Following a court challenge, a California Court of Appeals upheld a $300 million judgment against Johnson and Johnson while reducing the award by $42 million.
More than a decade ago, women seeking help for urinary incontinence or pelvic organ prolapse (POP) were often guided to a surgical solution involving the placement of mesh. With age and with childbirth, the supporting ligaments and muscles that support organs within the pelvic cavity can weaken. As that pelvic floor weakens, organs such as the cervix, bladder, uterus, and rectum sag downward, or prolapse into the vagina.
The bladder is a common factor in prolapse causing urinary incontinence. Approximately 3.3 million women each year in the US experience prolapse and women commonly experience slight to severe incontinence. Stress incontinence, or urine leakage following a sneeze, laughing, lifting, or exercise is uncomfortable and embarrassing. Women and men often experience stress incontinence with age.
Around the 1950’s, surgeons began using mesh for hernia repair in the abdominal wall. By the 1970’s, urologists and gynecologists were adapting mesh to correct pelvic organ prolapse. Still later, in the early 2000’s, medical device manufacturers brought transvaginal mesh products to market, specifically designed to treat stress incontinence and pelvic organ prolapse.
The use of transvaginal mesh for POP and incontinence became widespread. The synthetic mesh forms a net or sling to support the bladder or reinforce the vaginal wall. The mesh is placed through the vagina, hence the term “transvaginal mesh.”
Since that time, more than 100,000 lawsuits have been filed by women who developed a host of injuries from the mesh including infection, organ and tissue perforation, autoimmune troubles, and chronic pain. Pelvic mesh litigation is one of the biggest areas of litigation in the US at present.
In 2020, the State of California prevailed in a lawsuit against Johnson & Johnson over failure to disclose the risks of its pelvic mesh products. The $344 million judgement for the State was appealed by Johnson & Johnson. In early April 2022, a California Court of Appeals reduced the award by $42 million, but otherwise left the approximately $300 million judgment intact.
The size and confirmation of the judgment calls attention to the injuries experienced by women across the country who expected the mesh to boost their quality of life, not consign them to debilitating pain and worse. The US Food and Drug Administration has (FDA) banned urogynecologic surgical mesh as a device to repair damaged or weakened pelvic floor tissue, although some mesh products remain in use.
The lawsuits of women injured by mesh continue. And Johnson & Johnson has signaled it will appeal the recent Court of Appeals decision in California. More to come.
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