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Coloplast

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Coloplast is a leading global supplier of “intimate health care products,” covering ostomy care, wound and skin care, incontinence and urology. It faces lawsuits over its vaginal mesh products.

The Denmark-based company supplies its products – including catheters, ostomy bags, wound dressings, skin cleansers, antifungal products and vaginal mesh – to hospitals, retailers and consumers directly. Its world headquarters is in Humlebaek, Denmark, and the U.S. headquarters is in Minneapolis. Coloplast employs nearly 8,500 people in 55 countries.

Forbes ranked the company as the 12th Most Innovative Company of 2013, and Coloplast is considered one of the top 100 most sustainable companies in the world. The Ethisphere Institute – a think tank dedicated to ethics practices in business — named it one of the “World’s Most Ethical Companies” in 2012 and 2013, though some have questioned the independence of the group.

Despite the accolades, Coloplast has had to confront some hard realities in the medical device manufacturing industry. Some women reported that transvaginal mesh products harmed them, and some of them followed up by suing the company for damages in state and federal court. (Some of its competitors are having similar issues.)

Coloplast faces more than 1,200 in federal court and an unknown number in state courts. The overall number of lawsuits is more than 70,000.

Fast Facts about Coloplast
Established: 1957
Founder: Elise Sorensen
Headquarters: Humlebaek, Denmark
Size: 8,500 employees worldwide
2014 Revenue: $1.8 billion

History

Coloplast started in Denmark in 1954 with an idea. Nurse Elise Sorensen was concerned when her younger sister, Thora, then 32, had her colon removed after a cancer diagnosis. The operation saved her life but left her embarrassed and afraid to leave her house.

Newly invented plastic bags gave Elise an idea for a bag that would seal around the stoma (opening). She found a manufacturer to help her make her idea a reality, and distributed 1,000 ostomy bags to hospitals. Two years later, they were exporting two-thirds of the bags, and Coloplast was born.

“Every day at Coloplast, we find new inspiration in the story of Elise Sorenson – her passion, skills and love for her sister,” CEO Lars Rasmussen said in a video on the company’s website. “Our mission is to make life easier for people with intimate health care needs. We focus on easing the challenges of deeply private and personal medical conditions.”

Coloplast bought the urology division of Mentor Corp. in 2006 and relocated its North American headquarters operations from Atlanta and Santa Barbara, California, to Minneapolis – home of Mentor Urology. The company today has production facilities in Denmark, Hungary, France, China and the U.S., with the vast majority of its sales in Europe. It is traded on the Danish Stock Exchange.

The company never strayed from its roots and produces products in four areas: ostomy care, wound and skin care, incontinence and urology:

  • Ostomy care: Assura, Brava and SenSensura brand names.
  • Wound and skin care: Cleansers, moisturizers, anti-fungals, odor control and skin fold management products. The company also makes a variety of dressings, skin sealants and gels designed to cover wounds.
  • Incontinence: Help people with urinary system issues, spinal cord injuries, spina bifida and multiple sclerosis. Wide range of catheters and drain bags address many continence needs.
  • Urology: Focuses on male and female pelvic health. Treat erectile dysfunction, urinary incontinence, enlarged prostate, pelvic organ prolapse and kidney stones. Coloplast makes penile implants, testicular prosthetic devices, bladder slings and mesh products.

Transvaginal Mesh Lawsuits

Coloplast manufactures and markets several mesh products to treat pelvic organ prolapse and stress urinary incontinence in women.

Coloplast Vaginal Mesh Products
Pelvic Organ Prolapse Products Stress Urinary Incontinence Products
Exair Mesh Altis Single Incision Sling
Novasilk Aris Sling
Restorelle Supris Sling

In early 2012, the U.S. Food and Drug Administration (FDA) ordered Coloplast and other makers of mesh prolapse devices to conduct postmarket studies to address safety and effectiveness concerns. Two years later, the FDA announced it was seeking to recategorize prolapse mesh products as high-risk devices; this would require premarket testing before approval.

The devices are linked to serious injuries, including erosion, organ perforation and incontinence, which may require multiple surgeries to correct. Coloplast is among several manufacturers facing thousands of mesh lawsuits filed by women who were hurt by the implants.

In March 2014, the company settled 400 mesh cases for $16 million, amounting to $40,000 for each woman. The company set aside DKK 1 billion ($186 million) to cover future mesh litigation costs.

“Coloplast stands by its surgical mesh devices and is prepared to enter litigation,” the company said in a May 2014 statement. “However, if we believe seeking settlements is the right business decision, we will pursue them. Although we have proposed settlements, Coloplast does not admit any liability or that its devices are unsafe.”

In September 2015, Coloplast increased the amount of money set aside for mesh litigation to DKK 3 billion (about $457 million).

“We have been ordered by the judicial system in the U.S. to take preliminary steps towards actual litigation on 200 specific cases,” Coloplast President and CEO Lars Rasmussen said in a statement. “This means that our costs in relation to the litigation will increase. As a consequence, we have found it necessary to increase our provision.”

The Future

Coloplast is focusing on expanding business around the world. The company expanded production with the addition of a new factory in Hungary in 2007. In January 2013, the U.S. unit signed a three-year agreement with Novation, a leading health care supply chain company. The agreement put Coloplast products in 2,500 hospitals served by Novation. As a result, its ostomy products were available to 80 percent of the U.S. market.