulta Solo™ Synthetic Support
    •    Faslata® Allograft
    •    Pelvicol® Tissue
    •    PelviSoft® Biomesh
    •    Pelvitex™ Polypropylene Mesh

American Medical Systems®
    •    SPARC®
    •    BioArc®
    •    MiniArc®
    •    Elevate®
    •    Monarc®
    •    Perigree®
    •    In-Fast®
    •    Apogee®

What to do about your Transvaginal Mesh?
The most important thing to do if you are suffering from these symptoms is to go see a doctor.  The potential result from this mesh could be nothing more than an irritation, but it can be as severe as death.  So you have to take care of your body. 
There are also several lawyers who are filing lawsuits against these manufacturers who put profits over people.  If you were implanted with defective mesh you do have rights and may be able to hold the mesh manufacturer responsible for your medical bills, time  that you are out of work, time that you are away from your family and all of your other pain and suffering.  It is time that we put a stop to these companies who put these dangerous products on the market and ruin our lives.