Breast Mesh Lawsuit Investigation

Berger Montague PC is investigating claims on behalf of individuals who suffered serious complications from defective breast mesh, or ‘internal bra,’ implants. If you were injured, you may have legal options and our team is here to help.

What is Breast Mesh?

Breast mesh, also known as acellular dermal matrix (ADM) or surgical mesh, is used in breast reconstruction and augmentation procedures. Breast reconstruction surgery may involve mesh to help hold an implant in place or to replace missing structural support after mastectomy. Surgeons also insert mesh into the breast is often called the internal bra technique as the mesh goes under the breast or over the breast to support tissue and maintain shape.

There are generally two types of mesh used:

• Biologic Mesh – made from processed human or animal tissue and designed to permanently integrate into the patient’s own tissue
• Synthetic Mesh – made from plastic-like or other man-made materials that can be resorbable or non-resorbable

Manufacturers of these devices marketed the products as safe and effective aids in breast reconstruction, implant support, and cosmetic surgery. Growing evidence, however, suggests that these products were defectively designed, inadequately tested, and improperly marketed — leaving victims to suffer severe consequences.

FDA Warnings

On November 9, 2023, the U.S. Food and Drug Administration (FDA) issued a labeling update regarding the following Becton, Dickinson and Company (BD) mesh products:

• Phasix Mesh
• Phasix ST Mesh
• Phasix Plug and Patch
• Phasix ST Mesh with Open Positioning System (OPS)
• Phasix ST Mesh with Echo 2 Positioning System, and
• GalaFLEX Lite Scaffold
• GalaFLEX Scaffold
• GalaFLEX 3D Scaffold
• GalaFLEX 3DR Scaffold

The FDA noted that these products are only approved for use in soft tissue repair and reinforcement and have not been approved for use in breast surgery. The FDA stated that “the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

Injuries Linked to Breast Mesh

A study from 2021 found several complications occurred within six months of breast surgery involving mesh. The total complication rate per patient was 34% with about 13% of patients having their implants removed. Problems associated with mesh also occurred up to three years after the initial surgery.

A 2024 Aesthetic Surgery Journal Open Forum review analyzed data from several clinical studies involving synthetic mesh in implant-based breast reconstruction and it found that reoperation rates reached nearly 10% of patients and implant loss occurred in approximately 3% of patients.

FDA adverse event reports involving mesh used in breast surgeries reflect the same general complications described in medical literature and patient accounts.

Injuries linked to breast mesh include:

• Breast distortion or deformity
• Infection and inflammation
• Chronic pain
• Mesh migration or displacement
• Hemorrhage
• Scar tissue
• Seroma, or fluid buildup under the skin
• Mesh extruding from the tissues
• Implant rupture
• Hematoma, or blood pooling under the skin
• Tissue necrosis

In severe cases, you may need to undergo revision or implant removal surgery because of mesh complications. These are consistent with injuries reported from other mesh products.

Common Breast Mesh Brands and Manufacturers

Consult With Us

At Berger Montague, a large team of talented lawyers and professional staff are assigned to this important litigation. We are available to speak with you free of charge about your potential claims. If we decide to represent you in a lawsuit, we will enter into a written contingent fee agreement with you. A contingent fee agreement means we only get paid if we win, and that we will receive our fees from the amount paid by the defendants in the case.

About Berger Montague

Berger Montague is one of the nation’s preeminent law firms focusing on complex civil litigation, class actions, and mass torts in federal and state courts throughout the United States. With more than $2.4 billion in 2025 post-trial judgments alone, the Firm is a leader in the fields of complex litigation, antitrust, consumer protection, defective products, environmental law, employment law, securities, and whistleblower cases, among many other practice areas. For over 55 years, Berger Montague has played leading roles in precedent-setting cases and has recovered over $50 billion for its clients and the classes they have represented. Berger Montague is headquartered in Philadelphia and has offices in Chicago; Malvern, PA; Minneapolis; San Diego; San Francisco; Toronto, Canada; Washington, D.C., and Wilmington, DE.