Doyle APC

California Product Liability Attorneys

Breast Mesh and Internal Bra Lawsuits

Women across California are filing lawsuits against the manufacturers of surgical mesh products that were marketed and used in breast reconstruction, augmentation, and lift procedures, despite the fact that no surgical mesh has ever been approved by the U.S. Food and Drug Administration for use in breast surgery. Patients are reporting infections, mesh failure, reconstruction loss, chronic pain, disfigurement, and the need for revision or removal surgery, often years after their original procedure.

Our firm represents women injured by defective medical devices and is actively investigating breast mesh and internal bra cases. As a Southern California product liability firm with substantial experience litigating against the same manufacturers now under scrutiny in breast mesh cases, we are uniquely positioned to handle these matters from inception through trial.

Status of the Breast Mesh Litigation

Last Updated: May 2026

Breast mesh litigation is in its early stages. As of mid 2026, no federal multidistrict litigation (MDL) has been established and no class action has been certified. Individual lawsuits are being filed and investigated across the country, and consolidation into an MDL or coordinated state-court proceeding is widely anticipated as case filings increase.

This is the formative stage of the litigation, when claims are first being filed, discovery is being shaped, and bellwether candidates are being identified. Patients who file early are generally best positioned because their cases help define the contours of the litigation and influence how settlements are ultimately structured.

Several key developments have driven the current wave of filings:

  • November 2023 FDA Action. The FDA issued a letter to healthcare providers reiterating that no surgical mesh product is cleared or approved for breast augmentation or reconstruction, and that the benefit-risk profile for this use remains undefined. The FDA required Becton, Dickinson and Company (BD) to update labeling on its GalaFLEX and Phasix mesh products to disclose that the devices have not been determined to be safe or effective for use in breast surgery.
  • March 2021 FDA Safety Communication. The FDA had previously identified the acellular dermal matrix (ADM) products AlloMax and FlexHD as associated with higher rates of complications, including infection, explantation, and reoperation, when used in breast reconstruction.
  • Whistleblower Disclosures. Dr. Hooman Noorchashm, a former BD medical director and safety monitor, has publicly stated that he raised internal safety concerns about GalaFLEX, including concerns about breast cancer recurrence in clinical trial patients that he alleges were not adequately reported to the FDA. He has since filed formal petitions with the agency regarding off-label marketing of these products in breast surgery.
  • Comparable Mesh Settlements. In October 2024, BD settled approximately 38,000 hernia mesh claims involving C.R. Bard products for an amount estimated to exceed $1 billion. The transvaginal mesh litigation, which involved similar polypropylene and biologic mesh products implanted in women, resulted in many thousands of lawsuits and multi-billion-dollar global settlements paid by Boston Scientific, Ethicon, C.R. Bard, Coloplast, American Medical Systems, and others. These resolutions help frame how breast mesh claims may ultimately be valued.

What Is an “Internal Bra”?

The “internal bra” refers to a surgical technique in which a sheet of mesh, either synthetic or derived from human or animal tissue, is implanted inside the breast to support tissue, reinforce an implant pocket, or hold the position of a breast lift. Surgeons began adopting these products in cosmetic and reconstructive breast surgery on the theory that the mesh would reduce mechanical stress, prolong surgical results, and lower the risk of complications such as “bottoming out” or implant displacement.

These products were originally cleared by the FDA through the 510(k) process for unrelated uses, such as soft-tissue reinforcement or hernia repair. None were tested, studied, or approved by the FDA for use in breast tissue. Many patients were never told that the mesh placed inside their body had not been cleared for that purpose.

Reported Injuries and Complications

Patients harmed by breast mesh and internal bra products report a wide range of complications that often require additional surgery and long-term medical care. Published literature suggests that more than one in three women who receive mesh in breast surgery experience some form of complication, with a meaningful percentage requiring removal of the mesh, additional revision surgery, or loss of the breast implant entirely.

The injuries most commonly associated with these products include:

  • Chronic and Recurrent Infection. Mesh in the breast pocket can harbor bacteria and produce persistent infections that do not respond to antibiotics, sometimes requiring removal of the mesh and the implant.
  • Mesh Migration, Erosion, and Failure. The mesh can shift, fold, bunch, or break apart inside the breast, distorting the shape of the breast, damaging surrounding tissue, and exposing the mesh through the skin.
  • Seroma and Fluid Collection. Persistent fluid buildup around the mesh that often requires repeated drainage or surgical intervention.
  • Reconstruction Failure and Implant Loss. Mesh-related complications frequently cause the breast implant to drop, displace, or be lost entirely, undoing the surgical result and forcing additional reconstructive procedures.
  • Capsular Contracture. Hardening, distortion, and pain caused by an aggressive scar tissue response around the implant and mesh.
  • Tissue Necrosis and Skin Breakdown. Loss of viable tissue overlying the mesh that can require debridement and grafting.
  • Chronic Pain and Nerve Injury. Persistent burning, pulling, or sharp pain in the breast, chest wall, or surrounding areas, sometimes accompanied by numbness.
  • Disfigurement and Scarring. Permanent changes in breast shape, symmetry, and appearance that may be cosmetically and psychologically devastating, particularly for women who underwent reconstruction after a mastectomy.
  • Interference with Imaging. Mesh can obscure or complicate mammograms, ultrasounds, and MRI studies used to detect breast cancer recurrence.
  • Revision and Explant Surgery. Many patients ultimately require one or more procedures to remove the mesh, treat infection, replace lost tissue, or attempt a second reconstruction.

These complications can emerge weeks, months, or years after the original surgery. Many women initially attribute their symptoms to ordinary post-surgical healing or to the breast implant itself, without realizing that mesh was used and that the mesh may be the cause of their problems.

