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...
FDA Lists Benefits And Risks Of Surgical Mesh For Hernia Repair
The Food and Drug Administration is providing patients with information on the pros and cons of hernia mesh surgery, a procedure that has come under intense scrutiny in recent years.
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
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.