Illinois Injury and Mass Tort Lawyer Blog
The FDA Informs Providers About Labeling Updates
Surgical mesh products are used to repair and reinforce soft tissue in patients where the tissue has some weakness. In particular, mesh is used to help reinforce the hernia. However, doctors have increasingly been using surgical mesh products, even though the safety and effectiveness in breast surgery hasn’t yet been determined by the FDA. The United States Food and Drug Administration has informed doctors, nurses and other health care providers of new labeling updates for Becton, Dickinson and Company mesh products. These products include the following: GalaFLEX Lite Scaffold, GalaFLEX Scaffold, GalaFLEX 3D Scaffold, GalaFLEX 3DR Scaffold, Phasix ST Mesh, Phasix Plug and Patch, Phasix ST Mesh with Open Positioning System (OPS), and Phasix ST Mesh with Echo 2 Positioning System. If you were injured by any of these types of surgical mesh products, you should call the seasoned Chicago-based product liability lawyers Moll Law Group.
Consult Moll Law Group About Surgical Mesh
The FDA issued its letter to ensure that doctors, nurses, and hospitals knew that Becton, Dickinson and Company had updated its product warnings to indicate that surgical mesh products haven’t been determined to be safe and effective for purposes of breast surgeries by the FDA. Health care providers have been asked to read the warnings.
However, if you are asymptomatic after mesh was used in your surgery, the FDA has not recommended that the mesh be removed or operated upon. The FDA has called for clinical evaluations to figure out whether the mesh products have benefit when they’re used for breast surgery. It also commented on the lack of clinical evaluations at a General and Plastic Surgery Devices Panel in 2019.
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