Published by If you received a breast reconstruction or augmentation using GalaFLEX mesh and have experienced serious complications, surgical revision, implant failure or chronic pain, you may qualify for a GalaFLEX lawsuit.
Contact our legal team for a free case evaluation—no fees unless you recover compensation.
Table Of Contents
What’s the Problem?
GalaFLEX mesh, manufactured by Becton Dickinson, has been marketed to plastic surgeons as a supportive “internal bra” scaffold in breast reconstruction or augmentation. However, the U.S. Food and Drug Administration (FDA) has formally warned that no surgical mesh has been cleared or approved for use in breast surgeries—and yet GalaFLEX has been used off-label for that purpose.
While some early studies claim safety in limited settings, adverse event reports describe capsule-contracture, mesh bunching, tissue necrosis and chronic pain in patients whose reconstructive procedures included GalaFLEX. These developments form the foundation of a potential GalaFLEX lawsuit: users assert that off-label use, inadequate data and misleading marketing led to serious harm.
Latest GalaFLEX Litigation Updates
- November 13 2023 – The FDA issued a formal letter to physicians warning that surgical mesh products including GalaFLEX are not proven safe for breast reconstruction or augmentation [1].
- October 9 2025 – Legal publications revealed surge in investigative-stage claims against mesh brands like GalaFLEX, examining whether manufacturers misrepresented safety and marketed devices for off-label “internal bra” use [2].
- 2024–2025 – Surgeon-marketers and implant manufacturers faced scrutiny for allegedly promoting GalaFLEX for unapproved use, sparking questions about liability and patient protection [3].
Product & Usage Overview
GalaFLEX mesh is composed of poly-4-hydroxybutyrate (P4HB), a bioresorbable material originally cleared for soft-tissue reinforcement in non-breast applications.
Despite its off-label adoption in breast reconstruction, GalaFLEX remains explicitly labeled as not having demonstrated safety or effectiveness for breast-surgery indications.
In breast procedures, implants may be reinforced with this mesh to support lower-pole lift or pocket stability, often described as an internal sling or “internal bra.”
Yet expert commentary warns that the dynamic, hormonally influenced breast environment is fundamentally different than hernia repairs or other reinforcement uses, making mesh performance unpredictable.
Injuries & Side Effects
Patients implanted with GalaFLEX have reported a range of serious complications, including:
– Infection or abscess formation at the mesh or implant site
– Capsular contracture requiring removal or explantation
– Seroma or chronic fluid accumulation under the breast
– Mesh migration, detachment or bunching causing implant deformation
– Implant rupture, loss of reconstruction or revision surgery
– Tissue necrosis, scarring or interference with breast imaging
These adverse outcomes can result in multiple surgeries, long-term pain, disfigurement and emotional trauma.
Do You Qualify for a GalaFLEX Lawsuit?
You may be eligible to file a claim if you:
– Underwent breast reconstruction, augmentation or revision surgery involving GalaFLEX mesh
– Experienced one or more complications such as revision surgery, pain, infection or implant failure
– Can provide medical records identifying GalaFLEX or P4HB mesh use
– Are within your state’s statute of limitations for medical device injury claims
Evidence Required for a GalaFLEX Lawsuit
Key documentation may include:
– Surgical notes specifying GalaFLEX implantation or mesh brand/model
– Explantation records, pathology, or device-removal reports
– Imaging studies showing mesh migration, bunching or implant issues
– Medical bills, treatment records, therapy notes and witness statements
– Marketing materials or surgeon correspondence referencing internal-bra mesh adoption
Damages You Can Recover
Compensation in a GalaFLEX lawsuit may cover:
– Past and future medical expenses for revision, removal or reconstructive surgery
– Lost wages, diminished earning capacity or lifestyle impact
– Pain, suffering, disfigurement or loss of enjoyment of life
– Emotional distress, loss of consortium or wrongful-death damages if applicable
– Punitive damages when intentional mis-marketing or recklessness is proven
Legal Grounds & Liability Theories
Claims may include:
– Defective design – mesh was unsuited for breast anatomy and lacked proper clinical data
– Failure to warn – manufacturers did not adequately disclose off-label status and risk of serious complications
– Negligence – incorrect marketing of mesh for non-approved use without sufficient safety evidence
– Strict liability – product placed in market caused injury despite manufacturer’s knowledge of risks
Whether the claims are directed at surgeons or manufacturers, the alleged off-label promotion and injury‐burden provide core grounds for a GalaFLEX lawsuit.
Statute of Limitations & Timing
Legal deadlines vary by state, typically 1-3 years from date of injury or discovery. Because mesh complications often manifest months or years post-surgery, early evaluation by legal counsel is vital to preserve your right to pursue a GalaFLEX lawsuit.
Frequently Asked Questions
- Is GalaFLEX approved for breast surgery? — No. The FDA has confirmed no surgical mesh is cleared or approved for breast augmentation or reconstruction.
- Do I need to have surgery to qualify? — Revision or removal often strengthens claims, but qualification is based on documented complications related to GalaFLEX mesh use.
- Are there class-actions for GalaFLEX? — At this time cases are in the investigative phase; a formal GalaFLEX MDL or class action may form as filings increase.
Why You Should Act Now
If you received GalaFLEX mesh and have experienced complication, surgery or chronic harm, exploring a GalaFLEX lawsuit promptly ensures your rights are protected. Gathering medical records, preserving evidence and obtaining expert legal counsel early strengthens your position and supports recovery.
The public health implications of this mesh misuse are unfolding—and if you’ve suffered because of it, you may be in a position to hold manufacturers accountable through a GalaFLEX lawsuit.
Related Articles:
References
- https://www.fda.gov/medical-devices/letters-health-care-providers/labeling-updates-bd-mesh-products-letter-health-care-providers
- https://www.medtechdive.com/news/fda-bd-surgical-mesh-breast-surgery/699538/
- https://www.youhavealawyer.com/breast-mesh-lawsuit/