It was supposed to make the lives of women suffering from pelvic organ prolapse (POP) and stress urinary incontinence (SUI) easier, but ended up causing untold amounts of grief to thousands of women and their families all over America.
The manufacturers of faulty transvaginal mesh devices continue to be punished, with the latest being the Ethicon Inc. unit of Johnson & Johnson, which was slapped with a verdict of $3.25 million in West Virginia on Sept. 5.
The legal tussle between the makers of the faulty transvaginal mesh products and victims who have taken them to court over it continues. It is estimated that over 50,000 women have filed lawsuits related to these devices. Johnson & Johnson alone faces 33,000 lawsuits.
The transvaginal mesh is a medical device implanted in women with weakened pelvic floor muscles that result in organs like the bladder and the uterus dropping into the vagina. The sling-like mesh is surgically implanted by being inserted through the vagina, or abdominally, to provide support to the pelvic muscles and prevent them from falling through the vaginal walls.
It seemed like an effective solution to an age-old problem when it was first introduced to treat POP in 1996, but this device has led to a number of complications in many women who have undergone this implant, and in extreme cases has even caused the death of the patients. Some of the most common post-implant complaints include:
• Vaginal erosion
• Organ perforation
• Vaginal bleeding
• Painful intercourse
• Infection
• Chronic constipation
• Mesh protruding into the surrounding soft tissue
• Relapse of POP and SUI
Since the mesh is implanted in the body as a permanent solution, tissue and blood vessels grow around it over time. This makes the removal of the mesh a complicated process, requiring a number of revision surgeries. Needless to say this results in a lot of pain for the patient, both physical and emotional.
Transvaginal Mesh Lawsuits
Transvaginal mesh devices have been made by a number of companies, and complainants allege they were deliberately misled by the manufacturers about the efficacy of their products. American Medical Systems, Boston Scientific, C.R. Bard, Coloplast, and Ethicon are some of the makers against whom lawsuits were filed and are pending in the state and federal courts across the US.
The verdict returned by a West Virgina jury against Ethicon this past Friday is not the first of its kind. The timeline of verdicts and settlements on this matter includes the following:
• $5.5 million verdict against C.R. Bard (July, 2012)
• $54.4 million settlement by AMS (June, 2013)
• $11 million verdict against Ethicon (February, 2013)
• $2 million verdict against C.R. Bard (July, 2013)
• $16 million settlement by Coloplast (March, 2014)
• $830 million settlement by AMS (May, 2014)
• $3.27 million verdict against Ethicon (September, 2014)
The FDA’s Stand on the Issue
The Food and Drug Administration (FDA) has changed its tune many times on the transvaginal mesh devices. For the majority of its existence the transvaginal mesh was declared and deemed safe to use but as complaints started pouring in in big numbers, especially over the period between 2005-2007, the FDA advised medical practitioners to exercise caution when using this device. In 2008 it said this device could cause complications, though rarely. In 2011, it finally issued that health complications arising from the implant of this device are not rare. It also stated “it is not clear that transvaginal POP repair with mesh is more effective than traditional non-mesh repair in all patients with POP and it may expose patients to greater risk.”
A year later the FDA announced that Johnson & Johnson had been selling its transvaginal mesh devices without proper regulatory approval, following which the company filed a request with the FDA to stop the sale of its surgical mesh products.
What does the future hold?
The blame for the malfunctioning transvaginal mesh devices lies at multiple levels. The makers did not carry out adequate testing prior to releasing their devices into the market, and it seems like the FDA reacted a bit too late. And thousands of American women paid a heavy price, as a result. It’s a gruesome tale of apathy and greed for profits. As more cases go to trial, we can expect a bigger number of verdicts and settlements to make the news. Does this mean each and every woman affected by a faulty transvaginal implant will receive justice? We sure hope so, though the compensation will differ from case to case. If you or someone you know is being troubled by their surgical mesh implant, get in touch with us to learn of the legal options available to you in this regard.