Breast Mesh Lawsuit Overview

Over the past decade, surgical mesh implants have become increasingly common in breast reconstruction and cosmetic augmentation procedures. Marketed as an “internal bra,” these materials are used to provide added support under the breast and help maintain implant position and shape.

However, breast mesh lawsuits allege that manufacturers failed to disclose the risks of using mesh in breast surgeries, and negligently promoted their products for unapproved, off-label purposes. The U.S. Food and Drug Administration (FDA) has confirmed that no surgical mesh has ever been approved as safe and effective for breast reconstruction or augmentation, yet the devices were widely adopted in the medical community.

Many women have since reported serious complications, including infections, chronic pain, mesh migration, and reconstruction failure. Breast mesh injury lawyers are now investigating whether the manufacturers misrepresented the safety of these products and ignored mounting evidence of harm linked to their off-label use in breast surgeries.

Who Is Eligible for a Breast Mesh Lawsuit?

Financial compensation may be available through a breast mesh lawsuit settlement for individuals who underwent breast reconstruction, augmentation, or revision surgery that involved the use of a mesh implant and subsequently developed serious complications, including:

• Infection or abscess formation, including cases requiring antibiotics, hospitalization, or surgical removal
• Chronic pain or nerve damage around the chest, breast, or underarm area
• Seroma (persistent fluid buildup or swelling beneath the breast)
• Capsular contracture, in which scar tissue tightens painfully around the implant
• Mesh migration or displacement, leading to asymmetry, breast distortion, or loss of implant support
• Implant rupture or reconstructive failure requiring removal or replacement
• Interference with breast imaging, including mammogram or ultrasound detection issues
• Permanent scarring or disfigurement following mesh removal
• Removal, replacement, or revision surgery due to mesh-related complications or failure

These lawsuits seek compensation for medical expenses, pain and suffering, lost income, and other financial losses caused by breast mesh complications.

2025 Breast Mesh Lawsuit Updates

• November 14, 2025 Update: A former Becton Dickinson medical director is warning that GalaFLEX mesh is being used off-label in breast reconstruction without evidence that it is safe or effective. He says the material may cause complications and could even interfere with detecting recurrent breast cancer. His statements have led to growing interest in breast mesh lawsuits involving women who experienced injuries after implantation.
• November 10, 2025 Update: Breast mesh use continues to surge in reconstruction and cosmetic surgery, even though no mesh product has been approved by the FDA for use in breast tissue. Studies and FDA warnings highlight higher risks of infection, implant failure, and revision surgery, raising new safety concerns as sales grow. These issues are driving more women to investigate breast mesh lawsuits over off-label marketing and device complications.

How Internal Bra Mesh Products Work

Internal bra mesh products were developed to provide internal support and stability during breast reconstruction, augmentation, or revision surgeries. These devices are used to strengthen weakened tissue, improve breast shape, and prevent implants from shifting or sagging over time.

Unlike traditional breast lifts that rely only on skin tightening, internal bra surgery uses a layer of mesh material inside the breast to create a permanent or semi-permanent foundation. The mesh acts as an internal sling or hammock, supporting the lower pole of the breast and reinforcing soft tissue where it may be too thin or weak to hold an implant securely.

In breast reconstruction after mastectomy, surgeons use mesh to replace or strengthen tissue removed during cancer surgery, or to rebuild the breast pocket for an implant or tissue expander. The same mesh materials are also used in revision surgeries to correct issues such as implant bottoming out, asymmetry, or loss of shape from prior procedures.

These products are typically made from either synthetic absorbable polymers, such as poly-4-hydroxybutyrate (P4HB), or biologic materials derived from processed human or animal tissue. They are marketed under names like “bioresorbable scaffold” or “tissue matrix,” and are designed to either dissolve gradually or integrate with the surrounding tissue over time.

While the idea behind breast mesh support is to improve results and longevity, these devices were never approved by the FDA for use in breast surgery, and no studies have proven that they are safe or effective for this purpose. Despite their increasing popularity, the materials behave differently inside the breast than in other parts of the body, a problem that has led to reports of mesh breakdown, loss of support, and reconstruction failure.

Why Internal Bra Mesh Fails

Although internal bra mesh was intended to strengthen weak tissue and provide lasting breast support, many products have proven unstable once implanted. The breast is a dynamic, constantly moving area, and these materials often behave unpredictably inside soft, delicate tissue that was never part of their original design testing.

