Ethicon is facing a new lawsuit over pelvic mesh adverse side effects that the plaintiff says she would have avoided had she known about them.

In March 2014, plaintiff Kimberly C. received a pelvic mesh implant to primarily treat a condition known as stress urinary incontinence.

Women who have a weakened pelvic floor leak urine when they cough, sneeze or exercise because the muscles that support the bladder are not as strong as they used to be. Giving birth to a child can result in a weak pelvic floor.

By receiving the pelvic mesh implant, Kimberly’s stress urinary incontinence was supposed to improve.

Pelvic Mesh Adverse Side Effects

Pelvic mesh maker Ethicon is accused of misrepresenting the safety and efficacy of its products because the pelvic mesh products have high failure rates, high complication rates, fail to perform as intended and often result in severe and irreversible injuries to women, including Kimberly.

The list of alleged pelvic mesh adverse side effects is long.

The mesh is made of polypropylene material that can cause an immune reaction that results in injuries. In some mesh products, polypropylene is mixed with monocryl, a partially dissolvable mesh that increases the risk of an immune reaction and an inflammatory response.

Problems include biomechanical issues because the mesh’s design allows strong amounts of friction between the mesh and underlying tissue, resulting in the tissue itself to degrade.

Because the product is designed to be inserted transvaginally, the mesh becomes in contact with high levels of bacteria, yeast, and fungus that adhere to the mesh. Adverse reactions and injuries result when the immune system reacts, breaking down the surrounding tissue.

The risk of pelvic mesh adverse side effects is heightened because the doctor inserting the mesh does so “blindly,” increasing the chance of nerve damage and damage to other internal organs.

The mesh is not porous enough to prevent scar tissue from forming around it, resulting in mesh contraction. This can lead to nerve damage and pain, erosion of the mesh into nearby organs, and failure of the device.

The mesh allegedly has a propensity to “creep,” or to become deformed when under prolonged tension in the body. Pelvic mesh adverse side effects include matting against delicate and sensitive vaginal and pelvic areas, causing pain upon normal activities such as walking or defecating.

Pelvic Mesh Not Proven Better Than Traditional Non-mesh Repair

In looking at evidence from 1996 through 2011, the FDA in July 2011 concluded that “a mesh procedure may put the patient at risk for requiring additional surgery or for the development of new complications. Removal of the mesh due to mesh complications may involve multiple surgeries ad significantly impair the patient’s quality of life. Complete removal of mesh might not be possible.”

In December of that year the American College of Obstetricians and Gynecologists and the American Urogynecologic Society acknowledged serious pelvic mesh adverse side effects.

They released the statement, “There are increasing reports of vaginal pain associated with changes that can occur with mesh (contraction, retraction, or shrinkage) that result in taut sections of mesh… Some of these women will require surgical intervention to correct the condition, and some of the pain appears to be intractable.”

Kimberly’s lawsuit contends that Ethicon did know or should have known about the pelvic mesh adverse side effects that she and others would ultimately endure and had an obligation to disclose those possibilities to doctors and patients.

The Pelvic Mesh Lawsuit is Case No. 1:16-cv-07106, in the U.S. District Court for the Southern District of New York.