Breast Mesh Lawsuit

If you went in for breast surgery and left with a surgical mesh implanted in your body, you expected it to help you heal, not leave you facing another medical problem.

Instead, you may be living with deep, constant pain, sudden swelling, red-hot infections, or physical deformities as the mesh pulls, hardens, or tears through internal tissue. Many women were later surprised to learn that the mesh used in their breast surgery had not been cleared or approved by the FDA for that purpose.

When multinational medical device companies put profit before human safety, Freese & Goss is prepared to take them on. With over $1 billion recovered for victims of defective medical products and in other negligence cases, our team knows how to take on huge corporations and win.

If you or a loved one had a breast procedure using surgical mesh and suffered serious complications, call us directly today at (214) 761-6623 or fill out our online form for a 100% free case review.

“This law firm is the best I’ve ever been to. In fact, Ms. Blanca is the nicest lady in the world. She not only took care of my case and got me way more than I expected, but she also stayed with me every step of the way. I really appreciate her so much. If anything were ever to happen to me again, she would be the first person I’d call. I would recommend anyone who needs a great lawyer to go to Ms. Blanca.”

– Linda F. | Client

Do You Qualify for an Internal Bra Mesh Lawsuit?

Not every breast mesh case involves the same products, procedures, or injuries. At Freese & Goss, we carefully review the details of each situation to determine whether someone may have a potential claim.

You may have a potential breast mesh lawsuit if:

1. A qualifying mesh product was used during your breast procedure

The current investigation focuses on certain synthetic mesh products, including:

• GalaFLEX mesh
• Phasix-family mesh products manufactured by Becton Dickinson (Bard)

These products were used by some surgeons during breast procedures even though they were not specifically approved by the FDA for breast augmentation, breast reconstruction, or other cosmetic breast surgeries.

2. The mesh was implanted during a qualifying breast procedure

Potential cases may involve procedures such as:

• Breast lifts 
• Breast augmentation
• Breast reconstruction after mastectomy
• Certain revision breast surgeries

3. You experienced complications linked to the mesh

Potentially qualifying injuries may include:

• Revision surgery or mesh removal, or a recommendation from a medical professional that revision or removal is needed because of mesh-related complications
• Infection or abscess formation
• Seroma (fluid buildup around the surgical site)
• Mesh erosion or migration
• Implant drooping, displacement, or breast asymmetry
• Chronic breast pain or nerve-related symptoms, especially when a medical provider has connected the symptoms to the mesh
• Permanent scarring or disfigurement
• Other complications involving inflammation, device failure, or the need for corrective surgery

4. The timing and circumstances of your procedure may matter

Very early revision procedures may require additional review to determine whether the issue was related to the mesh itself or a common complication associated with the original surgery.

If you are unsure what type of mesh was used during your procedure, that does not mean you cannot have your case reviewed. Medical records, operative reports, and implant documentation may help identify the product used during your surgery.

Every case is different. Freese & Goss can review your medical history, the device involved, and the complications you experienced to help determine whether you may have a claim. Schedule a free, no-obligation case review today by calling (214) 761-6623 or filling out our private online form.

What Is a Breast Mesh?

A breast mesh, sometimes marketed as an “internal bra,” is a flexible sheet of synthetic or biologic material that some surgeons use during cosmetic or reconstructive breast procedures. 

It is sewn into the breast tissue or around an implant to create a supportive sling that helps reinforce the breast, maintain its shape, or keep an implant in position while the body heals.

Some breast mesh products are made from synthetic materials that are designed to gradually dissolve as new tissue forms. Others are made from processed human or animal tissue, known as biologic mesh, which is intended to integrate with the body’s natural tissue. 

While both types are used to reinforce soft tissue, the current litigation is primarily focused on certain synthetic mesh products.

How Surgical Mesh Is Used in Breast and “Internal Bra” Surgeries

During cosmetic and reconstructive breast procedures, surgeons may implant surgical mesh to provide added support where natural tissue alone may not be enough. 

Depending on the patient’s anatomy and the procedure being performed, mesh may be used to reinforce weakened tissue, support breast implants, or help maintain breast shape during healing.

