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Vaginal MeshInjuries from Mesh Implant Severe and Debilitating

Vaginal Mesh

Litigation Updates

Remaining TVM Cases Are Prepared for Trial

April 2018 - Following the settlement of thousands of cases on January 30, 2018, MDL Judge Goodwin ordered that hundreds of remaining TVM cases be worked up for trial.

C.R. Bard Hit With $33 Million Pelvic Mesh Verdict in NJ

April 12, 2018 – On Thursday, New Jersey state jury awarded a plaintiff $33 million in damages to be paid by C.R. Bard. After four weeks of trial and deliberations, the jury found Bard guilty of manufacturing unsafe pelvic mesh products as well as failing to warn doctors and consumers about the potential adverse health risks associated with the company's pelvic mesh products.


The plaintiff, Mary McGinnis, filed the lawsuit in 2011, claiming that her injuries were a result of the defective design of Bard's pelvic mesh products – Avaulta Solo Support System & Align Trans-Obturator Urethral Support System. The lawsuit further claimed that Bard failed to properly inform doctors and patients of the adverse health risks associated with the products.

The jury found Bard guilty on both counts, awarding McGinnis $23 million in compensatory damages. Bard was ordered to pay an additional $10 million to McGinnis' husband, who was a named co-plaintiff.

McGinnis underwent Avaulta Solo procedure in March 2009 to support her bladder. The Align system was meant to treat stress urinary incontinence.

McGinnis claims that her subsequent injuries were a direct result of her pelvic mesh device. The plaintiff went on to argue that Bard failed to make public the known risks associated with the device and, if she or her doctor were aware of these risks, neither herself nor her doctor would have chosen to undergo the 2009 procedure.

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Vaginal Mesh

Surgical mesh, which is used for transvaginal mesh surgery and bladder slings, is a medical device that is generally used to repair weakened or damaged tissue (specifically in pelvic organ prolapse (POP) or stress urinary incontinence (SUI)). It is made from either porous synthetic material or biologic material.

On July 13th, the FDA issued an Alert stating that serious complications associated with vaginal mesh/bladder slings for transvaginal POP repair are not rare. In fact, the FDA noted that they have received thousands of voluntary reports from patients, friends or doctors indicating complications occurring as a result of the vaginal mesh/bladder sling, with at least 10 of the reports resulting in deathRecent studies estimate that the actual rate of injury is likely to increase significantly, which should not be surprising considering that more than 100,000 of these types of procedures are performed annually.  There could be tens of thousands of injuries and hundreds of deaths according to reports made to the FDA.


What is the Bladder Sling/Vaginal Mesh Product Used for?

The bladder sling/vaginal mesh product is implanted during surgery to repair POP and SUI. The synthetic mesh has edges that are in some cases piercing the surrounding tissue and puncturing the bladder, uterus, or bowel. The “patches” can also migrate doing irreparable damage as they move around. Women are also suffering horrible infections because of the mesh.

These types of mesh underwent virtually no safety review by the FDA or any other regulatory agency before being put on the market by manufacturers.


What are the Injuries?

The injuries that women are suffering from this mesh implant are severe and debilitating and could have been avoided had people had the proper information.

The edges of the mesh/sling cut through the skin after implantation causing infection and cutting into nearby structures sometimes puncturing the bladder, bowel, and uterus.

Additionally, the petroleum-based synthetic material is particularly capable of causing infection because the material itself is a “breeding ground” for bacteria.  Complications from these infections include incontinence, extreme pain during intercourse, UTI, back pain, inability to walk, etc.  Some of these infections spread through the whole body and lead to death.

There are other safer alternatives to synthetic mesh (biological mesh for example) that should be considered before the decision is made to use synthetic materials.  Sometimes these injuries can take years to develop after the initial surgery.


Can the Bladder Sling/Mesh be Removed?

Once the mesh is implanted it is very difficult to remove. Even after multiple surgeries, doctors are sometimes unable to remove all of the mesh which by that point has become infused to the surrounding tissue, causing life-long problems.

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