By the Editorial Staff | Updated June 2026 | No Fee Unless You Win

Women who had surgical mesh or scaffold products implanted during breast reconstruction, augmentation, or lift procedures and suffered serious complications may have legal options. Lawsuits allege these products were used off-label without adequate warnings or testing. Attorneys are reviewing claims from women across the country.

Case at a Glance

• What’s Alleged: Manufacturers promoted surgical mesh and scaffold products for use in breast surgery without FDA approval for that purpose, and failed to warn doctors and patients about serious complication risks
• Products Involved: Phasix Mesh, GalaFLEX Scaffold, and related BD products used in breast procedures
• Alleged Injuries: Revision surgery, removal surgery, abscess, adhesions, fistula, mesh migration, scarring, sagging, and other serious complications
• Key FDA Point: The FDA has confirmed no surgical mesh has been approved for use in breast surgery, making these uses off-label
• Current Status: Early-stage active litigation; no formal MDL established yet; cases being investigated and filed nationwide
• Cost to You: $0 upfront. Contingency fee only.

What Is the Breast Mesh Lawsuit About?

Surgical mesh and scaffold products have been used in breast reconstruction, augmentation, lifts, and so-called internal bra procedures for years. These products were originally designed for other types of surgeries, such as hernia repair. Plaintiffs allege that manufacturers promoted or allowed these products to be used in breast tissue without adequate testing in that setting and without FDA approval for that purpose.

The U.S. Food and Drug Administration has confirmed that no surgical mesh product has been approved for use in breast surgery, including breast reconstruction, augmentation, or mastopexy. That finding is central to these lawsuits because it establishes that when surgeons used these products in breast procedures, they were doing so in an off-label context that plaintiffs allege was not properly disclosed to patients.

Women who had these products implanted and later developed serious complications are now filing lawsuits alleging that the manufacturers knew about the risks associated with using mesh in breast tissue and failed to provide adequate warnings to surgeons or patients. The litigation is still in its early stages. No formal federal MDL has been established yet, and no widely reported settlements have been reached. But attorneys are actively investigating and filing claims, particularly involving BD products such as GalaFLEX and Phasix. Litigation status may change as cases develop.

What Does “Off-Label” Mean?

When a medical device is used off-label, it means it is being used in a way that the FDA has not reviewed or approved. Surgeons are allowed to use devices off-label, but patients and doctors should understand that the safety and effectiveness for that specific use may not have been studied. Plaintiffs allege that the use of these mesh products in breast surgery was off-label and that the risks were not adequately communicated to patients before their procedures.

Which Products Are Involved?

Attorneys are reviewing claims involving specific surgical mesh and scaffold products that were implanted during breast procedures. The surgery must have occurred in the United States. If you do not recall the exact brand of mesh used, that is acceptable under current case guidelines. This list is subject to change as the litigation develops.

Phasix Product Line (BD)

• 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

GalaFLEX Product Line (BD)

• GalaFLEX Lite Scaffold
• GalaFLEX Scaffold
• GalaFLEX 3D Scaffold
• GalaFLEX 3DR Scaffold
• Other breast mesh products (name required if known)

Do Not Recall the Brand? You May Still Qualify: Many women do not know the exact name of the mesh product implanted during their procedure. Under current case guidelines, if you cannot recall the brand, you may still proceed. An attorney can help identify the product through surgical records and operative notes. What matters most is that you had a breast surgery involving mesh or a scaffold product and suffered a qualifying complication as a result.

Alleged Injuries Being Reported

These cases involve complications that go beyond ordinary post-surgical discomfort. Pain alone does not qualify under current case guidelines. The alleged injuries attorneys are reviewing are documented medical complications that required treatment. You must be able to provide the approximate dates when each injury began, and must have received some form of treatment or medical consultation for the injury. Eligibility criteria may change as the litigation develops.

Surgical Complications

• Additional or revision breast mesh surgery due to complications
• Breast mesh removal due to complications
• Abscess
• Fistula

Physical Harm

• Adhesions
• Mesh migration
• Scarring
• Sagging
• Other serious injury more severe than pain alone (description required)

Mesh Removal Is Itself a Qualifying Injury

Because breast mesh is typically permanent or semi-permanent, having it removed or revised is not routine. If you had a revision or removal surgery due to complications from your original breast mesh procedure, that surgery itself may be considered a qualifying injury, since it would only occur if the original implant caused problems. Medical records documenting the removal or revision will be an important part of the claim.

Treatment Is Required: To qualify under current case guidelines, you must have received treatment for your injury. Treatment includes a consultation with a medical provider regarding your qualifying complications, since a record of that consultation can serve as proof the injury occurred and was addressed. You must also be able to provide the name and address of the facility that implanted the mesh, any facility that removed it, and all treatment providers involved in your care. These criteria are subject to change.

Who May Qualify?

These claims have specific requirements. All of the following must apply for a claim to move forward under current guidelines. Eligibility criteria may change as the litigation develops.

General Eligibility Requirements

• Had one of the qualifying breast mesh or scaffold products surgically implanted during a breast procedure
• The breast implant surgery occurred in the United States
• Experienced at least one qualifying complication as a result of the mesh, beyond pain alone
• Can provide the approximate dates when each injury or complication began
• Received treatment or medical consultation for the qualifying injury
• Can provide the name and address of the facility that implanted the mesh, the facility that removed it if applicable, and all treatment providers
• Is a lawful U.S. resident currently residing in the United States

Why These Cases Have Legal Weight

The FDA’s position that no surgical mesh has been approved for breast surgery is a foundational element of these lawsuits. It means that every time one of these products was used in a breast procedure, it was being used outside the scope of what regulators had reviewed and approved. Plaintiffs allege that manufacturers knew their products were being used this way and failed to conduct the studies or issue the warnings that an off-label use of this significance required.

