Published by If you underwent breast reconstruction or augmentation surgery using Phasix mesh and later experienced chronic complications, implant failure or revision surgery, you may qualify for a Phasix lawsuit.
Contact our experienced legal team today for a free case evaluation—no fees unless you recover compensation.
Table Of Contents
What’s the Problem?
The mesh product known as Phasix, manufactured by C.R. Bard or Becton Dickinson, was originally cleared for soft-tissue reinforcement in hernia and abdominal surgery—not breast procedures. But it has since been used off-label in breast reconstruction or augmentation as part of so-called “internal bra” techniques. [1]
The U.S. Food & Drug Administration (FDA) has made clear that “no surgical mesh product is cleared or approved for breast surgery, including augmentation or reconstruction.” [2]
Reports show that mesh like Phasix may degrade or fail prematurely in breast tissue—leading to implant collapse, infection, seroma, chronic pain or multiple revision surgeries. [3]
This mismatch between marketing, off-label use and actual safety creates the foundation for a Phasix lawsuit.
Latest Phasix Litigation Updates
- November 9, 2023 – The FDA issued a Letter to Health Care Providers stating that several mesh products including Phasix Mesh and Phasix ST are not proven safe or effective for breast augmentation or reconstruction. [2]
- October 15, 2025 – Legal news outlets reported that breast mesh products such as Phasix are now being investigated in mass-tort litigation following recent studies documenting higher complication rates in breast reconstruction cases. [3]
- March 31, 2021 – Earlier FDA safety communication highlighted that acellular dermal matrix (ADM) and similar mesh devices when used in breast surgeries showed significantly higher explantation, reoperation and infection rates. [4]
Product & Usage Details
Phasix is a biologic synthetic mesh made of poly-4-hydroxybutyrate (P4HB), designed to support tissue healing and gradually resorb within 12 to 18 months. [1]
While cleared for hernia repair and similar uses, its application in breast reconstruction is entirely off-label. The absence of breast-specific trials means surgeons and patients relied upon the mesh under assumptions—not evidence—that it would hold implants or tissue in place long-term.
The breast environment, with hormonal influences, movement and implant weight, is fundamentally different than the abdomen—rendering mesh performance unpredictable.
Injuries & Side Effects
When mesh like Phasix is implanted in a breast environment, complications may include:
– Infection and abscess formation requiring drainage or mesh removal
– Seroma or persistent fluid accumulation around implant pockets
– Capsular contracture and implant shift or extrusion
– Mesh migration, detachment or early resorption leading to sagging or loss of breast form
– Implant failure or the need for full revision or explantation
– Chronic pain, nerve injury, skin necrosis or impaired breast-cancer surveillance
Each of these can lead to multiple surgeries, prolonged recovery periods, and emotional or cosmetic distress.
Do You Qualify for a Phasix Lawsuit?
You may be eligible if you:
– Underwent breast reconstruction, augmentation or revision surgery involving Phasix mesh
– Experienced complications such as infection, implant failure, revision surgery or chronic issues linked to the mesh
– Can provide medical records identifying Phasix mesh use, revision or explantation history
– Are within your state’s statute of limitations for medical device injury claims
Evidence Required for a Claim
To establish a Phasix lawsuit, you should gather:
– Surgical records referencing “Phasix”, “Phasix ST” or “P4HB mesh”
– Operative notes, explantation records, pathology or imaging showing mesh or implant issue
– Medical bills, discharge summaries, and revision surgery documentation
– Photos of deformity, scarring, asymmetry or device failure
– Marketing or promotional materials suggesting mesh was intended as a “support scaffold” for breast implants
Damages You Can Recover
Possible recoveries in a Phasix lawsuit include:
– Past and future medical expenses for mesh removal, reconstruction and rehabilitation
– Lost wages or reduced earning capacity due to recovery or ongoing complications
– Pain and suffering, emotional distress, loss of enjoyment of life, or disfigurement
– Compensation for invasive procedures or corrective treatment plans
– Punitive damages when manufacturers marketed mesh for unapproved breast use while aware of risk
Legal Grounds & Liability Theories
Claim theories may include:
– Defective design – Mesh wasn’t engineered for the breast’s dynamic, hormonal and movement-prone environment
– Failure to warn – Manufacturers did not adequately disclose that Phasix was not approved for breast use or detail long-term risks [3]
– Negligent marketing – Use of slogans and imagery promoting Phasix as a “support net” for implants despite lack of approval
– Strict liability – Manufacturers produced and marketed a device they knew would likely be used off-label in breast scenarios and caused harm
Because use of Phasix in breast surgery was never approved, yet widely marketed and implanted, the basis for liability in a Phasix lawsuit is clear.
Statute of Limitations & Timing
Statutes vary by state (typically one to three years from discovery of injury or surgical revision). Because mesh complications may surface years later, prompt legal review is essential to preserve rights in any potential Phasix lawsuit.
Frequently Asked Questions
- Was Phasix approved for breast surgery? – No. The FDA states that no surgical mesh is cleared or approved for breast reconstruction or augmentation. [3]
- Do I need revision surgery to qualify? – Not necessarily. You may still qualify if you experienced serious complications, recorded damage or need ongoing treatment.
- Are there class-action lawsuits? – At present cases are being investigated; a formal mass-tort docket may form for claims involving Phasix and other breast mesh products. [3]
- Is there a recall? – Not yet. While there is no formal recall of Phasix for breast use, regulatory warnings and litigation hold strong potential for liability.
Why You Should Act Now
If you have Phasix mesh and suffered implant failure, infection or chronic pain, it is vital to seek legal guidance now. Early action preserves records, ensures timely evaluation and positions you to file or join a Phasix lawsuit.
Millions of women trusted mesh-supported breast procedures, and when those devices failed, they were left with physical, emotional and financial consequences. If that describes your experience, you may be in a position to restore your health and financial stability through a Phasix lawsuit.
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References
- https://www.aboutlawsuits.com/breast-mesh-lawsuit/
- https://www.fda.gov/medical-devices/letters-health-care-providers/labeling-updates-bd-mesh-products-letter-health-care-providers
- https://www.aboutlawsuits.com/breast-mesh-lawsuit/breast-mesh-problems-fda-warnings-off-label-use/
- https://www.fda.gov/news-events/fda-brief/fda-warns-about-differing-complication-rates-acellular-dermal-matrix-type-surgical-mesh