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    FDA Halts All US Sales of Surgical Mesh

    Following thousands of patient lawsuits and a spike in adverse event reports, the US Food and Drug Administration (FDA) on Tuesday ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately. Since FDA reclassified surgical mesh products to class III (high risk) in 2016, the agency said the two manufacturers, Boston Scientific ...
  • FDA Cracks Down on Transvaginal Mesh, Will Require Companies to Submit Data or Pull Products

    The US Food and Drug Administration (FDA) has announced that it will seek to regulate transvaginal mesh products more stringently, calling them high-risk devices that will be required to undergo FDA's thorough premarket approval (PMA) process. Background Transvaginal mesh has been used to treat female urological conditions, and in particular those caused by weakened pelvic muscles, which can lead to a pelvic organ prolapse (POP). In the EU, they have been used since the...
  • FDA Orders Surgical Mesh Manufacturers to Study Risks

    The US Food and Drug Administration (FDA) issued a safety communication yesterday warning consumers about problems associated with surgical mesh implants and ordering manufacturers of the devices to conduct new studies in light of those safety concerns. The mesh, used to treat pelvic organ prolapse and stress urinary incontinence , has been associated with pain, infections, urinary problems, bleeding and discomfort .  FDA said that it has received more than 1,...