Women across the country are filing lawsuits after suffering serious complications following breast reconstruction, augmentation, reduction, and revision procedures involving GalaFLEX® and Phasix® surgical mesh products. These devices, sometimes marketed as part of an "internal bra" technique, were used to provide additional support to breast tissue and implants. However, many patients later experienced severe complications requiring additional surgeries, prolonged medical treatment, and permanent injuries.
Breast Mesh Lawsuit Attorneys
When Breast Mesh Causes Serious Complications, We Fight Back
At Maggio Law, we are investigating claims involving women who underwent breast surgery between 2015 and the present and later developed complications associated with implanted breast mesh. If you suffered serious injuries after receiving GalaFLEX or Phasix mesh, you may have the right to pursue compensation.
Breast Mesh Litigation
Current breast mesh (or internal bra mesh) litigation involves allegations that manufacturers promoted certain surgical mesh products for use in breast procedures despite the absence of FDA approval or clearance specifically for breast augmentation or reconstruction.
The litigation focuses largely on products, including:
- GalaFLEX Scaffold
- GalaFLEX Lite
- GalaFLEX 3D
- Phasix Mesh
- Phasix ST Mesh
According to the U.S. Food and Drug Administration (FDA), there are currently no surgical mesh products cleared or approved for use in breast surgery, including breast augmentation or breast reconstruction. The FDA has specifically stated that the safety and effectiveness of surgical mesh in breast surgery have not been established.
Reported Breast Mesh Complications
Infection and Abscesses
Some women experienced severe infections around the mesh or implant site, requiring:
- Hospitalization
- Intravenous antibiotics
- Drainage procedures
- Surgical removal
Seromas
Fluid accumulation around the implanted mesh may lead to:
- Discomfort
- Delayed healing
- Repeated drainage procedures
- Additional surgeries
Capsular Contracture
Capsular contracture occurs when scar tissue tightens around a breast implant, causing:
- Pain
- Hardening
- Distortion
- Cosmetic deformity
Mesh Migration
Some women allege the mesh shifted from its intended position, causing:
- Pain
- Asymmetry
- Structural failure
- Tissue damage
Nerve Damage and Chronic Pain
Persistent nerve injuries may lead to:
- Chronic pain
- Numbness
- Hypersensitivity
- Reduced quality of life
Other Complications
- Reconstructive Failure: Some patients report complete failure of breast reconstruction procedures, requiring multiple corrective surgeries.
- Skin Necrosis: Loss of blood flow can lead to tissue death, delayed healing, infection, and permanent scarring.
- Implant Rupture: Complications involving mesh may contribute to implant failure and additional corrective procedures.
FDA Safety Concerns
In November 2023, the FDA issued a communication regarding several Becton, Dickinson and Company (BD) mesh products, including GalaFLEX and Phasix products.
The agency emphasized:
- The safety and effectiveness of surgical mesh in breast surgery have not been established
- No surgical mesh products are cleared or approved for breast augmentation or breast reconstruction
- Updated warnings and precautions were added to product labeling
These FDA statements have become a central issue in many breast mesh lawsuits.
Companies Named in Breast Mesh Lawsuits
Becton, Dickinson and Company (BD)
Many lawsuits identify BD as a primary defendant because of its involvement with:
- GalaFLEX Scaffold
- GalaFLEX Lite
- GalaFLEX 3D
- Phasix Mesh
- Phasix ST Mesh
- AlloMax
C.R. Bard
Many complaints also name C.R. Bard, which manufactured or distributed certain mesh products before becoming part of BD.
Galatea Surgical and Tepha
Some lawsuits name Galatea Surgical and Tepha for their involvement in developing and commercializing GalaFLEX products.
Why Choose Maggio Law?
Insurance companies and large medical device manufacturers often have enormous resources devoted to defending these claims. Maggio Law fights for people—not corporations.
Our firm is built on a simple principle: injured people deserve full compensation, not quick resolutions that leave them paying the price. We take a hands-on approach to every case and work directly with our clients throughout the legal process.
When you hire Maggio Law, you get:
- Direct attorney access
- Personalized representation
- Thorough case investigation
- Experience handling complex injury litigation
- No fees unless we recover compensation
If you believe breast mesh complications have changed your life, we want to hear your story.
