Breast Mesh Lawsuit [2025 Update]

What Is Breast Mesh?

Breast mesh refers to a category of surgical devices that health care providers use in breast surgery to reinforce weakened areas, provide general soft tissue support, or stabilize the breast shape after reconstruction or cosmetic enhancement.

Breast mesh implants are placed inside the chest to create a supportive scaffold that integrates with natural tissue over time.

In breast lift surgery, the material is often positioned to provide additional internal support, especially for patients with thin skin or a history of significant sagging.

Breast reconstruction surgery may involve mesh to help hold an implant in place or to replace missing structural support after mastectomy.

Internal bra procedures use similar techniques, placing mesh beneath the breast to create a long-term internal sling intended to reduce recurrent sagging or implant malposition.

Surgeons have relied on several types of mesh in these operations, including synthetic mesh use in aesthetic procedures and biologic mesh options in medically necessary reconstruction.

Synthetic mesh is typically made from resorbable polymers that dissolve slowly as the body forms new connective tissue.

Biologic mesh is created from processed human or animal tissue and is designed to integrate more naturally into the surrounding anatomy.

Both materials are marketed to enhance durability and prevent complications related to weak support tissue, yet many patients report outcomes that differ significantly from what they were told to expect.

How Breast Mesh Works in Cosmetic and Reconstructive Surgery

Breast mesh is implanted beneath the skin and soft tissue to act as an internal support structure during cosmetic and reconstructive breast surgeries.

Surgeons use these mesh devices to reinforce weakened areas, stabilize breast implants, and improve aesthetic outcomes when tissue alone cannot provide adequate support.

In breast reconstructive surgery, the material helps create or maintain the implant pocket, especially for patients who have lost significant tissue after mastectomy.

Mesh is also used in other breast surgeries, including complex revisions where prior procedures have compromised natural tissue strength.

Both synthetic and biologic options are designed to integrate with the body.

The intended purpose is long-term reinforcement, though performance varies widely among patients.

Common ways mesh is used in cosmetic and reconstructive settings include:

• Creating internal support for breast implants during augmentation or revision
• Reinforcing weakened tissue in lift procedures
• Providing structural stability during reconstruction after mastectomy
• Maintaining breast shape in patients with poor soft-tissue quality
• Supporting implant position to reduce malposition or recurrent sagging

Types of Breast Mesh Used in Surgery

Surgeons rely on two primary categories of materials when using surgical mesh in breast procedures: biologic mesh and synthetic mesh.

These products are designed to reinforce weakened areas, improve implant stability, and provide long-term structural support in cosmetic and reconstructive operations.

Biologic mesh is derived from processed human or animal tissue and is engineered to integrate with the body permanently, creating a natural scaffold as new tissue forms.

Synthetic mesh, by contrast, is typically made from bioresorbable polymers that dissolve over time, allowing the body to replace the mesh with its own collagen while still offering significant early strength.

Mesh use in breast surgeries varies depending on the patient’s anatomy, the surgeon’s technique, and whether the goal is reconstruction, augmentation, or revision, but both biologic and synthetic mesh options are common across these applications.

Because each material behaves differently once implanted, understanding the distinction between them is essential when evaluating outcomes, complications, or potential product issues.

FDA Status and Safety Concerns Surrounding Breast Mesh Products

The FDA warns that no surgical mesh products have been approved by the FDA specifically for use in breast surgery, including breast augmentation and implant-based reconstruction.

In recent communications to health care providers, the agency stated that the safety and effectiveness of surgical mesh in breast surgery has not been determined, despite growing off-label use in reconstruction and mastopexy procedures.

In 2021, the FDA warns about differing complication rates among acellular dermal matrix (ADM) products used in implant-based breast reconstruction.

The agency’s analysis suggested that certain ADMs, particularly FlexHD and AlloMax, may have a higher chance of major complications, explantation, reoperation, and infection compared with some other ADMs or with no ADM use at all.

This safety communication made clear that different mesh products do not all perform the same way and that risk profiles can vary significantly by brand.

In 2023, the FDA issued a letter tied to labeling updates for several BD mesh products (including Phasix and GalaFLEX) used for soft-tissue reinforcement.

