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Coloplast

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Coloplast is a medical device manufacturer based in Denmark. The company markets catheters, ostomy bags, wound dressings, skin cleansers, antifungal products and transvaginal mesh to hospitals around the world.

Coloplast History

Coloplast got its start in 1954 when Danish nurse, Elise Sorensen, sought to help her sister in the wake of a cancer surgery that involved the removal of her colon. The recent invention of plastic bags gave Sorenson the idea for an ostomy bag, and she soon convinced plastics manufacturer Aage Louis-Hansen to produce her invention. Three years, later Coloplast was born.

Coloplast’s U.S. headquarters is located in Minneapolis, Minnesota. In 2006, the company purchased the urology division of Mentor Corp. – Mentor Urology – and d relocated its North American headquarters to Minneapolis. Today, Coloplast markets and manufactures devices in four product categories:

• Ostomy care under the Assura, Brava and SenSensura brand names
• Wound care
• Incontinence
• Urology

Coloplast employs nearly 8,500 people in 55 countries, including Denmark, Hungary, France, China and the U.S. The company reported revenues of $1.8 billion in 2014.

Transvaginal Mesh Litigation

Coloplast markets a number of transvaginal mesh products used to treat women with stress urinary incontinence or pelvic organ prolapse. These products include:

• Altis Single Incision Sling
• Aris Sling
• Exair Mesh
• Novasilk
• Restorelle
• Supris Sling

In 2011, the U.S. Food & Drug Administration (FDA) disclosed that it had received 3,000 reports of complications among transvaginal mesh recipients, and cautioned that use of the devices for prolapse repair appeared to offer patients no added benefits over alternative therapies. As such, the agency no longer considered complications associated with this particular procedure to be rare.

In 2012, Coloplast and other mesh manufacturers were ordered to conduct post-market studies to better assess their safety profiles. In 2014, the FDA announced it was seeking to re-categorize mesh used in prolapse repair as high-risk medical devices.

Tens of thousands of women have filed transvaginal mesh lawsuits against Coloplast and other medical device companies.  Plaintiffs claim that mesh manufacturers failed to properly test their products, and did not provide adequate warnings regarding the risks associated with the devices.

In March 2014, Coloplast settled 400 mesh lawsuits s for $16 million. It also set aside $186 million to cover future cost associated with the litigation. In September 2015, the company disclosed that it had increased the amount of money set aside for transvaginal lawsuits to $457 million.