Gynecare Prolift

February 5, 2016

FDA Ups Transvaginal Mesh Warning Label as “High Risk Devices”

According to the U.S. Food and Drug Administration (FDA), the popular plastic transvaginal mesh device that has been used to repair pelvic organ prolapse (POP) transvaginally, or through the vagina, will have to undergo rigorous safety studies before being available to be used in patients.

The FDA issued two final orders to vaginal mesh manufacturers and notified the public that the agency is strengthening the medical data requirements for surgical mesh.

FDA Classifies Plastic Vaginal Mesh as High Risk

April 30, 2014

FDA: Reclassification of Trans Vaginal Mesh as High Risk Device

by Dr. Shezad Malik

The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

What is Pelvic Organ Prolapse?

September 30, 2013

Bard, Boston Scientific, Endo Health/AMS Vaginal-Mesh Makers Settlement on the horizon

by Dr. Shezad Malik

As a Texas Vaginal Mesh attorney, and Dallas medical doctor, we are reporting this important potential transvaginal mesh settlement breakthrough. According to sources, C.R. Bard Inc., and other makers of vaginal-mesh implants, are in advanced talks to settle thousands of vaginal mesh product liability lawsuits.

Bard, Endo Health Solutions Inc. the parent of AMS, Boston Scientific Corp., Coloplast and Cook Medical Inc. manufacturers making vaginal mesh devices to treat pelvic organ prolapse (POP) and treat stress urinary incontinence (SUI) in talks about settling all suits.

Johnson & Johnson, which also faces suits over the vaginal mesh devices, isn’t involved in the talks.

September 25, 2013

Bard, Ethicon, Boston Scientific, AMS, Coloplast Vaginal Mesh Litigation

by Dr. Shezad Malik

Transvaginal mesh injury lawsuits are consolidated and coordinated in 6 individual multidistrict litigations (MDLs) established in the federal court system. These injury claims against vaginal mesh manufacturers have now become the largest pending litigation in the U.S.

30,000 Active Mesh Lawsuits and Climbing

There are more than 30,000 complaints filed in U.S. District Courts over injuries with transvaginal mesh and bladder sling products. These medical devices have been used for treatment of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI).

September 16, 2013

Bard Avaulta Mesh Cases Beginning to Settle

by Dr. Shezad Malik

According to reports, C.R. Bard Inc., has agreed to settle a one of its Avaulta vaginal-mesh implant lawsuits, which allegedly caused severe urinary problems. This case was set for trial this month in New Jersey.

Bard agreed to pay an undisclosed sum to resolve Melanie Virgil’s claims that Bard’s Avaulta Plus insert caused urinary problems. Virgil’s case had been set for a Sept. 23 trial in state court in Atlantic City.

According to the filings, the 56-year-old woman said she needed three surgeries to address urinary problems created by the insert.

September 2, 2013

Bard Settles 2nd Avaulta Transvaginal Mesh Lawsuit

by Dr. Shezad Malik

Recently, Bard settled the second federal Avaulta bellwether trial over its alleged defective transvaginal mesh devices. The settlement was announced by U.S. District Judge Goodwin, who is supervising the transvaginal mesh product liability lawsuits in Charleston, W.Va.

As previously noted, in the first Bard Avaulta bellwether trial, the jury awarded $2 million to a woman who claimed that Bard failed to warn of defects in its product that caused her mesh side effects. The settlement ended the second trial, brought by a North Carolina woman, Wanda Queen. A third bellwether case goes to trial on October 8 and a fourth on November 4.

Over 20,000 Trans Vaginal Mesh Lawsuits Pending

August 20, 2013

Bard Avaulta Vaginal Mesh Trial $2M Plaintiff’s Verdict

by Dr. Shezad Malik

Last week, a federal jury in West Virginia awarded $2 million in damages in a Bard Avaulta vaginal mesh defective product liability claim. The verdict included punitive damages to punish CR Bard Inc., the manufacturer for selling a defective product that has been linked to severe internal injuries.

This is the first federal Vaginal Mesh verdict, in more than 25,000 vaginal mesh lawsuits pending in the federal court system.

Plaintiff Suffered Serious Injuries

July 18, 2013

Bard Avaulta Mesh Trial Ends Abruptly

by Dr. Shezad Malik

U.S. District Judge Joseph Goodwin presiding over the first federal Bard Mesh trial has declared a mistrial. This trial involved complications associated with Bard Avaulta mesh. On the second day of trial, a gynecological expert mentioned that the Bard Avaulta mesh has been removed from the market. In pre-trial rulings, the parties agreed that evidence of the products subsequent withdrawal would be excluded because it may bias the jury.

What is Bard Avaulta Mesh?

Bard Avaulta mesh is used for transvaginal surgical repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). Thousands of women have claimed that Avaulta plastic mesh have caused them to suffer serious and catatrophic injuries when the mesh may eroded through the vagina.