GalaFLEX Lawsuit

GalaFLEX is the most popular type of breast mesh used in “Internal Bra” surgeries, but it is also linked to severe side effects like infection, pain, disfigurement, or needing another surgery.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting GalaFLEX Breast Mesh injury cases in all 50 states. If you were injured by Internal Bra Surgery with GalaFLEX Breast 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 GalaFLEX?

GalaFLEX is the most popular type of mesh used in breast mesh surgery, including the “Internal Bra” plastic surgery and other types of breast lifts and breast reconstructions to hold the weight of implants.

Unlike most other types of surgical mesh, which are flat pieces of material designed for hernia repairs and other soft-tissue surgeries, GalaFLEX 3D Scaffold is shaped like a bra-cup, implanted under the breast, sutured to the chest wall, and primarily used in breast surgery.

What is the Risk?

Plastic surgeons widely tout the benefits of the “Internal Bra,” while failing to warn women about the unproven results, high expense, and potentially devastating risk of side effects from breast mesh implants.

Some of the potential risks include:

• Pain or discomfort
• Infection (may lead to abscess or sepsis)
• Tissue damage
• Breast reconstruction failure
• Contracture (tissue around the implant becomes tight and hardened)
• Breast asymmetry
• Disfigurement
• Lack of intimacy with partners
• Needing another surgery (re-operation or revision surgery)
• And more

GalaFLEX and Breast Cancer Risk

There are reports of patients who developed breast cancer after GalaFLEX was used in their breast mesh surgery.

The FDA has also received a report from a former BD employee who warned about a possible risk of breast cancer from the P4HB materials used in GalaFLEX, especially for breast cancer survivors who received the mesh after undergoing a reconstruction after a mastectomy (surgery to remove the breasts).

According to the report:

“P4HB materials can activate a pro-oncogenic immune response named the “m2 macrophage” response. Because P4HB activates m2 macrophages, its use in women with breast cancer patients is potentially dangerous. Additionally, introduction of any pro-inflammatory mesh product in a breast cancer resection space, could interfere with subsequent surveillance of cancer recurrences and, thus, lead to a life-threatening delay in diagnosis.”

GalaFLEX Lawsuits

Law firms are pursuing GalaFlex lawsuits against BD and other manufacturers of breast mesh products. These lawsuits rely on legal claims specifically targeting the defective design of GalaFlex.

GalaFLEX is NOT Approved for Breast Mesh Surgery

GalaFLEX 3D is a mesh product that is engineered and designed in the shape of a bra cup. Not surprisingly, it is one of the most popular breast mesh products. However, this is an unapproved “off-label” use that is NOT approved or evaluated by the FDA, and the 510(k) approval for GalaFLEX had zero mention of breast mesh surgery.

What is GalaFLEX?

The GalaFLEX™ Scaffold was created by Galatea Surgical Inc., a company that is now owned by Becton Dickinson (BD).

GalaFLEX looks like a sheet of flexible mesh material in varying widths, lengths, and shapes — including the GalaFLEX 3D™ Scaffold that is designed and shaped like a “demi-bra” cup, or breast sling.

What is GalaFLEX Made Of?

GalaFLEX is made of poly-4-hydroxybutyrate (P4HB), a high-strength, fully-absorbable biopolymer that stimulates an inflammatory response in the body, which causes the body to produce scar-tissue growth around the mesh. This is supposed to provide a scaffold for new tissue to slowly replace the mesh as it is slowly dissolved by the body.

What is P4HB?

P4HB was originally approved by the FDA for use in sutures, and it is now used in surgical mesh products that were originally intended for hernia repairs and soft-tissue surgeries to reinforce weakened tissue.

Since then, manufacturers have aggressively used the 510(k) pathway to achieve quick FDA-approval for P4HB in surgical mesh products, including many unapproved surgeries like the “Internal Bra” or breast reconstruction surgeries in women who have survived breast cancer.

GalaFLEX Approved Under 510(k) Approval Pathway

The original version GalaFLEX Mesh was FDA approved on May 21, 2014 under the 510(k) approval pathway, which is a fast way for companies to get new devices on the market. Instead of going through rigorous clinical trials and studies, a 510(k) approval allows new devices on the market so long as the manufacturer claims it is “substantially equivalent” to previous devices that are used for the same indications.

What Is GalaFLEX Approved For?

GalaFLEX mesh is approved as a “scaffold for soft-tissue support and to repair, elevate, and reinforce deficiencies where weakness or voids exist that require the addition of material to obtain the desired surgical outcome. This includes reinforcement of soft tissue in plastic and reconstructive surgery, and general soft tissue repair.”

Types of GalaFLEX Mesh

BD sells the following GalaFLEX mesh products:

• GalaFLEX™ Scaffold (rectangular sheet of mesh in 5 sizes)
• GalaFLEX LITE™ Scaffold (circular or rectangular sheet of mesh that is thinner than the original GalaFLEX)
• GalaFLEX 3D™ Scaffold (mesh is formed into a 3D shape that looks like a bra cup or sling)

FDA Warns Providers About Using GalaFLEX for Breast Surgery

In November 2023, the FDA updated the warning label on GalaFLEX and other BD mesh products to make it clear that no types of mesh are FDA-approved for breast surgery.

According to the FDA:

“The safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

How Can a Lawsuit Help?

Lawsuits for GalaFLEX internal bra injuries may involve severe side effects, expensive medical bills, lifelong disfigurement, decreased quality of life, loss of consortium (intimacy) with a partner, and more.

If you were injured by GalaFLEX in your breast mesh surgery, our lawyers may be able to help you join a class action or file an individual lawsuit. The results of a lawsuit depend on the circumstances of each case, but lawyers will try to seek justice and financial compensation.

Each case is unique and no outcome is guaranteed. However, a GalaFLEX lawsuit may end in a settlement or other financial cash payout for injuries, medical bills, pain and suffering, disfigurement or scarring, loss of income or earning potential, and other serious losses due to physical, emotional, or financial payments due to severe injury.

Do I Have a GalaFLEX Lawsuit?

The Schmidt Firm, PLLC is currently accepting GalaFLEX injury cases in all 50 states. If you were injured by Internal Bra Surgery with GalaFLEX Breast 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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