Published by If you underwent breast reconstruction or augmentation and received DuraSorb mesh support—and later experienced implant failure, revision surgery or chronic complications—you may qualify for a DuraSorb lawsuit.
Contact our legal team for a free case review—no fees unless we recover compensation for you.
Table Of Contents
What’s the Problem?
The DuraSorb mesh product, designed and marketed for soft tissue reinforcement in general surgery, has been used off-label in breast procedures despite lacking FDA clearance specifically for breast reconstruction or augmentation. [1]
While the manufacturer touts its bioresorbable, monofilament design, medical device experts warn that breast tissue and implant dynamics differ significantly from the intended abdominal environment—creating heightened risk for migration, failure or early absorption. [2]
Patients with DuraSorb mesh implanted in breast surgeries have subsequently reported complications including implant sagging, pain, inflammation and revision procedures—a basis for a potential DuraSorb lawsuit.
Latest DuraSorb Litigation Updates
- October 9, 2025 – Reports surfaced of increasing investigation into breast mesh devices like DuraSorb and GalaFLEX for high revision rates in breast reconstruction cases. [3]
- November 13, 2023 – The FDA issued a formal warning statement clarifying that no surgical mesh is approved for breast reconstruction or augmentation. [1]
- February 23, 2021 – The first U.S. patient was enrolled in an investigational study tying DuraSorb mesh directly to breast reconstruction use—despite the lack of full long-term safety data. [4]
Product & Usage Overview
DuraSorb® is a polydioxanone (PDO) monofilament resorbable surgical mesh manufactured by Surgical Innovation Associates (SIA) and later acquired by Integra LifeSciences. [5]
While cleared for general soft tissue reinforcement, it does not carry explicit FDA approval for breast implant-based reconstruction. [2]
Plastic surgeons adopted DuraSorb in implant-based cases as an “internal sling” or mesh support under the assumption of safe resorption—but early data and regulatory commentary suggest those assumptions may have been premature.
Injuries & Side Effects
Among the complications cited by patients with DuraSorb in breast surgery contexts are:
– Seroma or fluid accumulation that remains unresolved
– Implant malposition, sagging or asymmetry due to mesh support failure
– Mesh bunching, migration or early resorption before tissue reinforcement is complete
– Infection, chronic pain, rippling or need for explantation or revision surgery
– Hardening of the reconstruction area, difficulty in imaging and aesthetic dissatisfaction
These events frequently lead to additional surgeries, prolonged recovery and emotional hardship.
Do You Qualify for a DuraSorb Lawsuit?
You may be eligible if you:
– Underwent breast reconstruction, augmentation or revision where DuraSorb mesh (monofilament PDO) or similar absorbable mesh was used
– Experienced documented complications such as revision/explantation, pain, implant loss, infection or deformity
– Possess operative notes, implant records or explantation documentation identifying mesh brand or type
– Are within the statute of limitations period for your state’s medical-device injury claims
Evidence You’ll Need
To support a DuraSorb lawsuit you’ll want to collect:
– Surgical notes indicating DuraSorb or PDO mesh implantation
– Explantation or revision procedure records and pathology reports
– Imaging studies, photos or surgeon reports showing mesh migration or implant failure
– Medical bills and therapy records related to the complication
– Surgeon or clinic communications referencing mesh use or any provided “internal bra” support
Damages You Can Recover
Principally, you could recover:
– Past and future medical expenses including mesh removal, revision surgeries and rehabilitation
– Lost wages, diminished earning capacity or limitation of normal activities
– Compensation for pain and suffering, disfigurement, and emotional distress
– Wrongful death damages in the rare instance of fatal complications
– Punitive damages if it’s shown that the manufacturer marketed the product for a use it knew was unsupported
Legal Grounds & Liability Theories
Possible legal claims include:
– Defective design – DuraSorb was never developed for breast implant settings and may degrade prematurely in that environment
– Failure to warn – Patients and doctors were not adequately informed about off-label use, lack of approval and scarcity of long-term data
– Negligent marketing – Promoting mesh as internal-bra support despite insufficient clinical evidence
– Strict liability – Asserting DuraSorb caused injury even when used as intended in breast-related surgeries
With allegations centered around off-label use and technical failure in a unique anatomical region, the DuraSorb lawsuit base is clear.
Statute of Limitations & Timing
The statute of limitations for medical device claims varies, generally one to three years from the date of injury discovery or surgery revision. Because mesh-related complications might emerge years later, contacting a lawyer early is essential to secure evidence and meet deadlines for a DuraSorb lawsuit.
Frequently Asked Questions
- Was DuraSorb approved for breast reconstruction? – No. While cleared for soft-tissue use, no mesh including DuraSorb has explicit FDA approval for breast reconstruction or augmentation. [2]
- Can I file a lawsuit if I haven’t had revision surgery yet? – Yes. If you have documented complications, ongoing pain or deformity tied to mesh use, you may still have a claim.
- Are there class actions for DuraSorb? – Litigation remains in early phases; individualized claims may precede a consolidated mass-tort for DuraSorb and similar mesh products.
- Is the mesh being recalled? – Not at this time, but regulatory warnings and off-label use investigations support the DuraSorb lawsuit potential.
Why Act Now
If you received DuraSorb mesh and suffered complications like implant failure, chronic pain or revision surgery, you should seek legal guidance now. Acting promptly increases the likelihood of preservation of surgical records, helps protect your rights and positions you to pursue a DuraSorb lawsuit.
Because the use of DuraSorb and similar internal-bra meshes is under growing legal scrutiny, now may be the time to hold responsible parties accountable—and seek compensation for the harm caused.
Related Articles:
References
- https://www.medtechdive.com/news/fda-bd-surgical-mesh-breast-surgery/699538/
- https://pubmed.ncbi.nlm.nih.gov/36427930/
- https://www.aboutlawsuits.com/breast-mesh-lawsuit/
- https://www.biospace.com/first-us-patient-implanted-in-pivotal-ide-study-of-durasorb-monofilament-mesh-use-in-prosthetic-breast-reconstruction/
- https://investor.integralife.com/news-releases/news-release-details/integra-lifesciences-announces-definitive-agreement-acquire-0