Published by If you underwent breast reconstruction or augmentation using mesh marketed as an “internal bra” (brands such as GalaFLEX, Phasix, Strattice or AlloDerm) and experienced infection, implant failure or revision surgery, you may qualify for an internal bra lawsuit.
Our legal team specializing in medical device litigation offers a free review of your case; no fees unless recovery is secured.
Table Of Contents
What’s the Problem?
Mesh products originally designed for hernia repair or soft-tissue reinforcement have been repurposed off-label in breast reconstruction and augmentation—with mounting evidence of failure when used as an “internal bra.” [1]
The Food and Drug Administration (FDA) has confirmed that no surgical mesh has been cleared or approved for primary use in cosmetic or reconstructive breast surgery. [2]
Reported complications include mesh degradation, migration, tissue necrosis, chronic pain, implants shifting or failure, seromas and repeat revision surgeries. [3]
Latest Internal Bra Litigation Updates
- October 2025 – Legal firms announce investigations into internal bra products including GalaFLEX, Phasix, Strattice and AlloDerm in breast surgery cases. [1]
- October 2025 – New clinical review revealed internal-bra mesh revision rates approached 10 %, infection rates reached 4 % and implant loss in 3 % of cases studied. [3]
- November 2023 – FDA issued safety communication advising surgeons and patients of risks tied to mesh use in breast reconstruction—emphasizing lack of approval for cosmetic breast procedures. [2]
Product & Usage Details
Medical mesh brands under review were marketed for breast applications and include:
– GalaFLEX, GalaSHAPE, GalaFORM (Becton Dickinson)
– Phasix and Phasix ST (C.R. Bard)
– DuraSorb Monofilament Mesh (Integra)
– Strattice Reconstructive Tissue Matrix (Allergan / LifeCell)
– AlloDerm Regenerative Tissue Matrix (Allergan / LifeCell) [1]
Though cleared for a limited range of soft-tissue repairs, none were explicitly approved for breast reconstruction or cosmetic breast procedures. Their off-label deployment as an “internal bra” exposed patients to shifting loads, hormonal changes, and movement-driven mechanical stress—none of which were addressed in original studies.
Injuries & Complications
Complications stemming from internal-bra mesh implants include:
– Infection, abscess and skin/tissue necrosis
– Seroma (fluid accumulation) or chronic drainage requiring intervention
– Implant droop, asymmetry, extrusion or outright reconstructive failure
– Mesh migration, hardening and detachment from tissue
– Interference with imaging or mammography and permanent disfigurement
Each of these conditions may require revision surgery, involve extended recovery, impose added medical costs and emotional trauma.
Do You Qualify for an Internal Bra Lawsuit?
You may qualify for legal action if you:
– Underwent breast reconstruction, augmentation or lift using mesh branded as an “internal bra”
– Experienced one or more complications such as infection, implant failure, revision surgery, chronic pain or cosmetic asymmetry
– Can provide medical records including the mesh brand or type, proof of revision surgery or removal, and indication the mesh was used
– Were implanted in the U.S. within the applicable statute of limitations window
Evidence You’ll Need
To support your internal bra lawsuit, gather:
– Medical records showing mesh implantation, surgical notes or operative reports
– Brand identification of the mesh (e.g., GalaFLEX, Phasix, Strattice)
– Revision or explant surgery records, imaging studies, pathology reports
– Photographs of physical disfigurement, scarring, implant drift or other changes
– Statements from your surgeon or clinic indicating complications
Damages You Can Recover
Potential recoverable damages may include:
– Medical costs for implant removal, reconstruction and therapy
– Lost wages or diminished earning capacity if you missed work or medical complications prevented normal activities
– Expense of corrective surgeries and ancillary treatments
– Emotional distress, pain and suffering, loss of enjoyment of life and disfigurement
– Punitive damages if manufacturer conducted business with conscious disregard for safety
Legal Theories & Grounds for This Lawsuit
Legal claims in internal bra lawsuits may be based on:
– Defective design: meshes not engineered for the dynamic environment of breast tissue, causing early failure
– Off-label marketing: alignment of mesh products with breast reconstruction despite lacking FDA clearance for this use [3]
– Failure to warn: patients were not fully informed of the altered risks when mesh was used as an internal bra
– Negligent manufacturing or deployment: substandard materials, improper surgeon training or testing gaps
– Strict liability: manufacturer should be held accountable when devices cause harm despite compliance efforts
Because manufacturers marketed these meshes specifically for breast use without the appropriate approvals, a strong basis exists for liability.
Statute of Limitations & Timing
Statutory deadlines vary by state but commonly span one to three years from discovery of injury or removal of the device. Because mesh complications may surface several years later, acting promptly ensures preservation of evidence and legal rights.
Frequently Asked Questions
- Is there a recall for internal bra meshes? – While not formally recalled, the FDA has issued warnings and manufacturers are under investigation, forming the basis for an internal bra lawsuit. [2]
- Do I have to pay anything upfront? – Most product-liability attorneys handle internal bra litigation on a contingency basis—no fees unless you recover.
- What if the mesh was removed years ago? – You may still qualify if removal or revision happened within the statute of limitations and you can show prior injuries or damage.
- Are there class actions? – Investigation is ongoing; some cases may be grouped as mass torts depending on the mesh brand and jurisdiction.
Why Act Now?
If you received a mesh implant marketed as an internal bra, later endured implant loss, revision surgery, infection or disfigurement—you should explore your legal rights today. Early action ensures evidence is preserved, specialists are engaged and you can maximize your potential recovery.
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References
- https://www.youhavealawyer.com/breast-mesh-lawsuit/
- https://www.aboutlawsuits.com/breast-mesh-lawsuit/breast-mesh-problems-fda-warnings-off-label-use/
- https://www.aboutlawsuits.com/breast-mesh-lawsuits-may-follow-studies-linking-internal-bra-implants-to-complications/
- https://www.motleyrice.com/medical-devices