In that letter, FDA warns that, although it is aware of increased mesh use in breast surgeries, no surgical mesh is cleared or approved for breast augmentation or reconstruction, and the benefit-risk profile in this setting remains undefined.

BD was required to update warnings and precautions to better reflect these uncertainties and potential risks when mesh is placed in the breast.

Across these communications, regulators repeatedly connect breast mesh to higher rates of complications and mesh failure in some patients, including infection, implant loss, repeat operations, and reconstruction breakdown.

While the FDA is not currently recommending automatic removal of mesh in patients without symptoms, the agency stresses that surgeons and patients should have clear discussions about the off-label nature of mesh use in breast surgeries, the lack of breast-specific approvals, and the known risk of serious adverse outcomes when these devices fail.

Breast Mesh Manufacturers Under Review

Surgical mesh brands used in breast procedures are now under heightened scrutiny because of increased reports of serious complications tied to off-label use in breast reconstruction and augmentation.

One of the most prominent companies under review is Becton Dickinson and Company (BD), whose mesh products have been explicitly flagged by the Food and Drug Administration for unclear safety and effectiveness in breast tissue.

The agency reminded health care providers that BD’s mesh devices, although cleared for soft-tissue repair, are not approved by the FDA for breast surgery, and must carry updated labeling to reflect this fact.

Mesh recipients who received products like BD’s GalaFLEX or Phasix as part of “internal bra” techniques may now face elevated risks because the devices were used in ways not studied or approved.

Another manufacturer under attention is the company behind the acellular dermal matrix brand AlloMax, which the FDA tied to higher complication rates in implant-based breast reconstruction.

These developments reflect broader concerns that using surgical mesh in breast procedures (particularly when manufactured or marketed by specific companies) may involve defective medical devices and undisclosed risks.

Manufacturers under review include:

• Becton Dickinson and Company (BD) – Makers of GalaFLEX, Phasix and other mesh devices; the FDA issued a letter reminding providers that BD’s mesh products are not cleared for breast surgery and labeling was updated accordingly.
• C.R. Bard / BD (via acquisition) – Through its acquisition of Bard, BD inherited products like AlloMax, which the FDA found to have elevated complication rates in breast reconstruction.
• MTF Biologics (FlexHD brand) – The FDA specifically cited FlexHD ADM for higher rates of explantation, infection and reoperation in breast reconstruction patients; it is being reviewed in litigation.
• Allergan / LifeCell (AlloDerm brand) – Although this brand showed comparatively lower complication rates in some studies, it is still under review as part of the broader ADM/mesh category in breast surgery.
• Integra LifeSciences (SurgiMend brand) – One of the ADM products used for breast reconstruction whose outcomes are compared against higher-risk brands; still under investigation for possible mesh-related injuries.
• Other synthetic and biologic mesh device manufacturers – Several smaller or less-publicized companies making mesh devices for soft-tissue reinforcement are being evaluated because their products have been used off-label in breast procedures; the full list may expand as litigation develops.

Breast Mesh and Internal Bra Complications

Breast mesh and internal bra complications have become a growing concern for patients who underwent breast augmentation, lift procedures, or implant-based reconstruction using these materials.

Many individuals expected added support and long-term stability, only to experience painful and unexpected outcomes months or even years after surgery.

Reports increasingly describe complications that disrupt healing, alter breast shape, or interfere with daily movement and comfort.

Some patients face issues severe enough to require medical intervention, including additional surgeries to address damage caused by the implanted mesh.

Complications such as abscess formation, mesh migration, and more can place a significant emotional and physical burden on people who sought cosmetic improvement or reconstructive relief.

As more cases emerge, health care providers and investigators are paying closer attention to the patterns of harm associated with these devices.

The seriousness of these complications is central to the growing wave of breast mesh lawsuits now being reviewed across the country.

Infection and Abscess Formation

Infections surrounding breast mesh or “internal bra” scaffolds can occur when bacteria colonize the implant pocket or mesh surface, sometimes leading to a chronic abscess.

