Boston Scientific’s Sec. 522 Studies On Pelvic Mesh Show It’s Too Risky, FDA Says
Executive Summary
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.
You may also be interested in...
Boston Scientific Pays $189M To Resolve Pelvic Mesh Cases
The settlement puts to rest product liability and patient safety suits in 47 states and the District of Columbia.
FDA Yanks Transvaginal Mesh From US Market; Boston Sci 'Surprised'; Firms Have 10 Days To Submit Withdraw Plan
Transvaginal mesh products made by Boston Scientific and Coloplast were ordered pulled from US shelves by the agency on Aug. 16. Under the rare FDA order, the two firms must immediately stop selling the mesh and have 10 days to submit plans to the agency outlining how they will recall their unimplanted devices.
Surgical Mesh And Sling Devices Must Undergo Post-Market Studies
FDA sends post-market study orders to 33 manufacturers of urogynecologic surgical mesh used for pelvic organ prolapse and to seven makers of single-incision mini-slings used for stress urinary incontinence.