What is a Transvaginal Mesh?

In short, Transvaginal literally means "trough the Vagina"
According to Wikipedia Transvaginal Mesh is ment to treat "stress urinary incontinence", often caused by weak pelvic floor muscles.


Millions of women in the United States suffer from conditions that are caused by the weakening of the pelvic floor muscles. Whether this weakening is caused by childbirth, aging or other causes, it can lead to a variety of serious medical problems. The majority of women who suffer from weakened pelvic floor muscles develop stress urinary incontinence or pelvic organ prolapse. These conditions have affected women for centuries, but new medical advancements are being made all the time. The use of transvaginal mesh seemed promising at first, but it's now clear that this seemingly effective option actually hurts far more than it helps.

Pelvic Organ ProlapseBecause conditions like pelvic organ prolapse and stress urinary incontinence are caused by weakened pelvic floor muscles, the most obvious way to treat them is by strengthening or supporting those muscles. There is a variety of surgical and non-surgical options that offer varying degrees of success. The placement of transvaginal mesh, which is a sling-shaped piece of synthetic mesh, seemed to be an effective way to permanently resolve this issue for many women. As a result, the procedure skyrocketed in popularity after being introduced in the 1990s.

During the procedure, which is usually called transvaginal mesh revision surgery, the piece of synthetic mesh is implanted transvaginally, which means that it is passed through the vagina before being implanted. By handling the procedure in this manner, surgeons can avoid making large incisions. The mesh is designed to strengthen and support the pelvic floor muscles, which have typically weakened to the point of bulging and descending through the vaginal wall to cause a variety of health issues.


When is it Prescribed?

Since the procedure was introduced during the 1990s, hundreds of thousands of women have had it performed. Weakened pelvic floor muscles in and of themselves aren't enough to make a doctor prescribe this treatment. A resulting medical problem usually prompts the recommendation, and there are two primary examples: pelvic organ prolapse and stress urinary incontinence.

Pelvic organ prolapse, or POP, (bladder prolapse) happens when the pelvic floor muscles are weakened to the point that they can no longer provide the necessary support to organs like the bladder and uterus. As a result, these organs bulge and descend through the vaginal wall, which results in significant pain and a variety of other symptoms. Needless to say, this is something that most women are eager to have corrected as quickly and efficiently as possible. When presented with the option of transvaginal mesh revision surgery, patients often feel that it's the best option.

Stress urinary incontinence, or SUI, can happen with or without pelvic organ prolapse. Without strong pelvic floor muscles providing support, the bladder may sag and press against other organs. This leads to urinary incontinence, and episodes can be triggered by simple, involuntary acts like sneezing, coughing and laughing. Many women also have accidents when exercising or engaging in sports.

Trans vaginal mesh is also sometimes called a transvaginal sling because it is placed in a way that mimics the support of the previously strong, healthy pelvic floor muscles. On paper, it seems like an effective and reasonable way to correct problems like SUI and POP. Unfortunately, that has been largely disproved.

Complications

The list of complications from this transvaginal implant that can develop due to the placement of this synthetic mesh is extensive and includes:

  • erosion of the mesh into the bowel, bladder or vagina
  • pain
  • serious infection
  • recurrence of stress urinary incontinence or pelvic organ prolapse
  • painful intercourse
  • excessive, ongoing vaginal discharge and drainage
  • vaginal scarring and shortening
  • skin breakage
  • contraction of the mesh sling
  • vaginal bleeding
  • protrusion of the device
  • erosion of vaginal epithelium
  • vaginal shrinkage

Vaginal Mesh Bladder InjuryIn addition to suffering from complications that are caused by the placement of the mesh itself, many women suffer from complications that are directly caused by the act of placing the mesh. The most common intraoperative injuries that occur are perforations of the bladder, bowel or blood vessels.

After suffering from one or more of these complications, a considerable number of women require surgical or medical intervention. In many instances, hospitalization is required as well.

The FDA Continues to Investigate

Complaints about complications related to trans vaginal mesh placement started picking up steam from 2005 to 2007. Due to the increased number of complaints, the FDA instructed doctors to exercise caution when performing this procedure and also advised them to pass warnings along to patients. Despite these measures, the number of complaints continued to rise. In the last three years alone, the FDA has received thousands of complaints and issued a safety warning. The agency's investigation into the matter is ongoing.

