A consumer recently filed an Advantage Fit lawsuit, claiming that the transvaginal mesh product caused her to sustain severe pain and bladder problems.

Plaintiff Carolyn C. alleges she was implanted with the Advantage Fit system in April 2012 to treat her urinary incontinence. As an alleged result of her implantation, Carolyn developed bladder stones which she had removed in January 2017.

In May 2017, Carolyn claims, she underwent additional surgery to remove mesh from the Advantage Fit system which had eroded into her bladder. Carolyn says she underwent a final surgery a year later in May 2018 to remove additional mesh which had further eroded into her bladder and caused bladder lesions. Carolyn claims that her surgeries and health problems were a direct result of her implantation with the Advantage Fit system.

Boston Scientific manufactured their Advantage Fit system to treat pain, discomfort, and urinary incontinence. The system uses polypropylene mesh implanted in the vaginal wall to “correct and restore normal vaginal structure”.

“They are specifically promoted to physicians and patients as an innovative, minimally invasive procedure with minimal local tissue reactions, minimal tissue trauma, and minimal pain while correcting urinary incontinence,” the Advantage Fit lawsuit claims.

Despite claims that the system is effective and safe, the Advantage Fit lawsuit claims that it can cause serious health complications. Scientific evidence allegedly shows that the mesh used in the Advantage Fit is biologically incompatible with human tissue, causing an immune response. According to the Advantage Fit lawsuit, the immune response can cause the degradation of the mesh and the formation of severe reactions.

In October 2008, the U.S. Food and Drug Administration (FDA) released a public health notification, informing the public that they had received over a thousand complaints over the period of three years regarding the Advantage Fit mesh system.

The agency released another communication in July 2011, saying that a review of data associated with the Advantage Fit mesh system showed that the product’s complications were an area of “continuous serious concern”. Complications reportedly include neuromuscular problems, vaginal scarring/shrinkage, and emotional problems. The FDA concluded that these complications were “not rare”.

The FDA concluded that “a mesh procedure may put the patient at risk for requiring additional surgery or for the development new complications. Removal of the mesh due to mesh complications may involve multiple surgeries and significantly impair the patient’s quality of life. Complete removal of mesh may not be possible.”

Carolyn claims that Boston Scientific knew or should have known about the risks associated with their Advantage Fit products but failed to warn their consumers. The Advantage Fit lawsuit claims that the company “actively and intentionally misled” consumer about the safety of their products, allowing the public to believe that the mesh system is safe and effective.

The Advantage Fit lawsuit seeks compensatory damages, exemplary damages, court costs, and attorneys’ fees.

The Advantage Fit Lawsuit is Case No. 3:18-cv-02338-L in the Dallas County Civil District Court.