Many of the same meshes now used in breast surgery were first cleared by the FDA for hernia repair or general soft tissue reinforcement. When moved into the breast environment—where movement, temperature, and moisture differ dramatically—their structural integrity can quickly deteriorate.

Over time, several patterns of breast mesh failure have been reported:

• Premature degradation: Absorbable meshes, like those made from P4HB polymers, can dissolve too quickly, leaving the implant unsupported before healing is complete.
• Loss of tensile strength: Mesh fibers can stiffen, stretch, or weaken under constant strain, causing the material to lose its intended shape.
• Poor tissue integration: If the mesh fails to incorporate into the surrounding tissue, it can detach from the implant pocket or fold on itself, leading to uneven support.
• Inflammatory breakdown: The body may recognize mesh fibers as foreign material, triggering inflammation that erodes tissue and interferes with healing.
• Mechanical stress and fatigue: Daily motion, exercise, or muscle contraction from the chest wall can cause repetitive strain, pulling the mesh away from fixation points.

These mechanical and biological failures often start gradually but can compromise the breast’s shape and support over time. When the mesh no longer holds its position, the implant can shift, the reconstruction can collapse, or scar tissue can form around distorted mesh fibers, making corrective surgery difficult.

While marketed as innovative or absorbable scaffolds, most internal bra meshes were never designed to endure the long-term mechanical stress of the breast, raising serious concerns about their durability and safety.

Internal Bra Failure Revision Surgery

When an internal bra mesh begins to fail, many women eventually require revision surgery to remove the material, reposition implants, or rebuild the breast pocket. The timing and approach depend on the type of mesh used, how the body has reacted to it, and the extent of tissue damage caused by the implant’s movement or breakdown.

Revision procedures are often complex because the mesh is partially absorbed or fused with surrounding tissue. In some cases, surgeons must dissect scar tissue and remove remaining mesh fragments, which can increase bleeding risk and prolong healing. For biologic or synthetic meshes that have degraded unevenly, removal can leave irregular tissue planes or thin skin coverage, requiring additional reconstructive techniques.

After removal, the surgeon may:

• Replace the implant with a smaller or differently shaped device to restore symmetry.
• Reinforce the pocket with new tissue flaps or fat grafting instead of another mesh.
• Perform a breast lift or capsulectomy to reshape tissue and remove hardened scar tissue (capsular contracture).
• Delay reconstruction to allow inflammation or infection to resolve before further procedures.

Recovery from revision surgery can take several months and may require staged operations to achieve the desired cosmetic result. In cases of infection, the mesh and implant are typically removed together, and reconstruction is postponed until the tissue fully heals.

Women who have undergone revision procedures often report loss of sensation, persistent pain, or visible scarring due to the invasive nature of mesh removal. For many, these secondary surgeries are physically and emotionally draining — especially when the original “internal bra” procedure was marketed as a permanent solution that would improve long-term support and appearance.

Internal Bra Failure Side Effects

When internal bra mesh products fail, women can experience a wide range of painful and sometimes disfiguring complications. These side effects from breast mesh implants often develop gradually, beginning with subtle discomfort or swelling, and can progress to severe infection, tissue loss, or total reconstruction failure.

Because these products were never approved by the FDA for breast surgery, their behavior inside the body is unpredictable. Many internal bra side effects stem from how the mesh interacts with surrounding tissue, how quickly it degrades, and whether it triggers an inflammatory or immune response.

