Internal Bra Class Action Lawsuit Overview
The Internal Bra class action lawsuit centers on the Galaflex Scaffold, a bioabsorbable mesh implanted during breast surgery to provide internal support, mimicking a bra’s lift. Approved under the FDA’s 510(k) clearance in 2016, the device was promoted for use in mastopexy (breast lifts) and augmentation, promising durability for up to 18 months. However, reports of mesh degradation, inflammation, and tissue rejection have surged, leading to a wave of lawsuits [1]. Women aged 25-55, often undergoing cosmetic procedures, are the primary plaintiffs, alleging the mesh causes chronic pain, seromas, and the need for removal surgeries costing $10,000-$20,000 each.
The Internal Bra class action lawsuit claims Galatea Surgical failed to disclose risks in FDA submissions and marketing, violating consumer protection laws. Similar to the 2018 Bard hernia mesh litigation, which settled for $4.2 billion, these cases highlight systemic issues in medical device safety. With over 500 complaints to the FDA since 2018, the class could include thousands, seeking damages for medical bills, lost wages, and emotional suffering.
Affected Internal Bra Devices and Procedures
The Internal Bra class action lawsuit targets:
- Galaflex Scaffold: Absorbable poly-4-hydroxybutyrate mesh, used in breast lifts and augmentations since 2016. Implanted under the skin to support tissue, it degrades over 12-18 months but can cause adverse reactions [2].
- Related Procedures: Mastopexy with internal bra technique, often combined with implants, performed by plastic surgeons nationwide.
Patients can identify involvement by checking surgical records for Galaflex use. The mesh’s biocompatibility claims are central to the litigation.
Hazards of Internal Bra Complications
Internal Bra complications include:
- Inflammation and Infection: Mesh degradation triggers immune responses, causing swelling and abscesses.
- Chronic Pain: Persistent discomfort requiring pain management or surgery.
- Tissue Rejection: Body attacks the mesh, leading to necrosis or capsular contracture.
- Revision Surgery Needs: Removal procedures to alleviate symptoms.
The Internal Bra class action lawsuit argues these risks were foreseeable but downplayed [2].
Symptoms of Internal Bra Injuries
Women experiencing issues may notice:
- Early Signs: Redness, swelling, or mild pain at the implant site.
- Progressive Symptoms: Chronic aching, firmness, or seroma formation.
- Severe Effects: Fever, pus discharge, or tissue necrosis requiring emergency care.
- Long-Term Impacts: Scarring, asymmetry, or psychological trauma from body image changes.
Treatment costs range from $5,000 for monitoring to $20,000+ for revisions [3].
Consumer Actions and Legal Remedies
Victims should:
- Consult a surgeon for mesh removal if symptomatic.
- Document medical records and surgical notes.
- Contact a Internal Bra class action lawsuit attorney for a free consultation.
Remedies include refunds, medical coverage, and damages.
Prospects for an Internal Bra Class Action Lawsuit
The Internal Bra class action lawsuit has strong potential:
- Product Liability: Defective mesh under FDA 510(k) clearance.
- Negligence: Failure to conduct long-term studies.
- Failure to Warn: Inadequate risk disclosures.
- Fraud: Misleading marketing about durability.
Plaintiffs may recover $50,000-$500,000 per case, with multidistrict litigation possible [3]. Precedents like the $4.2 billion Bard hernia mesh settlement offer hope.
Do I Have an Internal Bra 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 Internal Bra class action lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Internal Bra Class Action Lawsuit Evaluation: If you underwent breast surgery with Galaflex mesh and experienced complications like pain or infection, you should contact our law firm immediately. You may be entitled to compensation by filing an Internal Bra class action suit, 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