Case type Defective Medical Devices

Breast Mesh & Internal Bra Complications

Surgical mesh is sometimes used during breast reconstruction, augmentation, reduction and lift procedures to provide added support. This technique is often called an “internal bra.” Lawsuits allege that some patients were not adequately warned about complications linked to mesh used in breast surgery, including infection, chronic pain, fluid buildup, mesh exposure, tissue damage and the need for additional surgery.

If you experienced serious complications after breast surgery involving surgical mesh, CBW Law wants to hear your story. Tell Us Your Story.

Breast surgery can involve more than an implant.

During some procedures, a surgeon may place surgical mesh inside the breast to reinforce tissue or help support an implant. Patients may hear this described as an “internal bra.”

Products used in these procedures include synthetic surgical mesh and other materials designed to reinforce soft tissue.

The U.S. Food and Drug Administration has said it is aware of increased use of surgical mesh in breast surgery. The FDA has also stated that the safety and effectiveness of surgical mesh in breast surgery, including augmentation and reconstruction, has not been determined by the agency1.

Women are now filing breast mesh lawsuits alleging that certain manufacturers failed to adequately test or warn about risks associated with their products when used in breast procedures.

Reported complications can include infection, pain, fluid buildup, mesh exposure or movement, tissue damage, breast deformity and problems that lead to revision or removal surgery.

If you experienced serious complications after breast surgery involving surgical mesh, CBW Law wants to hear your story.

What Do Breast Mesh Lawsuits Allege?

Breast mesh lawsuits focus on surgical mesh that was placed during breast procedures such as:

  • Breast reconstruction
  • Breast augmentation
  • Breast lift
  • Breast reduction
  • Implant revision
  • Post-mastectomy reconstruction

The FDA has stated that the safety and effectiveness of surgical mesh in breast surgery has not been determined1.

Lawsuits allege that certain manufacturers promoted or sold mesh that was ultimately used in breast procedures without providing adequate warnings about potential risks.

Claims may include allegations involving:

  • Failure to adequately warn patients and doctors
  • Inadequate testing for use in breast procedures
  • Product design
  • Instructions and labeling
  • Marketing of the products
  • Complications that required additional medical care or surgery

These are allegations being made in individual lawsuits. Manufacturers may dispute the claims.

What Is an Internal Bra?

An “internal bra” is a term used to describe a surgical technique that provides added internal support to breast tissue or an implant.

A surgeon may place mesh or another scaffold material inside the breast and attach it to surrounding tissue.

The goal is to provide support while tissue heals or to help keep the breast or implant in position.

An internal bra is a surgical technique. It is not a specific brand or a single medical device.

What Products Are Being Reviewed in Breast Mesh Lawsuits?

Breast mesh litigation is developing, and different products may be involved.

Products being investigated or named in current litigation include mesh and scaffold products such as:

  • GalaFLEX
  • GalaFLEX Lite
  • GalaFLEX 3D
  • GalaFLEX 3DR
  • Phasix Mesh
  • Phasix ST Mesh

Other surgical mesh or scaffold products may also be involved.

Do not rule yourself out just because you do not recognize one of these names. Many patients were never told the brand of the mesh used in their surgery.

GalaFLEX and Phasix Mesh

GalaFLEX and Phasix products are made from poly-4-hydroxybutyrate, often shortened to P4HB. P4HB is a material the body slowly absorbs over time23.

The FDA has stated that certain BD mesh products, including GalaFLEX and Phasix products, are cleared for the repair and reinforcement of soft tissue where weakness exists1.

However, FDA clearance for soft-tissue reinforcement is not the same as an FDA finding that the products are safe and effective specifically for breast surgery.

In November 2023, the FDA informed health care providers that BD had updated warnings and precautions in the labeling for several mesh products, including GalaFLEX and Phasix products1.

The FDA also stated that the safety and effectiveness of surgical mesh in breast surgery had not been determined. It said no surgical mesh products are cleared or approved by the FDA for use in breast surgery1.

The FDA’s 2023 letter was about labeling updates. It was not a recall. The FDA also said it was not recommending removal of mesh in patients who have no symptoms1.

What If I Don’t Know Which Mesh Was Used?

Many patients may not know that mesh was used or may not remember the product name.

The product may be identified in:

  • Operative reports
  • Surgical records
  • Implant records
  • Hospital records
  • Medical device stickers or labels

You do not need to know the brand before contacting CBW Law.

