DrugJustice

Covidien Agrees to Settle 11,000 Transvaginal Mesh Claims

transvaginal mesh claims

On June 23, 2015, Covidien agreed to settle upward of 11,000 transvaginal mesh claims involving one of its products. Here's what victims need to know.

On June 23, 2015, Covidien agreed to settle over 11,000 transvaginal mesh claims. According to Reuters, patients filing transvaginal mesh claims say it caused severe, painful side effects.

Though the settlement amount wasn’t listed, this marks an important step forward in TVM litigation.

Transvaginal Mesh Claims Continue to Rise

In addition to its own 11,000 cases, Covidien products given to another device manufacturer will also be addressed. There’s dispute between the two companies, but C.R. Bard does have mesh products.

Covidien isn’t alone—many other manufacturers were hit with similar transvaginal mesh claims, including Bard. Unfortunately, the device proves both destructive and dangerous for many women globally. This is partly due to a loophole in the approval process as well as failure to warn about risks.

TVM was originally designed to treat vaginal vault prolapse, organ prolapse, and urinary incontinence in women who gave birth or are over age 50. It’s meant to hold organs that are slowly falling into the bladder and vagina in their proper places to prevent pain, damage and further incontinence.

Injuries Let to Initial TVM Product Recall

Its development began after a different kind of surgical mesh, primarily used in the abdomen, was approved by the FDA, as it caused few issues and had to undergo relatively rigorous testing. The first marketed TVM product was actually recalled due to injuries. But somehow, additional mesh products were released through the FDA’s 510(k) approval process. The problem? Mesh behaves radically differently when it’s implanted in the vagina than it does in the abdomen.

The vagina is what many surgeons refer to as “clean contaminated.” In other words, it’s populated by a wealth of healthy (and necessary) bacteria. Unfortunately, this makes it impossible for totally bacteria-free surgery. After the mesh is implanted, a disintegrating wound often develops. This allows the product to travel through the vaginal wall and cause serious pain and complications, both during intercourse and regular activity.

Perhaps even more painful and debilitating is the TVM removal procedure. Multiple surgeries are frequently required to remove the product in its entirety, if they’re successful. Because mesh integrates with tissue so pervasively, it does not always come out.

What You Can Do

Those harmed after getting TVM implanted may be eligible to file tranvaginal mesh claims. It’s a good idea to have an experienced attorney first review your case, as he or she will be able to help you determine how to move forward and whether you can file against a drug manufacturer such as Covidien. Reuters reported that more than 100,000 transvaginal mesh claims have been filed in the U.S., and there has never been a better time to make your claim.

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