Published by If you underwent breast reconstruction, augmentation, or revision surgery using AlloMax acellular dermal matrix (ADM) and experienced serious complications like infection, implant failure, or multiple revision surgeries, you may have a potential claim.
Our experienced medical device litigation team offers a free, no-obligation review of your case—no fees unless we recover compensation for you.
Table Of Contents
What’s the Problem?
AlloMax is a human-derived acellular dermal matrix manufactured by C.R. Bard (now a part of Becton Dickinson) and cleared for certain soft-tissue and hernia repair applications. Though it has been used off-label in breast reconstruction procedures as an “internal bra” support material, the FDA has made clear that no mesh products—including ADM—are cleared or approved for breast augmentation or reconstruction [1][2].
In March 2021, the FDA issued a safety communication stating that certain ADM products, including FlexHD and AlloMax, were associated with higher complication rates—such as implant removal, reoperation and infection—when used in implant-based breast reconstruction [3]. These findings highlight the basis for potential claims regarding AlloMax mesh complications in breast surgery.
Latest AlloMax Litigation Updates
- March 31, 2021 – FDA issued a Safety Communication stating that ADM products including AlloMax, when used in breast reconstruction, showed significantly higher risks of explantation, reoperation, and infection compared to other reconstruction techniques [3].
- October 15, 2025 – Legal reporting noted that breast mesh devices like AlloMax remain in investigation and may trigger future coordinated litigation efforts as more patients come forward [4].
- November 13, 2023 – The FDA reiterated that no surgical mesh products are cleared for breast surgery and urged surgeons and patients to carefully consider mesh use in breast reconstruction [2].
Product & Off-Label Usage
AlloMax ADM is processed human donor skin stripped of cells to create a collagen scaffold intended for reinforcement of soft tissues. Its FDA clearance covers use in soft-tissue repair but not breast reconstruction or cosmetic breast procedures.
Despite this, some surgeons use AlloMax in implant-based breast reconstruction, describing its placement beneath or around implants for improved support, calling it an “internal brace” or “hammock.”
Because the breast is not the tissue environment for which AlloMax was evaluated—especially with respect to implant weight, motion, and hormonal changes—the mesh may behave differently, creating risks that are now becoming more evident [3][4].
Reported Injuries & Side Effects
Patients implanted with AlloMax mesh in the breast context have faced complications such as:
– Infection or abscess formation necessitating surgical intervention
– Implant loss, need for explantation or reconstructive revision
– Seroma or persistent fluid accumulation under the implant pocket
– Mesh bunching, migration, detachment or observable deformity
– Skin necrosis, tissue breakdown, chronic pain or nerve damage
– Multiple surgeries, extended recovery, cosmetic and emotional consequences
Each of these documented outcomes reflects the kind of harm prompting investigation into mesh use in breast surgery and forms the basis of potential legal action provided the mesh product and procedure identify as AlloMax.
Am I Eligible for a Claim Involving AlloMax?
You may have legal standing if you:
– Underwent breast reconstruction, augmentation, lift, or revision surgery in which AlloMax mesh was used
– Experienced complications such as infection, implant failure, sagging, revision surgery, chronic pain or deformity
– Possess medical records or operative notes identifying AlloMax or ADM use
– Are within the statute of limitations for your state regarding medical device or product liability claims
Evidence You Should Gather
Essential documentation includes:
– Surgical reports citing “AlloMax,” “ADM,” or “acellular dermal matrix” as implant material
– Medical or pathology records related to explantation or revision surgery
– Imaging or photographs showing mesh or implant complications (migration, distortion, infection)
– Treatment bills, recovery history, physical therapy records
– Informed consent forms or surgeon communication referencing mesh use and potential risks
Possible Compensation and Damages
What injured patients may recover in a claim:
– Medical costs for mesh removal, reconstructive surgery, hospital stays, and therapy
– Lost income or reduced earning potential due to recovery or impairment
– Compensation for pain, suffering, emotional distress, disfigurement or loss of normal life activities
– If manufacturer misconduct is shown, potential punitive or exemplary damages
Because claims involving AlloMax mesh are in investigational phases, damage amounts will vary depending on severity and need for ongoing treatment.
Legal Theories & Grounds for Claims
Claims tied to AlloMax mesh may include:
– Defective design: AlloMax was neither tested nor cleared for breast implant reinforcement and may fail prematurely
– Failure to warn: Surgeons and patients were not adequately informed that the product was used off-label and associated with heightened complications [3]
– Negligent marketing: The mesh was promoted or distributed for breast reconstruction despite lacking approval and long-term safety data
– Strict product liability: If the mesh caused injury through reasonably foreseeable use, the manufacturer may be liable
While no verified AlloMax-specific class action is publicly reported, the data published by FDA and medical literature indicate substantial risk and compound the case for individual claims.
Statute of Limitations & Filing Timeline
Health-device claims vary across jurisdictions, typically allowing one to three years from date of injury knowledge or surgical revision. Because ADM mesh complications may emerge slowly—sometimes years after implantation—early legal review is advisable to avoid missing filing windows.
Frequently Asked Questions
- Was AlloMax approved for breast reconstruction? No. The FDA has stated no mesh or ADM product is cleared for breast surgery.
- Is a class action filed for AlloMax mesh in breasts? Not to date. While ADM mesh cases are under review, a targeted AlloMax class action has not been publicly filed.
- Do I need to have had revision surgery to participate? Not necessarily. Documented complications linked to mesh use may suffice for a claim.
- Does this apply only to reconstruction after a mastectomy? No. The same mesh is used in augmentation, lift and revision cases; any use of AlloMax in breast procedures may be eligible for review.
Next Steps
If you received AlloMax mesh in a breast procedure and suffered complications like implant failure, infections, revision surgeries, or deformity, consider requesting a free consultation with a lawyer experienced in medical device litigation. Early legal evaluation ensures preservation of records, timely evidence gathering and a stronger position to pursue compensation.
Legal investigations into internal-bra mesh use—including AlloMax—are underway. Don’t delay your opportunity to explore your rights and potential recovery.
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References
- https://www.fda.gov/news-events/fda-brief/fda-warns-about-differing-complication-rates-acellular-dermal-matrix-type-surgical-mesh
- https://www.medtechdive.com/news/fda-bd-surgical-mesh-breast-surgery/699538/
- https://www.yourlawyer.com/defective-products/allomax-lawsuits/
- https://www.aboutlawsuits.com/breast-mesh-problem-prompted-fda-warnings-off-label-use/