AlloMax Lawsuit

Investigating AlloMax Breast Reconstruction Lawsuits

Investigations into AlloMax breast reconstruction lawsuits are part of broader litigation involving biologic and synthetic mesh used in breast procedures, including breast reconstruction surgery and internal bra surgery.

These cases examine whether certain breast mesh products were associated with higher complication rates, and whether patients were adequately warned about known risks before implantation.

In March 2021, the FDA issued a safety communication indicating that AlloMax showed higher complication rates in breast procedures compared to some alternatives, reinforcing concerns raised by patients and clinicians.

The FDA has also stated that it has not approved any surgical mesh products specifically for use in breast surgery, including breast augmentation and reconstruction, even though these products have been marketed and used for those purposes.

AlloMax litigation remains active, while some other mesh manufacturers involved in breast mesh lawsuits have reached settlements.

Legal investigations continue to focus on how mesh products were designed, tested, and promoted for off-label use in breast surgeries, particularly where patients later experienced severe breast pain, chronic pain, infection, or loss of breast implants.

Complications such as infection and implant loss have been reported at higher rates in some patients who received breast mesh implants compared to those who did not, prompting further scrutiny of product performance and warnings.

Breast mesh lawsuits, including those involving AlloMax, commonly allege that manufacturers failed to warn surgeons and patients about the risks associated with mesh use in breast surgeries and overstated the benefits of these products in marketing materials.

Lawsuits involving AlloMax are filed by patients who underwent breast reconstruction, augmentation, or revision surgeries using the product and later required additional treatment.

Common allegations raised in breast mesh lawsuits include:

• Failure to adequately warn about risks associated with using biologic and synthetic mesh in breast procedures
• Defective design that interfered with proper integration into surrounding tissue
• Increased risk of chronic pain and severe breast pain following implantation
• Higher rates of infection, implant loss, or revision surgery after breast reconstruction surgery
• Mesh migration or breakdown that compromised breast implants or surgical outcomes
• Marketing mesh products for internal bra surgery and other breast applications without FDA approval for those uses

Many individuals who underwent breast surgeries involving mesh report serious complications that may qualify them for a breast mesh lawsuit.

Victims of AlloMax-related complications often seek compensation for medical expenses, lost wages, pain and suffering, and permanent disfigurement.

The potential value of breast mesh lawsuits is still being determined, as the litigation remains in relatively early stages and no global settlements involving AlloMax have been reached to date.

What Is AlloMax?

AlloMax is a surgical mesh made from donated human skin tissue that has been processed to remove living cells, leaving behind a collagen framework.

This type of material is known as an acellular dermal matrix, or ADM. In breast reconstruction surgery, plastic surgeons may use AlloMax to help support breast tissue, reinforce the implant pocket, or stabilize a tissue expander after a mastectomy.

It is sometimes described to patients as part of an “internal bra” approach, where the mesh is stitched inside the body to provide added structural support during healing.

AlloMax has been manufactured and sold by C. R. Bard and its subsidiaries, which are now part of Becton, Dickinson and Company, commonly referred to as BD.

In lawsuits involving AlloMax, BD is typically named as the defendant.

The product was marketed to health care providers for use in a variety of soft-tissue repair procedures, including breast reconstruction, even though the FDA has not approved any surgical mesh products specifically for use in breast surgery, including breast augmentation or reconstruction.

From a patient perspective, AlloMax is intended to integrate with the body’s tissue over time. When that process does not occur as expected, complications can follow.

Some patients report infection, wound healing problems, or implant failure that requires additional surgery to remove or replace a breast implant or tissue expander.

These outcomes are a key focus of AlloMax lawsuits, which examine how the product was designed, how it was marketed to plastic surgeons, and whether patients were adequately warned about known risks associated with its use in breast reconstruction surgery.

How AlloMax Is Used in Breast Reconstruction and Internal Bra Procedures

In breast reconstructive surgery, AlloMax may be implanted to help stabilize a tissue expander or breast implant following mastectomy.

Plastic surgeons sometimes use it as part of an internal bra technique, where the material is sutured inside the body and intended to support tissue during the healing process.

AlloMax is one of several surgical mesh devices classified as medical devices that are placed in direct contact with breast tissue and implants.

Similar techniques may also be used in revision procedures or in combination with breast lift surgery to reinforce the lower portion of the breast.

AlloMax is typically used in the following ways:

• Secured to the chest wall or muscle to help position a tissue expander or implant
• Placed along the lower pole of the breast to provide internal support
• Used to reinforce weakened tissue during revision or reconstructive procedures
• Implanted alongside other surgical mesh devices during complex breast surgeries

Potential Injuries Linked to Breast Mesh and Acellular Dermal Matrices

Breast mesh complications can develop when implanted material does not incorporate into the body as expected or when healing is disrupted by inflammation, fluid, or bacterial contamination.

