Coloplast

Coloplast is a Denmark-based supplier of medical care products including ostomy care, continence care, wound and skin care, and products for interventional urology including implantable mesh and slings. Coloplast’s U.S. headquarters are in Minneapolis, Minnesota. Coloplast has faced thousands of lawsuits for harm caused by its transvaginal mesh and bladder sling medical devices.

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  • About Coloplast
  • History of Coloplast
  • Coloplast Products
  • Coloplast Legal Issues
  • Coloplast and Transvaginal Mesh

About Coloplast

Coloplast is a Denmark-based supplier of personal medical care products including incontinence and urology supplies, wound and skin care products, ostomy care products and devices for interventional urology. The global manufacturer is headquartered in Humlebaek, Denmark with U.S. headquarters in Minneapolis, Minnesota. Coloplast employs an estimated 12,000 people worldwide and had about $2.7 billion in revenue in 2019.

In many ways, Coloplast is considered to be a highly progressive company. It was ranked by Forbes magazine as one of the world’s most innovative companies until 2017 and is amongst the 100 most sustainable companies coming in at number 67 with “green” practices. It has also been recognized as the medical device company with the best patient reputation according to UK research organization, PatientView along with being awarded accolades as a “good” company to work for.

Despite the fact that Coloplast has spent several years the “World’s Most Ethical Companies” list compiled by a business ethics group, The Ethisphere Institute, Coloplast has faced thousands of lawsuits for harm caused by its transvaginal mesh medical devices.

History of Coloplast

Coloplast was founded in 1954 when a Danish nurse, Elise Sorenson came up with an ostomy bag and an adhesive ring that fit tightly to the skin as a solution to help her sister with ostomy care and fear of going into public. The ostomy bag and adhesive seal allowed patients a good deal more freedom without significant fear of leakage or odor.

In 2006, Coloplast acquired the urology business of Mentor Corporation, based in Minneapolis, Minnesota. Coloplast moved its US headquarters to Minneapolis after the acquisition. In 2016, Coloplast acquired a direct-to-consumer marketer, comfort Medical which allowed the company to begin selling products without using a distributor.

Coloplast is a publicly-owned Danish corporation and is traded on the Danish Stock Exchange. Coloplast has experienced between 6 and 11 percent revenue growth each quarter for several years and is projected to bring over $3 billion in revenue for 2020.

Coloplast Products

The company has since expanded beyond the original ostomy bag into additional “intimate healthcare” issues to help patients with “challenges of deeply private and personal issues” such as:

  • Ostomy care with brand name ostomy products such as Assura, Brava and SenSura pouches, adhesives, and supplies for both adults and pediatric patients.
  • Wound care with a range of skin care products for bed-ridden or incontinent patients including cleansers, anti-fungals, skin barrier and dressings.
  • Bladder care products such as catheters and urine bags for patients with spinal cord injuries or disorders.
  • Interventional urology care with a number of surgical devices for urological and pelvic disorders in both men and women including implantable transvaginal and surgical mesh and bladder slings for stress urinary incontinence (SUI) and pelvic organ prolapse (POP)

The surgical urology product line includes surgical devices used for:

  • Erectile dysfunction
  • Testicular replacement
  • Male urinary incontinence
  • Endourology (kidney stone removal)
  • Stress urinary incontinence (SUI) in women
  • Pelvic organ prolapse (POP) in women

Coloplast manufactures surgical tools and surgical transvaginal mesh products and bladder slings used for female pelvic organ prolapse and stress urinary incontinence. Some of these products have resulted in severe adverse events when implanted in patients and are currently the subject of at least 1,200 lawsuits.

Coloplast Legal Issues

Coloplast is only one of several manufacturers named in transvaginal lawsuits and many companies are expected to pay $20 thousand or much more to each patient. In preparation to address multiple claims over transvaginal mesh lawsuits, Coloplast made provisions to set aside nearly $180 million for future US legal expenses.

In March of 2014, Coloplast agreed to pay $16 million to settle 400 lawsuits regarding transvaginal mesh products, however an estimated 1,500 lawsuits were consolidated in the US District Court for the Southern District of West Virginia under Judge Joseph R. Goodwin. The company also paid $600 thousand to the State of Minneapolis after failing to fulfill promised job-creation goals, even though they had received over $3 million in relocation aid to move company headquarters.

In 2015, the company also agreed to pay $3.2 million in 2015 to settle U.S. Department of Justice lawsuit claims of paying kickbacks to physicians. The company was accused of providing cash incentives, giving rebates and price concessions to suppliers and sales personnel as incentives for use of Coloplast products.

In 2016, the company paid an additional $600 thousand to settle U.S. Department of Health and Human Services accusations of missing mandatory price reporting deadlines and separately in 2016, Coloplast was part of a multi-company agreement to pay $11.5 million for 2,000 lawsuit claims in California.

In 2017, a New Orleans lawsuit was dismissed after a man had claimed that he was injured by his penile implant, however the company may still be facing numerous transvaginal mesh and bladder sling lawsuits.

Coloplast and Transvaginal Mesh

Transvaginal mesh was first introduced in the mid-1990s for surgical treatment of stress urinary incontinence. The first products were modeled after surgical mesh that had been in use for other surgical repair procedures such as hernia repair but the initial “bladder sling” was only on the market for three years before it was recalled due to safety concerns.

Transvaginal surgical mesh is used to treat pelvic organ prolapse and stress urinary incontinence caused by weakened pelvic muscles in females. Though it was thought to be safer and more effective than more traditional procedures due to its “transvaginal” implantation through the vagina rather than through abdominal incision, it has caused a number of severe adverse events which are permanently disabling and even life threatening including:

  • Mesh erosion – into the vaginal wall causing shrinkage, bleeding, and extreme pain
  • Organ perforation – mesh erosion all the way through the vaginal wall or into other organs such as the kidneys
  • Revision surgery – both to repair damage caused by the mesh and to treat the original condition

Coloplast transvaginal mesh products that may have caused injury include:

  • Axis Biologic
  • Suspend Biologic
  • Novasilk Mesh
  • Exair Mesh
  • RestorelleSmartmesh
  • Aris Sling
  • Minitape Sling
  • Omnisure Sling
  • Supris Suprapubic Sling

In addition to the many that have been injured by transvaginal mesh or sling products, some patients have also died from those injuries caused by transvaginal mesh. Some Coloplast lawsuits have been settled but others may still remain in court systems.

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