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Transvaginal Mesh

Hughes and Coleman Injury Lawyers represent women alleging they suffered serious side effects and/or injuries as the result of the synthetic transvaginal mesh. This surgical mesh is made from polypropylene and it is used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), which are both commonly seen in women occurring when the internal support structure of the vagina fails. This medical procedure inserts a transvaginal mesh (TVM) to hold the woman’s internal organs (*urethra, cervix, and rectum) in place.

Pelvic organs prolapse and stress urinary incontinence occur when the connective muscles and tissues, which surround the pelvic organs and support them, grow weak and stretch. This occurs often after childbirth or long-term heavy lifting. In 2010, there were more than 75,000 women who underwent transvaginal mesh surgery to repair pelvic organ prolapse.

This synthetic mesh is implanted through incisions made through the vagina wall (transvaginally) to reinforce tissues around the descended pelvic organ. It can be inserted either with the posterior or anterior approach.

Update – February 2012: The FDA Orders Transvaginal Mesh Manufacturers to Conduct Safety Trials and Patient Advocacy Groups Call for Vaginal Mesh Recall

On January 4, 2012, the FDA ordered Johnson & Johnson, C.R. Bard, Boston Scientific, along with 30 other surgical mesh manufacturers to conduct new studies on the effectiveness and the safety of the vaginal mesh when used in the treatment of pelvic organ prolapse and stress urinary incontinence. The FDA letter is a follow-up on a recommendation from an FDA advisory panel in September 2011 that stated it was necessary for vaginal mesh used in pelvic organ prolapse to be reclassified as a high-risk medical device.

The FDA order is the result of an increase in the number of serious injuries confirmed caused by certain vaginal mesh products and that manufacturers heavily marketed these vaginal mesh products without first conducting adequate human studies. In addition, adequate risk information was lacking.

A recent vaginal mesh study published in the New England Journal of Medicine  indicated troubling results pertaining to these procedures. Data revealed women who had transvaginal mesh inserted suffered significantly higher rates of serious complications.  In the past 3 years the FDA received more than 3,800 reports relating to complications as a result of the surgical mesh used to repair POP.  More than 650 patients have filed vaginal mesh lawsuits, and there are 7 deaths associated with POP repair. Three of these were related to the mesh placement procedure.

The most common surgical mesh device complications include:

  • Vaginal mesh
  • Vaginal scarring
  • Shrinking and/or contraction of the mesh
  • Infection
  • Vaginal epithelium
  • Neuro-muscular problems
  • Resurgence or onset of urinary problems such as incontinence
  • Bladder, bowel, and blood vessel perforation

In some cases, the complications led to severe pelvic discomfort and pain. Additional surgery was required to remove the vaginal mesh, and permanent life-changing injuries occurred. Furthermore, these problems can result in additional complications, such as the need for a second surgery, IV therapy, blood transfusions, and the treatment of hematomas or abscesses.

Update: The FDA has issued an urgent safety communication advising transvaginal mesh patients and their healthcare providers to consider alternatives to the use of transvaginal mesh.

It is estimated nearly 50% of all women between the ages of 50 and 79 have some degree of prolapse. About 11% will require surgery to repair the prolapse, and about 33% of these women will need a second surgery to correct problems stemming from the condition or initial surgery.

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If you are suffering from complications due to transvaginal mesh, you may be entitled to compensation for your injuries. Don’t fight this battle alone—let one of the experienced attorneys at Hughes & Coleman do the work for you. Products liability claims involving defective medical devices are complicated lawsuits which require in-depth knowledge about manufacturing and design processes. Instead of trying to represent yourself in a complex lawsuit, let an attorney represent you so that you can focus on healing. Scheduling a conference is 100% free; just call or fill out a case evaluation form so that one of our lawyers can analyze your claim.

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