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The Coloplast Mesh Litigation

Defective Medical Devices


In 2010, doctors in the United States inserted more than 70,000 mesh devices in patients, threading them through incisions in the vagina to fortify pelvic muscles that failed to support internal organs or to treat incontinence, according to court filings.

Sometimes the failure of these devices is masked by other symptoms, pelvic pain, infection, aches in joints in the back and shooting pain down the leg. Women are often told they are “getting old” by doctors perplexed by the symptoms. Doctors, too, have been kept in the dark about the downside of mesh established in almost all of the trials .

The product liability lawsuits claiming injuries from transvaginal mesh or bladder slings used for repair of pelvic organ prolapse and female stress urinary incontinence are centralized in the multidistrict litigation (MDL). In February 2012, MDL cases against the mesh manufacturers were consolidated. This legal process streamlines hundreds of individual claims against the companies. The U.S. District Court for the Southern District of West Virginia is the site of the coordinated litigation for transvaginal pelvic mesh lawsuits. Judge Goodwin is the federal judge who oversees the consolidation of the transvaginal mesh cases in Charleston, West Virginia, which include Coloplast.

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Defendant’s Pelvic Mesh Products that are listed in Coloplast complaint are as follows:

  • T-Sling-Universal Polypropylene Sling
  • Aris-Transobturator Sling System
  • Supris-Suprapubic Sling System
  • Novasilk-Synthetic Flat Mesh
  • Suspend-Tutoplast Processed Fascia Lata
  • Exair-Prolapse Repair System
  • Axis-Tutoplast Processed Dermis
  • Restorelle
  • Smartmesh
  • Omnisure
  • Minitape

The women in these lawsuits assert that the mesh implants can erode, cause infection and pain, bleeding and require mesh-removal surgeries. Since the mesh was a permanent implant, it becomes deeply embedded in the abdomen and some of the devices erode after being implanted, which can cause organ damage, pain and make sexual intercourse painful.

Bellwether trials have been used in our legal system where there are large numbers of similar claims or lawsuits against the same defendant. A bellwether trial is a procedure where a representative case or cases are selected to be tried before a jury to assist the court and the parties in evaluating information and evidence, and possibly predicting future trends about the larger group of cases. Judge Goodwin is overseeing the bellwether trials. There has been no bellwether cases tried and there are no trial settings in this MDL against Coloplast.

In 2014, Bloomberg News reported that Danish device maker Coloplast agreed to pay $16 million to settle mesh lawsuits. The plaintiffs with whom settlements have been made are reportedly receiving approximately $40,000 each from Coloplast.

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