The FDA is warning patients that FlexHD is not approved for breast surgery and it has been linked to high rates of complications like infections, implant removal, and needing surgery.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting FlexHD injury cases in all 50 states. If you or somebody you know was injured by FlexHD Internal Bra 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.
FlexHD Lawsuits
Women who have an internal bra with FlexHD or any other type of breast mesh may qualify to file a lawsuit. These lawsuits may involve serious injuries linked to breast mesh, such as:
- Infection
- Disfigurement or scarring
- Breast asymmetry
- Pain and discomfort
- Needing another surgery to remove the mesh
- Reconstruction failure
- Red Breast Syndrome (RBS)
- And more
What is FlexHD?
FlexHD is a surgical mesh product that is manufactured by MTF Biologics, also known as the Musculoskeletal Transplant Foundation (MTF), which is also the world’s largest tissue bank.
FlexHD is one of several brands of surgical mesh that are being used for breast surgeries like the “Internal Bra,” despite a lack of approval from the FDA.
For example, the marketing materials for FlexHD Pliable say it is “specifically designed for breast reconstruction.” It is available in a Breast Kit with two pieces of bra-shaped mesh from the same donor.
What is Internal Bra Mesh?
Internal bra mesh is advertised for breast support, reconstruction, and revision breast surgery. The mesh is formed into a bra-cup shape, placed under an artificial breast implant to provide additional support, and then attached to the patient’s chest wall using sutures.
Breast mesh is now commonly used in breast reconstructions, augmentations, breast lifts, and breast cancer patients who are undergoing an implant-based reconstruction after a mastectomy.
Is FlexHD Approved for Breast Surgery?
No. No types of surgical mesh are FDA-approved for any type of breast surgery. The FDA has also specifically warned about higher rates of complications from FlexHD breast mesh.
FDA Warning for High Complication Rates of FlexHD Breast Mesh
In March 2021, the FDA published a warning about significantly higher complication rates for FlexHD in breast surgeries, such as explantation (implant removal), re-operation, and infection. 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.”
What Type of Mesh is FlexHD?
FlexHD is a type of surgical mesh called an Acellular Dermal Matrix (ADM). This mesh was originally intended for hernia repairs and other soft-tissue surgeries, and it has not been cleared for breast surgery.
FlexHD is manufactured from human donor skin that has been processed to remove the cells, leaving behind a scaffold of natural connective tissue that primarily consists of collagen and elastin.
Is FlexHD Permanent?
Yes. FlexHD is a non-absorbable permanent mesh implant made from human skin, unlike some other surgical meshes that slowly dissolve in the body over time. FlexHD remains in the body as a scaffold for new tissue-growth. This new tissue is actually scar-tissue that forms when the body’s immune system responds to the foreign FlexHD implant by triggering inflammation in the breast.
FlexHD and Red Breast Syndrome (RBS)
FlexHD is specifically linked to an inflammatory condition called Red Breast Syndrome (RBS). This condition is poorly understood, but causes a red skin rash over the breast, sometimes accompanied by pus-filled blisters and severe tissue inflammation, but without an infection.
Do I Have a FlexHD Lawsuit?
The Schmidt Firm, PLLC is currently accepting FlexHD injury cases in all 50 states. If you or somebody you know was injured by FlexHD Internal Bra 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.
Attention Lawyers: We consider a referral from another law firm to be one of the greatest compliments. If your firm is interested in referring us a case or for us to send you a list of previous award judgments and/or average referral fees, please visit the Lawyer Referral section of our website.
The Schmidt Firm, PLLC has been recognized as one of the nation’s leading plaintiffs' law firms and handles cases in all 50 states. We are very proud of our legal achievements, but equally self-respecting of our firm's reputation for providing personal attention to each and every client we represent.
