Phasix Class Action Lawsuit: The Emerging Battle for Breast Mesh Victims
Phasix class action lawsuits are surging as patients report debilitating complications from the Phasix mesh, a bioabsorbable scaffold implanted during breast surgery to provide structural support. Approved by the FDA in 2015 under the 510(k) pathway as a hernia repair device, Phasix was repurposed for cosmetic procedures like mastopexy and augmentation, but its rapid degradation has caused inflammation, seromas, and tissue rejection in hundreds of women [1].
The Phasix class action lawsuit alleges that BD knew or should have known about the mesh’s instability but failed to conduct adequate post-market surveillance, resulting in unnecessary surgeries and lifelong suffering. Similar to the $4.2 billion Bard hernia mesh settlement, these Phasix class action lawsuit claims seek to hold BD accountable for a device that promised durability but delivered distress.
Phasix Mesh: The Product Behind the Class Action Lawsuit
The Phasix class action lawsuit targets BD’s Phasix ST Mesh, a monofilament scaffold made from poly-4-hydroxybutyrate (P4HB) polymer, marketed for soft tissue reinforcement in breast procedures. Implanted under the skin, it aims to maintain lift for 12–18 months while degrading, but cases show premature breakdown causing pain and revision needs [2].
Women aged 30–50, often seeking aesthetic enhancements, are the primary class in the Phasix class action lawsuit, with over 500 FDA MAUDE reports since 2015 documenting complications. The mesh’s off-label use for breasts, despite hernia approval, is central to the legal argument.
Complications Driving the Phasix Class Action Lawsuit
Phasix complications include:
- Chronic Inflammation: Persistent swelling and pain from immune rejection.
- Infection and Seroma: Fluid buildup and bacterial entry due to mesh degradation.
- Tissue Erosion: Mesh burrowing into skin or muscle, requiring excision.
- Capsular Contracture: Hardening around implants from foreign body response.
The Phasix class action lawsuit argues these risks were foreseeable but undisclosed [3].
Symptoms of Phasix Mesh Injuries
Patients in the Phasix class action lawsuit report:
- Early Symptoms: Localized pain, redness, or swelling at the implant site.
- Progressive Signs: Firmness, itching, or fluid drainage from seromas.
- Severe Effects: Fever, pus discharge, or tissue necrosis requiring emergency removal.
- Long-Term Impacts: Scarring, asymmetry, or psychological trauma from body dissatisfaction.
Medical costs range from $5,000 for monitoring to $20,000+ for revisions [4].
Consumer Actions for Phasix Lawsuit Victims
Victims should:
- Consult a surgeon for mesh evaluation and removal.
- Preserve medical records and surgical notes.
- Reach out to a Phasix class action lawsuit attorney for a free case review.
These steps bolster a Phasix class action lawsuit claim.
Legal Basis for a Phasix Class Action Lawsuit
The Phasix class action lawsuit relies on:
- Product Liability: Defective mesh under FDA 510(k) clearance.
- Negligence: Inadequate long-term testing.
- Failure to Warn: Lack of risk disclosures for off-label use.
- Fraud: Misleading claims of biocompatibility.
Plaintiffs may recover $50,000–$500,000 per case, with multidistrict litigation likely [3]. The $4.2 billion Bard settlement provides a model for Phasix class action lawsuit success.
Do I Have a Phasix Class Action Lawsuit?
The Class Action Litigation Group at our law firm is an experienced team of trial lawyers focusing on the representation of plaintiffs in Phasix class action lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Phasix Class Action Lawsuit Evaluation: If you underwent breast surgery with Phasix mesh and suffered complications like pain, infection, or revision needs, you should contact our law firm immediately. You may be entitled to compensation by filing a Phasix class action lawsuit, and our lawyers can help.
References
- https://www.youhavealawyer.com/breast-mesh-lawsuit/
- https://www.drugwatch.com/phasix/
- https://www.consumernotice.org/legal/breast-mesh-lawsuits/
- https://www.fda.gov/medical-devices/breast-implants/risks-and-complications-breast-implants
- https://www.nejm.org/doi/full/10.1056/NEJMra1703260