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The FDA Informs Providers About Labeling Updates

surgery-1822458_6401-e1712683689856Surgical 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 decided.  The United States Food and Drug Administration has informed doctors, nurses and other health care providers that it is imposing 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 been asked to update its labels. The company did update its product warnings to indicate that surgical mesh products haven’t been determined to be safe and effective for purposes of breast surgeries. 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.

Additionally, health care providers have been asked to report adverse events or suspected such events that they experience with the Becton, Dickinson and Company mesh products, as well as the surgical mesh manufactured by others. Reports can be made through MedWatch, which is the adverse event reporting program the FDA operates. Similarly, the manufacturers of mesh and other devices need to abide by Medical Device Reporting regulations. Similarly, those who work for health care providers are expected to report events according to the procedures put in place by the facilities for which they work.

It’s not clear yet how safe mesh is for use in breast surgery. When a patient is injured by a mesh product, he or she may need to pursue damages in a product liability lawsuit. These are lawsuits brought to recover damages. Typically the damages are compensatory, meaning they are intended to make up for losses suffered or that will be suffered in the future. For example, if you need another surgery to remove surgical mesh, you may be able to recover damages that cover the future surgery along with any pain, emotional distress, lost wages, and other medical bills.

Call the seasoned Chicago-based product liability lawyers of Moll Law Group for a consultation if you were injured by mesh that was used in a breast surgery. We represent injured children and families across the country, and billions have been recovered in the lawsuits with which we’ve been involved. Complete our online form or call us at 312.462.1700.

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