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WOMEN'S HEALTH: Transvaginal Mesh

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 

See also: Mesh Medical Device News Desk 

I am excited to report that I will be doing some follow up stories for an old friend, Eric Chaffin, of Chaffin Luhana LLP about prolapse and vaginal mesh complications. Eric is the one who originally approached me about doing the below vaginal mesh series a couple of years ago when he was with his old law firm. Eric, and his now law partner, Roopal Luhana, have their own firm in NYC, Chaffin Luhana LLP. Eric and Roopal were some of the first attorneys in the country to represent women in the Bard Avaulta mesh litigation and in Gynecare mesh lawsuits. They continue to represent women in these medical device cases, as well as in other vaginal mesh litigations, including representing women in cases against Boston Scientific and American Medical Systems regarding allegedly defective vaginal mesh. You can learn more about the vaginal mesh cases Chaffin Luhana is handling through the vaginal mesh information website that Chaffin Luhana sponsors. I also hope that you will visit us soon here at Natural Health News to read the first of what I anticipate will be a multiple part follow up series regarding vaginal mesh.

The following list contains the major products and their manufacturers involved in this industry.  They are used in the surgeries, and are related to many of the complications associated with these procedures. (Source: Chaffin Luhana)
Vaginal Mesh Devices Implicated

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®

Informed Consent is a major factor in any surgical procedure.  If you would like to get a copy of our newsletter on this topic, please make a donation on the main Natural Health News page and note 'IC' in the note when you order via PayPal.

UPDATE: 19 June, 2011
Several years ago I was commissioned by a consumer injury law firm to write a series of articles. One of those articles, addressed issues with the transvaginal mesh device.  This article is also found on our other websites, and

In the past several months I have noticed an increasing number of TV ads for this device from consumer injury law firms.  I have also noticed a viral spread of this article which has booted the reader ship of my blog, Natural Health News, by thousands of readers daily. 

This tells me that many women must be very interested in this topic, either because they have had this surgery and are facing problems, or they have been advised to have this operation.

Alternatives to the surgery are available options.  I hope to educate you about an important one that can do a great deal to prevent and correct this condition.

Should you wish a copy of this new article please email us and request it.  

There are herbs and herbal combinations that can be used to help with incontinence, pain, inflammation and other problems you may be facing. 

Please consider a donation to Creating Health Institute via PayPal and help us continue this important work.

You can also support this work by using Goodsearch search and shop for benefit of Creating Health Institute CHI.

We also offer other services, including our Health Forensics program, and products for your health and wellbeing.

As originally written in 2009, in cooperation with Eric Chaffin, this article has created an internet storm -

Transvaginal Surgical Mesh Origins 

Polypropylene was first developed in the 1950s as a thermoplastic polymer resin of propylene and is made from petroleum. Polypropylene may be molded or extruded into many forms, including fibers for suture material, specially produced mesh and nonwoven sheet applications. Nonwoven polypropylene fabric later began to be extruded from polymer melts rather than from fibers.

Quaternary ammonium biocides are used as a disinfectant and germ killing substance because they disrupt the cell membrane and proteins. QUATS may not, however, be fully effective against Pseudomonas bacteria. Also, researchers have found in laboratory experiments that oleamide, which interacts with neurotransmitters, may leak out of polypropylene plastics.

Polypropylene Knitted Mesh (PPKM) fabrics are comprised of monofilament yarns, which are engineered for the manufacturing of textile fabrics. The polymer and manufacturing processes that are used produce fabrics with properties that are ideally suited for the manufacturing of medical device applications. Medical applications include hernia mesh patches, stress urinary incontinence (SUI) slings, and vaginal prolapse suspenders.

Nonwoven polypropylene fabric has been used for similar applications.

Problems with polypropylene fabrics have led to warnings being issued for various products made from nonwoven material and in some cases, the manufacturers have stopped marketing the products

According to adverse reports submitted to the FDA from nine different manufacturers, more than 1,000 people have suffered severe complications from surgical mesh implants. The reports include infection, pain, urinary problems and bowel, bladder or blood-vessel perforations. The repaired prolapse may have recurred or incontinence increased. Additional surgeries to remove mesh have been required because of vaginal erosion.

Transvaginal Surgical Mesh to Treat SUI

Sudden Urinary Incontinence (SUI) is estimated to affect as many as 11 million women in the United States. It is generally defined as the sudden, involuntary loss of urine when a patient is laughing, sneezing, coughing or exercising. SUI is caused by anything that may have led to serious pelvic muscle strain or weakness such as vaginal childbirth. It can be exacerbated by estrogen and other hormonal imbalance accompanying menopause.

Nearly 40% of all adult American women will experience various degrees of SUI during their lifetime. Symptoms can range from occasional leakage of a few drops of urine to complete loss of urine under certain conditions of stress. Although nonsurgical methods such as dietary changes, bladder retraining, Kegel exercises, biofeedback, pessaries, electrostimulation, and drug therapies have been used successfully to treat these women, many patients eventually require surgical repair to relieve their symptoms.