• Infection and abscess formation: When mesh material breaks down or detaches, it can create small spaces where bacteria collect, leading to persistent infection or abscesses. These infections may appear months after surgery and cause pain, swelling, redness, or drainage. In many cases, both the mesh and the implant must be surgically removed to prevent systemic infection or sepsis.
• Seroma and fluid buildup: The body can respond to mesh breakdown by producing fluid around the implant pocket, forming a seroma. Fluid accumulation causes swelling, pressure, and discomfort, and often signals an inflammatory response. Persistent seromas may need repeated drainage and can lead to chronic inflammation if left untreated.
• Capsular contracture: As mesh fibers deteriorate, they can stimulate excess scar tissue to form around the implant, creating a thick capsule that tightens painfully. This condition distorts the breast’s shape, hardens the tissue, and can become more severe as inflammation continues, sometimes requiring surgical correction.
• Mesh migration or detachment: If the mesh fails to bond with surrounding tissue, it can slip or detach from the chest wall. This causes the implant to lose its lower support, resulting in visible asymmetry or a condition known as “bottoming out,” where the breast appears to drop and the nipple sits unnaturally high. Corrective surgery is often needed to remove or reposition the mesh and implant.
• Implant rupture and reconstructive failure: Loss of mesh support places additional stress on the implant, increasing the chance of rupture or collapse. In reconstructive patients, complete mesh failure can destroy the surgical result, leading to multiple revision surgeries. Many women experience scarring, indentation, and tissue thinning after mesh removal.
• Nerve damage and chronic pain: Internal bra mesh is typically anchored near the pectoral muscle, where nerves can be compressed by inflammation or scar tissue. Over time, patients may develop sharp, burning pain or numbness in the breast or underarm area. In some cases, the nerve irritation continues even after mesh removal.
• Skin erosion and tissue necrosis: Severe inflammation or infection can cause the mesh to erode through soft tissue or thin the skin above the implant. This can lead to open wounds, visible mesh exposure, or tissue death (necrosis). These complications almost always require implant removal and reconstructive repair.
• Breast distortion and asymmetry: When the internal mesh sling collapses or detaches, the breast can lose its shape and alignment. The result may include drooping, dimpling, or visible deformity, particularly if only one breast is affected. These aesthetic issues often require revision surgery and can cause significant emotional distress.
• Interference with mammograms and breast imaging: Some mesh materials can interfere with imaging tests, such as mammograms and ultrasounds. Mesh placement or scarring can obscure tissue detail, making it harder to detect early signs of breast cancer or other abnormalities. In some cases, this interference delays diagnosis and treatment.
• Inflammation and autoimmune response: In certain patients, degraded mesh particles may trigger a broad immune reaction, causing fatigue, joint pain, or systemic inflammation. These reactions are still being studied but resemble immune responses reported in other implanted polymer and biologic devices.

Internal bra mesh side effects vary in severity but often stem from mesh degradation, poor tissue integration, or chronic inflammation. Many women who develop these problems must undergo revision or removal surgeries, sometimes multiple times, to correct damage and restore breast structure.

Breast Mesh Products Linked to Complications

A growing number of breast mesh and internal bra products have been associated with painful complications and reconstructive failures after surgery. These devices were marketed to surgeons as supportive scaffolds meant to hold implants in place, improve shape, and strengthen weakened tissue.

However, none of these mesh materials have been approved by the U.S. Food and Drug Administration (FDA) for use in breast surgery, and many were originally cleared for hernia or general soft-tissue repair through the FDA’s 510(k) process. The off-label use of these devices has led to reports of infection, capsular contracture, mesh breakdown, and revision surgeries among women who underwent breast reconstruction or cosmetic augmentation.

Who Is the Breast Mesh Lawsuit Being Investigated Against?

Lawyers are currently investigating potential breast mesh lawsuits against several medical device manufacturers that designed, produced, and marketed surgical mesh products promoted for off-label use in breast reconstruction and cosmetic augmentation procedures.

Although these devices were sold as safe “internal bra” supports, none have been approved by the U.S. Food and Drug Administration (FDA) for breast-specific use. Attorneys are reviewing whether these companies failed to warn about the risks of mesh degradation, infection, and reconstructive failure.

Potential claims are being reviewed against the following manufacturers and product lines:

• Becton Dickinson & Company (BD): Manufacturer of the GalaFLEX, GalaFORM, and GalaSHAPE mesh scaffolds through its Galatea Surgical subsidiary, and producer of Phasix and Phasix ST mesh through its C.R. Bard division.
• Integra LifeSciences Corporation: Developer of DuraSorb Monofilament Mesh and SurgiMend biologic mesh, both used off-label in breast reconstruction and revision surgeries.
• Allergan / LifeCell Corporation: Makers of AlloDerm and Strattice biologic meshes, derived from human and porcine tissue, which have been widely used in post-mastectomy reconstruction procedures.
• Ethicon, Inc. (a subsidiary of Johnson & Johnson): Distributor of FlexHD biologic mesh, identified by the FDA in 2021 as having higher rates of infection and implant removal following breast reconstruction.