Common uses for breast mesh include:

• Breast reconstruction after a mastectomy: Mesh may be used to create or reinforce the implant pocket when there is not enough remaining skin or muscle to support a breast implant on its own.
• Breast lifts (“internal bra” procedures): Some surgeons place mesh beneath the breast to create an internal sling that supports the tissue and is intended to reduce future sagging.
• Breast augmentation and revision surgery: Mesh may be used during initial implant surgery or corrective procedures to reinforce thin tissue, improve implant positioning, address asymmetry, or provide additional support after previous surgeries.

How Long Do I Have to File a Breast Mesh Lawsuit?

Every state has its own statute of limitations that determines how long a person has to file a product liability claim. 

Breast mesh complications can sometimes develop gradually, making these deadlines more complicated than a typical injury claim. Symptoms may appear months or even years after the original procedure, particularly in cases involving chronic pain, inflammation, mesh migration, implant changes, scarring, or the need for revision surgery.

Factors that may affect the deadline to bring a claim can include:

• The date of your breast augmentation, lift, reconstruction, or revision surgery
• When you first experienced symptoms or were diagnosed with a mesh-related complication
• Whether a doctor linked your complications to the mesh product
• Whether you underwent mesh removal, implant removal, or corrective revision surgery
• The laws and discovery rules in the state where your claim is filed

Because missing a legal deadline could prevent you from pursuing compensation, it is important to speak with an attorney as soon as possible if you believe you were injured by a breast mesh product. 

Defective Products Named in Breast Mesh Injury Lawsuit

Freese & Goss is investigating claims involving certain synthetic breast mesh products made by Becton Dickinson and its subsidiaries, including C. R. Bard and Galatea Surgical.

If one of the following products was used during your breast surgery and you later experienced serious complications, you may be eligible to file a breast mesh lawsuit:

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

Financial Compensation a Breast Mesh Lawsuit Attorney Will Seek on Your Behalf

Breast surgery can already be a major financial and emotional investment. When complications develop afterward, the cost of additional procedures, medical care, and time away from work can create a strain you could not have anticipated. 

A lawsuit may seek compensation for the physical, financial, and emotional harm caused by complications, including:

• Medical expenses for initial breast procedures, corrective surgeries, and follow-up care
• Future medical treatment and long-term care needs related to mesh complications
• Costs associated with mesh removal, implant removal, replacement, or revision procedures
• Lost wages or reduced earning capacity caused by additional surgeries, recovery time, or ongoing complications
• Physical pain and discomfort caused by infections, nerve symptoms, scarring, or other mesh-related injuries
• Emotional distress and psychological harm caused by unexpected complications and changes to your breasts after surgery
• Compensation for permanent scarring, asymmetry, disfigurement, or other lasting physical changes
• Loss of enjoyment of life and the impact complications may have on relationships, confidence, and daily activities
• Out-of-pocket expenses related to travel, caregiving, medications, and other costs tied to treatment

When a medical device maker faces claims over an unapproved or faulty product, they use corporate lawyers trained to minimize what happened to your body. However, research highlights a major difference in outcomes for people who work with an attorney.

According to a nationwide legal study conducted by Martindale-Nolo, 91% of injury victims who hired an attorney recovered compensation, compared to just 51% of those who tried to handle their claims alone.

Our History Taking on Defective Mesh Manufacturers

Breast mesh litigation is still developing, but Freese & Goss has decades of experience handling complex medical device cases involving mesh injuries. Our attorneys understand how to investigate claims involving device design, safety warnings, manufacturer conduct, and the serious impact these products can have on patients’ lives.

With more than $1 billion recovered for injured clients, Freese & Goss has earned national recognition for taking on powerful medical device manufacturers and pursuing justice for people harmed by defective products. Our prior mesh litigation results include:

• $5,700,000 Verdict: This groundbreaking victory involved injuries caused by a pelvic mesh device with allegations of defective design and inadequate warnings. It was the first plaintiff verdict involving the TVT-Abbrevo mesh device.
• $1,200,000 Verdict: This case involved a pelvic mesh device that allegedly caused injuries due to design issues and failure to provide proper warnings. It resulted in the first trial and first plaintiff verdict involving the TVT-O mesh product.

