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Citing the lack of "reasonable assurance" on safety and efficacy, the FDA ordered the immediate removal of surgical mesh products for the transvaginal repair of pelvic organ prolapse in the US market. The action applies to the two remaining suppliers: Boston Scientific (BSX -2.7%) and Coloplast.
The agency ranked devices in Class III (High Risk) in 2016, forcing manufacturers to submit pre-market approval (PMA) requests.
BSX then filed PMAs for its Uphold LITE Vaginal Support System and Xenform and Coloplast Soft Tissue Repair System for its Restorelle DirectFix Anterior system. In February, an FDA advisory committee recommended that efficacy be based on the superiority of devices over native tissue repair at 36 months, the safety criterion being equivalence with tissue repair native. The FDA accepted and decided not to approve the products as the companies did not provide this data.
BSX, Coloplast, Johnson & Johnson (JNJ + 1.8%) and Becton, Dickinson & # 39; s C.R. Bard (BDX -0.5%) still deal with thousands of product liability lawsuits.
Previously: FDA Strengthens Requirements for Surgical Mesh Products (January 4, 2016)
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