In breast reconstruction and support procedures, internal bra mesh complications may begin with persistent swelling, abnormal firmness, or pain that does not track with normal recovery.

Biologic meshes, including acellular dermal matrices, are designed to act as a scaffold for tissue in-growth, but outcomes can vary based on patient factors, surgical technique, and post-operative events.

When complications occur, infection is one of the most serious problems because it can compromise the surgical site and threaten the implant pocket.

Ongoing inflammation and wound problems can also drive scar tissue formation that tightens or distorts the reconstructed breast, sometimes changing implant position and appearance.

Some patients experience tissue damage from impaired blood flow, pressure on thin skin flaps, or breakdown of the wound edge.

In severe cases, tissue death can develop, including necrosis of skin or deeper tissue, which may require debridement and additional operations.

If the implant becomes exposed, contaminated, or unstable, surgeons may recommend implant removal as part of infection control or reconstruction salvage.

Possible injuries and complications reported in connection with breast mesh and acellular dermal matrices include:

• Surgical site infection, including deep infection involving the implant pocket
• Necrosis and other forms of tissue death affecting skin flaps or underlying tissue
• Tissue damage from poor perfusion, wound breakdown, or implant pressure
• Chronic seroma or persistent fluid collections requiring aspiration or drains
• Hematoma or bleeding that requires surgical evacuation
• Wound dehiscence, delayed healing, or incision separation
• Implant exposure, implant contamination, or implant rupture secondary to complications
• Implant malposition, asymmetry, or deformity related to poor support or scar contracture
• Capsular contracture and painful scar tissue formation around the implant
• Chronic pain, burning pain, or hypersensitivity at the surgical site
• Mesh migration, folding, or bunching that changes breast contour
• Mesh failure, including loss of structural support or breakdown of the implanted material
• Need for revision surgery, repeated washouts, or staged reconstruction changes
• Explantation, including implant removal and delayed re-implantation
• Permanent scarring, contour defects, or disfigurement following complications

Not every complication proves a product-related claim, and many outcomes depend on individual medical factors and surgical circumstances.

In an internal bra lawsuit, the focus is usually on documentation: operative notes, product identification, post-operative complications, and the treatment required to address infection, necrosis, or implant removal.

This medical record timeline often drives how breast mesh complications and internal bra mesh complications are evaluated.

FDA Communications on Breast Mesh and Acellular Dermal Matrices

FDA communications on breast mesh and acellular dermal matrices matter because many internal bra mesh products are used in breast reconstruction even when the FDA has not cleared or approved surgical mesh specifically for breast surgery.

The agency has issued device safety messaging warning that complication rates can vary by ADM product in implant-based reconstruction, and it has also required labeling updates for certain BD mesh products used in breast procedures.

The items below are the core FDA communications and FDA-hosted patient guidance that come up most often when evaluating breast mesh and ADM claims:

• March 31, 2021: FDA Safety Communication (public notice) on ADM complication-rate differences in implant-based breast reconstruction: In 2021, the FDA warned about differing complication rates among acellular dermal matrix (ADM) products used in implant-based breast reconstruction.
• March 31, 2021: “FDA In Brief” summary of the same Safety Communication: This FDA newsroom post summarizes the safety communication and reiterates that the notice was directed to patients, caregivers, and health care providers regarding higher chances of complications with certain ADM products.
• April 2021: FDA email/bulletin distribution of the Safety Communication (GovDelivery bulletin): FDA-distributed bulletin reiterating the Safety Communication language that certain ADM products used in implant-based breast reconstruction may have a higher chance for complications or problems.
• Letter to Health Care Providers: Labeling Updates for BD Mesh Products: FDA letter stating that the safety and effectiveness of surgical mesh in breast surgery, including augmentation and reconstruction, has not been determined by the FDA, and referencing labeling updates for BD mesh products.
• FDA patient guidance page: “Breast Implant Surgery” (includes “Surgical Mesh and Breast Surgery” section): FDA patient-facing guidance explaining what surgical mesh is, including that some meshes are human- or animal-derived ADMs, and directing patients to discuss mesh risks and alternatives with their surgeon.

In 2023, the FDA issued a letter stating that although it is aware of increased mesh use in breast surgeries, no surgical mesh is cleared or approved for breast augmentation or reconstruction.

Do You Qualify for a Breast Mesh Lawsuit?

