Coloplast A/S will pay $16 million to settle lawsuits related to their vaginal mesh products. In more than 400 cases, women were seeking restitution for injuries they sustained while using the products. Each claimant will receive around $40,000 in restitution.
Coloplast, headquartered in Humlebaek, Denmark, also manufactures urine and ostomy bags, intended for patients recovering from surgery. In 2012, the U.S. Food and Drug Administration ordered vaginal mesh manufacturers to collect data on complications from their devices, including organ damage.
Claimants in the case have agreed not to speak publicly about the Coloplast settlement.
The devices are used to support internal organs, for treatment of pelvic organic prolapse, or to prevent urinary stress incontinence. More than one million women have used the device since 1999. Many users suffer pain and injury from use of the insert. Court records showed complaints of discomfort, incontinence, bleeding, infection, and other complaints.
Coloplast was one of five manufacturers of vaginal mesh inserts to meet with lawyers, to discuss how best to handle 29,000 lawsuits. Johnson and Johnson did not participate in talks. That company ceased making the devices when the first suits were filed. Corporate managers at Coloplast made the official announcement of the settlement during a stock exchange announcement.
Similar suits are still in progress against other manufacturers of vaginal mesh inserts. These actions may resolve into a global settlement for injuries caused by the use of vaginal mesh inserts.