By Robert J. Boumis  |  October 6, 2014

Category: Legal News

iStock-Vaginal-Mesh-Woman-PainA pelvic mesh lawsuit was filed by an Indiana woman who allegedly suffered serious complications from pelvic mesh used in her surgery.

Plaintiff Janie Livingston filed her pelvic mesh lawsuit against Ethicon, a subsidiary of medical giant Johnson & Johnson that produces medical implants.

Pelvic mesh, also called transvaginal mesh, bladder slings, and TVT mesh, is a type of surgical implant, used to treat stress urinary incontinence (SUI), and pelvic organ prolapse (POP). In these disorders, the musculature and other support structures of the pelvis weaken, causing organs to fall out of place. Pelvic mesh is designed to help hold these organs in place. However, pelvic mesh lawsuits like Livingston’s allege that the surgical implant can have serious side effects.

Livingston’s pelvic mesh lawsuit alleges that after she had pelvic mesh implanted in 2010, she suffered serious complications. Pelvic mesh lawsuits have alleged that pelvic mesh can cause a host of medical problems. This can include mesh erosion. In mesh erosion, friction causes the mesh to wear through the very structures it is intended to support and protect. Additionally, mesh erosion lawsuits allege that pelvic mesh can cause other complications like embedment, in which tissue grows around the mesh, causing severe pain and making it very difficult, and sometimes even impossible, to surgically remove the mesh. Others have reported nerve damage at the anchor points of the mesh.

One issue that has come up in pelvic mesh lawsuits is that the makers of pelvic mesh were able to skip several steps of U.S. Food and Drug Administration (FDA) testing. Under an FDA program called the 501(k) program, medical device manufacturers can skip several stages of FDA testing if the device they are manufacturing is “substantially similar” to existing technologies. Since pelvic mesh is surgical mesh manufactured in specific shapes for pelvic surgery, the makers of pelvic mesh were able to argue that pelvic mesh was similar enough to an existing, approved technology that it was able to skip several stages of FDA testing. However, lawsuits and recalls have suggested that pelvic mesh may have avoided testing that could have revealed risks including mesh erosion, embedment, and nerve damage at anchor points.

Livingston’s pelvic mesh lawsuit has joined others in a type of group legal action called a multidistrict litigation, or MDL. MDLs group similar lawsuits together to streamline the legal system by combining tens, hundreds, or even thousands, of individual lawsuits into a single coordinated proceeding. This can help save resources for all parties, allowing the legal system to avoid duplicating efforts.

The Ethicon Pelvic Mesh MDL is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, MDL No. 2327, filed in the U.S. District Court for the Southern District of West Virginia.

In general, vaginal mesh lawsuits are filed individually by each plaintiff and are not class actions.

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