DuraSorb Class Action Lawsuit: The Core Allegations
The DuraSorb class action lawsuit accuses SIA of releasing a device with known absorption variability that can lead to adverse tissue reactions, particularly when placed in the highly vascularized breast environment. Unlike permanent meshes, DuraSorb is marketed to dissolve over 12–18 months, but clinical reports and FDA adverse event data reveal cases of rapid breakdown, causing seromas, capsular contracture, and chronic discomfort.
Lawsuits filed in federal courts, including the Northern District of Illinois, claim SIA relied on limited hernia data to promote DuraSorb for breast use without conducting dedicated long-term studies, violating patient safety protocols. The DuraSorb class action lawsuit seeks to consolidate thousands of claims under multidistrict litigation (MDL), mirroring the path of hernia mesh cases that resulted in multibillion-dollar settlements.
Plaintiffs argue that SIA’s marketing emphasized “natural integration” while omitting warnings about degradation fragments that can migrate and provoke immune responses, leaving women with distorted results and the burden of additional surgeries.
The DuraSorb class action lawsuit gained traction after a 2024 FDA safety communication highlighted over 600 MAUDE reports of mesh-related complications in soft tissue applications, with a significant portion linked to breast procedures.
Women in their 40s and 50s, often undergoing reconstruction after mastectomy or cosmetic lifts, report not only physical pain but also emotional distress from altered body image and repeated medical interventions. Early discovery motions in the DuraSorb class action lawsuit are requesting SIA’s internal degradation studies and surgeon training materials to prove the company knew of the risks but proceeded with aggressive off-label promotion.
DuraSorb Mesh: The Device Under Scrutiny
DuraSorb mesh, manufactured by Surgical Innovation Associates, is a monofilament scaffold composed of poly-4-hydroxybutyrate (P4HB), designed to provide temporary structural support during tissue healing. Cleared via the FDA’s 510(k) pathway in 2018 for hernia repair, it was quickly adopted for breast surgery to maintain lift and volume, with surgeons suturing it beneath the skin to create an internal sling.
The DuraSorb class action lawsuit claims that while the mesh performs adequately in abdominal wall repairs, its behavior in breast tissue—where movement and vascularity differ—leads to unpredictable absorption and inflammatory cascades.
Patients describe the mesh “crumbling” or “dissolving too fast,” leaving voids that fill with fluid or scar tissue, requiring explantation and reconstruction. The lawsuit highlights SIA’s failure to update labeling despite post-market data showing higher complication rates in breast applications compared to hernia use.
The DuraSorb class action lawsuit also questions the 510(k) clearance process, arguing that equivalence to predicate hernia meshes does not justify cosmetic use without separate clinical trials. With revision surgeries averaging $15,000–$25,000, the financial and emotional toll on plaintiffs is substantial, fueling demands for compensatory and punitive damages.
Complications Central to the DuraSorb Class Action Lawsuit
Complications from DuraSorb mesh include:
- Premature Degradation: Mesh breaks down faster than advertised, causing tissue voids and asymmetry.
- Chronic Inflammation: Immune responses to degradation byproducts lead to persistent swelling and pain.
- Seroma and Hematoma: Fluid or blood pockets form around the implant, requiring drainage.
- Infection Risk: Bacterial colonization in degraded areas necessitates antibiotics or surgery.
These issues, documented in over 600 FDA reports, form the basis of the DuraSorb class action lawsuit.
Symptoms Reported in DuraSorb Lawsuits
Patients in the DuraSorb class action lawsuit experience:
- Initial Discomfort: Tenderness or warmth at the surgical site within weeks.
- Progressive Pain: Throbbing or stabbing sensations as mesh degrades.
- Visible Deformities: Lumps, dents, or asymmetry in breast contour.
- Severe Reactions: Fever, redness, or discharge indicating infection.
- Psychological Impact: Anxiety or depression from body image changes and surgical trauma.
Treatment costs range from $5,000 for monitoring to $25,000+ for revisions and psychological care.
Steps for DuraSorb Lawsuit Plaintiffs
Affected individuals should:
- Seek surgical evaluation for mesh status and removal options.
- Collect medical records, surgical reports, and expense documentation.
- Consult a DuraSorb class action lawsuit attorney for a complimentary case review.
These actions strengthen a DuraSorb class action lawsuit claim.
Legal Foundation of the DuraSorb Class Action Lawsuit
The DuraSorb class action lawsuit is built on:
- Product Liability: Defective degradation in breast tissue applications.
- Negligence: Lack of dedicated breast-specific clinical trials.
- Failure to Warn: Inadequate risk disclosures for off-label use.
- Fraudulent Promotion: Overstating integration while hiding variability.
Plaintiffs may recover $50,000–$500,000 per case, with MDL consolidation likely. The $4.2 billion Bard hernia mesh settlement offers a precedent for DuraSorb class action lawsuit outcomes.
Do I Have a DuraSorb 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 DuraSorb class action lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free DuraSorb Class Action Lawsuit Evaluation: If you underwent breast surgery with DuraSorb 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 DuraSorb 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