By Karina Basso  |  October 13, 2014

Category: Legal News

Transvaginal Mesh LawsuitIn early October, Endo International PLC agreed to a $400 million vaginal mesh settlement to settle several lawsuits alleging Endo’s vaginal mesh implant products eroded in a number of female consumers and caused them pain and suffering.

This vaginal mesh settlement will resolve over 10,000 vaginal mesh lawsuits filed against Endo and are valued at about $48,000 per case.

In response to the settlement news, Endo has stated that they have settled “substantially all” the vaginal mesh lawsuits that remained against Endo’s American Medical Systems Holdings unit, which manufactures and distributes the Perigee, Apogee and Elevate vaginal mesh implants.

This is not the first time Endo has agreed to a multi-million dollar settlement to resolve vaginal mesh lawsuits.

In June 2013, Endo paid $54.4 million to resolve an unknown number of vaginal mesh lawsuits. Additionally, earlier this year, Endo agreed to a $830 million settlement to resolve another 20,000 vaginal mesh lawsuits, which specifically alleged that the women who used the Endo mesh product suffered organ damage. This Endo settlement was submitted just a day before the U.S. Food and Drug Administration (FDA) announced that all vaginal mesh inserts and implants would undergo stricter safety requirements.

Taking into account the 2013 settlement and the two 2014 vaginal mesh injury settlements, Endo has agreed to pay a grand total of $1.3 billion to resolve vaginal mesh product liability litigation.

The consolidated Vaginal Mesh Lawsuits are In re: American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, in the U.S. District Court for the Southern District of West Virginia.

Background on Vaginal Mesh

Vaginal mesh (also known as transvaginal mesh systems) are medical devices designed to treat pelvic organ prolapse. The vaginal mesh implants are manufactured from porous synthetic materials or biological materials and are then inserted into the body to repair stress urinary incontinence (SUI) or pelvic organ prolapse (POP) damaged tissues. In some cases, vaginal mesh can also be implanted to lift the bladder as a form of treatment for urinary incontinence.

For many years, vaginal mesh was considered an effective medical device safe for human implantation. However, the FDA released a Public Health Notice in 2011 warning women of the many dangers associated with vaginal mesh implants.

According to the FDA report, “Over the past three years, FDA has received over 1,000 reports from nine surgical mesh manufacturers of complications that were associated with surgical mesh devices used to repair POP and SUI. These mesh devices are usually placed transvaginally utilizing tools for minimally invasive placement.”

Some vaginal mesh side effects women may experience after product implantation include:

  • Pain during sexual intercourse
  • Urinary issues
  • Pelvic organ prolapse
  • Scarring in the vaginal area
  • Perforated bowels, bladder, and/or blood vessels
  • Erosion of mesh into the vagina
  • Infection
  • Various organ injuries

The majority of serious vaginal mesh side effects require additional surgeries and treatments to resolve complications, such as vaginal mesh removal surgery, IV therapy, blood transfusions, and surgical draining of abscesses and hematomas.

Thousands of women across the United States have filed vaginal mesh lawsuits or joined vaginal mesh class action lawsuits and consolidated multidistrict vaginal mesh product liability litigation after allegedly sustaining personal injuries from transvaginal mesh implants, bladder slings, vaginal slings, or other types of vaginal mesh medical devices to treat a pelvic prolapse condition.

In general, vaginal mesh lawsuits are filed individually by each plaintiff and are not class actions.

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