FDA Orders Surgical Mesh Products Pulled From US Market
Law360 (April 16, 2019, 6:52 PM EDT) -- The U.S. Food and Drug Administration on Monday ordered Boston Scientific and Coloplast — the only two remaining manufacturers of surgical mesh meant for the transvaginal repair of pelvic organ prolapse — to stop selling those mesh products in the U.S.
The order stems from the agency's reclassification of the devices as high-risk in 2016, which required their manufacturers to submit premarket approval applications to continue marketing them in the U.S., according to the FDA. The order covers Boston Scientific Corp.'s Uphold Lite Vaginal Support System and Xenform Soft Tissue Repair System, and Coloplast AS' Restorelle DirectFix Anterior Mesh.
Stay ahead of the curve
In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.
Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
Create custom alerts for specific article and case topics and so much more!