On November 9, 2023, the FDA sent a letter to doctors about surgical mesh made by BD. The company had updated the warnings on several of its mesh products, including GalaFLEX and Phasix. The FDA used the letter to make a wider point. It said it knows mesh is being used more often in breast surgery, but it has not found that mesh is safe and effective for that use. That letter is now part of the background to the breast mesh lawsuits being filed today.
What the FDA said
The letter was short. It made three main points.
- BD had updated the labeling for certain mesh products, including new warnings and precautions
- The FDA is aware of increased use of surgical mesh in breast surgery
- The safety and effectiveness of surgical mesh in breast surgery, including augmentation or reconstruction, has not been determined by the FDA
The FDA also said there are no surgical mesh products cleared or approved by the agency for use in breast surgery. It asked doctors to read BD’s updated labeling and follow the instructions for use.
One more line matters for patients. The FDA said it was not recommending surgery to remove mesh in patients who have no symptoms. If you have mesh and feel fine, the letter does not tell you to have it taken out. Questions about your own health belong with your doctor.
The products named in the letter
The FDA listed nine BD products. All of them are made for soft-tissue repair.
- Phasix Mesh
- Phasix ST Mesh
- Phasix Plug and Patch
- Phasix ST Mesh with Open Positioning System
- Phasix ST Mesh with Echo 2 Positioning System
- GalaFLEX Lite Scaffold
- GalaFLEX Scaffold
- GalaFLEX 3D Scaffold
- GalaFLEX 3DR Scaffold
Cleared is not the same as proven for breast surgery
The FDA said these products “are cleared for the repair and reinforcement of soft tissue where weakness exists.” That is a broad use. It is not a finding about breast surgery.
Many devices reach the market through a process called 510(k) clearance. A company shows that its device is similar to one already sold. The original GalaFLEX mesh was cleared this way in May 2014. Clearance allows a product to be sold. It does not mean the FDA studied it for every way a surgeon might use it.
Doctors are allowed to use a cleared device in ways its label does not list. This is called off-label use. Placing mesh as an “internal bra” during a breast lift, augmentation or reconstruction is one example.
Was this a recall?
No. The letter was about labeling. It did not announce a recall of GalaFLEX, Phasix or any other mesh.
Why the letter matters in breast mesh lawsuits
Women who have filed lawsuits point to the FDA’s statements. They allege that manufacturers did not give patients and doctors enough warning about risks when mesh was used in breast surgery. BD and the other companies named can dispute those claims, and no court has found them liable.
If you had complications after a breast procedure, you can read more about breast mesh litigation, the products involved and what records may help. An attorney can review what happened, but no lawyer can promise a settlement or result.
This article is general information about how these cases work. It is not legal advice, it does not create an attorney-client relationship, and no two claims are alike. If something here sounds like your situation, the useful next step is a conversation about the facts.