Coloplast is a company based in Denmark. It makes health care products, specifically things like catheters, wound dressings, vaginal mesh, ostomy bags, and antifungal products. With about 8,500 employees and a presence in more than 50 countries, this is a major player in the medical and health care industry.

Coloplast has gotten a lot of attention for being sustainable, for developing and making innovative products to make patients more comfortable, and for ethical business practices. It hasn’t always been smooth sailing, though, for this company. Its transvaginal mesh products have proved to be dangerous, high-risk, and harmful to women, many of whom are now suing the company.  

Coloplast – Overview

The Danish company Coloplast makes what is known as intimate health care products, those items needed for some of the most private and personal health care needs. The company says that its goal is to make products to help people be more comfortable and that are related to conditions that aren’t easy to talk about, like incontinence.

They make ostomy products, catheters and mesh for urinary, bladder, and pelvic organ problems, wound and skin care products, and devices and products for urology surgery. Coloplast claims that in addition to making these intimate care products, they are devoted to corporate responsibility with a lower environmental footprint, ethical standards in manufacturing, fair practices with employees, and by providing high quality products to customers. While Coloplast has largely lived up to these standards, there have been some missteps, particularly with transvaginal mesh.

History

The history of Coloplast goes back to 1954 when a nurse named Elise Sorenson saw a dramatic change in her sister’s quality of life following an operation for an ostomy. She feared accidents that would be embarrassing and refused to leave the house, becoming very isolated. Sorenson thought up an idea for an ostomy bag that would fit tightly and catch any leaks, preventing embarrassing accidents. This simple invention helped people like her sister go back to living a normal life again.

With that compassionate beginning, a whole company devoted to helping people be more comfortable with intimate health problems was born. Today, ostomy products make up a big part of what Coloplast does, but the company also expanded that first idea into products for wound care, incontinence, urology, and skin care.

Coloplast makes ostomy products under the brand names Brava, SenSenura, and Assura. Skin care products and wound care products include cleanser and moisturizers, antifungal creams, skin sealants and gels for covering wounds, products for skin folds, odor treatments, and wound dressings. Urology and incontinence products include bladder slings, transvaginal mesh, prosthetic testicular implants, catheters, draining bags, and much more.

In recent years Coloplast has continued to expand, in spite of financial and legal problems arising over its transvaginal mesh. New production facilities have been added in the last decade and the company signed a deal in 2013 with Novation to provide more Coloplast products to U.S. hospitals.

Transvaginal Mesh

Coloplast aims to help patients, but with one type of product, the company has caused harm to many women. Coloplast is not alone in this. Several companies have made transvaginal mesh products and kits that have led to serious complications as well as pain, bleeding, and additional surgeries for women being treated for pelvic organ prolapse and stress urinary incontinence.

In each of these conditions, organs and tissues in the pelvic region have become weakened. This causes organs like the bladder or uterus to slip out of place or the bladder to be unable to hold in urine. To treat the conditions the traditional method is to surgically insert a sling or mesh under the uterus, bladder, or neck of the bladder to provide the missing support.

A newer treatment is to use the same kind of mesh, but to insert it vaginally instead of through an abdominal incision. Initially, surgeons and gynecologists simply took surgical mesh and trimmed it to the right size. Companies like Coloplast realized that they could create and sell mesh sized and shaped just for this procedure and even started selling the mesh in kits with special tools.

One of the problems that has arisen with this type of procedure is that it is often conducted by a gynecologist, not a surgeon, and in a doctor’s office, which is not necessarily sanitized as an operating room would be. This along with the mesh itself has caused infections and a number of other complications in women receiving transvaginal mesh.

Complications

Since 2008, the U.S. Food and Drug Administration has issued several safety warnings about transvaginal mesh. The warnings state that serious complications can result from the procedure and that the classification for the device defines it as high-risk.

Some of the complications of transvaginal mesh include bleeding, infections, scar tissue formation, urinary incontinence, worsening of prolapse or the uterus or bladder, and serious pain. Even more severe is the risk of erosion, the movement of the mesh through pelvic tissue and the perforation by the mesh of organs and tissue. This kind of damage can cause bleeding, pain, infections, and often requires surgery to correct.

Lawsuits

Coloplast and other makers of transvaginal mesh have faced a number of lawsuits over the complications caused by the products that were supposed to be safer than traditional surgery. In 2014 Coloplast reached a settlement in about 400 cases brought by women harmed by their transvaginal mesh. The settlement was for $16 million, or about $40,000 for each woman represented in the case. The company also reserved another $186 million for any future settlements that year and added to it in 2015.

In spite of these settlements, Coloplast has not admitted to any negligence or liability and has stated that it stands by its transvaginal mesh products. With more money in reserve to settle future cases, there may be compensation available for anyone who has been harmed by the mesh, but has yet to file a case. If you were affected by Coloplast’s products, speak with a lawyer to find out what your rights and options are.