BD, the manufacturer of both the Phasix and GalaFLEX product lines, has already resolved a large hernia mesh litigation portfolio. Attorneys and industry observers have noted that this prior litigation history may affect how breast mesh claims are valued and defended going forward, making this an important early window for potential claimants.

What the Lawsuits Allege

• Off-Label Use Without Adequate Warning: Plaintiffs allege that mesh and scaffold products were used in breast surgery without FDA approval for that purpose, and that manufacturers failed to warn surgeons and patients about the risks specific to that off-label use.
• Failure to Test: Lawsuits claim that these products were not adequately studied for use in breast tissue before being promoted for or used in breast reconstruction and augmentation procedures.
• Defective Design: Some complaints allege that the products were not suitable for use in breast tissue and that their design created foreseeable risks of migration, infection, and other serious complications.
• Products Liability: Plaintiffs argue that the products were defective as marketed because they were sold and promoted in ways that did not accurately reflect the risks of using them in breast surgery.
• Negligent Manufacturing and Marketing: Lawsuits claim that manufacturers actively promoted these products for breast procedures or allowed their widespread off-label use without taking steps to ensure patient safety or provide appropriate disclosures.

Subject to Change: This litigation is still in its early stages. The products covered, the qualifying injuries, the legal theories being pursued, and the overall status of the litigation may all change as cases develop. No formal MDL has been established as of the date of this page. This page will be updated regularly. A legal review is the best way to get current information specific to your situation.

Who May Have a Claim

A claim may be available for women who had a Phasix, GalaFLEX, or other qualifying breast mesh or scaffold product surgically implanted during a breast procedure in the United States and who later suffered a documented complication beyond pain alone. The surgery must be linked to a specific product, and the person must have received treatment for the complication and be able to provide relevant facility and provider information.

The claimant must be a lawful U.S. resident currently residing in the United States. You do not need to remember the exact brand of mesh used before reaching out. An attorney can help identify the product through your surgical records.

You do not need everything organized before reaching out. A case review is free, confidential, and can help identify what records may be needed and whether your situation may qualify.

Frequently Asked Questions

Can I file a lawsuit if I had breast mesh or a scaffold implanted during breast reconstruction and developed complications?

You may qualify if you had a Phasix, GalaFLEX, or other qualifying breast mesh or scaffold product implanted during a breast procedure in the United States and suffered a documented complication beyond pain alone. You must have received treatment or medical consultation for the complication and be able to provide information about the facilities involved. A case review can help assess whether your specific situation may qualify under current guidelines.

Which breast mesh and scaffold products are included in these lawsuits?

Attorneys are currently reviewing claims involving the Phasix Mesh line including Phasix Mesh, Phasix ST Mesh, Phasix Plug and Patch, and Phasix ST Mesh with OPS or Echo 2 positioning systems, as well as the GalaFLEX Scaffold line including GalaFLEX Lite, GalaFLEX Scaffold, GalaFLEX 3D Scaffold, and GalaFLEX 3DR Scaffold. Other breast mesh products may also qualify. If you do not remember the exact brand, you may still be able to proceed. A case review can help identify the product through your surgical records. This list is subject to change.

What complications from breast mesh surgery may qualify for a lawsuit?

Alleged injuries currently under review include revision surgery due to complications, mesh removal surgery, abscess, adhesions, fistula, mesh migration, scarring, and sagging. Pain alone does not qualify. The injury must be a documented medical complication for which you received treatment. You must also be able to provide the approximate date when each complication began. Eligibility criteria may change as the litigation develops.

I do not remember the brand of mesh used in my breast surgery. Can I still file a claim?

Yes. Under current case guidelines, you may still proceed even if you do not recall the exact brand of mesh used during your procedure. An attorney can help identify the specific product through your surgical records and operative notes. What is most important is that you had a breast surgery involving mesh or a scaffold product and experienced a qualifying complication as a result.

Why is the FDA’s position on breast mesh important to these lawsuits?

The FDA has confirmed that no surgical mesh product has been approved for use in breast surgery, including breast reconstruction, augmentation, or mastopexy. This means that every use of these products in breast procedures is considered off-label. Plaintiffs allege that manufacturers knew their products were being used this way and failed to conduct adequate studies or provide sufficient warnings about the risks specific to breast tissue. That off-label use without proper disclosure is a central legal argument in these cases.

What medical records and information will I need to support a breast mesh lawsuit?

You will need to be able to provide the name and address of the facility where the mesh was implanted, the facility where it was removed if applicable, and all treatment providers involved in your care for mesh-related complications. You should also be able to provide the approximate dates when your complications began. You do not need to gather all of these records before reaching out. An attorney can help identify what documentation exists and guide you through what may be needed.

How much does it cost to find out if I qualify for a breast mesh lawsuit?

Nothing. The case evaluation is free and confidential. If a case is accepted, attorneys work on a contingency fee basis, meaning there are no upfront costs and no legal fees unless the case results in a settlement or verdict in your favor. No outcome or recovery can be guaranteed.

Think You May Have a Case?

Our team works with women who have suffered serious complications after breast mesh or scaffold products were used in their surgery. A case review is free, confidential, and comes with no obligation.

• A brief conversation about the procedure, the product involved, and what complications occurred
• No documents needed before we talk
• No fees unless your case results in a recovery

See if Your Situation Qualifies →

This litigation is still developing. The sooner you reach out, the more options you may have.