Historically, and for many decades, the Kelley plication or the Marshall-Marchetti (Krantz) procedures have been the main hospital based surgical treatments for reinforcing the bladder neck in order to prevent unintentional urine loss.

Other surgical techniques have been used to correct pelvic organ prolapse (POP), a related condition.

Transvaginal Surgical Mesh to Treat POP

The problem of incontinence for women from various causes becomes more common after pregnancy and in menopause, when surgery can be recommended after other non-intrusive treatments are not found effective.

These conditions are referred to as Pelvic Organ Prolapse(POP).

POP is the term that describes a condition when a pelvic organ drops from its normal location and pushes against the walls of the vagina. This generally occurs when muscles that hold pelvic organs in place are weakened or stretched by childbirth or surgery. POP can lead to symptoms that include pain, discomfort, loss of bladder control and constipation.

Mentor Sling

One popular product, known as the transobturator vaginal sling, was made by Mentor Corporation. This product was more commonly called “OB Tape.”

Mentor manufactured an OB Tape vaginal sling that was not recalled, but the company stopped marketing it in the spring of 2006. The product used a nonwoven material which made it different in design than most other mesh devices. The nonwoven fabric is alleged to have blocked oxygen and nutrients, substantially increasing the risk of problems such as infection. This impedance potentially can cause serious problems with the device that may not appear for months, or even years following implantation surgery.

The complication rate could very easily reach 20% of all patients who used the Mentor sling.

At least 35,000 women may have been treated with the OB Tape vaginal sling between 2003 and 2006 to treat female stress urinary incontinence (SUI). The bladder sling is designed to prevent involuntary leakage that occurs when pelvic muscles supporting the bladder and urethra are stressed or weakened. A number of women have filed Mentor sling lawsuits.

A study published in the Journal of Urology in October 2006 highlighted the risk of complications associated with the OB Tape sling. More than 13% of the women who received the Mentor Sling for incontinence allegedly have suffered vaginal extrusions. Many more cases reported women who suffered chronic vaginal discharge and abscesses.

Symptoms of OB Tape Sling injury may include but are not be limited to:

· High fever

· Vaginal Pain

· Pelvic Pain

· Pain During Sex

· Chronic Infections

· Perineal Cellulitis

· Severe Pain in the Back, Hips and Legs

If you have had this surgery and are experiencing any of these or other symptoms not listed here, immediately contact your health care provider.

If you have suffered an injury or Mentor sling side effects from surgery involving the use of a Mentor sling, and would like to learn about your legal rights and pursuing a Mentor sling lawsuit, you can find information at Consumer Injury Lawyers.

Other Transvaginal Surgical Meshes

Another product, Gynecare’s Prolift Sling, created serious problems that required additional surgery that has caused permanent injury. The Avaulta Bard surgical mesh, which is used to treat POP and SUI have also been the subject of Avaulta transvaginal mesh lawsuits. It has led some consumer advocates to call for an Avaulta transvaginal mesh recall.

If you have had a prolene mesh pelvic floor repair system and have suffered complications, you may have a viable product liability claim. In October 2008 the FDA transvaginal mesh alertwas issued for at least nine manufacturers of vaginal sling products.

Overall use of these surgical mesh products has been associated with severe and debilitating injuries including vaginal extrusions, urinary tract erosions, infection and nerve pain. Other known complications include, but are not limited to, mesh erosion, mesh shrinkage, granuloma from tissue injury or dyspareunia (pain with sexual relations).

Product and procedure failure with the tape sling products have required additional surgeries to remove the mesh, along with an increased risk of more injury.

If you have suffered an injury from any surgery involving the use of the surgical meshes referred to in the above article and would like to learn about your legal rights, you can find information from Consumer Injury Lawyers, a consumer advocacy legal website that provides helpful information to consumers about various drugs and medical devices, including for example information about the recent reports of zinc poisoning caused by denture cream, including information about denture cream lawsuits such as how to file a Fixodent lawsuit orPoligrip lawsuit.

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 Bernstein Liebhard, LLP.

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

Subsequent articles about transvaginal mesh since my original article was published  in 2009 -

