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Health care giant Johnson and Johnson was sued this week by the attorneys general of California and Washington for misrepresenting the risks of vaginal mesh implants, causing severe complications for thousands of women. The company responded by calling the lawsuits unjustified.
But the devices were recently reclassified as high-risk by the Food and Drug Administration and there are already product liability lawsuits against the company for injury from them. Let's consider the claims.
Why This Device?
Pelvic organ prolapse describes a condition of shifting organs on the pelvic floor. It can happen to women after childbirth, a hysterectomy or menopause, and the vaginal mesh devices are used to treat the condition. The mesh is also used to treat stress urinary incontinence (SUI) as described ably by an appellate court in a product liability case last year:
SUI is the involuntary loss of urine when the bladder is put under stress such as from sneezing, coughing, laughing, or exercising. Using a ... curved needle, a surgeon pulls the [mesh] tape through incisions in the anterior wall of a woman's vagina ... form[ing] a hammock underneath the urethra to help prevent the leakage of urine.
After reports of thousands of injuries from this insertion, however, the FDA now considers these devices dangerous and is scrutinizing them more closely. Meanwhile, the states are closing in on Johnson and Johnson.
California and Washington sued on behalf of thousands of women who they say were injured by the Johnson and Johnson devices, seeking penalties and an end to advertising of the vaginal mesh. The states were part of a national investigation, led by the California attorney general.
According to the lawsuit filed in California, Johnson and Johnson and its Ethicon unit falsely marketed the devices as a safe and superior alternative to non-mesh treatments for pelvic floor disorders, despite knowing that they could cause pain, bleeding, loss of sexual function and other side effects. "Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products," California Attorney General Kamala Harris said in a statement.
If you have been injured by a vaginal mesh, or due to any other defective product, talk to a lawyer. Many attorneys consult for free or a minimal fee and will be happy to hear your story.