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Billionaire-Backed Coloplast Sets Aside More Money for Lawsuits

Billionaire-Backed Coloplast Sets Aside More Money for Lawsuits

(Bloomberg) --

Coloplast A/S, a medical equipment maker controlled by Denmark’s billionaire Louis-Hansen family, has set aside an additional $60 million for U.S. settlements related to its surgical vaginal mesh products.

Coloplast made the 400 million-krone provision in Tuesday’s earnings report, which also included lower-than-expected fourth-quarter profits. The shares of the Danish company fell as much as 5.4% in Copenhagen trading, the most in a year.

The latest provision brings Coloplast’s total cost related to the case to 5.65 billion kroner since 2013.

Coloplast said in Tuesday’s statement that it has settled more than 95% of the cases it knows of and that it hasn’t seen an increase in the number of new lawsuits. The company made the additional provision to cover the remaining lawsuits, which are taking longer to resolve and are getting more expensive.

Mesh products, which help hold in organs, have been clouded by safety issues after doctors started implanting them through the vagina in 2002. Reported complications include pain, infection and even death on rare occasions. The U.S. Food and Drug Administration earlier this year ordered Coloplast and Boston Scientific Corp. to immediately stop the distribution and sale of the products in the U.S. because there isn’t enough evidence that they are safe or effective.

Coloplast also said it has now completed a strategic review of the urology division that was in charge of the mesh products. After confirming Bloomberg reports in June that it may sell the unit, Coloplast said on Tuesday that the review had found that the division “remains core to the Coloplast mission and future value creation.”

Read more: Coloplast Considers Sale of Urology Assets

The unit has “largely de-risked” after most of the mesh lawsuits have been settled and “interventional urology represents an attractive high growth market driven by demographics,” the company said. “The mass tort litigation is behind us.”

To contact the reporter on this story: Christian Wienberg in Copenhagen at cwienberg@bloomberg.net

To contact the editors responsible for this story: Tasneem Hanfi Brögger at tbrogger@bloomberg.net, Nick Rigillo

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