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Injured by GalaFLEX, Phasix, or Another Breast Mesh Implant?
If you or a loved one suffered complications after breast surgery involving GalaFLEX, Phasix, or another surgical mesh device marketed as an "internal bra," HSGLaW is here to fight for you. The FDA has confirmed that no surgical mesh product is cleared or approved for use in breast surgery. Our mass tort attorneys are investigating claims against the manufacturers who marketed these devices for procedures they were never cleared for.
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Known Risks
Breast Mesh Complications
In a letter dated November 9, 2023, the FDA addressed updated labeling for Becton, Dickinson and Company mesh products sold under the GalaFLEX and Phasix names. The agency stated that no surgical mesh products are cleared or approved for use in breast surgery, including augmentation and reconstruction. Despite this, these products have been widely used off-label in "internal bra" procedures.
Infection & Abscess
Bacteria can colonize the mesh surface or implant pocket, leading to chronic infections and abscess formation that resist antibiotics and often require surgical intervention to resolve.
Chronic Pain & Nerve Damage
Patients report persistent pain, burning sensations, numbness, and nerve damage around the chest wall, under the breast fold, and the lower pole, often lasting long after the initial surgery.
Mesh Migration & Erosion
The mesh can shift, detach, disintegrate, or erode through tissue, causing deformity, visible mesh through the skin, and wound breakdown that requires corrective surgery.
Implant & Reconstruction Failure
Mesh complications can undermine the entire procedure, resulting in complete implant loss. A 2024 review found implant loss in roughly 3% of cases involving synthetic mesh in breast surgery.
Tissue Necrosis & Seroma
The mesh can trigger tissue death (necrosis) and chronic fluid buildup (seroma) at the surgical site, compromising healing, increasing infection risk, and leading to long-term deformity.
Revision Surgeries
Studies show roughly 1 in 10 patients require additional surgery to address mesh-related problems, with some needing multiple corrective procedures.
Devices Under Review
GalaFLEX and Phasix Breast Mesh
Both product lines are manufactured by Becton, Dickinson and Company (BD). The FDA cleared them for the repair and reinforcement of soft tissue where weakness exists. Neither line is cleared or approved for use in breast surgery. In November 2023, BD updated the labeling on these products with new warnings and precautions.
GalaFLEX Scaffold
Becton, Dickinson and Company
- GalaFLEX Scaffold
- GalaFLEX Lite Scaffold
- GalaFLEX 3D Scaffold
- GalaFLEX 3DR Scaffold
GalaFLEX is a resorbable poly-4-hydroxybutyrate (P4HB) scaffold. It has been used off-label in breast lift, augmentation, and reconstruction procedures, where it is frequently described to patients as an "internal bra."
Phasix Mesh
Becton, Dickinson and Company
- Phasix Mesh
- Phasix ST Mesh
- Phasix Plug and Patch
- Phasix ST Mesh with Open Positioning System (OPS)
- Phasix ST Mesh with Echo 2 Positioning System
Phasix is a resorbable mesh line cleared for soft tissue reinforcement, including hernia repair. Use in breast procedures falls outside the indication the FDA cleared it for.
Not Sure Which Device You Received?
Most patients are never told the brand name of the mesh used in their surgery. Your operative report, implant card, or device sticker will list the product and a Unique Device Identifier (UDI). If you do not have those records, our team can request them from the hospital or surgical center on your behalf at no cost to you.
The FDA has stated that it does not recommend reoperation or removal of implanted surgical mesh in patients who are not experiencing symptoms. If you are having symptoms, talk to your physician about your medical options and contact us about your legal options.
Take Action
Do You Qualify for a Breast Mesh Lawsuit?
You may be eligible to file a claim if any of the following apply to you:
You had GalaFLEX, Phasix, or another surgical mesh placed in the breast region during augmentation, lift, reconstruction, or revision surgery
You developed infection, pain, deformity, seroma, tissue loss, or needed additional surgeries after the mesh was placed
You have medical records documenting the mesh placement and subsequent complications or revision surgeries
You experienced mesh migration, erosion, disintegration, rupture, or visible mesh through the skin
You don't know which mesh was used. If you had mesh placed and suffered complications, our team can identify the product through your medical records
Your surgery took place anywhere in the United States. HSGLaW represents clients nationwide from offices in Nashville, Louisville, Cincinnati, and Washington, D.C.
How It Works
Getting Started Is Simple. The Fee Is Free.
