Originally published by robertslawfirm.
To date, more than 87,000 transvaginal mesh lawsuits have been filed in the U.S., making pelvic mesh litigation the largest and most complicated mass tort action in history. In fact, one of four civil cases in the U.S. today deals with pelvic mesh. The cases involve seven different manufacturers, and have been consolidated for pretrial proceedings in the U.S. District Court for the Southern District of West Virginia under Judge Joseph Goodwin. History Lawsuits against mesh manufacturers began cropping up more than 10 years ago. Almost 4,000 injuries were reported to the U.S. Food and Drug Administration between 2005 and 2010. These complaints involved complications from mesh inserts used in pelvic organ prolapse (POP) surgery, including pelvic pain, bleeding, organ damage, infection and urinary problems. In January 2012, the FDA ordered mesh manufacturers to perform safety studies on their products. In January 2016, the FDA reclassified transvaginal mesh as a high-risk medical device and ordered manufacturers to address safety concerns by submitting new applications that demonstrate their products are safe and effective. These new requirements apply only to mesh products used to repair POP in women. Settlements Following a number of verdicts in favor of plaintiffs in pelvic mesh suits, Judge Goodwin urged manufacturers to cut their losses and settle claims. To date, the following settlements have been announced: American Medical Systems — announced a settlement of $54.4 million for an unspecific number of claims in June 2013 and another settlement of $830 million to settle approximately 20,000 claims in […]
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