Is There a Breast Mesh Lawsuit?

Our lawyers are investigating potential breast mesh and internal bra lawsuits against manufacturers that marketed surgical mesh implants for use in breast reconstruction and cosmetic surgery.

Originally developed for hernia repair and general soft-tissue reinforcement, these surgical mesh products were later marketed to plastic surgeons as a way to create an “internal bra” that could provide lasting support after breast reconstruction or augmentation.

However, as their use expanded, growing reports of mesh degradation, hardening, and detachment from surrounding tissue began to surface. Despite being promoted as safe and effective, the U.S. Food and Drug Administration (FDA) has confirmed that no surgical mesh has been cleared or approved for use in breast reconstruction or cosmetic breast surgery.

As a result of these products being promoted for unapproved surgical uses, attorneys are investigating whether manufacturers misled surgeons and patients about the safety of mesh implants in breast reconstruction and cosmetic procedures.

Which Breast Mesh Products Are Under Investigation?

Our breast mesh injury lawyers are reviewing claims involving the following internal bra products, which were marketed for use in breast reconstruction or augmentation procedures despite never being approved by the FDA for these purposes:

• GalaFLEX, GalaFORM, GalaSHAPE (Becton Dickinson / Galatea Surgical)
• Phasix, Phasix ST (C.R. Bard / Becton Dickinson)
• DuraSorb Monofilament Mesh (Integra LifeSciences)
• AlloDerm Regenerative Tissue Matrix (Allergan / LifeCell Corporation)
• Strattice Reconstructive Tissue Matrix (Allergan / LifeCell Corporation)
• FlexHD Biologic Mesh (Ethicon / Johnson & Johnson)
• AlloMax Surgical Mesh (C.R. Bard / Becton Dickinson)
• SurgiMend Biologic Mesh (Integra LifeSciences)

Off-Label Internal Bra Uses

Although marketed as an advanced support material, breast mesh is typically used to replace or reinforce tissue that has been weakened, removed, or stretched during surgery. Surgeons often use it to help shape and stabilize the lower breast, strengthen the implant pocket, or maintain breast contour after cancer reconstruction.

Each year, thousands of women receive mesh implants during various types of breast procedures, including:

• Breast Reconstruction after Mastectomy: Used to replace tissue removed during cancer surgery and form a supportive base for an implant or tissue expander.
• Breast Augmentation: Placed beneath or around implants to improve shape, symmetry, or lift in patients with thin or stretched skin.
• Breast Lift (Mastopexy): Reinforces the breast’s lower pole to prevent sagging and extend the longevity of results.
• Breast Reduction Surgery: Used to reshape and support tissue after removal of excess fat and glandular tissue.
• Revision Surgery or Implant Replacement: Supports weakened tissue and corrects implant malposition or “bottoming out” from previous procedures.

These products were originally cleared for soft-tissue repair, not for use inside the delicate, dynamic breast environment, where motion, heat, and hormonal changes can affect how the material behaves and breaks down over time.

FDA Breast Mesh Warnings

Although surgical mesh products have been used for years in hernia repair and general soft-tissue reinforcement, none have ever been approved or cleared by the U.S. Food and Drug Administration (FDA) for use in breast reconstruction or cosmetic breast surgery.

Despite this, several mesh manufacturers promoted their devices for off-label breast applications, marketing them as safe “internal bra” supports. As reports of infection, inflammation, and reconstruction failure increased, the FDA issued formal warnings reminding surgeons and patients that these devices were not cleared for breast implantation and that their safety had never been established in breast tissue.

FDA Letter to Health Care Providers (November 2023)

In November 2023, the FDA issued a Letter to Health Care Providers warning that synthetic surgical meshes such as GalaFLEX, Phasix, and similar devices were being used in breast procedures without adequate clinical safety data. The agency emphasized that:

“The FDA is aware of increased use of surgical mesh products in breast surgery. However, the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.“

This communication followed growing reports of mesh degradation, hardening, and detachment from surrounding tissue, leading to pain, infection, and reconstructive failure.

The FDA urged surgeons to fully inform patients of these risks and to avoid assuming that approval for soft-tissue repair extends to breast applications. The agency also encouraged reporting of adverse events involving any mesh used during breast surgery.

FDA issued formal warnings reminding surgeons and patients that these devices were not cleared for breast implantation and that their safety had never been established in breast tissue.

FDA Safety Communication on Acellular Dermal Matrix (March 2021)

In March 2021, the FDA released a Safety Communication on Acellular Dermal Matrix (ADM) Products used in breast reconstruction, finding that certain biologic mesh materials, including FlexHD, AlloMax, and Strattice, were linked to higher rates of infection, implant loss, and reoperation compared to other reconstruction techniques.

The FDA’s review included data from adverse event reports and published studies, showing that these biologic meshes carried significant complication risks when implanted in breast tissue.

