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 along with newly-acquired voice and respiratory care products. 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 $2.8 billion in revenue in 2021.
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, particularly amongst those 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 by multiple companies and organizations.
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
The Coloplast story began 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. With the founding of the Coloplast company in 1957, 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. In November 2021, Coloplast acquired Atos medical, giving the company a number of devices in the area of voice and respiratory care.
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 2022.
Coloplast 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, implantable 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 the company has faced at least 1,200 lawsuits for injuries caused by the devices.
Coloplast Legal Issues
Coloplast is only one of several manufacturers named in transvaginal lawsuits and many companies have paid $20 thousand or much more to each patient. In preparation to address multiple claims over transvaginal mesh lawsuits, Coloplast initially made provisions to set aside nearly $180 million for future US legal expenses. Since that time, estimates show that the company may have actually paid much more in legal costs.
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. Many of these lawsuits have already been settled, and the company has likely paid over $700 million in claims, though additional lawsuits are ongoing.
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. 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 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. A number of remaining transvaginal mesh trials have been conducted after court functions resumed post-COVID, some of which have been decided in favor of plaintiffs but others were decided in favor of Coloplast.
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. Many Coloplast lawsuits have been settled but others may still remain in court systems.
FDA Concerns Over Transvaginal Mesh
In 2011, the U.S. Food and Drug Administration (FDA) began examining the subject of “fixated” transvaginal mesh and bladder slings, which are held in place with sutures, due to the large number of serious injuries caused by the devices. A number of companies, including Coloplast were ordered to undergo Postmarket Surveillance Studies, known as “522” studies to address safety and effectiveness concerns related to the devices. In 2018, though many transvaginal mesh devices had already been discontinued, manufacturers were ordered to discontinue selling the products. Two companies, Coloplast and Boston Scientific who still wished to sell transvaginal mesh, were required to resubmit Premarket Approval Applications (PMA), along with the 522 results. Boston Scientific’s application was rejected due to a lack of “reasonable assurance of safety and effectiveness”. A similar result was announced for Coloplast, however the company continues to sell another type of sling, known as “fixation-less” which is not held in place with sutures and a lighter form of mesh used for pelvic organ prolapse and stress urinary incontinence
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
- The Coloplast History, Coloplast US (2020)
- Coloplast Product Families, Coloplast US (2020)
- Surgery under scrutiny: What went wrong with vaginal mesh, WBUR (11/2011)
- Coloplast Said to Pay $16 Million to Settle vaginal-Mesh Suits, Bloomberg (03/2014)
- POP AE and Effectiveness rates, registry, 522 Postmarket Surveillance Studies, U.S. Food and Drug Administration (2022)
- FDA’s Activities: Urogynecologic Surgical Mesh, U.S. Food and Drug Administration (2022)