Related article 2011
Mesh is riskier but higher success rates for treating pelvic organ prolapse
Friday, 13 May 2011
For women with pelvic-organ prolapse, a transvaginal mesh kit improves treatment success rates compared with traditional colporrhaphy. However, the treatment comes at a cost of more surgical complications and adverse events, according to a randomised trial in Scandinavia.
Women treated with the mesh kit were more likely to be free of prolapse a year later as defined by both objective and subjective measures (60.8% versus 34.5%, P<0.001), said Dr. Daniel Altman of Danderyd Hospital in Stockholm, and colleagues.
But adverse events were more frequent in the mesh group both in the hospital and during follow-up, the researchers reported in the May 12 issue of the New England Journal of Medicine.
"When one is counselling patients regarding surgical options, the benefits of the mesh kit must be balanced against the higher rates of surgical complications and postoperative adverse events associated with this approach," the authors concluded.
Although the most common operation for pelvic-organ prolapse is anterior colporrhaphy for prolapse of the anterior vaginal wall, the use of standardised mesh kits has rapidly grown in popularity, despite the lack of evidence that the approach is better than traditional surgery.
"Our results highlight the need for a careful evaluation of surgical innovations, which are often widely adopted in the absence of data from clinical trials," Altman and his colleagues wrote.
At 53 centres in Sweden, Norway, Finland, and Denmark, the researchers compared repair with a transvaginal polypropylene-mesh kit (200 patients) with traditional colporrhaphy (189 patients) in women with prolapse of the anterior vaginal wall.
Mean age of the patients was 65.1 in the colporrhaphy group and 64.3 in the mesh group.
The mesh kit used was the Gynecare Prolift Anterior Pelvic Floor Repair System kit.
The primary outcome was a composite of an objective determination of the lack of prolapse indicated by stage 0 or 1 according to the Pelvic Organ Prolapse Quantification system and a subjective report of the absence of vaginal bulging 12 months after the surgery.
At that one-year mark, women treated with the mesh kit were more likely to be free of prolapse (OR 3.6, 95% CI 2.2 to 5.9). Both components of the primary endpoint favored the mesh group, as well.
However, surgery took longer for those in the mesh group (52.6 versus 33.5 minutes). They also had greater mean intraoperative blood loss (84.7 mL versus 35.4 mL), and more frequent need for intraoperative cystoscopy. All differences were significant at P<0.05.
Those findings were "consistent with the more invasive nature of this procedure as compared with colporrhaphy," according to the authors.
The mesh group also had higher rates of bladder perforation (3.5% versus 0.5%) and of usually or always having pain during sexual intercourse (7.3% versus 2%), although neither difference reached statistical significance (P=0.07 for both).
Inguinal pain and bladder-emptying difficulties were more common during the hospital stay for patients who underwent mesh repair, as was new stress urinary incontinence during follow-up (12.3% versus 6.2%, P=0.05).
Vaginal wound revision was required by 3.2% of the patients in the mesh group, which "is higher than the complication rates reported after the use of midurethral sling procedures for incontinence but lower than in another study of the use of transvaginal mesh for prolapse surgery," according to Altman and his colleagues.
There were two deaths -- one in each group -- but both were related to cardiovascular disease.
Source: D. Altman, et al., "Anterior colporrhaphy versus transvaginal mesh for pelvic-organ prolapse,"New England Journal of Medicine 2011; 364: 1826-1836.

UPDATE: 13 July
By Kristina Fiore, Staff Writer, MedPage Today, July 13, 2011

FDA Beefs Up Transvaginal Mesh Warning 

Transvaginal placement of surgical mesh to treat pelvic organ prolapse may carry more risks than other surgical options, without any evidence of greater benefit, the FDA said.

The agency warned that mesh placed transvaginally was associated with adverse events including erosion through the vaginal tissue, pain, infection, bleeding, pain during intercourse, organ perforation from surgical tools used in the placement procedure, and urinary problems
Some reports cited the need for additional surgeries or hospitalization to treat complications or remove the mesh, the agency said.
The number of adverse events linked to the device has been increasing in recent years. About 1,500 reports were filed between 2008 and 2010 -- five times as many as in 2005 to 2007, according to the FDA.
The agency first issued a safety communication on the product in 2008.
"The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh," William Maisel, MD, MPH, deputy director of FDA's center for devices and radiological health, said in a statement. "Mesh is a permanent implant -- complete removal may not be possible and may not result in complete resolution of complications."
In its review of the literature from 1996 to 2010, the FDA found that patients who have transvaginal pelvic organ prolapse repair with mesh are exposed to additional risks compared with those who have repair with stitches alone.
They found that while the mesh often corrected the anatomy, there was no evidence of greater clinical benefit than non-mesh surgery.
In 2010, there were at least 100,000 pelvic organ prolapse repairs with surgical mesh. About 75,000 of these were transvaginal procedures, the FDA said.
The agency said that doctors should recognize that, in most cases, pelvic organ prolapse can be treated without mesh.
It also warned clinicians that mesh implants are permanent, and future repairs may challenging, putting patients at risk for additional complications and surgeries.
The FDA emphasized that the current warning does not apply to mesh placed abdominally, or to treatment for stress urinary incontinence. In September, an FDA advisory committee will meet to discuss the safety and efficacy of the mesh products in those indications.

UPDATE: 17 August, from the UK D. Mail 16.8.11

by Lois Rogers.
1000s of women have been left severely damaged by an implantable 'sling' operation to treat problems following childbirth.
The NHS faces a crisis on a par with the compensation claims for leaking silicone breast implants in the 1990s. Up to 40,000 women in UK are believed to have received an implantable plastic mesh called trans-vaginal tape (TVT) which is intended to support the pelvic organs to prevent incontinence. But in an estimated 10% of cases the mesh disintegrates within months. The tiny fragments, measuring only a few millimetres, migrate & become embedded elsewhere in the body, triggering infection & inflammation. Women can be left in intractable pain. Despite some women undergoing 10 or more operations to remove the mesh, surgeons say it is impossible to get it out completely. As a result, the sling procedures is no longer recommended in USA as the FDA say it exposes women to risk. 

Resources for FDA UPDATES

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