AlloMax Mesh has been linked to serious injuries when it is used in “off-label” breast surgeries like the internal bra.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting AlloMax injury cases in all 50 states. If you or somebody you know was injured by breast mesh or internal bra surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Internal Bra Mesh Litigation Group or call toll free 24 hours a day at (866) 920-0753.
What is AlloMax?
AlloMax Surgical Graft is a mesh implant that is linked to significantly higher rates of infections, implant removal, and needing another surgery when it is used in breast surgeries, according to the FDA.
This resulted in several safety warnings for AlloMax, for example:
“The FDA’s analysis suggested that two ADMs, FlexHD and Allomax, may have a higher risk profile than others. In particular, there were higher rates of major complications, explanation, additional operations and infections two years following surgery.”
Is AlloMax Approved for Breast Surgery?
No breast mesh products have been cleared or evaluated by the FDA for internal bra surgery. The use of these mesh products is “off-label.”
The FDA has not approved AlloMax or any other type of surgical mesh product for breast surgery, internal bra, breast lifts, augmentations, or breast reconstructions.
What is the Risk?
Doctors may claim that mesh is useful for helping to support sagging tissues, or help hold up the weight of an artificial breast implant. However, breast mesh has been linked to serious risks, including:
- Severe infection
- Disfigurement
- Abnormal breast shape
- Nerve damage
- Scarring
- Loss of sensation (numbness)
- Pain
- Additional surgeries
- And more
Who Makes AlloMax?
AlloMax Surgical Graft is manufactured by C.R. Bard / Davol Inc., a company that was acquired by Becton, Dickinson and Company (BD) in December 2017.
What Type of Mesh is AlloMax?
AlloMax Surgicla Graft is a type of surgical graft that is manufactured from human cadaver skin. The skin has been processed to remove the cells, leaving behind a scaffold of collagen. This type of product is also called an Acellular Dermal Matrix (ADM).
Is AlloMax Permanent?
Yes. AlloMax and other types of ADM mesh products are permanent implants. AlloMax is a scaffold that is made of human collagen, which does not dissolve in the body, unlike some other types of mesh products that are slowly absorbed by the body.
AlloMax is supposed to be a permanent implant to help support or repair soft tissues. Once it is implanted in the body, the body responds to the foreign AlloMax implant with inflammation and scar-tissue growth around the implant, which reinforces or repairs weak tissues.
FDA Warning for AlloMax Breast Surgery Risks
In March 2021, the FDA published a Safety Warning about “significantly higher complication rates” when AlloMax was used in implant-based breast reconstruction surgeries, including infections, implant removal, and needing another operation. According to the FDA:
“The analysis showed significantly higher complication rates of explantation (implant removal), reoperation and infection in patients with FlexHD and AlloMax brands of ADM two years following surgery, when compared with patients who received SurgiMend or AlloDerm brands, or no ADM.”
Mesh Injury Lawsuits Have Been Filed Nationwide
Over the past few years, tens of thousands of lawsuits have been filed by people who were injured by side effects of surgical mesh, hernia mesh, and vaginal mesh.
Even so, doctors are increasingly using mesh products for unapproved breast surgeries without fully warning their patients about the unproven results, added costs, and potential risk of devastating side effects like disfigurement, infection, or needing another surgery.
What Do Mesh Lawsuits Claim?
Lawsuits against the manufacturers of surgical mesh products generally claim that patients and doctors were not fully informed about the risk of severe side effects. Some lawsuits also claim that these mesh products were aggressively advertised for “off-label” surgeries.
How Can a Lawsuit Help?
Women who were injured by breast mesh may qualify to file a lawsuit against the manufacturer.
Every case is unique, but a lawyer may be able to help you file a lawsuit and seek compensation for your pain and suffering, medical expenses, long-term disfigurement or other injuries (i.e., chronic pain, loss of sensation, scarring, etc.) and more.
Do I Have an AlloMax Lawsuit?
The Schmidt Firm, PLLC is currently accepting AlloMax injury cases in all 50 states. If you or somebody you know was injured by breast mesh or internal bra surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Internal Bra Mesh Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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