Coloplast Transvaginal Mesh Class Action Lawsuit Alleges Serious Side Effects

Coloplast Canada, a transvaginal mesh manufacturer, has been hit with a class action lawsuit for alleged serious side effects. This Quebec application for authorization was initiated just as the AMS transvaginal mesh settlement secured Class Members $20,858,488 worth of damages.

The Coloplast class action lawsuit was brought by two representative plaintiffs, Françoise Sureau Dit Blondin and Véronique Sauriol before the Superior Court of Québec. The plaintiffs alleged that the defendant, Coloplast Canada, misrepresented the safety of their products, breached their duty to warn consumers and were negligent.

The medical device in question, transvaginal mesh, is used to treat Stress Urinary Incontinence (SUI) and Pelvic Organ Prolapse (POP) in women. The device is designed like a net to support weak vaginal walls and/or support organs in the area.

The device also has reported side effects including, among others, vaginal scarring, mesh erosion, infection, pain, urinary problems, incontinence, recurrence, bladder perforation, and pain during sex. Victims of transvaginal mesh complications often have to undergo additional surgeries to remedy these problems.

Françoise’ Story

In February 2019, Françoise underwent surgery to implant Coloplast’s Aris mesh. Immediately after the procedure, Françoise began experiencing pain in her groin, leg and hip.

Eventually, the complications evolved to include acute and chronic pain in the groin, pelvis, hip and lower back, “comparable to electric shocks in the pelvic region,” narrowing of the vagina, frequent itching in the pelvic region, urinary problems and dyspareunia, according to the Coloplast class action lawsuit.

Françoise claims she had an active life prior to the implant, yet now, she relies on a cane which she cannot walk without for more than ten minutes.

The Coloplast class action lawsuit alleges that Françoise and Class Members were not informed of potential complications of the mesh implant by doctors or by the manufacturer. The plaintiffs claim that they would never have agreed to have the mesh implanted had Coloplast properly informed them of the serious risks associated with the medical device.

Coloplast’s Misrepresentation

Coloplast began marketing and selling mesh products in Canada to treat POP and SUI in 1996.

The class action proposal claims that Coloplast’s products were marketed and sold without any studies demonstrating their safety or efficacy. Moreover, the mesh products were marketed and sold by Coloplast to physicians and patients as “safe and reliable surgical devices, constituting a less invasive approach than conventional surgical techniques, and the most effective on the market for the treatment of POP and SUI.”

Contrary to the representations made by Coloplast, the risks of serious complications are substantially higher for women who use mesh products than for those who use traditional reconstructive surgery, according to the Coloplast class action lawsuit.

The Coloplast class action lawsuit continues that the mesh products have a high failure and complication rate. Additionally, because mesh products are permanent, there is no safe and effective procedure in Canada to remove them in the event of complications.

Consequently, Françoise plans to travel to the U.S. to undergo surgery to remove the mesh product, costing her approximately $25,000.

Moreover, the Coloplast class action proposal highlights that transvaginal mesh complications were well-known to Coloplast.

In February 2010, Health Canada issued an advisory to hospitals regarding complications associated with transvaginal mesh products. About a year later, the Committee on Gynecologic Practice recommended that transvaginal mesh implants should only be reserved for severe cases, where the expected benefits could justify exposure to risks of serious complications.

In April 2019, the FDA ordered all manufacturers of mesh products, including Coloplast, to stop selling transvaginal mesh products in the U.S. Likewise, Health Canada released a recall concerning Coloplast mesh products in the same year.

Class Members of the Coloplast class action lawsuit include Canadian residents who were implanted with mesh products manufactured, marketed, distributed and/or sold by Coloplast and who suffered damages as a result.

Class Members also include family members, legal representatives and the estates of those who were implanted with Coloplast’s transvaginal mesh and suffered damages as a result.

The Coloplast class action lawsuit seeks the following damages:

• $500,000 per Class Member who received the implant;
• $100,000 for family members, legal representatives and estates; and
• $20,000,000 in punitive damages.

Health Canada announced it will continue to monitor the safety of mesh products, and will take further action if new safety concerns are identified.

Did you or someone you know suffer from transvaginal mesh complications? Tell us your story in the comment section below!

The plaintiffs are represented by Lambert Avocat Inc.

The Coloplast Class Action Lawsuit is Françoise Sureau Dit Blondin, et al. v. Coloplast Canada Corporation, in the Superior Court of Québec, District of Montreal, Canada.

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