UPDATE (January 2012)
Congress to Hold Hearing Regarding FDA Approved Vaginal Mesh (Bladder Slings)

Congress will hold a hearing over growing concerns that FDA approved medical devices are causing individuals throughout the country to suffer debilitating and potentially life-threatening complications.

Earlier this month, the FDA also called for more studies into the safety of vaginal mesh products used to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI) in women, following growing reports of problems, and the agency's own analysis which brought into question whether they provide any health benefits. Women in the Chicagoland area have sued the makers of the vaginal implant.

An estimated 300,000 synthetic transvaginal meshes were implanted in women in the U.S. in 2010, with many of these being from Chicagoland against Bard, Boston Scientific, AMS and Ethicon/Gynecare

The FDA issued a warning in 2011 about the risks of problems when vaginal mesh products are used, especially for repair of pelvic organ prolapse as it could find no benefit in using transvaginal mesh to treat POP when compared to older, safer alternatives.

Between 2008 and 2010, the FDA received more than 1,500 reports of transvaginal mesh complications, including erosion of the mesh into the vagina, contraction or shrinkage of the mesh, infections, pelvic pain, urinary problems, vaginal scarring and other complications.

A growing number of transvaginal mesh lawsuits have been filed in courts across the country by women who say that vaginal sling manufacturers created defective products and failed to warn doctors or patients adequately about the risk of complications.

***

There are hundreds of product liability lawsuits against various medical device manufacturers as a result of problems with transvaginal bladder mesh systems, which have been linked to reports of infection, vaginal erosion, pelvic pain and other complications. 

Some plaintiffs are now calling for the vaginal mesh litigation pending against four different companies to be centralized in multi-district litigation before one judge in the U.S. District Court for the Southern District of West Virginia who now has all federal Bard Avaulta mesh lawsuit.

Motions were filed on November 28, calling for dozens of Boston Scientific pelvic mesh lawsuits, American Medical Systems (AMS) mesh lawsuits and Ethicon/Gynecare mesh lawsuits to be centralized before the judge All of the vaginal mesh lawsuits involve defects with pelvic repair products used during transvaginal surgery to repair pelvic organ prolapse (POP) or stress urinary incontinence (SUI), which caused women to experience painful and debilitating complications.

Persons injured, including ones in Chicago, have requested that currently unconsolidated litigation for vaginal mesh products sold by Boston Scientific, AMS and Ethicon/Gynecare be put into a MDL.

Once the FDA issued warnings about an increasing number of adverse event reports associated with vaginal mesh, patients became concerned as the FDA concluded there was no evidence that transvaginal mesh kits used for repair of pelvic organ prolapse provide any benefit over other available means of treatment.

UPDATE Vaginal Mesh Lawsuits under consideration for multi district litigation?:

Vaginal mesh lawsuits  are under consideration for multi district litigation, which we have experience with. 

Last summer, the FDA issued a warning about the risk of transvaginal mesh problems, especially when used for repair of pelvic organ prolapse. In recent years, a growing number of women have filed adverse event reports with the FDA after experiencing infection, erosion of the mesh through the vagina and other serious complications.

Complaints involve design defects with a variety of surgical mesh products.   Products include AMS surgical mesh products, including the AMS Apogee, AMS BioArc, AMS Elvate, In-Fast Unltra, MiniArc, Monarc, AMS Perigee, SPARC and Straight-In mesh. Brands include Bard, Johnson and Johnson, Ethicon and others.

Vaginal mesh is implanted in women to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

·         Erosion, Extrusion or Protrusion of the Mesh

·         Mesh Contraction or Shrinkage

·         Infection

·         Pelvic Pain or Pain During Sexual Intercourse

·         Other Problems or Complications after Bladder Surgery

We have experienced in multi-district litigation. Contact my office today if you have suffered side effects from the use of vaginal mesh. I offer a free consultation.