Breast mesh lawsuits are evaluated individually, and any settlement amount, if one is reached, depends on the strength of the evidence, the severity of the injuries, and the overall impact on the individual’s health and livelihood.

Many qualifying cases involve mesh used during breast augmentation, breast lift procedures, implant-based breast reconstruction, or revision surgeries where additional support was added beneath the breast tissue.

Eligibility often turns on whether the patient experienced complications that required additional treatment, revision surgery, or implant removal after mesh placement.

Product identification is a core issue, and patients can often confirm which mesh they received by reviewing surgery records for device stickers, a Unique Device Identifier (UDI), and the device lot number.

If those details are missing from the paperwork you have, hospitals and surgical centers typically maintain operative reports and implant logs that can be requested.

Consulting with a licensed attorney can clarify whether the medical timeline and records support an internal bra lawsuit based on the specific mesh and complications involved.

Timely action matters because statutes of limitations vary by state, commonly running two to four years from the injury or from when the problem was discovered.

A case review usually focuses on documented complications, the surgical course, and whether the post-operative outcome deviated from what would be expected in routine recovery.

Gathering Evidence for an AlloMax Breast Mesh Lawsuit

Strong evidence is essential in a breast mesh lawsuit because it documents exactly which product was used and how your injuries developed over time.

Medical records, imaging, and operative notes help establish a clear connection between the mesh and the complications you experienced.

To start an internal bra mesh claim, you typically need proof that you received a breast mesh implant, proof of your injuries, and documentation showing the damages you suffered.

A well-supported breast mesh claim is built on records that identify the product, capture the complication timeline, and show what treatment and losses followed.

Evidence in these cases may include:

• Operative report and surgical notes describing where the mesh was placed and how it was secured
• Implant log, device stickers, and any Unique Device Identifier (UDI) information tied to AlloMax
• Device lot number, catalog number, and manufacturer information from the facility record
• Post-operative visit notes documenting symptoms, wound issues, or changes in breast shape or pain levels
• Imaging records when relevant, such as ultrasound, MRI, or CT scans used to evaluate fluid collections or implant problems
• Lab results and culture reports if infection was suspected or confirmed
• Hospitalization records, IV antibiotic records, and wound care documentation
• Records of revision surgery, washouts, debridement, implant exchange, or implant removal
• Photographs of wound breakdown, tissue loss, or visible complications when available
• Itemized medical bills and insurance statements showing treatment costs
• Employment records showing lost wages or time off work due to complications and recovery
• A written timeline of symptoms and treatment milestones to align with the medical chart

Potential Damages in Breast Mesh Lawsuits

Damages are the legally recognized losses a person claims after an injury, and they can include both financial costs and the broader impact the complications had on daily life.

In breast mesh lawsuits, damages often reflect the real-world consequences of additional surgeries, extended recovery, and permanent changes to the body.

Breast mesh lawyers review medical records, billing statements, employment documentation, and the treatment timeline to assess what costs have already occurred and what care may be needed going forward.

They also evaluate non-economic harm, including chronic pain, scarring, and emotional distress tied to disfigurement, repeated procedures, or loss of reconstruction outcomes.

The goal is to document damages in a way that is specific, provable, and consistent with the individual’s medical course.

Damages in these cases may include:

• Past medical expenses related to complications, including hospital care, antibiotics, and wound treatment
• Future medical expenses, including revision surgery, reconstruction planning, and follow-up care
• Costs of implant removal, implant exchange, or staged reconstruction after failure or infection
• Lost wages and reduced earning capacity from time away from work or long-term limitations
• Physical pain, including chronic pain and ongoing sensitivity at the surgical site
• Emotional distress related to disfigurement, loss of reconstruction progress, or repeat surgeries
• Scarring, tissue loss, and permanent disfigurement
• Out-of-pocket costs such as travel for specialty care, prescriptions, and medical supplies
• Loss of enjoyment of life due to limitations, ongoing symptoms, or persistent complications

TorHoerman Law: Investigating Lawsuits Related to Breast Mesh Implants

Breast mesh implant claims often come down to documentation, a clear medical timeline, and proof of which product was implanted.

When complications lead to infection, tissue loss, revision surgery, or implant removal, the consequences are not theoretical, they show up in operative notes, hospital records, and long-term treatment plans.

TorHoerman Law is investigating breast mesh implant lawsuits involving products used in reconstruction, augmentation, revision, and internal bra procedures, including cases where patients report serious complications after mesh placement.

If you believe a breast mesh implant contributed to your injuries, TorHoerman Law can review your surgical records, complication history, and damages to determine whether the evidence supports a claim.

Contact TorHoerman Law to request a case review and learn whether your situation may qualify for legal action.