GalaFLEX and Phasix are two names that come up often in breast mesh lawsuits. Both are made by BD, and both are built from a material called P4HB that the body slowly absorbs. They are cleared by the FDA for soft-tissue repair. But the FDA has said that no surgical mesh is cleared or approved for breast surgery. Many patients do not know which mesh, if any, was used in their own surgery. Here is a plain-English guide.
What these products are
GalaFLEX is a knitted mesh, sometimes called a scaffold. There are several versions, including GalaFLEX, GalaFLEX Lite, GalaFLEX 3D and GalaFLEX 3DR. The original GalaFLEX mesh was cleared by the FDA in May 2014.
Phasix is a family of mesh products used mainly in hernia repair. Versions include Phasix Mesh and Phasix ST Mesh.
What P4HB is
Both product lines are made from poly-4-hydroxybutyrate, or P4HB. It is a material made by bacteria through fermentation. Over time, the body breaks it down and absorbs it. In its FDA clearance summary, Phasix mesh was described as being essentially absorbed within 12 to 18 months.
The idea is that the mesh supports tissue while the body builds new tissue in its place.
How the mesh is used
The FDA says these BD products are cleared for “the repair and reinforcement of soft tissue where weakness exists.” That includes uses like hernia repair.
Some surgeons have also used this kind of mesh in breast procedures. Placed inside the breast, it can act as an “internal bra” to support tissue or an implant. This may happen during:
- Breast lifts
- Breast reductions
- Breast augmentation
- Breast reconstruction, including after a mastectomy
- Implant revision
What the FDA has said
On November 9, 2023, the FDA told doctors that BD had updated warnings and precautions on nine GalaFLEX and Phasix products. The FDA said the safety and effectiveness of surgical mesh in breast surgery has not been determined. It added that no surgical mesh products are cleared or approved by the FDA for breast surgery.
The FDA did not recall GalaFLEX or Phasix in that letter. It also said it was not recommending that patients without symptoms have mesh removed.
What lawsuits allege
Women who have sued allege that they were not properly warned about risks when this mesh was used in breast surgery. Reported complications include infection, pain, swelling, seroma, mesh exposure and the need for revision or removal surgery.
BD and the related companies can dispute these claims. No court has found them liable. You can read more about GalaFLEX breast mesh claims and how they are reviewed.
How to find out what mesh you have
You may not know if mesh was used, or which one. These records may help:
- Your operative report, which describes what the surgeon did
- Implant or device records, which may list the product name and lot number
- Stickers or labels from the product packaging, which are sometimes placed in your chart
- Hospital or surgery center records
- Records from any later revision or removal surgery
You can ask your surgeon’s office or hospital for copies of your records. You do not need these records before talking to a lawyer about breast mesh complications. No attorney can promise a settlement or outcome, but a review can start with what you know today.
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.