Investigations focus on whether these companies marketed or allowed their products to be used in unapproved breast surgeries without conducting appropriate safety testing or disclosing the risks of tissue damage, implant failure, and recurrent inflammation.

What Are Breast Mesh Lawsuits Expected to Allege?

While no lawsuits have been filed yet, attorneys reviewing potential claims anticipate that breast mesh lawsuits will raise similar allegations to those seen in prior hernia and vaginal mesh litigations. These include:

• Off-label promotion: Manufacturers allegedly encouraged or failed to prevent their products from being used in breast surgeries, even though they were not cleared or approved for those indications.
• Failure to warn: The companies are accused of omitting key information about the risks of infection, scarring, and premature mesh breakdown.
• Defective design: The materials may degrade too quickly, harden, or detach, leading to loss of implant support and reconstruction failure.
• Negligent misrepresentation: Surgeons and patients were allegedly led to believe that these meshes would provide lasting support when long-term safety data did not exist.
• Concealment of adverse events: Plaintiffs may argue that manufacturers ignored or downplayed reports of complications and continued marketing these devices for breast use.

These claims are being investigated nationwide to determine whether women who received these mesh implants have experienced similar patterns of complications.

Is There An Internal Bra Class Action Lawsuit?

At this time, no breast mesh class action lawsuit has been filed, nor has a formal multidistrict litigation (MDL) to coordinated proceedings for internal bra claims been established. Attorneys across the United States are in the early stages of identifying potential plaintiffs and evaluating injury reports.

Several different manufacturers are involved in the sale of breast mesh products, and many of the same materials have been marketed under multiple brand names. The investigation phase is critical to determining how widespread these issues may be and which products share the same design or material defects. If a substantial number of women come forward, attorneys are expected to seek consolidation of the claims in federal court to coordinate pretrial proceedings and ensure consistent rulings.

This approach is similar to the process used in prior mesh litigations, including those involving hernia mesh and transvaginal mesh devices, which led to settlements after early trials revealed consistent design and safety problems.

Internal Bra Mesh Lawsuit Settlements

Women who underwent breast reconstruction or augmentation with mesh implants that later failed may be entitled to financial compensation. Potential damages could include:

• Medical expenses for implant removal, revision, or reconstructive surgeries
• Hospitalization and follow-up treatment costs
• Lost income or reduced earning capacity
• Pain and suffering associated with chronic pain, infection, or nerve damage
• Emotional distress and diminished quality of life
• Permanent scarring, asymmetry, or disfigurement

Potential Breast Mesh Settlement Amounts

Since claims remain in the early investigative stages, there are currently no settlements or court awards related to breast mesh injuries. However, the potential value of these claims will likely depend on the severity of complications and the extent of corrective surgeries required.

Based on similar mesh litigations, future settlement amounts could be influenced by:

• The type of mesh material implanted
• Whether multiple revision or removal surgeries were required
• The degree of scarring or permanent disfigurement
• Long-term complications such as nerve damage or infection
• Economic losses, including medical bills and lost income

While the value of any potential breast mesh lawsuit will depend on the facts of the case, previous mass tort mesh settlements, such as those involving pelvic and hernia mesh products, have ranged between $50,000 and over $1 million per plaintiff, depending on the severity of injuries and strength of the evidence.

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

Every state has its own statute of limitations, which limits how long a person has to file a product liability lawsuit. In most jurisdictions, the filing deadline ranges from one to three years after an individual discovers, or should have discovered, that their injury was caused by a medical device.

The deadline may vary based on several factors, including:

• The date of the initial breast reconstruction or augmentation procedure
• When complications such as infection, pain, or mesh failure were first diagnosed
• When the mesh was surgically removed or revised
• Whether the claim involves product liability or medical malpractice

Since these deadlines differ from state to state, women who believe they may have a claim are encouraged to contact an attorney as soon as possible to ensure their rights are preserved.

Have a Breast Mesh Lawyer Review Your Case

Attorneys are investigating potential breast mesh lawsuits for women who experienced complications following breast reconstruction or cosmetic augmentation procedures that involved surgical mesh implants.

Free case evaluations are available nationwide to determine whether financial compensation may be available. There are no fees or expenses unless a recovery is obtained in your case.

If you or a loved one required revision or removal surgery due to breast mesh failure, submit your information for review and learn whether you may qualify to pursue a claim.