The FDA has flagged higher infection rates in implant-based breast reconstruction with certain acellular dermal matrices (ADMs), a type of surgical mesh.

Once infection establishes a biofilm on the mesh, it becomes difficult to eradicate without explantation of both mesh and implant.

For some patients, the infection manifests as swelling, redness, foul discharge or non-healing wounds weeks or months after surgery.

In reported cases the infection has required hospitalization, IV antibiotics, and surgical debridement or complete implant removal.

One MAUDE adverse event report described a patient hospitalized for an enterococcus faecalis infection linked to a mesh used in breast reconstruction; the patient underwent implant and mesh removal.

Seromas and Chronic Fluid Buildup

Seromas are pockets of clear fluid that build up in the space created after breast surgery, and they can be an especially concerning complication when mesh or an internal bra device is present because the scaffold creates additional dead space or disruption of tissue.

While many seromas after standard breast or reconstructive procedures may resolve on their own, the presence of mesh can delay reabsorption, lead to persistent fluid collections, and may require repeated drainages or surgical interventions.

Persistent seromas increase the risk of infection, delayed healing, and may transform into chronic fluid cavities encapsulated by scar tissue.

In breast reconstruction and cosmetic breast procedures using mesh, this risk is compounded because mesh use in breast surgeries often involves greater dissection, more foreign material, and a longer healing trajectory.

One study noted that mesh-assisted internal-bra techniques have limited long-term data and that fluid collection (seroma) remains a “known complication” of these newer devices.

Clinically, patients may feel a soft lump under the skin, notice visible swelling or rippling, or experience discomfort or tightness as the fluid presses on surrounding tissues.

Imaging such as ultrasound often shows the well-defined pocket of fluid adjacent to the surgical site.

Because seromas can undermine the intended support function of the mesh and lead to revision surgery, they are a significant factor in the litigation and safety concerns around breast mesh and internal-bra applications.

Hematoma and Postoperative Bleeding

Hematoma and postoperative bleeding are recognized complications following breast surgeries that involve mesh devices or internal bras, and they can significantly undermine surgical outcomes.

In implant-based breast reconstruction with mesh support, a meta-analysis found a hematoma formation rate of approximately 2.5% across several studies.

Bleeding into the surgical pocket may occur because mesh use in breast surgeries creates additional dissection, larger operative fields, and potentially more vascular disruption.

Once a hematoma forms, it can increase pressure on tissues, impair blood flow, impair wound healing, and raise the risk of further complications such as infection or skin necrosis.

Some patients with mesh-assisted breast reconstruction required urgent intervention (such as evacuation of the hematoma or removal of the mesh and implant) to prevent catastrophic tissue loss or reconstructive failure.

The presence of mesh may also make drainage and management of bleeding more complex, since the scaffold can maintain space for accumulation and interfere with collapse of the cavity that would normally facilitate healing.

Delayed Wound Healing and Tissue Necrosis

Delayed wound healing and tissue necrosis are significant complications in breast surgeries that incorporate mesh devices or internal bra techniques.

The presence of a foreign scaffold in the breast pocket may increase surgical site tension and disrupt normal blood supply, making healing slower and more unpredictable.

A 2021 review cited wound-healing disorders with necrosis in the mesh group of breast reconstruction patients.

The use of surgical mesh can amplify risk factors for necrosis because the mesh requires tissue integration and may compress or tether overlying skin flaps, reducing perfusion and oxygenation.

Flap or skin necrosis after mastectomy and reconstruction is already linked to inadequate blood flow, tension, and prior radiation; when mesh is added, those risks can compound.

For patients, this may manifest as darkened or bluish skin, open wounds, delayed closure of the incision, or exposed mesh and implant surfaces requiring urgent surgical management.

Studies show that delayed wound healing in implant-based reconstruction leads to more revision surgeries and worse outcomes than patients without wound issues.

Because tissue necrosis undermines the structural integrity of the reconstruction or augmentation, it also increases the risk of implant loss, mesh exposure, and long-term deformity—key injury pathways in breast mesh lawsuits.

Capsular Contracture and Excessive Scar Formation

Capsular contracture occurs when scar tissue around a breast implant tightens and hardens, causing the breast to feel firm, distorted, and sometimes painful.

