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Transvaginal Mesh Failure Lawsuit

Transvaginal Mesh Failure Lawsuit

Until recently, medical professionals believed transvaginal mesh was a minimally-invasive surgical option for patients suffering from pelvic organ prolapse and stress urinary incontinence. However, reports from the FDA have suggested transvaginal mesh fails, causing complications in patients such as erosion and infection. Patients who experience transvaginal mesh failure have needed corrective surgery, IV therapy, blood transfusions and drainage of hematomas or abscesses.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting transvaginal mesh failure cases in all 50 states. If you or somebody you know has been injured by transvaginal mesh failure, you should contact our firm immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Transvaginal Mesh Failure: An Overview

One of the treatment options suggested to women with pelvic organ prolapse (POP) and stress urinary incontinence (SUI) is vaginally-placed surgical mesh. The mesh is inserted through small stitches made in the vaginal wall in order to support a bulging organ during POP or to support the urethra during SUI. The mesh is cut and tailored to the organ it supports, making it custom fit to each person.

Unfortunately, patients have reported complications caused by the failure of the transvaginal mesh.

Transvaginal mesh failure occurs when the mesh fails to bind to the pelvic tissues. As a result, the body rejects the mesh sewn into it. Consequently, the mesh may start to poke its way through the vaginal wall and protrude out of the vaginal tissue. This complication is more commonly known as “erosion.” Erosion may result in extreme pain, infection, bleeding or vaginal discharge.

Some patients undergo corrective surgery to have the portion of the protruding mesh removed. However, the failed mesh implant may be impossible to fully remove.

As William Maisel, deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health states:

“Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”

When the mesh cannot be fully removed, it may lead to life-long side effects. Erosion can cause vaginal scarring, which will decrease a patient’s quality of life and may cause long-term pain, including dyspareunia — which is characterized by pain during sexual intercourse.

Symptoms of Transvaginal Mesh Failure

The following symptoms may be signs of failing transvaginal mesh:

  • Erosion
  • Infection
  • Bleeding
  • Vaginal discharge
  • Organ perforation
  • Pelvic pain
  • Vaginal pain
  • Dyspareunia
  • Inability to engage in sexual intercourse
  • Recurrence prolapse or incontinence
  • New onset of urinary incontinence
  • Vaginal scarring, shortening
  • Mesh contraction

FDA Warning on Failure of Transvaginal Mesh

In October 2008, the FDA initially warned of the risk of complications associated with transvaginal mesh implants. In its Public Health Notification, the FDA stated complications were relatively rare, occurring in 1,000 patients after POP and SUI repair.

The most commonly reported side effects resulting from transvaginal mesh failure were erosion, pain, urinary problems, recurrence, organ perforation and vaginal scarring.

In the warning, the FDA advised surgeons to undergo specialized training on mesh implant techniques, watch for complications, and warn patients about complication risks and remind them the implant is permanent.

However, the FDA recently updated its warning in July 2011. In the update, the FDA rescinded its previous statement that complications were rare. Instead, the FDA made clear that complications were not rare. Since its 2008 notification, the FDA received an additional 2,874 reports of injury, death and malfunction in transvaginal mesh procedures for POP and SUI repair. Seven deaths were linked to POP repairs. Three of them were directly associated with mesh placement failure. The other four deaths appeared to be due to other post-operative medical complications.

The July 2011 report also notified patients that transvaginal mesh procedures put them at greater risks of complications over traditional non-mesh procedures.

Additionally, the FDA added to the list of transvaginal mesh failure side effects in its July report. The side effect of mesh contraction was unreported prior to 2008. However, between 2008 and 2010, patients reported mesh contraction or shrinkage, which could cause permanent vaginal shortening, vaginal tightening and/or vaginal pain.

Due to the severity of the symptoms associated with transvaginal mesh failure, transvaginal mesh patients may want to contact a transvaginal mesh lawyer or attorney with The Schmidt Firm, PLLC to discuss the potential for a transvaginal mesh failure lawsuit.

What is Transvaginal Mesh?

Transvaginal mesh is a device that can be made from natural material or from synthetically-created material. It is divided into four categories: non-absorbable synthetic (made of polypropylene or polyester), absorbable synthetic, biological (made from bovine or porcine sources) or composite (a combination of the previous categories).

Most commonly, surgical POP and SUI repairs use non-absorbable synthetic polypropylene mesh.

The FDA reports transvaginal mesh failure is associated with up to nine vaginal mesh manufacturers. The majority of complications have been reported among products made by Johnson & Johnson, Boston Scientific Corp., American Medical Systems, Cook, Covidien and CR Bard. Mesh materials are also manufactured by General Medical Devices and Caldera Medical.

Do I have a Transvaginal Mesh Failure Lawsuit?

The Schmidt Firm, PLLC is currently accepting transvaginal mesh failure cases in all 50 states. If you or somebody you know has been injured by transvaginal mesh failure, you should contact our firm immediately for a free case consultation. Please use the form below to contact our Product Liability Litigation Group or call toll free 24 hours a day at (866) 920-0753.

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