UPDATE: First Vaginal Mesh Trials to Be Heard in New Jersey (11/2011)

The first Vaginal Mesh lawsuits will be heard in November 2012 in New Jersey. Judge Carol E. Higbee is overseeing the consolidated vaginal mesh lawsuits in New Jersey Superior Court.

Approximately 350 transvaginal mesh lawsuits have been centralized under Judge Higbee for pretrial proceedings.

Judge Higbee issued a scheduling order on October 28 indicating preliminary discovery for cases being prepared for early trial dates will be completed by March 30. Also, expert witnesses will be deposed by October 5.

All of the vaginal mesh complaints state that the manufacturer of the products knew that the vaginal mesh products were unreasonably dangerous, but they continued to manufacture them.

Contact my office today if you have suffered side effects from the use of vaginal mesh. I offer a free consultation.

UPDATE: Prominent Consumer Group Petitions FDA to Recall Vaginal Mesh

Public Citizen, a prominent consumer advocacy group representing 225,000 members, has petitioned the FDA to issue a recall for transvaginal mesh used to treat pelvic organ prolapse. 

The vaginal mesh in question was used in an estimated 67,500 surgical procedures in the U.S. in 2010.

Public Citizen claims that the procedures involving vaginal mesh offer no clinically significant benefits in comparison to surgical repairs performed without the use of vaginal mesh, and that the high rates of complications outweigh the potential benefits.

Transvaginal mesh products, sometimes called bladder slings or vaginal surgical mesh, are designed to support organs that have "fallen" in older women or women who have had children, to prevent them from pressing on the bladder and vagina. 

Issues revolving around the use of transvaginal mesh have resulted in thousands of reports being filed with the FDA.

Public Citizen has requested that the FDA recall transvaginal mesh and require future mesh products designed to treat pelvic organ prolapse to be classified as class III medical devices. Such a classification will require rigorous premarket approval.

Transvaginal mesh lawsuits have been filed by women throughout the United States who have experienced problems through the use of these bladder slings. 

If you have suffered complications from the use of bladder slings or vaginal mesh, please contact my office immediately for a free consultation.

Complications from the use of Bard Avaulta Vaginal Mesh:

A mesh used to treat pelvic organ prolapse, has caused complications for many patients.

I am currently investigating potential product liability cases involving the use of Bard Avaulta Vaginal Mesh (Bard Avaulta Pelvic Support System). These medical devices are sometimes referred to as “pelvic mesh” or “bladder slings.” 

Used to correct and restore normal vaginal structure after a pelvic organ prolapse, the Bard Avaulta mesh is surgically implanted.

In October of 2008, the FDA issued Public Health Notifications regarding the use of surgical mesh like Bard Avaulta’s.  The use of the product had been the source of hundreds of reports of complications – some severe. The FDA warns of potentially serious complications resulting from the placement of surgical mesh products.

In a recent article in the Chicago Tribune, "Mesh used in Pelvic surgeries under scrutiny," it was reported that the director of pelvic medicine fellowship program at Loyola University Medical Center in Maywood, Illinois said that they do not do mesh surgeries as there are better alternatives. It was reported Mayo Clinic also does not do the transvaginal mesh surgeries.

Complications arising from the use of Bard Avaulta Mesh include:

• infections,

• pelvic pain,

• urinary incontinence and development of urinary retention,

• painful urination,

• pain with sexual relations,

• mesh erosion into the vagina, bladder, intestines and uterus,

• mesh shrinkage or migration,

• scar tissue formation,

• granuloma formation,

• neuropathic pain, 

Vaginal Mesh Lawyers / Vaginal Mesh Lawsuit

I am reviewing potential vaginal mesh lawsuits.  If you have suffered complications through the use of vaginal mesh, you may be entitled to compensation. 

Judges may soon consolidate the growing number of vaginal mesh lawsuits, and it is important that you speak to an attorney immediately.

I offer a free consultation to help you understand your legal options; contact my office today.

PLOUFF LAW OFFICES, P.C.
1-800-913-1708.