Tell us what happened and what you know about your surgery.

Should You Speak With a Breast Mesh Lawyer?

CBW Law wants to hear from people who experienced significant complications after a breast procedure involving surgical mesh.

Procedures may include:

  • Breast reconstruction
  • Breast augmentation
  • Breast lift
  • Breast reduction
  • Implant revision
  • Reconstruction after mastectomy

Potential complications may include:

  • Infection
  • Chronic breast pain
  • Inflammation
  • Seroma or fluid buildup
  • Mesh exposure
  • Mesh erosion
  • Mesh movement or displacement
  • Delayed wound healing
  • Tissue damage or tissue death
  • Capsular contracture
  • Breast deformity
  • Implant problems
  • Reconstruction failure
  • Revision surgery
  • Mesh removal
  • Implant removal

You do not need to have had revision or removal surgery before you contact us. Some people are still deciding on treatment with their doctors.

The facts and medical history should be reviewed before any conclusions are made about a potential breast mesh lawsuit.

What Information Can Help a Breast Mesh Attorney Review a Claim?

Medical records can help show what product was used and what happened afterward.

Information that may be useful includes:

  • Date of the original breast procedure
  • Type of breast surgery
  • Surgeon
  • Hospital or surgical center
  • Operative report
  • Product or implant records
  • Mesh manufacturer
  • Mesh product name
  • Photos of complications
  • Records of infection or wound problems
  • Imaging
  • Records of follow-up treatment
  • Revision surgery records
  • Mesh removal records
  • Implant removal records
  • Pathology reports, when applicable

Do not assume there cannot be a claim because you do not have these records.

CBW Law can begin by listening to what happened and working out what information may be important to review.

How a Breast Mesh Lawsuit May Move Forward

The process begins with understanding the procedure and the complications that followed.

CBW Law may ask about:

  • When the breast surgery occurred
  • Why the procedure was performed
  • Whether mesh was used
  • When symptoms began
  • Treatment after the original surgery
  • Whether another procedure was recommended
  • Whether revision or removal surgery occurred

Medical records can then help identify the mesh product and document treatment.

Breast mesh litigation is still developing. Cases are being filed individually, and the way this litigation moves forward can change over time.

No one can promise that a breast mesh case will become part of a class action or multidistrict litigation.

Are There Breast Mesh Settlements?

Breast mesh litigation involving internal-bra procedures is still developing. We are not aware of any publicly reported breast mesh settlement or jury verdict in these cases.

Settlements in hernia mesh or pelvic mesh cases involve different products, different uses and different litigation. They do not tell you anything about a breast mesh settlement.

A breast mesh settlement is not guaranteed. The value or outcome of one case cannot be predicted from another case.

CBW Law will not promise a settlement amount or result. Our role begins with listening to what happened.

Plain English

Understanding Breast Mesh Medical Terms

Surgery records and doctor visits can be full of new words. Here is what some of them mean, in plain English.

Words you may hear

Surgical Mesh
A medical device used to reinforce or support weak or damaged soft tissue.
Internal Bra
A surgical technique that adds support beneath breast tissue or an implant. The technique may use surgical mesh or another scaffold material.
Seroma
A pocket of fluid that can collect under the skin after surgery.
Capsular Contracture
Hardening and tightening of scar tissue that forms around a breast implant. It can change the shape or feel of the breast and may cause pain.
Mesh Exposure
A complication in which mesh becomes exposed through surrounding tissue or a wound.
Tissue Necrosis
The death of body tissue. It can occur when tissue does not receive enough blood or is severely damaged.
Revision Surgery
Another operation performed to correct or treat a problem from an earlier procedure.
Explant
The surgical removal of an implanted medical device. In a breast procedure, this could involve removal of mesh, a breast implant or both.

Educational only. These are plain-language summaries, not medical definitions and not medical or legal advice. Ask your doctor what any of these words mean for you.

Questions

Breast Mesh Lawsuit Frequently Asked Questions

The questions patients ask first, answered in plain English.

What is breast mesh?

Surgical mesh is a medical device used to reinforce or support soft tissue. Some surgeons use mesh during breast reconstruction, augmentation, lifts, reductions or revision procedures to provide added support.

What is an internal bra?