In 2010, almost 300,000 women received transvaginal mesh implants. Although it has been in use since for over 20 years, the Food and Drug Administration has only just issued a public safety warning about potential safety issues and complications involved with the procedure. It was originally touted as a low-risk, simple procedure women with pelvic organ prolapse or stress urinary incontinence. It is generally the same type of mesh that is used in hernia repair procedures. Unfortunately, it hasn’t been as successful in more recent medical applications in women. Countless women have suffered various types of severe complications due to the lack of research and testing prior to market introduction. There was very little testing or research done before introducing the mesh for transvaginal use. The lack of evaluation prior to market use has caused thousands of women to file lawsuits due to life-changing, severe complications. The Food and Drug Administration has flopped around for years on the safety issue of transvaginal mesh. In 2008, they issued a public health notice that informed consumers that complications were possible but rarely occurred. In 2011, they backtracked to say that serious complications were actually not that rare. They finally ordered manufacturers of the mesh to conduct post-market safety studies. After the Food and Drug Administration fast-tracked the approval for mesh to be used in transvaginal application, thousands of women have filed lawsuits due to severe, damaging complications. It is estimated that 10 percent of women who have transvaginal mesh implanted for prolapse experience complications within the first year after the procedure. Complications Associated with Transvaginal Mesh • Vaginal Bleeding • Urinary Incontinence • Vaginal Scarring and Shortening • Pelvic Pain • Difficulty Moving • Constipation • Mild to Severe Abdominal Pressure • Recurrence of Pelvic Organ Prolapse • Perforation of Bowels and Pelvic Organs • Erosion of Mesh Through Vaginal Tissue • Potential Exposure or Extrusion of Mesh

Medical Studies Raise Serious Questions

Issues like POP and SUI are so common that studies about the most commonly prescribed treatments are regularly performed. One study, which was reported by the New England Journal of Medicine, was especially troubling. The study compared the trans vaginal placement of mesh with colporrhaphy, a surgical procedure that involves stitching connective tissue together to strengthen pelvic muscles.

The study cast a spotlight on the many side effects that were caused by the placement of synthetic mesh slings. It also highlighted the high risk of product defect. The New England Journal of Medicine reported that women who undergo the procedure are seven times as likely to suffer from bladder perforations and nearly twice as likely to suffer from loss of bladder control. The report also stated that 3.2 percent of women ultimately need corrective surgery following the procedure.

Synthetic Mesh Sling Manufacturers and Products

The most commonly used synthetic mesh slings are manufactured by Johnson & Johnson, C.R. Bard, American Medical Systems and Boston Scientific Corporation. Popular brand names include the Elevate Anterior and Apical Prolapse Repair System, Pelvicol Tissue, Gynemesh, the Advantage Sling System, and Avaulta Plus BioSynthetic Support System and Pelvitex Polypropylene Mesh.

Are You Suffering as a Result of the Placement of Trans Vaginal Mesh?

If you have suffered from complications due to the placement of transvaginal mesh, you may be eligible to collect damages. Although the FDA's investigation is ongoing, the right legal representation can help you recoup losses due to the following:

  • emotional distress
  • pain and suffering
  • out-of-pocket medical expenses directly caused by the procedure
  • the loss of the ability to have sexual relations
  • a drop in your quality of life
  • lost wages

Surgical Mesh Lawsuit LawyerSadly, thousands of women are suffering needlessly this very minute due to issues with their trans vaginal slings. If you are one of them, there is no need to sit idly by and suffer in silence. There are ongoing investigations into product defects and problematic surgical procedures, and the right attorney can help you build a strong case in order to seek the compensation that you deserve.

Transvaginal Mesh Lawsuits

Don't suffer in silence for another minute. The American Legal Alliance is here to help you get the compensation that you deserve. We are experts on trans vaginal mesh slings and the resulting complications and medical problems that occur, and we are ready to assist you with your case.

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Medical complications often are life-changing. It could take multiple surgeries to correct the damage inflicted. In many cases, complications can leave irreversible painful effects. Contact us today for a free consultation.

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