Breast Mesh Lawsuits May Follow Recent Studies Highlighting Internal Bra Complications

New and evolving research raises concern over breast mesh complications experienced by women nationwide, which could become the subject of product liability lawsuits given the long history of mesh defects.

As new studies continue to link internal bra mesh implants to infections, tissue damage and reconstruction failures, many women are now questioning whether manufacturers withheld safety information that could have prevented life-altering complications.

Originally developed for hernia repair and other soft-tissue reinforcement procedures, breast mesh implants were later adapted for off-label use in cosmetic and reconstructive breast surgery. These devices are typically made from synthetic polymers or biologic materials known as acellular dermal matrices (ADMs), which are designed to integrate into tissue and gradually dissolve over time.

Manufacturers promoted products like GalaFLEX, Phasix, Strattice, AlloDerm and others to plastic surgeons as surgically innovative “internal bras” that could support breast implants, reinforce weakened tissue and improve long-term cosmetic results.

With the growing use of breast mesh implants, complications have become increasingly common. In the dynamic and hormone-sensitive environment of the breast, many of these materials have degraded, hardened or detached from the chest wall, leading to serious injuries such as infection, asymmetry, implant rupture and reconstruction failure.

Over the past several years, reports of breast mesh complications have grown steadily. Women who once turned to these products for support after cancer reconstruction or augmentation are now facing painful revision surgeries, chronic inflammation and permanent scarring.

Amid mounting safety warnings and newly published clinical research, breast mesh lawsuits are now being investigated against manufacturers accused of concealing known risks while promoting these products for unapproved use in breast reconstruction surgery.

Studies Link Breast Mesh to Severe Injuries

Several recent studies have raised serious concerns about the safety and long-term outcomes of breast mesh implants, particularly when used in reconstructive procedures following mastectomy or cosmetic breast augmentation.

Despite years of manufacturer claims that these devices are safe and effective, clinical evidence now points to a consistent pattern of complications, including infection, implant loss and the need for revision surgery.

Internal Bra Infections, Implant Loss & Reoperations

In 2024, researchers published a comprehensive literature review in Aesthetic Surgery Journal Open Forum, analyzing 31 clinical studies focused on synthetic mesh use in implant-based breast reconstruction.

This review compiled complication data across both retrospective and prospective trials involving thousands of patients. While study sizes and designs varied, the overall trends were consistent:

• Reoperation was required in nearly 10% of cases, often due to mesh-related issues such as infection, implant malposition or tissue erosion.
• Implant loss occurred in 3% of patients, suggesting that mesh failure directly contributed to reconstruction breakdown.
• Infection rates reached 4%, even when antibiotic prophylaxis was used.
• Seroma formation — or chronic fluid buildup near the implant site — was reported in approximately 3% of cases.

The authors concluded that while synthetic mesh may offer temporary structural support, it also increases the risk of surgical complications. They also noted that long-term safety data is limited, especially beyond the first 12 to 18 months post-implantation.

Long-Term Risks of Breast Reconstruction Mesh

A year earlier, a 2023 meta-analysis published in the Aesthetic Surgery Journal examined 24 peer-reviewed studies covering over 2,000 implant-based breast reconstruction cases involving biosynthetic mesh, including absorbable monofilament scaffolds like GalaFLEX and Phasix.

To minimize confounding variables, researchers excluded studies with concurrent radiation therapy or multiple simultaneous procedures. Across the pooled data, they found:

• Infection occurred in 5% of patients, often requiring mesh removal.
• Seromas developed in 5%, contributing to discomfort, swelling and prolonged drainage.
• Skin necrosis was observed in 5.5%, typically where mesh contact compromised vascular supply.
• Implant loss was reported in nearly 4%, frequently requiring full revision surgery.

The study emphasized that even “resorbable” meshes marketed as safer alternatives carried meaningful complication risks, particularly in the uniquely dynamic and hormonally influenced breast environment. Researchers cautioned that heat, motion and tissue remodeling can accelerate material degradation, undermining the intended structural support and provoking inflammatory or immune responses.

Together, these studies have prompted increased scrutiny from the medical and legal communities. Critics question why mesh manufacturers continued marketing their products for breast procedures in the absence of FDA approval or robust long-term clinical data demonstrating safety and efficacy.

The Aftermath of Internal Bra Complications

The consequences outlined in recent studies go far beyond statistics, revealing a wave of painful, invasive treatments many women were never warned about.

In the Aesthetic Surgery Journal reviews, reoperation rates reached nearly 10%, most often triggered by mesh-related infections, tissue erosion or implant displacement. These complications frequently require surgical removal of the mesh, a technically demanding procedure in the breast where the material may be partially fused with nerves and vascular tissue. In many cases, complete removal isn’t possible, and the surgery carries a heightened risk of nerve damage, scarring or breast deformity.

Despite these risks, many women say they were never informed that the mesh being used in their breast reconstruction or augmentation was not specifically approved by the U.S. Food and Drug Administration (FDA) for that purpose, or that it had limited long-term safety data. Some patients report that their surgeons referred to the material only as “internal support” or a dissolvable scaffold, with no mention of mesh failure, implant loss or the possibility of multiple revision surgeries.

Even when infections were caught early, reported in up to 5% of cases, treatment often required IV antibiotics, surgical drainage or partial implant removal. In more severe cases, entire implants were lost, forcing women to delay or abandon reconstruction altogether due to tissue damage or health risks.

Other patients developed seromas or skin necrosis, requiring prolonged wound care, fluid drainage or additional flap surgeries to repair damaged tissue. In every instance, the recovery process became longer, more painful and far more costly than expected.

The risks highlighted in recent studies were often not shared with patients beforehand, in part because manufacturers promoted these mesh products without fully disclosing their limitations or long-term safety concerns.

Breast Mesh Lawsuits Under Investigation

As mounting evidence links internal bra mesh implants to serious complications, breast mesh injury lawyers are now investigating product liability claims against manufacturers for marketing these devices for unapproved use in breast reconstruction and augmentation surgeries, despite lacking FDA clearance and long-term safety data.

The breast mesh lawsuits are being reviewed for women who received mesh products like GalaFLEX, Phasix, Strattice, AlloDerm or others, and later experienced:

• Infections or abscess formation
• Mesh migration or detachment
• Implant rupture or reconstruction failure
• Chronic pain, nerve injury or disfigurement
• Revision or explant surgery

The claims allege that companies failed to warn about the risks of implanting mesh in delicate breast tissue and misled surgeons about its safety. Many of these manufacturers have previously faced large-scale litigation over similar mesh failures in hernia and pelvic floor procedures.

Free case evaluations are available, and there are no fees unless a recovery is obtained.