This echoed earlier safety controversies involving hernia mesh and transvaginal mesh, which were also marketed for soft-tissue reinforcement but later tied to widespread patient injuries and recalls. The FDA’s position remains clear:

“There are no FDA-approved or cleared surgical mesh products for use in breast surgery“

Breast Mesh Side Effects & Complications

Complications from internal bra mesh implants often develop gradually as the material weakens, detaches, or triggers inflammation inside soft breast tissue. The breast is a highly dynamic area, constantly affected by movement, body heat, hormones, and natural tissue changes, which can cause mesh products to behave unpredictably once implanted.

When the material fails to integrate or begins to degrade, it can lead to a cascade of physical reactions that cause pain, infection, and tissue damage.

Common Internal Bra Failure Side Effects

• Infection and abscess formation: As the mesh breaks down or separates from surrounding tissue, tiny spaces form where bacteria can accumulate. Once infection sets in, antibiotics alone are often ineffective, and both the mesh and implant may need to be surgically removed.
• Seroma and chronic fluid buildup: The body may produce excess fluid in response to irritation or foreign material. When mesh integrity weakens, this fluid collects around the implant pocket, causing swelling, discomfort, and pressure that often require repeated drainage.
• Capsular contracture: As the body reacts to the degraded mesh, scar tissue thickens around the implant. This capsule can tighten painfully, harden the breast, and distort its shape. Chronic inflammation caused by mesh particles often worsens the contracture over time.
• Mesh migration or detachment: If the mesh fails to anchor securely to the chest wall or integrate with tissue, it can shift or pull away from its original position. This movement disrupts implant placement, leading to drooping, asymmetry, or a “bottoming out” appearance.
• Implant rupture or reconstructive failure: The loss of mesh support places added pressure on the implant shell, increasing the risk of rupture or collapse. When this occurs, the breast pocket may lose its structure entirely, resulting in reconstruction failure that requires additional surgery.
• Skin erosion or tissue necrosis: Persistent infection or inflammation can thin the overlying skin, allowing mesh fibers to erode through soft tissue. This may cause open wounds, visible mesh exposure, or tissue death that demands emergency removal.
• Breast distortion or deformity: As the mesh collapses or stiffens unevenly, the breast can lose shape, volume, and symmetry. Patients often report dimpling, indentation, or irregular contouring, especially when one breast is more affected than the other.
• Chronic pain or nerve injury: Mesh is typically anchored near the chest wall, where inflammation and scar tissue can compress surrounding nerves. This can result in sharp or burning pain, muscle tightness, or numbness that persists long after the mesh is removed.
• Autoimmune or inflammatory response: In some women, breakdown particles from synthetic or biologic mesh may trigger a systemic immune reaction. Symptoms such as fatigue, joint pain, or chronic inflammation may appear months or even years after surgery.

In many cases, these complications require revision or explant surgery to remove the mesh and implant, treat infection, and rebuild the breast pocket. For some women, the damage is permanent, leaving visible scarring, pain, and loss of reconstruction results.

Studies Linking Breast Mesh to Serious Injuries

Although breast mesh implants were marketed as safe and effective tools for improving surgical outcomes, several recent studies have identified meaningful complication rates when these materials are used in reconstruction and augmentation.

Clinical research shows that mesh placed in breast tissue can lead to infection, seroma, implant loss, and other complications that often require revision or removal surgery.

Breast Mesh Failure, Reoperation and Implant Loss Rates

A 2024 Aesthetic Surgery Journal Open Forum review analyzed data from 31 clinical studies involving synthetic mesh in implant-based breast reconstruction.
Researchers found that:

• Reoperation rates reached nearly 10%, with many procedures required to address mesh-related complications.
• Implant loss occurred in approximately 3% of patients.
• Infection developed in about 4%.
• Seroma formation was observed in roughly 3% of cases.

The study concluded that synthetic mesh can contribute to postoperative complications and that long-term safety data for breast mesh remain limited.

Breast Mesh Infection and Seroma Formation Rates

Another 2023 meta-analysis published in the Aesthetic Surgery Journal examined 24 studies covering more than 2,000 breast reconstructions using biosynthetic mesh.

The authors reported measurable rates of mesh-related complications, including:

• Infection in approximately 5% of cases
• Seroma (fluid buildup) in about 5% of patients
• Skin necrosis in 5.5%, and implant loss in nearly 4%

Researchers concluded that even bioresorbable mesh products carry a substantial risk of infection, inflammation, and reconstructive failure, particularly when used in breast tissue, where constant motion and moisture can accelerate material breakdown.

Manufacturers Should Have Known About Breast Mesh Failure Risks

The growing concerns over breast mesh implants follow a long history of similar problems involving surgical mesh products made by many of the same companies now under investigation.

