Coloplast is a Denmark- based supplier of personal medical care products including ostomy care products, incontinence and urology supplies, and wound and skin care products. The global manufacturer is headquartered in Humlebaek, Denmark with US headquarters in Minneapolis, Minnesota.
In most ways, Coloplast is a highly progressive company. It was ranked by Forbes magazine as the 25th Most Innnovative Company in the world in 2013 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 was named one of the “World’s Most Ethical Companies” in both 2012 and 2013 by an business ethics group, The Ethisphere Institute, Coloplast is facing thousands of lawsuits for harm caused by its transvaginal mesh medical devices.
Coloplast employs an estimated 8,500 people worldwide and had about $2 billion in revenue in 2013.
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.
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.
- Urology care with a number of surgical devices for urological and pelvic disorders in both men and women.
The surgical urology product line includes surgical devices used for:
- Erectile dysfunction
- Testicular replacement
- Male urinary incontinence
- Endourology (kidney stone removal)
Coloplast also manufactures surgical tools and surgical transvaginal mesh products 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.
In 2006, Coloplast acquired the urology business of Mentor Corporation, based in Minneapolis, Minnesota. Coloplast moved its US headquarters to Minneapolis after the acquisition and now has facilities in five companies with the majority of sales in the EU. Coloplast is a public 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 currently on target to bring over $2.1 billion in revenue for 2014.
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
- 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.
Coloplast in the Future
In January of 2013, Coloplast signed an agreement with Novation, the largest Group Purchasing Organization in the US to place its products into 2,500 additional hospitals, doubling its market spread. The current agreement runs through December of 2015.
In March of 2014, Coloplast agreed to pay $16 million to settle 400 lawsuits regarding transvaginal mesh products;however an estimated 1,500 lawsuits have been consolidated in the US District Court for the Southern District of West Virginia under Judge Joseph R. Goodwin. The company made provisions to set aside nearly $180 million for future US legal expenses. 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.