Coloplast Vaginal Mesh Postmarket Data Shows Similar Safety To Native Tissue Repair
The company’s review of patient safety data found similar adverse event rates between patients treated with transvaginal mesh and those treated surgically. However, the FDA still says the benefits of the treatment do not outweigh its risks
You may also be interested in...
The US FDA says final data from two Boston Scientific postmarket studies have reinforced the agency’s position that the company’s transvaginal mesh to treat pelvic organ prolapse (POP) has a poor benefit-risk profile. The firm’s mesh has been off the US market since 2019.
News We’re Watching: Smart Watch Blood Glucose Warning, $100M For Women’s Health, Zimmer Surgical Robot Clearance
This week, the FDA reminded consumers that smart watches and rings are not blood glucose monitors; First Lady Jill Biden announced a $100M women’s health initiative; and the Zimmer ROSA Shoulder System got FDA clearance.
The document waives the annual registration fee for companies with gross sales below $1m that are currently going through bankruptcy.