For decades, manufacturers such as C.R. Bard, Ethicon, and Atrium have faced transvaginal mesh lawsuits and hernia mesh lawsuits over similar products that caused infection, erosion, and tissue damage. Despite billions paid in settlements and years of public safety warnings, these same companies introduced new mesh products for use in the breast—again without adequate testing or FDA approval.

Transvaginal Mesh Failures

Transvaginal mesh was marketed as a minimally invasive way to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Manufacturers claimed it would restore pelvic support and improve women’s quality of life.

Instead, thousands of women experienced vaginal erosion, chronic pelvic pain, organ perforation, and nerve injuries when the mesh hardened or cut into surrounding tissue. After multiple FDA safety warnings and a 2016 reclassification that required new premarket approval, all major transvaginal mesh products were withdrawn from the market.

More than 100,000 vaginal mesh lawsuits were filed against manufacturers including Ethicon (Johnson & Johnson), C.R. Bard, and Boston Scientific, resulting in widespread recalls and billions of dollars in transvaginal mesh settlements and verdicts.

Hernia Mesh Failures

Hernia mesh devices, often made of polypropylene or absorbable polymers, were similarly promoted as durable, long-term repairs for abdominal wall defects. Over time, many of these products were linked to infection, adhesions, migration, and mesh shrinkage, particularly in high-moisture, high-movement areas of the body—conditions very similar to the breast environment.

Thousands of hernia mesh lawsuits have been filed against Bard, Ethicon, and Atrium, resulting in multidistrict litigations (MDLs) and substantial financial settlements.

A Repeated Pattern of Corporate Negligence

Despite years of evidence showing that these materials can cause severe complications inside the body, mesh manufacturers continued to promote similar products for breast reconstruction and augmentation. The same polymers, biologic matrices, and scaffold designs used in failed pelvic and abdominal meshes were repurposed for “internal bra” procedures, this time marketed as a cosmetic and reconstructive innovation.

Manufacturers knew or should have known that implanting mesh in the breast, a soft tissue environment prone to movement and infection, could result in many of the same injuries already documented in prior mesh litigations:

• Infection and abscess formation
• Tissue erosion and necrosis
• Chronic pain and nerve injury
• Mesh detachment and deformity

The parallels are unmistakable. The same companies, using similar materials, are once again accused of putting profits before patient safety, despite decades of warnings about the dangers of mesh implants in living tissue.

How Long Do I Have to File a Breast Mesh Lawsuit?

Every state has its own statute of limitations that governs how long an individual has to file a product liability lawsuit. In most jurisdictions, these deadlines range from one to three years after the date an injury was, or reasonably should have been, discovered.

Breast mesh complications often appear months or even years after surgery, which can make determining the applicable deadline more complex. The time to file a claim may depend on several factors, including:

• The date of the initial breast reconstruction, augmentation, or revision surgery
• When symptoms or complications related to the mesh were first diagnosed
• Whether the mesh has been surgically removed or replaced
• State-specific discovery rules governing medical device injuries

Women who believe their injuries may be related to breast mesh failure should consult an attorney as soon as possible to determine how the statute of limitations may apply to their circumstances and to ensure their right to pursue compensation is protected.

How Much Is a Breast Mesh Lawsuit Settlement Worth?

The value of a potential breast mesh lawsuit settlement will depend on the specific facts and circumstances of each individual case. Since the litigation remains in the investigative stage, no settlements or verdicts have yet been reached. However, the factors that typically influence compensation in medical device claims are well established.

In evaluating a breast mesh claim, attorneys consider:

• Nature and extent of the injuries: The severity of medical complications, such as infection, chronic pain, or tissue loss, plays a significant role in determining the potential value of a claim.
• Need for revision or removal surgery: Cases involving multiple surgeries, prolonged recovery, or permanent disfigurement generally support higher damages due to the increased physical and emotional toll.
• Duration and degree of pain and suffering: Ongoing pain, nerve damage, or loss of sensation may be considered when assessing non-economic damages.
• Impact on quality of life: Women who experience long-term physical limitations, emotional distress, or loss of confidence following reconstructive failure may be entitled to compensation for diminished quality of life.
• Medical expenses and financial losses: Past and future medical costs, as well as any lost wages or reduced earning capacity, are important components of a damages calculation.
• Evidence of negligence or misconduct: If it is shown that manufacturers promoted mesh products for unapproved uses or withheld safety information, punitive damages may be warranted to deter similar conduct in the future.

Each breast mesh lawsuit will be evaluated individually, and any settlement amount will depend on the strength of the evidence, the severity of the injuries, and the overall impact on the individual’s health and livelihood.

Are There Any Costs to Hire an Internal Bra Mesh Lawyer?

There are absolutely no out-of-pocket costs to review your case or hire our attorneys. Potential claims are evaluated for individuals throughout the United States, and all cases are handled on a contingency fee basis.

Through the use of contingency attorney fees, individuals have access to the experience and resources of our national law firm for their Breast Mesh lawsuit settlement — regardless of their individual financial resources.

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