Coloplast is a Denmark-based company that supplies intimate health care
products to hospitals and individual consumers. The business was started
by Elise Sorensen, a nurse who was determined to invent a device that
helped her sister who had recent colon removal surgery. Elise developed
a bag that collected waste without causing her sister to become embarrassed
while away from home. To this day, the company’s goals remain helping
people and easing challenges that arise from private and personal medical
conditions. Coloplast produces products for ostomy care, wound treatment,
incontinence, and urological needs. Like many medical manufacturers, this
company produced transvaginal mesh devices to help treat pelvic organ
prolapse and similar conditions. These products have faced legal challenges
from patients who claim they were injured after using the devices. Coloplast
firmly stands by its products and admits no liability. It continues to
distribute its products to over 80 percent of the U.S. market.
Recalls Issued Against Coloplast
In 2010, Coloplast issued a “Class II” recall on its Titan
Inflatable OTC Penile Prosthesis. It was made to help men suffering with
erectile dysfunction. The Titan OTC consists of a three-piece design with
a unique one-touch release valve for simpler deflation ability. As a button
is pressed, fluid is transferred from a reservoir to cylinders, which
helps a man achieve a natural looking erection. The product was recalled
because certain pumps were manufactured under a process that was never
tested or evaluated.
One year later, the company recalled its Trident Catheter Valve. This unit
connected a catheter bag to an overnight drainage bag. Its main goal was
to help a patient retrain the bladder and lower reliance on urine bags.
However, a set of lots failed a routine sterility test, which raised concerns
of customer safety. This was not the first time one of Coloplast’s
products was found to contain the possibility of contamination. Some lots
of the company’s sterilization pads and swabs were recalled overseas as well.
In November 2014, Coloplast recalled its Conveen Urine Collector Leg Bag.
It was meant as a convenient and discreet solution for people who suffered
from urinary incontinence but wanted to remain active. The device wrapped
around the leg and faced inward so that it was undetectable. Unfortunately,
the device was known for potential leakage when the bag was filled.
Lawsuits Facing Coloplast
In recent years, numerous lawsuits have been filed against Coloplast and
similar manufacturers who provide vaginal mesh and sling devices. Product
liability suits claim women have experienced extreme complications and
problems following transvaginal mesh surgery to repair incontinence and
pelvic organ prolapse. The devices are known to erode, shrink, and cause
pain and infection.
A product from Coloplast that has received the most complaints is Aris
Transobturator Tape. One particular lawsuit was filed by a woman in Texas
who alleged she suffered tremendous injuries from complications after
pelvic mesh implantation with this device. She claimed the manufacturer
did not adequately research its product before aggressively marketing
it to the public. It also failed to provide enough warnings about the
high risk of complications resulting from surgery. This woman and other
defendants are fighting for compensation for pain and suffering caused
by this product. Other items targeted by litigation include Novasilk,
Supris, and Restorelle.
As of August 2012, federal judges consolidated current and future Coloplast
pelvic mesh lawsuits. This eliminated duplicative discovery, lowered costs,
and allowed for more efficient resolutions. Suits from all across the
country were transferred into one courtroom where litigation occurred.
Verdicts Against Coloplast
The Denmark-based manufacturer was bombarded by numerous lawsuits against
its transvaginal mesh devices. In 2014, it agreed to end several suits
that alleged the company’s products caused serious injuries. The
settlement was reported to award innocent victims $16 million in total.
Although it paid the money, Coloplast never admitted purposely marketing
anything that compromised the public’s safety. No liability was
Despite the high number of lawsuits filed against these devices, the details
of each case are similar. Innocent victims explain the internal damage
suffered from these products and the painful surgeries that followed to
repair the injuries. Plaintiffs filing lawsuits have made claims that
manufacturers failed to test and safely design the mesh products before
using them in humans. If this is true, it is clear negligence on the part
of Coloplast and the other manufacturing companies.
FDA Sanctions Facing Coloplast
Following thousands of reports from women who suffered debilitating complications
of transvaginal mesh surgery, the FDA decided to reclassify these products
with a high risk label. This means manufacturers must undergo more stringent
approval requirements. The federal agency continues to review studies
regarding these types of products and has not clearly determined whether
mesh surgical repairs are more effective than other treatments. Today,
this organization warns patients about serious complications that are
likely to occur after transvaginal mesh devices are implanted.
Although Coloplast’s mesh devices were never officially recalled,
other similar products from different manufacturers were withdrawn from
the market. Back in 2011, the FDA formed an advisory committee to discuss
the problems brought on by transvaginal mesh. In the past, these products
were approved through the controversial “510k” process, which
is the fast track system that allows companies to introduce new devices
without testing as long as the devices are “substantially”
equivalent to devices already on the market. Today, premarket testing
is mandatory on these types of products before anything becomes widely
distributed. However, the public and government entities are not satisfied
with these actions and call for a complete ban of transvaginal mesh. The
American Urological Society does not agree with a total ban of these products.
This organization believes hospitals and health systems must adopt stricter
credential guidelines so that only qualified doctors can perform these
types of surgeries.
Despite the negativity and financial losses surrounding its pending and
past litigation, Coloplast shows no signs of slowing down. The manufacturer
intends to expand its international operations. A few years back, it signed
an agreement with Novation, a leading U.S. healthcare supply chain. Hopefully,
it will continue to produce products that benefit patients and not bring