Transvaginal Mesh Side Effects

So far, there are more than one hundred lawsuits concerning transvaginal surgical mesh filed in various state courts around the country and now three separate but related motions have been filed to consolidate those cases before a judge in the Southern District of West Virginia.

Plaintiffs from 83 different cases are suing American Medical Systems, 41 cases are suing Ethicon, and 30 cases are suing Boston Scientific – all makers of synthetic surgical mesh used to treat stress urinary incontinence and pelvic organ prolapsed (POP). Unfortunately, the complication rate is unusually high and many women experience devastating pelvic pain, infections, erosion of the mesh through organs, degrading and hardening of the mesh, and nerve damage.

According to the FDA, the adverse events for POP implants had increased five-fold in the two year period ending December 31, 2010, when compared to the three previous years. But the FDA’s database of complications, known as “adverse events” is known to represent only a fraction of real-world injuries from defective medical devices.

Mesh Complications Unknown

According to the Government Accountability Office (GAO), 99 percent of complications associated with medical devices were not reported to the FDA. The more serious the complication, the less likely it was to be reported.
Bottom line, no one really understand how often these defective products fail.

If the U.S. Judicial Panel on Multidistrict Litigation grants the motions, the lawsuits would be moved to Chief Judge Joseph R. Goodwin. He is already familiar with mesh issues since he’s overseen the Avaulta Pelvic Support mesh cases since October 2010.

Farah & Farah Florida transvaginal mesh injury lawyers understand that, unlike a class action, a multidistrict litigation allows similar complaints to join forces, thereby reducing the cost of litigation and sharing discovery gathered from the other side. The cases are still considered individually and generally any settlement is determined sooner, depending on the degree of injury and the number of people in the multidistrict litigation.

Read more: http://www.digitaljournal.com/pr/530346#ixzz1hJsjPMfk

The first of the trials for transvaginal mesh manufacturer Ethicon/Gynecare, a subsidiary of Johnson & Johnson, are scheduled before a jury a year from now in New Jersey Superior Court. Known as Bellwether trials, the cases test the theories other cases to follow will use. The outcomes will not be binding in the lawsuits that follow, but they will help determine the value of the cases still ahead.

So far, at least 350 lawsuits have been filed over the J & J Ethicon/Gynecare transvaginal mesh. The cases are to be heard before the same judge in a New Jersey courtroom.

J & J makes the following transvaginal mesh products:

• Gynecare Prolift mesh
• Gynecare Prolene mesh
• Gynecare Gynemesh
• Gynecare TVT sling

Whatever their name, they are all made from a synthetic prolene and are designed to reinforce tissues and muscles that hold in place the uterus, the bladder, the top of the rectum, or the pelvic floor. When the mesh is implanted through the vagina it is known as a transvaginal placement.

Complications that may arise from the use of this mesh include: intense pelvic pain, infections, erosion of the mesh through organs, or a return of incontinence or prolapse. The cases allege that Johnson & Johnson understood the products were defective but continued to sell them, and that they also failed to warn patients about the serious complications associated with transvaginal mesh.

In July, 2011, the FDA issued a warning about the risks of surgical mesh placement in women and indicated the synthetic mesh does not appear to offer any benefit to the thousands who have opted for its placement. This is as close as the FDA has come to a recall without actually issuing one.

An FDA expert panel met in September, 2011 to consider a recall. The panelists appear to be leaning instead toward mandating a premarket review of transvaginal surgical mesh, which would include clinical studies that assure safety once they are placed in patients. At the present time, mesh approval does not require that it meet any standards of safety and efficacy.

Other mesh manufacturers include C.R. Bard, American Medical Systems and Boston Scientific, among others, who are also the subject of litigation. If you have experienced complications from using transvaginal mesh, the transvaginal mesh lawyers in Florida of Farah and Farah can help. Please call (800) 533-3555 for a no-cost consultation.

Hundreds of lawsuits have been filed against defective surgical mesh used to treat pelvic organ prolapse and incontinence in women. C.R. Bard is one major manufacturer and a Georgia law firm has filed to consolidate lawsuits from Florida, Georgia, and Indiana into multidistrict litigation in West Virginia. The request is for the 29 product liability lawsuits to join the hundreds filed and consolidated last October in Charleston, West Virginia.

Manufacturer C.R. Bard is the named defendant along with its subsidiary, Covidien.

The allegedly defective devices that injured women include the Pelvicol, PelviSoft, Pelvitex, Uretex, Align, or PelviLace products. The cases already pending in West Virginia include other Bard mesh products, including the Avaulta Biosynthetic, Avaulta Plus, and Avaulta Solo, as well as non-Avaulta products. (MDL 2187)

The product liability action alleges the surgical mesh is defective in its design and manufacturers failed to provide appropriate warnings of the risks associated with its use. In July, the U.S. Food and Drug Administration (FDA) issued a notification that it had received thousands of reports of adverse events or injuries associated with mesh from nine different manufacturers. Complications include erosion, infection, pain, bleeding, and repeated surgeries to have the mesh removed.

Product Liability – Transvaginal Mesh Complications

A Florida product liability lawsuit can be filed when any product is defective in its design, its manufacture, or its instructions which results in injury. Those named can include the manufacturer, the designer, and anyone in the distribution line.

More than 75,000 women a year are implanted with this defective product which never went through an approval process within the FDA for safety. Instead, it was approved for sale through an exchange of paperwork.

The Florida transvaginal mesh lawyers at Farah & Farah are talking to women injured by surgical mesh from all manufacturers which remains on the market for now. Please have a conversation with us at the first sign of pain and complications. A statute of limitations may exist on your case so a complimentary consultation as soon as possible is recommended. Call 1-800-533-3555 and we’ll be happy to set up a meeting.

Source: http://www.wvsd.uscourts.gov/MDL/Avaulta/index.html; http://www.aboutlawsuits.com/bard-pelvic-mesh-lawsuits-in-avaulta-mdl-21215/