Two types of surgical mesh that are commonly used in breast reconstruction surgery are linked to higher rates of infections, or needing another surgery, according to the FDA.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting breast reconstruction induced injury cases in all 50 states. If you or somebody you know has been injured by AlloMax or FlexHD surgical mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is the problem?
In March 2021, the FDA warned that the surgical mesh products FlexHD and AlloMax had “significantly higher major complication rates” when they were used off-label in unapproved breast reconstruction surgery.
FlexHD and AlloMax Linked to Higher Risks
Compared to other types of surgical mesh (or no mesh), patients who were implanted with FlexHD and AlloMax were more likely to suffer from infections, explantation, or need another surgery within 2 years.
What Are ADMs?
FlexHD (made by MTF Biologics) or AlloMax (made by BD) are surgical mesh products that are made of human or animal skin. These products are called an Acellular Dermal Matrix (ADM). The FDA has not approved any ADMs for post-mastectomy breast reconstruction.
Lack of FDA Approval Didn’t Stop Breast Surgeons
AlloMax and FlexHD are not approved for breast reconstruction. Even so, in the last few years, doctors have started commonly using these surgical mesh products “off-label” in reconstructive breast surgery. May patients are breast cancer survivors who had mastectomies.
What Are the Risks?
- Needing another surgery: Some patients who undergo a breast reconstruction with AlloMax or FlexHD mesh will need more surgery to fix problems that come up.
- Explantation: Breast reconstruction patients who experience complications with AlloMax or FlexHD may need surgery to remove the mesh, which can be difficult, especially if tissue has already grown into the mesh.
- Infections: Infections occur when surgical incisions are are contaminated with bacteria or fungus. Surgical infections usually appear within a few days to a week, but infection can occur any time after surgery. If antibiotics do not work, surgery may be necessary to remove the implant.
Do I have a Breast Reconstruction Lawsuit?
The Schmidt Firm, PLLC is currently accepting breast reconstruction induced injury cases in all 50 states. If you or somebody you know has been injured by AlloMax or FlexHD surgical mesh, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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