On Tuesday, Washington State Attorney General Bob Ferguson filed a consumer protection lawsuit against Johnson & Johnson, accusing the company of knowingly concealing the risks associated with a surgical mesh designed to treat pelvic floor conditions in women. As a result of Johnson & Johnson’s deception, thousands of Washington women face urinary and defecatory dysfunction, loss of sexual function, chronic inflammation, chronic pain, and risk of chronic infection.
According to the Attorney General’s Office (AGO), these complications can crop up years after the surgery, and are in many cases irreversible. Removal of the mesh is nearly impossible.
“It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception,” Ferguson said. “They believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials. This is an unacceptable way of doing business, and I will hold the company accountable.”
The lawsuit alleges thousands of violations of the Washington Consumer Protection Act (CPA), due to deceptive informational and marketing materials distributed to consumers and doctors. The attorney general will ask the court to prohibit Johnson & Johnson’s misleading marketing, find the company violated the CPA, and impose the maximum $2,000 civil penalty per violation, in addition to costs, fees and restitution.
Johnson & Johnson is the largest manufacturer and seller of these mesh devices in the U.S. Between 2005 and 2015, the company sold nearly 12,000 mesh devices in Washington.
The mesh is made of woven polypropylene threads, and is marketed to doctors and patients as a way to treat pelvic organ prolapse, or when organs shift from their normal position, and various bladder issues.
The mesh is inserted surgically, and is put into place by pulling it up through the vaginal canal, then through an incision in the vaginal wall, and finally permanently anchoring it in the body to hold up falling organs. According to the AGO, the mesh, its construction and infection-ridden insertion through the vagina have caused chronic infection, chronic inflammation, permanent loss of sexual function, and permanent urinary or defecatory dysfunction. The mesh can shift position and cut through the vaginal wall or into other organs.
The AGO alleges that the company did not tell consumers that the mesh can cause, and consumers are likely to experience, chronic foreign body reaction and chronic inflammation as the body constantly fights to rid itself of this foreign material.
The AGO also claims that the company did not tell consumers that mesh causes and harbors infection, which can indefinitely live in the small weaves of mesh.
In addition, according to the AGO, the company did not inform consumers that severe erosion — or a complication where the mesh moves and protrudes into an organ or through the vaginal wall — causing chronic pain and dyspareunia, or painful intercourse, is a common complication. It is also alleged that the company did not tell consumers that this risk of erosion is lifelong, because the implant is permanent, or that erosion can cause chronic pain and injury to sexual partners.
The AGO is encouraging women who have Johnson & Johnson mesh devices and are experiencing symptoms can contact investigator MaryBeth Haggerty Shaw at MarybethH@atg.wa.gov or contact their Consumer Resource Center at 1-800-551-4636. Complaints can be filed at atg.wa.gov/file-complaint.
The case has been filed in King County Superior Court.
