A woman from South Carolina alleges one of Coloplast’s transvaginal mesh implants caused her serious permanent injuries that have greatly impacted her quality of life. The claim alleges the Aris transvaginal mesh product was defectively made and failed to contain sufficient warnings regarding potential device complications.

Plaintiff Tonya J. says she had the Aris transvaginal mesh product implanted to treat stress urinary incontinence (SUI) on Dec. 29, 2016, and had no initial complications.

The Aris transvaginal mesh product contains monofilament polypropylene mesh and is marketed to women suffering from stress urinary incontinence. Even though the polypropylene material is supposed to help encourage healing in the vaginal area, it has been alleged that it can cause a number of serious reactions.

This was allegedly the case with Tonya, who allegedly suffered a number of serious injuries at some point after the transvaginal mesh implant including foreign body reaction, pain, bladder retention, painful urination, dyspareunia, difficulty in emptying bladder, burning sensation and infection.

She claims the Aris mesh caused her a number of permanent transvaginal mesh injuries in her vaginal area, including disability and impairment. Tonya opted to file legal action against Coloplast after discovering the company allegedly knew or should have known their Aris transvaginal mesh implant could cause serious injuries.

Overview of Transvaginal Mesh Complications

Transvaginal mesh implants have been on the market for decades. They are used to give extra support to weakened or damaged muscle. These changes typically occur following a physically traumatic event like childbirth, which often causes either pelvic organ prolapse (POP) or stress urinary incontinence.

POP occurs when the woman’s pelvic muscles weaken, which allows nearby organs to move out of place. Transvaginal mesh is implemented to reinforce the vaginal wall and is supposed to prevent future occurrences. Stress urinary incontinence occurs when the patient urinates unintentionally during an activity, which is caused by stress on the bladder.

Transvaginal mesh can support the urethra or bladder neck, which can help control this function. Even though transvaginal mesh implants have helped millions of women treat these personal health problems, there have been a number of serious complications reported.

The FDA issued a warning regarding transvaginal mesh injuries in 2011, stating women may be at a higher risk of complications without any improvements to their quality of life. In 2016, the FDA issued a communication stating the classification of transvaginal mesh implants for POP treatment had been changed from moderate risk to high risk medical devices.

While the warning did not apply to SUI treatments, patients should still be wary of any side effects and should talk to their doctors if they are concerned.

It is important to note that a number of patients who experience transvaginal mesh complications often have to undergo revision surgery which can be more difficult than the initial implant procedure. Even though these complications can be devastating to patients, patients say Coloplast allegedly failed to disclose this information to the public.

At all times relevant, Tonya says she and her physician had relied on the marketing materials and product information provided by Coloplast and had no reason to be wary of serious injuries. Tonya is seeking a multitude of damages against Coloplast, including counts of negligence and failure to warn.

This Transvaginal Mesh Lawsuit is Case No. N19C-03-117 PEL, in the Superior Court of the State of Delaware.