Breast Mesh & GalaFLEX Lawsuits: What You Should Know
Suffering from Breast Mesh or Internal Bra Complications? You May Be Entitled to Compensation.
Have you or a loved one suffered complications from the implantation of GalaFLEX mesh, or any other brand of “breast mesh” or “internal bra”? If so, you may be entitled to compensation. Common breast mesh injuries found post-surgery may include [1]:
- Infection
- Pain
- Wound dehiscence (separation)
- Seroma (pockets of fluid)
- Mesh migration
- Hemorrhage
- Adhesions (scar tissue)
- Hematoma
- Inflammation
- Mesh Extrusion
- Recurrence of soft tissue defects
- Tissue Necrosis
- Revision Surgery
- Implant Removal Surgery
What is “Breast Mesh”?
In recent years, plastic surgeons have increasingly used surgical mesh products in breast procedures: breast lift (mastopexy), breast reduction, breast augmentation, or breast reconstruction surgery. [2] Breast mesh is often marketed as an “internal bra” to support implants, lift, or breast reconstruction.
NOT Approved by the FDA
In fact, the Food and Drug Administration (FDA) has stated that no surgical mesh products are cleared or approved for use in breast surgery (augmentation or reconstruction) in the United States. [3] Thus, when mesh is used in breast surgery, it is considered an “off-label” use.
What is GalaFLEX?
One of the better‐known breast mesh products is GalaFLEX, a biologically-derived polymer scaffold made from poly-4-hydroxybutyrate (P4HB), manufactured by Becton, Dickinson and Company. It is marketed as an “internal bra” mesh to reinforce soft tissue and improve the longevity of surgical results, etc. The mesh is supposed to reabsorb in the body in about 18-24 months. However, patients have reported adverse events of the mesh not dissolving in the body long after implantation, causing serious breast pain and inflammation.
Beckton, Dickinson, and Company acquired Tepha Inc., the parent company of Galatea Surgical, to grow its surgical mesh portfolio.
Types of GalaFLEX Mesh Used in Breast Surgery
Oliver-Zhang Law, PLLC is investigating reports from patients who were implanted with GalaFLEX who suffered complications after their breast surgeries. P4HB GalaFLEX products, include:
- GalaFLEX™ Scaffold
- GalaFLEX LITE™ Scaffold
- GalaFLEX 3D™ Scaffold
- GalaFLEX 3DR™ Scaffold
Potential Symptoms / Signs of Problems
If GalaFLEX mesh, or any other brand of P4HB breast mesh or internal bra, was used in your breast surgery, or suspect this material was used in your surgery, and are experiencing any of the following, you may need a medical evaluation — and possibly, you may also have a claim against the manufacturer and surgeon [4]:
- Persistent pain, discomfort, or unusual sensation in the breast area (especially around chest wall, under the breast fold, lower pole).
- Redness, swelling, fluid collection (seroma) or pockets of fluid around the mesh.
- Visible or palpable mesh, feeling the mesh through skin/thin tissue, or mesh that seems to shift or become exposed.
- Infection (even delayed), delayed wound healing, wound problems, increased firmness or hardness (capsular contracture) around the implant or mesh.
GalaFLEX Mesh Lawsuit and Breast Mesh Implant Lawsuit
If you believe you have been harmed because of breast mesh used in your surgery, you may have a product-liability and medical malpractice claim.
You should keep operative and post-operative records, the name/model/brand of any mesh implanted, records of any complications, infections, revision surgeries, and correspondence with your surgeon.
What should you preserve after mesh removal surgery?
If you have had your breast mesh removed, it is important to retain any materials post-mesh removal surgery and obtain pathology reports. These documents help identify the type and manufacturer of the mesh, such as GalaFLEX, and can serve as crucial evidence in your claim. Keeping these materials and reports can help verify which device caused your complications.
Why Choose Oliver-Zhang Law for Your GalaFLEX Lawsuit?
At Oliver-Zhang Law, PLLC, we understand how devastating it can be to experience pain, disfigurement, or revision surgeries following a breast augmentation, lift, or reconstructive procedure. Our team is actively investigating GalaFLEX and internal-bra mesh claims nationwide. We are committed to helping victims hold manufacturers and surgeons accountable.
When you choose us, you gain a legal team with:
- Proven Experience in Medical Device Litigation – We handle complex cases involving surgical mesh and medical products that have caused harm to patients.
- Medical Knowledge and Expert Access – Our attorneys work closely with medical experts to understand how mesh failures occur.
- Personalized Representation – We treat every client’s story with compassion and confidentiality. You are not just another case number — we will guide you through every step of the process.
If you suffered complications from GalaFLEX mesh, or any other brand of breast mesh, such as pain, infection, or the need for revision surgery after receiving a GalaFLEX or similar internal-bra mesh implantation, contact us today for a free and confidential consultation.
Contact Us Today
If you suspect that you may have sustained injuries due to breast mesh, then please call Oliver-Zhang Law, PLLC. Our attorneys are experienced in medical malpractice, products liability, defective medical devices, and more. Please contact us at 202-643-1110 or via email at [email protected] for a free consultation.
REFERENCES
[1] Michelle Llamas, FDA Warnings and Reports of ‘Internal Bra’ Complications May Lead to a Surge in Breast Mesh Lawsuits, DrugWatch (Oct. 30, 2025), https://www.drugwatch.com/news/2025/10/30/fda-warnings-and-reports-of-internal-bra-complications-may-lead-to-a-surge-in-breast-mesh-lawsuits/
[2] Nick Paul Taylor, FDA warns providers about using surgical mesh for breast surgery after BD label update, MedTechDive (Nov. 13, 2023), https://www.medtechdive.com/news/fda-bd-surgical-mesh-breast-surgery/699538/
[3] U.S. FDA, Labeling Updates for BD Mesh Products – Letter to Health Care Providers (Nov. 9, 2023), https://www.fda.gov/medical-devices/letters-health-care-providers/labeling-updates-bd-mesh-products-letter-health-care-providers?utm_medium=email&utm_source=govdelivery
[4] Sonya Williams et al., Efficacy of Mesh Use in Breast Surgery: A Comprehensive Review of Complications and Aesthetic Outcomes, Plast. & Reconstr. Surg. Global Open Feb. 2025 at 1, 3-4 https://journals.lww.com/prsgo/fulltext/2025/02000/efficacy_of_mesh_use_in_breast_surgery__a.30.aspx
Please contact our breast mesh class action lawyers for a free consultation if you believe that you have a breast mesh claim.
