Pelvic mesh devices have become the subject of safety concerns in recent years amidst reports that they can cause serious, sometimes permanent injuries. The devices were marketed to treat stress urinary incontinence and pelvic organ prolapse, but thousands of women allege that they only caused painful complications. According to The National Law Journal, a trial opened Monday in Bakerfield, California over a lawsuit alleging injuries from Ethicon’s TVT-Abbrevo pelvic mesh sling.
The lawsuit is filed on behalf of a woman who was implanted with the device in 2011 to treat stress urinary incontinence, which causes the involuntary release of urine during physical activity. Instead of helping with this issue, the suit alleges, the mesh resulted in pain and persistent urinary problems. The Plaintiff underwent surgery the following year to remove the device.
Ethicon, a subsidiary of Johnson & Johnson, is one of several manufacturers facing 60,000 lawsuits over mesh implants. The majority of these cases are pending in the U.S. District Court for the Southern District of West Virginia, where several multidistrict litigations have been established. Additional cases have been filed in state courts, including the one at hand.
Bakersfield was also home to the first trial over pelvic mesh devices in 2012. In that case, a jury awarded $5.5 million to a woman suing C.R. Bard. A California appellate court upheld the verdict last year, National Law Journal reports.
Plaintiffs point out that pelvic mesh devices were never clinically tested before they were sold and implanted in thousands of women. Due to a regulatory loophole known as 510(k), manufacturers only had to show that the slings were “substantially equivalent” to an older device.
Last September, a federal bellwether trial over Ethicon’s TVT-O sling resulted in a $3.27 million verdict. The jury found for the plaintiff on all counts: strict liability, design defect, failure to warn and negligence. In 2013, a New Jersey jury ordered J&J to pay $11.1 million to a woman allegedly injured from its Prolift transvaginal mesh.
In 2011, the U.S. Food and Drug Administration (FDA) warned that complications associated with transvaginal mesh devices are “not rare” and that these devices may be more harmful compared to other methods for treating pelvic organ prolapse.