Studies have found capsular contracture rates in implant-based breast reconstruction patients range between roughly 15% and 30% when no mesh or scaffold is used.

The use of biologic and synthetic mesh (such as ADM or P4HB scaffolds) in reconstruction and cosmetic procedures was introduced with the intention of reducing this risk by stabilizing the pocket and moderating scar response, but there remains mixed and limited long-term data on their effectiveness.

Even when mesh is used, excessive scar formation may still occur: the foreign material can initiate a heightened inflammatory response, encourage myofibroblast activity, and lead to a thickened, contractile capsule around the implant.

Patients with mesh-assisted internal bra or breast reconstruction may thus still experience scar bands, tightness, implant displacement, or visible distortion despite the intended “support” benefit of the scaffold.

Those requiring revision surgery for capsular contracture often face more complex procedures because the mesh and scar tissue have integrated, making removal or correction more difficult.

Because scar tissue formation and contracture undermine both aesthetic outcomes and functional comfort, they represent a significant pathway for injury claims in cases involving breast mesh.

Mesh Migration, Displacement, and Internal “Cording”

Mesh migration and displacement refer to situations where the breast mesh or scaffold shifts from its intended position, potentially altering breast shape and undermining the support framework.

In breast procedures that use mesh for “internal bra” techniques or implant-based reconstruction, tissue forces, gravity, and mechanical fatigue can cause the mesh to loosen or detach from its fixation points.

A recent narrative review found that implant displacement, bottoming out, and mesh malposition are among the complications reported in mesh-supported breast surgeries.

Some patients describe visible or palpable “cords” or bands beneath the skin.

These internal tethering points may represent scar tissue contracting around the mesh or mesh fibers pulling on breast tissue.

The presence of mesh may amplify the risk of cording because the scaffold creates additional interfaces for scar formation and tissue anchoring, which can act like cables under tension.

When mesh migration or internal cording occur, they frequently lead to revision surgeries, implant repositioning, or complete explantation, making these adverse outcomes a significant concern in litigation.

Mesh Extrusion and Tissue Erosion

Mesh extrusion and tissue erosion describe situations where the mesh or underlying implant becomes exposed through the overlying skin or incision, often after a period of delayed healing or skin thinning.

In implant-based breast reconstruction, reviews of complications list implant exposure as a key adverse outcome, particularly in cases with ischemia, necrosis, or poor-quality skin flaps.

Synthetic and biologic meshes both add a foreign surface under tension; if perfusion to the overlying tissues is compromised by tight closure, radiation, infection, or flap necrosis, those tissues can gradually break down until the mesh or implant is visible at the wound.

Case reports describe implant loss following mesh exposure when Vicryl or titanium-coated polypropylene meshes were used for caudal support, with the exposed construct ultimately requiring removal.

Broader reconstructive literature on internal support materials notes that non-absorbable synthetic meshes are “prone to palpability, erosion, [and] biofilm formation,” reflecting the chronic foreign-body response that can culminate in extrusion.

Once mesh extrusion occurs, the risk of infection and full reconstructive failure rises sharply, and standard management typically involves debridement and explantation of the mesh and often the implant.

Reconstruction Failure and Implant Loss

Reconstruction failure and implant loss occur when postoperative complications become severe enough that the breast implant (and often the mesh) must be removed entirely.

Clinical research on implant-based breast reconstruction using acellular dermal matrix (ADM) routinely identifies implant explantation as a major endpoint, with one prospective study reporting a total explantation rate of 4.90% in direct-to-implant reconstruction, most commonly associated with infection, wound problems, and skin-flap compromise.

The FDA likewise issued a 2021 safety communication showing that certain ADM products (specifically FlexHD and AlloMax) were linked to higher rates of explantation, reoperation, and infection compared with other ADMs or no ADM at all.

Broader reviews of immediate implant-based reconstruction demonstrate that complications such as surgical-site infection, wound dehiscence, and flap necrosis significantly increase the likelihood of reconstructive failure and implant removal.