An internal bra is a surgical technique that uses mesh, a scaffold or other material to support breast tissue or an implant from inside the body. It is not one specific product or brand.

Is surgical mesh FDA approved for breast surgery?

The FDA has stated that it is aware of increased use of surgical mesh in breast surgery. The agency has also stated that the safety and effectiveness of surgical mesh in breast surgery, including augmentation and reconstruction, has not been determined. Some mesh products are FDA cleared for broader soft-tissue repair and reinforcement, but that is different from a finding about their safety and effectiveness specifically in breast surgery.

How do I know if GalaFLEX or another mesh was used?

The product may be listed in your operative report, surgical records or medical device records. You do not need to know the product name before contacting CBW Law.

Do I need to have the mesh removed?

Whether to remove mesh is a medical decision for you and your doctor. You do not need to have had removal surgery just to speak with an attorney. The type and severity of the complication, medical recommendations, records and other facts may be important when reviewing a potential claim.

What if I had breast reconstruction after cancer?

Mesh may be used during reconstruction after a mastectomy as well as during cosmetic breast procedures. Tell us what type of procedure you had and what complications followed.

What if I do not have my medical records?

You can still contact CBW Law. Medical records may later help identify the product and document the procedure and complications.

Is there a breast mesh class action or MDL?

Breast mesh litigation involving internal-bra procedures is still developing. As of September 2026, we are not aware of a federal MDL or a certified class action for breast mesh claims. Lawsuits have been filed individually. That could change, and no one can promise how these cases will be grouped.

How much is a breast mesh lawsuit worth?

There is no standard value for a breast mesh lawsuit. The product involved, injury, medical treatment, additional surgeries, applicable law and other facts can affect an individual case. A lawyer cannot promise a settlement amount or outcome.

Talk to a Breast Mesh Attorney

You may not know the name of the mesh inside your body.

You may not know whether the complication you experienced is related to the mesh.

You do not need to figure that out alone before contacting CBW Law.

If you experienced infection, chronic pain, tissue damage, breast deformity, implant problems or another serious complication after breast surgery involving mesh, tell us what happened.

We can start with the information you have today.

Tell Us Your Story

This page is general information about breast mesh and internal bra complications. It is not legal or medical advice, and reading it does not create an attorney-client relationship. Talk to your doctor about your health and treatment. What the lawsuits describe are allegations, not findings, and the manufacturers may dispute them. No lawyer can promise a result or a settlement.

Keep reading

Breast mesh resources

Places to report a problem or keep reading away from any law firm’s website.

FDA

FDA letter on BD mesh labeling updates

The FDA’s November 9, 2023 letter to health care providers about GalaFLEX and Phasix labeling and mesh use in breast surgery.

Reporting

FDA MedWatch

The FDA’s program for patients and doctors to report a problem with a medical device.

FDA

FDA MAUDE database

The FDA’s public database of reports about medical device problems.

FDA

GalaFLEX 510(k) record, K140533

The FDA’s public clearance record for the original GalaFLEX mesh, cleared in May 2014.

Apparatus

Sources & Cited Articles

Different from Resources above. Resources are places to keep reading; this is the source material behind the factual and legal statements on this page, numbered so a marker in the text can point at one.

  1. Labeling Updates for BD Mesh Products – Letter to Health Care ProvidersU.S. Food and Drug AdministrationNovember 9, 2023 · Cited for the products covered, their clearance for soft-tissue repair and reinforcement, the FDA’s statements on mesh in breast surgery, and its recommendation on patients without symptoms. The letter concerns labeling, not a recall.
  2. 510(k) Premarket Notification K142818 — Phasix MeshU.S. Food and Drug AdministrationMarch 31, 2015 · The FDA’s clearance letter and summary for Phasix Mesh, submitted by Davol Inc., a subsidiary of C. R. Bard. Cited for its description of the mesh as a fully resorbable poly-4-hydroxybutyrate (P4HB) material and its indication for soft-tissue reinforcement.
  3. Fully resorbable poly-4-hydroxybutyrate (P4HB) mesh for soft tissue repair and reconstruction: A scoping reviewNational Library of Medicine, National Institutes of Health2023 · Cited for what P4HB is and how it is used in soft-tissue repair, including plastic and reconstructive surgery.

Accountability

Reviewed by

Craig Weiss, founder and managing attorney of CBW Law Firm

Craig Weiss

Managing Attorney · CBW Law

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