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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 ever discussed.

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 them harm.

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