Infection-specific studies further confirm that persistent or severe infections around an implant or mesh scaffold frequently necessitate full explantation because conservative treatment cannot eliminate bacteria once a biofilm forms on the implant surface.

Chronic Pain, Tightness, and Nerve Symptoms

Persistent pain after breast surgery, including mesh-supported procedures, has been documented in multiple studies, affecting a significant portion of reconstruction patients even years after their operations.

One prospective cohort of 213 women undergoing mastectomy or reconstruction found that pain in the upper breast, axilla and arm persisted at year-1 and year-5, with location differing by surgical method.

A systematic review covering over 26,000 patients revealed chronic pain in about 41.8% of mastectomy-only patients and nearly 49.5% of those who had immediate reconstruction.

Some of this pain is neuropathic in nature, stemming from nerve injury, neuroma formation, or scar-tissue tethering around implants or mesh scaffolds.

For example, a case series of women with breast implants found traumatic neuromas in the implant capsules and complete pain resolution after explantation.

Mesh-assisted breast procedures introduce additional foreign material and surgical dissection, which may heighten the risk of fibrosis, nerve entrapment, or scar contraction leading to tightness, pulling sensations or functional limitation of the arm/chest wall.

Research on post-breast surgery pain syndrome (PBSPS) confirms chest wall, axillary and breast pain can be caused by nerve damage, muscle spasm, and scarring after both oncologic and cosmetic surgeries.

Breast Deformities and Permanent Scarring

Deformities of the breast, such as rippling, contour irregularities, implant malposition, and visible asymmetry, are documented complications in implant-based reconstruction and augmentation when surgical mesh or scaffolds are used.

A recent retrospective cohort of 135 breasts undergoing prepectoral reconstruction found significantly worse aesthetic outcomes in the mesh/ADM group, with higher rates of severe capsular contracture that contributed to shape distortion.

Scar tissue formation is an inherent response to foreign implants and mesh devices, and when healing is compromised or tissue quality is poor, the resulting scars may be wide, thickened, tethered, or visually prominent.

Long-term follow-up studies of acellular dermal matrix (ADM) use in breast reconstruction report elevated revision surgery rates for deformity and undesirable cosmetic outcomes tied to tissue and scaffold integration.

Skin and flap necrosis, mesh exposure, or implant loss all increase the likelihood of permanent scarring and reshaping of the breast mound, leaving patients with results far from the intended aesthetic goal.

Because deformities and scarring often require further corrective surgeries (sometimes multiple) the emotional and functional consequences are substantial.

Revision Surgeries and Long-Term Complications

Revision surgeries are common when breast mesh or internal bra materials fail to integrate properly, cause ongoing pain, or contribute to structural changes in the breast over time.

Patients may undergo multiple corrective procedures to remove mesh remnants, reposition implants, treat chronic inflammation, or address deformities that develop months or years after the initial surgery.

Because mesh interacts directly with breast tissue, scar formation and long-term biomechanical changes can continue well beyond the early healing period, leaving some patients with persistent symptoms or progressive distortion despite prior interventions.

These cumulative complications often result in additional operative risks, higher medical costs, and long-lasting physical and emotional burdens.

Long-term complications can include:

• Chronic breast or chest wall pain
• Recurrent seromas or fluid buildup requiring ongoing intervention
• Persistent inflammation or localized immune reactions
• Progressive capsular contracture
• Implant malposition or recurrent ptosis
• Visible deformities or contour irregularities
• Thick, tethered, or hypertrophic scarring
• Loss of breast volume or asymmetry
• Need for conversion to autologous (tissue-based) reconstruction

Do You Qualify for a Breast Mesh Lawsuit?

You may qualify for a breast mesh lawsuit if you experienced serious complications after a breast procedure that involved mesh or an internal bra device.

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.

Patients often discover they qualify only after obtaining their operative reports, which reveal the specific type of mesh or ADM used during surgery.

You may still have a valid claim even if you were never told that mesh was implanted or were unaware the product was used off-label for breast surgery.

Individuals who developed infections, tissue necrosis, chronic pain, implant loss, deformities, or required revision surgeries are typically strong candidates for legal action.

