GalaFLEX Class Action Lawsuit: The Growing Litigation
GalaFLEX class action lawsuits are challenging the safety of the Galaflex Scaffold, a bioabsorbable mesh implant used in breast procedures to provide internal tissue support. Cleared by the FDA in 2016 via the 510(k) process, the device was positioned as a breakthrough for long-lasting breast lifts, but post-market reports reveal a pattern of failures, including inflammation, mesh degradation, and tissue rejection that require surgical removal.
A GalaFLEX class action lawsuit contends that Galatea Surgical underestimated these risks in its FDA submission and marketing, leading to widespread harm among women aged 25-55 seeking cosmetic enhancements. With over 500 adverse event reports to the FDA since 2018, including cases of severe pain and infection, the plaintiff pool is expanding rapidly, mirroring the fallout from hernia mesh scandals that resulted in billions in payouts. A GalaFLEX class action lawsuit attorney can evaluate your case, helping you join a coordinated effort to secure justice and reform medical device oversight [1].
The surge in GalaFLEX class action lawsuits stems from the device’s deceptive promise of durability—up to 18 months of support—despite evidence of premature breakdown. Women report “constant burning” and “unbearable pain,” forcing them back into surgery just months after their initial procedure, with removal costs averaging $15,000-$25,000. A GalaFLEX class action lawsuit seeks to address this by alleging design defects and inadequate testing, potentially unlocking compensation for thousands affected by what critics call a “ticking time bomb” in breast surgery.
Details of the GalaFLEX Implant and Procedures
GalaFLEX class action lawsuits target the Galaflex Scaffold and related surgeries:
- Galaflex Scaffold: A poly-4-hydroxybutyrate mesh implanted under the breast to support tissue during mastopexy or augmentation, marketed for 12-18 months of reinforcement before absorption. Used in 50,000+ procedures since 2016, with NDC codes 70610-100-1 (5 mg) and 70610-100-2 (10 mg) [1].
- Associated Procedures: Breast lifts (mastopexy) and augmentations where the mesh is placed to prevent sagging, often combined with implants.
Patients can confirm involvement via surgical records or by checking for “Galaflex” in procedure notes. The mesh’s “biocompatibility” claims are at the heart of the GalaFLEX class action lawsuit.
Complications and Hazards of GalaFLEX
GalaFLEX complications include:
- Inflammatory Response: The mesh triggers immune reactions, leading to swelling and abscesses.
- Chronic Pain Syndrome: Persistent aching that disrupts daily life and requires ongoing pain management.
- Infection and Rejection: The body rejects the material, causing necrosis or capsular contracture.
- Revision Surgery Necessity: Removal procedures to resolve symptoms, often with scarring and additional costs.
A GalaFLEX class action lawsuit argues these hazards were foreseeable but undisclosed, violating FDA clearance terms.
Symptoms of GalaFLEX Implant Injuries
Women affected by GalaFLEX may experience:
- Initial Signs: Redness, tenderness, or mild discomfort at the implant site shortly after surgery.
- Progressive Issues: Swelling, firmness, or seroma buildup, indicating inflammation.
- Severe Complications: Fever, pus drainage, or tissue death requiring urgent intervention.
- Long-Term Effects: Scarring, asymmetry, or psychological trauma from body image issues.
If these resonate, a GalaFLEX class action lawsuit attorney can help document your case for compensation.
Consumer Steps and Legal Remedies
If you’ve been harmed by GalaFLEX:
- Consult a plastic surgeon for mesh removal and symptom management.
- Gather medical records, surgical notes, and expense receipts.
- Reach out to a GalaFLEX class action lawsuit attorney for a free evaluation.
Remedies in a GalaFLEX class action lawsuit include refunds, medical cost coverage, and damages for pain and suffering.
Viability of a GalaFLEX Class Action Lawsuit
GalaFLEX class action lawsuits show promise:
- Design Defect: The mesh’s degradation rate was underestimated, per FDA data.
- Negligence: Lack of long-term clinical trials before market entry.
- Failure to Warn: Inadequate risk disclosures in marketing materials.
- Fraudulent Marketing: Overstated longevity claims to drive sales.
Plaintiffs may recover $50,000-$500,000 per case, with multidistrict litigation possible [4]. The 500+ FDA complaints bolster the case, similar to the $4.2 billion Bard hernia mesh settlement.
Do I Have a GalaFLEX 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 GalaFLEX class action lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free GalaFLEX Class Action Lawsuit Evaluation: If you underwent breast surgery with Galaflex Scaffold and suffered complications like pain or infection, you should contact our law firm immediately. You may be entitled to compensation by filing a GalaFLEX class action lawsuit, and our lawyers can help.
References
- https://www.youhavealawyer.com/breast-mesh-lawsuit/
- https://www.drugwatch.com/galaflex/
- 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