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Breast Mesh Lawsuits Grow as Women Report Internal Bra Complications

In 2026, women began filing lawsuits over surgical mesh used during breast surgery. The cases name BD and companies connected to its GalaFLEX and Phasix mesh. The women allege they were not warned about the risks of using mesh as an “internal bra.” The companies can contest these claims, and no court has made any finding. Here is what we know so far.

Who the lawsuits name

The lawsuits are aimed at Becton, Dickinson and Company, known as BD, and companies connected to its mesh products. FDA records list Tepha, Inc. as the company that submitted the original GalaFLEX mesh for clearance in 2014. They list Davol Inc., a subsidiary of C. R. Bard based in Rhode Island, for Phasix mesh. Bard is now part of BD.

Each case is filed on its own. The facts differ from person to person, including the type of surgery, when the mesh was placed and what happened afterward.

What the women allege

The lawsuits generally allege that mesh was used in breast surgery even though the FDA has never cleared or approved any surgical mesh for that use. They also allege that the companies did not warn women and their doctors enough about the risks.

Claims like these are usually brought under product liability law. They can include failure to warn, negligence and strict product liability, which focuses on whether a product was unsafe.

These are allegations. The companies may deny them, and they have not been proven in court.

Complications women describe

Women in breast mesh lawsuits and patients speaking to lawyers describe problems such as:

  • Infection
  • Chronic pain, including nerve pain
  • Swelling and inflammation
  • Seroma, a pocket of fluid under the skin
  • Mesh exposure through the skin or a wound
  • Tissue damage
  • Revision surgery or mesh removal

Mesh can be placed during reconstruction after a mastectomy, breast augmentation, breast lifts, breast reductions and implant revision surgery.

Where the FDA stands

In November 2023, the FDA told doctors that BD had updated warnings for GalaFLEX and Phasix products. The FDA said it has not determined that mesh is safe and effective in breast surgery. It also said no surgical mesh is cleared or approved for breast surgery. The letter was not a recall.

Plaintiff lawyers are organizing

The American Association for Justice is a national group of trial lawyers. In spring 2026, it formed a Breast Mesh Litigation Group for lawyers handling these cases.

A new litigation group shows that plaintiff attorneys are actively looking at these cases. It does not say anything about how any case will end.

Is there an MDL or settlement?

As of September 2026, we are not aware of a federal MDL for breast mesh claims. An MDL groups similar federal cases before one judge. We are also not aware of any class action, public settlement or jury verdict in breast mesh cases. Hernia mesh and pelvic mesh settlements involved different products. They are not breast mesh results.

A breast mesh settlement is not guaranteed. If you had problems after breast surgery involving mesh, you can learn more about internal bra mesh lawsuits and the records that can help a lawyer review what happened.

This article is general information about how these cases work. It is not legal advice, it does not create an attorney-client relationship, and no two claims are alike. If something here sounds like your situation, the useful next step is a conversation about the facts.

Sources and citations

Statutes, regulations, agency material and decisions referred to above.

  1. Labeling Updates for BD Mesh Products – Letter to Health Care ProvidersU.S. Food and Drug AdministrationNovember 9, 2023. Source of the product list, the clearance wording, the FDA’s statements on mesh in breast surgery and its recommendation on patients without symptoms.
  2. 510(k) Premarket Notification K140533 — GalaFLEX MeshU.S. Food and Drug AdministrationCited for the May 21, 2014 clearance of the original GalaFLEX mesh, submitted by Tepha, Inc.
  3. 510(k) Premarket Notification K142818 — Phasix MeshU.S. Food and Drug AdministrationMarch 31, 2015. FDA clearance summary for Phasix Mesh, submitted by Davol Inc., a subsidiary of C. R. Bard, in Warwick, Rhode Island. Cited for the P4HB material and its expected absorption time.

Vetted by

Stefan Rest, managing director of CBW Law

Stefan Rest

Managing Director, CBW Law

Stefan Rest has spent more than two decades advocating for consumers and helping people understand how the law may provide a path forward when they’ve been wronged. As Managing Director of CBW Law, he oversees client relations, the firm’s national law-firm network and new partnerships. He writes about developing litigation and consumer legal issues because the right information can help people recognize when their own story may matter.

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