Claims are also being reviewed for patients who experienced systemic symptoms or progressive complications believed to be linked to the implanted mesh.

Attorneys will evaluate when your symptoms began, how many procedures you underwent, and whether your injuries align with known complications associated with the product.

If you experienced these types of harm, you may be eligible to move forward with a legal claim and seek compensation for the physical, emotional, and financial impact.

Gathering Evidence for a 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.

Without this documentation, it becomes harder to prove that the mesh contributed to infection, tissue damage, or reconstruction failure.

Comprehensive evidence also allows attorneys to build a more accurate timeline of your symptoms, treatments, and long-term impact.

Important evidence includes:

• Operative reports identifying the mesh or ADM used
• Pathology reports, explant records, or surgical notes confirming mesh removal
• Office visit notes detailing complications, pain, or delayed healing
• Imaging studies (ultrasound, MRI, CT) showing fluid buildup, scar tissue, or implant changes
• Hospital records related to infection, necrosis, or emergency treatment
• Photos documenting visible deformities or wound issues
• Records of revision surgeries or implant loss
• Correspondence with your surgeon or clinic regarding complications
• Billing statements and medical expenses related to treatment and revisions

Potential Compensation and Damages in Breast Mesh Lawsuits

Damages represent the physical, emotional, and financial losses a patient experiences because of mesh-related injuries.

A lawyer evaluates medical records, surgical outcomes, long-term complications, and the overall impact on daily life to determine the full scope of these losses.

By analyzing both current and future needs, an attorney can calculate damages that reflect the real cost of treatment, recovery, and ongoing limitations.

This allows them to advocate for maximum compensation based on the severity and lasting effects of the injury.

Potential damages may include:

• Medical bills for initial and corrective surgeries
• Future medical care and long-term treatment needs
• Costs related to mesh or implant removal
• Lost wages or reduced earning capacity
• Pain and suffering
• Emotional distress and psychological harm
• Compensation for scarring or permanent disfigurement
• Loss of enjoyment of life
• Out-of-pocket costs related to travel, caregiving, or specialized care

Breast Mesh Products Named in Lawsuits and Regulatory Notices

Many of the ongoing lawsuits, as well as regulatory notices from the FDA, center on surgical mesh devices that were used off-label in breast procedures (such as implant-based reconstruction, augmentation, or internal-bra techniques) despite lacking formal approval for those uses.

Claims often assert that manufacturers marketed these products for breast surgery without adequate testing, and that patients have suffered serious complications like infection, implant loss, and revision surgeries as a result.

Products named in lawsuits and regulatory notices include:

• GalaFLEX Scaffold (poly-4-hydroxybutyrate (P4HB) synthetic mesh by Becton Dickinson and Company) used for internal-bra and breast lift/augmentation applications.
• Phasix Mesh (P4HB synthetic scaffold by BD): Cited in legal and regulatory alerts for use in breast surgeries despite lack of breast-specific clearance.
• AlloMax (human acellular dermal matrix (ADM) by C.R. Bard/BD): Flagged by the U.S. Food & Drug Administration (FDA) for higher complication rates in breast reconstructions.
• FlexHD (human ADM by MTF Biologics): Cited by the FDA for elevated risks when used in implant-based breast reconstruction.
• Strattice (porcine-derived ADM by Allergan/LifeCell): Listed among brands under investigation for off-label breast use and litigation.

TorHoerman Law: Investigating Breast Mesh Complications and Injuries

Breast mesh complications can lead to long-term pain, disfigurement, implant loss, and repeated surgeries that take a serious toll on a person’s health and quality of life.

Some patients may have never been told a mesh product would be used or were unaware that these devices were not approved for breast surgery, leaving them unprepared for the risks they now face.

TorHoerman Law is actively reviewing claims for individuals who experienced complications after procedures involving mesh, ADM products, or internal-bra devices.

If you suffered injuries linked to breast mesh, you may be eligible to take legal action and pursue compensation for the harm you’ve endured.

Contact TorHoerman Law today to learn whether you qualify for a breast mesh lawsuit.

You can also use the chat feature on this page to find out if you qualify for a breast mesh lawsuit.