If you experienced these complications and required revision or removal surgery, you may be eligible to file a claim. Contact our attorneys for a free case evaluation.

Products and Manufacturers Under Investigation

Several manufacturers and product lines are being investigated in breast mesh and internal bra cases. The most prominent include:

  • Becton, Dickinson and Company (BD), including its Galatea Surgical and C.R. Bard subsidiaries
    • GalaFLEX Scaffold (poly-4-hydroxybutyrate, or P4HB)
    • GalaFLEX 3D and GalaFLEX 3DR Scaffolds
    • GalaFLEX Lite Scaffold
    • GalaFORM and GalaSHAPE Scaffolds
    • Phasix Mesh and Phasix ST
    • AlloMax acellular dermal matrix
  • Allergan / LifeCell Corporation (now part of AbbVie)
    • AlloDerm Regenerative Tissue Matrix (human ADM)
    • Strattice Reconstructive Tissue Matrix (porcine ADM)
  • MTF Biologics
    • FlexHD acellular dermal matrix
  • Integra LifeSciences Corporation
    • SurgiMend Collagen Matrix
    • DuraSorb Monofilament Mesh
  • Ethicon, Inc., a subsidiary of Johnson and Johnson
    • Historical distribution of FlexHD and related products

The lawsuits allege that these manufacturers promoted, marketed, or allowed their products to be used in breast surgery without conducting adequate safety testing, without obtaining FDA clearance for that use, and without providing meaningful warnings to surgeons or patients about the risks of off-label breast implantation.

Primary Legal Claims

Plaintiffs in breast mesh lawsuits allege that the manufacturers profited from an off-label market in breast surgery that they were never authorized to enter. The core claims fall into four overlapping categories.

Promotion for an Unapproved Use: marketing, distributing, and allowing surgical mesh products to be used in breast reconstruction, augmentation, and lift procedures despite the absence of FDA clearance or approval and despite the lack of adequate clinical testing in breast tissue.

Failure to Warn: concealing or failing to disclose elevated rates of infection, mesh failure, reconstruction loss, and revision surgery, leaving patients and surgeons without the information needed to give or obtain informed consent.

Defective Design and Manufacture: selling mesh products that were unreasonably dangerous for their foreseeable use in breast tissue, including products that degraded too quickly, provoked excessive inflammatory responses, or otherwise failed to perform as represented.

Continued Marketing Despite Known Risks: continuing to sell and promote these products for breast use even after internal data, adverse event reports, regulatory warnings, and published clinical literature pointed to elevated complication rates.

Why Doyle APC is Uniquely Positioned for These Cases

Breast mesh litigation involves the same product categories, many of the same manufacturers, and many of the same legal theories that our firm’s attorneys have litigated for decades in pelvic mesh and hernia mesh cases. The firm’s mesh litigation experience is directly transferable to this emerging litigation.

  • Pelvic and Transvaginal Mesh Experience. The firm’s attorneys represented hundreds of women injured by defective pelvic and transvaginal mesh products manufactured by Ethicon, C.R. Bard, Boston Scientific, Covidien, Coloplast Corp., and American Medical Systems, among others. That litigation became one of the largest mass torts in U.S. history, involving more than 100,000 cases, and resulted in significant recoveries for women injured by these synthetic and biologic mesh products.
  • Hernia Mesh Experience. The firm currently represents patients in active hernia mesh litigation against Covidien, Ethicon, C.R. Bard, Atrium Medical, and other major manufacturers, including ongoing MDL and state court proceedings involving polypropylene and polyester mesh products.
  • Direct Experience with the Same Defendants. Several of the manufacturers named in breast mesh investigations, including C.R. Bard, BD, Ethicon, and Allergan/LifeCell, are companies our attorneys have litigated against in prior mesh and product liability cases. The firm has firsthand knowledge of how these companies design, market, and defend their products.
  • Complex Product Liability Practice. With more than 28 years of complex product liability and mass tort experience, our attorneys are prepared to advance these cases through extensive discovery, expert work, motion practice, and trial.

Who May Qualify

Our firm is investigating breast mesh and internal bra cases involving women who:

  • Underwent breast reconstruction, augmentation, lift (mastopexy), or revision surgery in which surgical mesh or an acellular dermal matrix was implanted;
  • Received a product from one of the manufacturers and product lines listed above (or were unsure of the product but have access to operative records that can identify it); and
  • Experienced significant complications such as infection, reconstruction failure, implant loss, chronic pain, mesh exposure or migration, tissue necrosis, capsular contracture, or related injuries, particularly where revision or removal surgery has been recommended or performed.

Most patients are not told which mesh product was used in their surgery. The operative report from your surgeon or hospital will typically identify the manufacturer and product. Our firm can help you obtain and review those records to determine whether your case may qualify.

Free Legal Consultation

If you or a family member experienced complications after a breast surgery involving surgical mesh or an internal bra technique, our attorneys can help you evaluate whether you have a claim. We offer free, confidential consultations to women across California and nationwide, and we work closely with referring attorneys who would like the firm to evaluate or co-counsel breast mesh matters.

Statutes of limitations for product liability claims vary by state. In California, the limitations period is generally two years from the date the injury was discovered or reasonably should have been discovered. Because complications from breast mesh often develop years after surgery, the discovery rule can be critical. It is important to speak with an attorney as soon as you suspect that mesh may be linked to your injuries.

The firm represents all clients on a contingency fee basis. You pay no upfront costs and no out-of-pocket fees. We advance the costs of litigation and receive a fee only if we recover compensation on your behalf. If there is no recovery, you owe us nothing.

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