Home     Search     Translate     

 

Please refer to additional materials on this subject found on our main blog  

  

WOMEN'S HEALTH: Transvaginal Mesh

 

 

FDA slow to take action on vaginal mesh. 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 ...

Sep 29, 2011

Lawsuits claiming negligence against mesh-makers have also implicated the FDA's review system for continuing to clear new mesh products under the 510(k) system, despite the predicate device being

pulled from U.S. ...

NEW ARTICLE:  The 10 Year Window

Transvaginal Mesh and Women’s Health

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 alert was 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 or Poligrip 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
.

New information regarding TV Mesh


Bookmark and Share


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