FDA Orders Transvaginal Mesh Products Off Market
The United States Food and Drug Administration (FDA), on April 16th, 2019, ordered all manufacturers of surgical mesh products intended for transvaginal treatment of pelvic organ prolapse to immediately cease distribution and sales of these products.
The FDA had classified these products as Class III, high risk in 2016, and this meant that the products’ manufacturers, Coloplast and Boston Scientific, needed to reasonably assure the FDA that the products were effective and safe. This assurance never came, leading to the decision to order that distribution and sales of the products be halted.
The announcement is the latest development in a long saga which began in 2008 when the FDA warned of complications related to the transvaginal use of surgical mesh for the treatment of pelvic organ prolapse and stress urinary incontinence. This warning was followed in 2011 with a safety communication and an analysis regarding transvaginal mesh.
The analysis listed vaginal mesh erosion, pain (including during sexual intercourse), urinary issues, infection, organ perforation and bleeding as common problems reported with implantation of transvaginal mesh. Neuromuscular problems, recurrent prolapse, emotional issues and vaginal shrinkage/scarring were also listed as reported problems in the analysis. The analysis identified three deaths associated with the use of transvaginal mesh.
The FDA ordered 34 manufacturers of transvaginal mesh to conduct post-market surveillance studies in September 2011. Most transvaginal mesh manufacturers ceased marketing surgical mesh for the treatment of pelvic organ prolapse after this order.
Many women have been awarded compensation for their transvaginal mesh injuries.
- R. Bard was ordered to pay a North Carolina woman $68 million in 2018 for damages related to chronic pain caused by her implanted transvaginal mesh.
- Ethicon Inc. was ordered to pay a Pennsylvania woman $57.1 million in 2017 for damages related to her transvaginal mesh eroding through her urethra three times, necessitating three revision surgeries.
- Ethicon Inc. was also ordered to pay a Pennsylvania woman $41 million in 2019 for damages related to the nine revision surgeries necessitated by her transvaginal mesh.
The transvaginal mesh lawyers at Nadrich & Cohen, LLP have been pursuing transvaginal mesh claims since 2010 and continue to represent women who have been harmed by the defective transvaginal mesh products.
If you believe that you may have a defective mesh claim, contact Nadrich & Cohen today for a free and confidential case evaluation. Time is of the essence, as many manufacturers have settled or are settling with injured transvaginal mesh patients.