Published by If you underwent breast reconstruction, augmentation, lift or revision surgery and received SurgiMend mesh—then experienced chronic complications such as infection, implant failure or revision surgery—you may have a potential claim.
Contact our experienced product liability team today for a free, no-obligation evaluation of your rights.
Table Of Contents
What’s the Problem?
SurgiMend is an acellular dermal matrix (ADM) derived from bovine (cow) tissue manufactured by Integra LifeSciences and cleared for soft-tissue reinforcement (such as abdominal wall repair) but not specifically approved for breast augmentation or reconstruction.
Recent regulatory and medical-journal activity indicates that ADMs when used off-label in breast surgeries may carry higher complication rates than previously recognized—even though SurgiMend is sometimes viewed as offering fewer complications than other brands.
For example, the U.S. Food and Drug Administration released a safety communication stating that certain ADM products used in implant-based breast reconstruction were associated with more frequent implant removal, infection or reoperation.
Although we are not aware of a publicly filed, SurgiMend-specific lawsuit focused solely on “internal bra” breast uses, SurgiMend is listed among ADM brands being evaluated in the broader “internal bra mesh” investigation.
Latest Updates
- March 31, 2021 – FDA issues safety communication revealing significantly higher complication rates for ADM mesh used in breast reconstruction, including SurgiMend among the brands referenced [1].
- November 13, 2023 – FDA reminds surgeons and patients that no surgical mesh is cleared or approved for use in breast augmentation or reconstruction [3].
- October 9, 2025 – Legal commentary reports that claims involving internal-bra mesh implants—including SurgiMend—are being gathered and investigated for product-liability cases [4].
Product & Usage Overview
SurgiMend is composed of bovine dermis processed into a biologic scaffold designed to support tissue healing and remodeling. It is cleared by the FDA for general soft-tissue repair but has not been cleared for breast implantation, lift or augmentation.
In breast procedures, surgeons use SurgiMend off-label—positions under or around implants or reinforced tissue zones—marketing it as an “internal bra” or “mesh sling” to provide enhanced support. However, breast tissue presents a unique biomechanical and hormonal environment.
Products like SurgiMend were not originally tested for these stresses: movement, implant weight, stretch, hormonal fluctuations and post-surgical dynamics in breast reconstruction differ substantially from abdominal or chest wall use.
Injuries & Side Effects
Patients who received ADM mesh including SurgiMend in breast surgery contexts may experience:
– Infection or abscess requiring mesh/implant removal and antibiotics
– Seroma or persistent fluid collection around implant or mesh pocket
– Implant malposition, sagging (“bottoming out”) or asymmetry due to mesh failure
– Mesh bunching, detachment, migration or early resorption leading to compromised support
– Skin or tissue necrosis, chronic pain or nerve injury at the mesh/implant interface
– Explantation or reconstructive revision with extended recovery, scarring and emotional distress
These problems highlight the type of harm being reviewed in internal-bra mesh investigations.
Do You Qualify for a Claim?
You may qualify if you:
– Underwent breast reconstruction, augmentation, lift or revision surgery involving SurgiMend mesh
– Experienced complications such as infection, implant loss, revision or explantation surgery, sagging, tissue breakdown or chronic pain
– Have medical records indicating SurgiMend mesh use or surgeon notes identifying “bovine dermal matrix,” “ADM,” or “internal bra mesh”
– Are within the statute of limitations in your state for medical device or product liability claims
Evidence Required for a Claim
Gathering evidence strengthens your position:
– Surgical records naming SurgiMend or bovine ADM mesh
– Pathology or explantation records confirming mesh removal or revision and reason
– Imaging, photographs or surgeon reports showing mesh failure, implant shift or deformity
– Medical billing records and treatment history documenting your complications
– Surgeon or clinic communications, and consent forms discussing mesh use in your procedure
Damages You Can Recover
Possible recoveries may include:
– Medical expenses for mesh/implant removal, revision surgery, reconstruction, long-term care
– Lost wages or diminished earning capacity due to recovery or ongoing complications
– Compensation for pain, suffering, emotional distress, scarring or disfigurement
– Cost of future corrective surgeries or implants
– Punitive damages in jurisdictions that permit them if misconduct is shown
Legal Theories & Grounds for Liability
Legal claims may include:
– Defective design – SurgiMend was not designed or tested for breast implant support and may prematurely fail
– Failure to warn – Doctors and patients may not have been adequately informed that SurgiMend use in breast reconstruction was off-label and associated with increased risk [1]
– Negligent marketing – The mesh was distributed and used in breast settings without rigorous safety data or FDA clearance
– Strict liability – SurgiMend caused injury or failure when used in a foreseeable manner
Even though no discrete lawsuit has been publicly reported with SurgiMend only, it is included in the larger internal-bra mesh investigations and may form part of consolidated litigation in the future.
Statute of Limitations & Timing
Statute-of-limitations deadlines vary by state, commonly between one to three years from when you discovered or should have discovered your injury. Because mesh complications can surface months or years after surgery, prompt consultation is important to protect your rights.
Frequently Asked Questions
- Was SurgiMend approved for breast implants or cosmetic procedures? – No. SurgiMend is cleared for soft-tissue repair but the FDA has stated no mesh device is approved for breast reconstruction or augmentation [3].
- Do I need revision surgery to file a claim? – Not necessarily. If you experienced documented complications tied to the mesh, you may still have a claim without full explantation.
- Will this become a class action? – Potentially. While no public class action is yet filed for SurgiMend specifically, internal-bra mesh cases including SurgiMend are being investigated and may consolidate if filing volumes increase [4].
Why You Should Act Now
If you received SurgiMend mesh in a breast-related procedure and suffered complications such as infection, revision surgery, implant failure or chronic pain, consider consulting a qualified attorney now. Early action helps preserve records, identify mesh brand usage, track surgical notes and assemble evidence for a potential claim.
These mesh products were marketed as innovative support solutions but used in ways that lacked approval and long-term safety data. If you believe SurgiMend played a role in your complications, you may be in a position to seek compensation for your injuries and losses.
References
- https://www.fda.gov/news-events/fda-brief/fda-warns-about-differing-complication-rates-acellular-dermal-matrix-type-surgical-mesh
- https://www.aboutlawsuits.com/breast-mesh-lawsuit/
- https://www.medtechdive.com/news/fda-bd-surgical-mesh-breast-surgery/699538/
- https://www.aboutlawsuits.com/breast-mesh-lawsuits-may-follow-studies-linking-internal-bra-implants-to-complications/