Articles Posted in Pelvic Mesh

Transvaginal Mesh Reclassified by FDA as Highest Risk Device

Published on: January 20, 2016 | By Clay Hodges

Mark this down in the “It’s About Time” column.

On January 4, 2016, the Food and Drug Administration (FDA) finally made the move to reclassify transvaginal mesh medical products from Class II to Class III.

Surgical mesh is a medical product that has been used for more than sixty years and is intended to provide “additional support when repairing weakened or damaged tissue.” FDA News Release. It is typically a plastic lattice-type mesh that is surgically implanted around weakened, loose human tissue (such as a vaginal wall). While surgical mesh can be used to treat different kinds of problems, such as hernia, the mesh that has caused much of the current suffering and most of the lawsuits involves transvaginal mesh (TVM). Pelvic organ prolapse (POP), where organs fall from their normal position and press against the vaginal walls, is one of the conditions treated by TVM.

Recent Transvaginal Mesh Trials: Two Losses, One Win for Injured Women (Part 4)

Published on: January 15, 2016 | By Clay Hodges

We’ve been looking at recent trial results in transvaginal mesh cases. In this (fourth) post we review two verdicts from October 2015, where juries concluded that the mesh manufacturers were not negligent. Thus, these injured women received no money for the failure of the transvaginal mesh. In a third case, decided on December 21, 2015, the jury awarded $12,500,000.00 to an injured woman. I will take a look at all three cases:

Cavness v. Kowalczyk et al. (Texas District Court, Dallas)

Product: Gynecare Prosima Pelvic Floor Repair System

Key Product Defendants: Ethicon, Inc. and Johnson & Johnson.

Jury Award: zero.

Date of Jury Verdict: October 5, 2015

Key Takeaway: A big win for Ethicon and Johnson & Johnson, defendants in the case.

Transvaginal Mesh: One Huge Verdict and One Key Court Ruling from 2015 (Part 3)

Published on: December 20, 2015 | By Clay Hodges

In this post, we continue our review of transvaginal mesh cases. We look at one (remarkable) jury verdict and one partial summary judgment decision in favor of the defendant from 2015. Many other cases are moving to trial. Going forward, I will keep you updated on jury verdicts and other key court decisions as they happen.

Barba v. Boston Scientific Corp. (Delaware Superior Court)

Products: Pinnacle Pelvic Floor Repair Kit Transvaginal Mesh and Advantage Fit Mid-Urethral Sling System

Jury Award: $100,000,000.00.

Date of Jury Verdict: May 28, 2015

Key Takeaway: A huge verdict for the plaintiff, Deborah Barba. This case was remarkable for the very high money award: one hundred million dollars, to a single woman.

Transvaginal Mesh Cases: Two Jury Verdicts and One Appeal (Part 2)

Published on: December 14, 2015 | By Clay Hodges

Transvaginal mesh lawsuits are finally getting their day in court. This is a good thing for the thousands of women who were injured, some severely, by the failure of the transvaginal mesh products sold by Ethicon (Johnson & Johnson), Boston Scientific, and other companies. In Part 1, we looked at three TVM jury verdicts from 2013 and 2014. In this post, we look at two jury verdicts and an appeal decision from November 2014.

Many other cases are moving to trial. In Part 3, I will discuss several jury verdicts from 2015.

Transvaginal Mesh Lawsuits: Key Jury Verdicts (Part 1)

Published on: December 3, 2015 | By Clay Hodges

Transvaginal mesh (TVM) is a plastic mesh product that is surgically implanted in women to repair or support weakened vaginal walls and other compromised tissue. Many women suffer from a condition called pelvic organ prolapse (POP), where an organ like the bladder prolapses from its normal position in the body and presses against the walls of the vagina. One of the main causes of this condition is childbirth. The FDA approved TVM for treatment of women with POP and other conditions like stress urinary incontinence more than a decade ago.

Sadly, TVM has caused terrible problems for thousands of women. Not only after transvaginal mesh was marketed and sold, women began complaining of different, often more serious problems. Complications include erosion of the vaginal wall, infections, urinary problems, pain during sexual intercourse, scarring, bowel or bladder perforation, and recurrence of pelvic organ prolapse or incontinence. Women have been forced to undergo surgeries to attempt to repair the damage done by transvaginal mesh. In some cases injured women have endured multiple surgeries.

The lawsuits followed. Fortunately for these (often severely) injured women, these cases are finally getting to trial and to jury verdicts. The good news is that some plaintiffs have received millions from juries for their injuries. But the TVM manufacturers have also scored victories.

Transvaginal Mesh: What Is It and Why So Many Lawsuits?

Published on: November 27, 2015 | By Clay Hodges

You have probably seen news reports (or at least the flood of TV commercials from law firms) about the suffering caused by the failure of transvaginal mesh (TVM) products. This is a unique medical device failure “story” because of the large number of women who have been affected. It is estimated that transvaginal mesh is implanted in more than 200,000 women each year in the United States. And by early 2015 well over 70,000 lawsuits have been filed against transvaginal mesh manufacturers because of injuries caused by TVM. More lawsuits are being filed each week.

But let’s back up.

Surgical mesh is a medical product that “is used to provide additional support when repairing weakened or damaged tissue.” FDA News Release April 29, 2014. It is a plastic lattice-type mesh that is surgically implanted around weakened, loose, sagging, or otherwise compromised human tissue (such as a vaginal wall). While surgical mesh can be used to treat different kinds of problems, such as hernia, the mesh that has caused much of the current suffering and most of the lawsuits involves transvaginal mesh.

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