Johnson & Johnson is facing a new Ethicon vaginal mesh multidistrict litigation (MDL) from women and their loved ones alleging the company’s vaginal mesh products caused them serious harm.

One of the most recent Ethicon vaginal mesh lawsuits comes from a North Carolina woman  who alleges the company’s Prolift vaginal mesh product caused serious complications. According to the Ethicon vaginal mesh lawsuit, plaintiff Norma P. had the Prolift vaginal mesh product implanted on Oct. 21, 2008.

Similar to other women who had vaginal mesh products prescribed to them, Norma had been recommended the product to treat either her pelvic organ prolapse (POP) and stress urinary incontinence (SUI).

Vaginal mesh is a mesh-like product which is directly implanted into the patient’s lower pelvic region to correct damage that occurred from traumatic incidents like childbirth.

Healthcare providers started using surgical mesh in the 1950s for hernia repair, but the product had eventually gained FDA approval for vaginal mesh use several decades later. Vaginal mesh is primarily used to treat pelvic organ prolapse and stress urinary incontinence and has helped millions of women discretely treat these conditions.

Overview of Ethicon Vaginal Mesh Allegations

However, soon after having the Ethicon vaginal mesh product implanted, Norma says she began experiencing painful complications that were not mentioned on the warning label.

These vaginal mesh complications included mesh erosion, infection, inflammation, scar tissue, organ perforation, organ prolapse, painful intercourse, urinary and fecal incontinence and chronic nerve damage, according to her vaginal mesh lawsuit.

Essentially, Norma reportedly lost all control of her lower pelvic organs allegedly due to the defective nature of the Ethicon vaginal mesh device. The damage was reportedly so extensive that Norma required several operations, during which portions of her female genitalia were removed.

Norma filed legal action Ethicon Inc. and parent company Johnson & Johnson for failing to warn her and her physicians about possible complications. Norma alleges the company either knew or should have known about these problems, and failed to properly disclose the risk to the general public.

It is important to note the FDA approved the Ethicon vaginal mesh product through the FDA 510(k) process, which did not require pre-market research or testing. Products that receive this approval had to prove to work at least an equivalent level to a similar already approved product.

During all times relevant, Norma had used Prolift vaginal mesh product for its intended use and did not deviate from medical instruction. Norma states that she would not have used the Ethicon vaginal mesh product if she had known the risks.

The Ethicon Vaginal Mesh Lawsuit is Case 2:17-cv-02908, in the U.S. District Court for the Southern District of West Virginia.