In 2019, the FDA ban on transvaginal mesh kits for pelvic organ prolapse repair was implemented, responding to reports of severe complications. This article explores the reasons for the ban, the impact on women’s health, and examines possible surgical and non-surgical alternatives. Key Takeaways The FDA banned the sale of all transvaginal mesh products for […]
Johnson & Johnson Seeks Supreme Court Review of $302 Million Fine in Pelvic Mesh Case
In 2020, Johnson & Johnson’s Ethicon unit was subject to a $344 million pelvic mesh judgment that found J&J failed to inform consumers about the risks of transvaginal devices. The original lawsuit, filed in 2016 by then-California Attorney General Xavier Becerra, alleged the misrepresentations made by J&J violated the state’s Unfair Competition Law and […]
FDA Continues Studies of the Dangers of Transvaginal Mesh
Even though transvaginal mesh devices used for transvaginal repair of pelvic organ prolapse (“POP”) are no longer commercially available, the FDA has required mesh manufacturers to conduct on-going studies to better understand what impacts the mesh has on women who have already been implanted with the mesh, long term. These studies are collaborative efforts with […]