You pay nothing unless we recover compensation on your behalf.
1
Submit Your Claim
Fill out the free case evaluation form or call us directly. It takes just minutes to get started and there is no obligation.
2
We Investigate
Our legal team reviews your case, identifies the device used, gathers evidence, and builds the strongest possible claim on your behalf.
3
We Fight for You
We pursue maximum compensation through aggressive negotiation or litigation, holding manufacturers accountable for the harm they caused.
Why HSGLaW
Trusted. Proven. Relentless.
HSGLaW is a dedicated partnership of experienced litigators committed to fighting for the people, not the powerful.
Mass Tort Experience
Our attorneys handle complex class actions and mass tort litigation nationwide. We have the resources and experience to take on the largest device manufacturers.
Compassionate Advocacy
We understand the physical and emotional toll of mesh complications. Our team provides caring, personalized attention to every client throughout the process.
No Fee Unless We Win
We work on a contingency fee basis. You pay nothing out of pocket. Our fees are only collected if we successfully recover compensation in your case.
Offices Across the Country
With offices in Nashville, Louisville, Cincinnati, and Washington, D.C., HSGLaW represents clients across the United States in breast mesh claims.
Common Questions
Frequently Asked Questions
Breast mesh is surgical mesh placed inside the breast to provide internal support, often called an "internal bra." It is used in breast reconstruction, augmentation, lift, and revision procedures. In a November 2023 letter, the FDA confirmed that no surgical mesh products are cleared or approved for use in breast surgery. Lawsuits allege that manufacturers marketed these products for unapproved breast uses without adequately testing them for that purpose or warning patients and surgeons about the serious risks involved.
GalaFLEX and Phasix are surgical mesh product lines manufactured by Becton, Dickinson and Company. The GalaFLEX line includes the GalaFLEX Scaffold, Lite Scaffold, 3D Scaffold, and 3DR Scaffold. The Phasix line includes Phasix Mesh, Phasix ST Mesh, Phasix Plug and Patch, and Phasix ST Mesh with the OPS or Echo 2 positioning systems. The FDA cleared these products for the repair and reinforcement of soft tissue where weakness exists, not for breast surgery. Your operative report, implant card, or device sticker will identify which product was used. If you cannot locate those records, our team can request them from your hospital or surgical center on your behalf.
No. These products have not been recalled, and they remain cleared by the FDA for soft tissue repair and reinforcement. What the FDA said in its November 2023 letter is that surgical mesh has not been determined to be safe and effective for use in breast surgery, and that BD had updated its labeling with new warnings and precautions. The FDA also stated that it does not recommend removal of implanted mesh in patients who are not experiencing symptoms. Claims in this litigation focus on how these devices were marketed for breast procedures and what patients and surgeons were told about the risks.
There is no upfront cost. HSGLaW works on a contingency fee basis, which means you pay nothing unless we recover compensation in your case. The initial case evaluation is completely free and confidential.
If a claim is successful, compensation in breast mesh lawsuits may include medical expenses (such as the initial surgery, treatments for complications, and revision or removal surgeries), lost wages, pain and suffering, emotional distress, and damages for permanent scarring or disfigurement. However, every case is different, and outcomes depend on the specific facts of your situation, the severity of your injuries, and the strength of the evidence. No result or particular level of compensation can be guaranteed. We encourage you to contact us for a free evaluation so we can give you an honest assessment of your individual circumstances.
Key evidence includes operative reports and medical records documenting the mesh placement, the type and brand of mesh used (device stickers, lot numbers, or Unique Device Identifiers if available), imaging and physician notes showing complications, and records of any follow-up treatments or revision surgeries. If you don't have all of this documentation, don't worry. Our legal team can help you request records from hospitals and surgical centers to build your case.
No. These lawsuits are against the manufacturers of the mesh products, not your surgeon. Consent forms cover general surgical risks but do not release manufacturers from their duty to properly test their products, warn about known defects, and refrain from marketing devices for unapproved uses.
This page is sponsored by Herzfeld, Suetholz, Gastel, Leniski and Wall. We are investigating potential claims involving GalaFlex and Phasix. These devices remain approved and/or cleared by the U.S. Food and Drug Administration unless and until it has been recalled by a government agency or through an agreement between a manufacturer and a government agency. Do not stop taking a prescribed medication without first consulting with your doctor. Discontinuing a prescribed medication without your doctor's advice can result in injury or death. Cases may be referred to another attorney or law firm.