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
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Boston Scientific’s Sec. 522 Studies On Pelvic Mesh Show It’s Too Risky, FDA Says
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.
EPA Gives Stakeholders Additional 15 Days For EtO Comments
The deadline for comments on the Environmental Protection Agency proposal, which trade groups say could lead to device shortages if implemented, has been moved from 12 June to 27 June.
‘Wait-and-See Time’: Panel Predicts Limited Congressional Action On Devices This Year
An expert panel at the FDLI annual meeting expects the US Congress to want to see more results from recent legislation on devices before it moves ahead with further FDA reform. Though, pandemic-related measures remain a priority.