Our prior experience and success in mesh litigation have primed our firm to take on the unique challenges in breast mesh litigation. Call (214) 761-6623 or fill out our online form to learn how we can help you in a Phasix or GalaFLEX lawsuit.

The Core Problem: Off-Label Use and Unapproved Applications

Although surgical mesh has long been used in other parts of the body, no surgical mesh product has been approved or cleared by the U.S. Food and Drug Administration (FDA) specifically for breast reconstruction, breast augmentation, or other cosmetic breast procedures. 

Even so, some manufacturers’ products were used in these surgeries through what is known as off-label use.

When medical device makers sold GalaFLEX or Phasix, they obtained clearance through general pathways for “soft tissue reinforcement,” such as those used in abdominal wall repairs. They then turned around and aggressively promoted these plastics to plastic surgeons for breast procedures.

Doctors are legally allowed to use medical devices “off-label,” meaning they can use an approved product for a purpose that has not been approved by the FDA. However, manufacturers are not allowed to market their devices for unapproved uses without reliable clinical evidence showing they are safe and effective for that purpose.

Your body isn’t a testing ground for plastic devices that were never cleared for breast tissue. If a synthetic mesh or “internal bra” left you dealing with dangerous and painful health complications, you have legal options.

The legal team at Freese & Goss knows how to uncover the truth in your surgical records, expose unapproved device marketing, and hold multi-billion-dollar manufacturers accountable. Let us take a look at what happened during your procedure and help you map out your next steps, with zero cost or pressure. Reach out today online or by calling (214) 761-6623.

Alleged Complications and Injuries in a GalaFLEX or Phasix Mesh Lawsuit

For many women, the first sign that something may be wrong is not just discomfort, but the need for more medical care. 

If you were advised by a medical professional to undergo revision surgery or mesh removal after developing complications from a breast procedure involving mesh, Freese & Goss may be able to help you understand your legal options. These complications may include:

• Infection and abscesses: Some patients develop infections around the mesh that require antibiotics, drainage procedures, or surgery to remove the mesh and address damaged tissue.
• Seromas: Fluid can collect around the surgical site, causing swelling, discomfort, and the need for repeated drainage procedures.
• Mesh erosion or migration: The mesh may shift from its intended position, break down improperly, or affect surrounding tissue.
• Implant drooping or asymmetry: When mesh does not provide the expected support, implants may shift, sag, or leave the breasts uneven in appearance.
• Chronic breast pain or nerve damage: Some patients report ongoing pain, burning, or nerve-related symptoms after mesh implantation.
• Permanent scarring or disfigurement: Complications involving infection, inflammation, or additional procedures may result in lasting changes to the breast’s appearance.
• Revision or mesh removal surgery: Some women require additional procedures to remove the mesh, revise the breast reconstruction, correct implant positioning, or address complications that developed after the original surgery.

FDA Warnings and Developments in Breast Mesh Litigation

Surgical mesh has been the subject of litigation and regulatory scrutiny for years in other areas, and that attention has increasingly extended to mesh products used in breast surgery. 

While certain surgical meshes were cleared for soft-tissue reinforcement applications, they were not specifically approved by the FDA for breast augmentation, breast reconstruction, or other cosmetic breast procedures.

March 2021 FDA Safety Communication on Breast Reconstruction Products

The FDA issued a safety communication regarding certain acellular dermal matrix (ADM) products used in implant-based breast reconstruction. The agency noted that complication rates varied among products and highlighted reported issues such as infection, reoperation, and implant-related complications.

November 2023 FDA Letter to Health Care Providers Regarding Surgical Mesh Use in Breast Procedures 

In November 2023, the FDA issued a Letter to Health Care Providers regarding updates to labeling for certain surgical mesh products, including products manufactured by Becton Dickinson and its subsidiaries, such as GalaFLEX and Phasix.

The FDA stated that surgical mesh products had not been determined to be safe and effective for use in breast surgery, including breast augmentation, reconstruction, or other breast procedures.

The agency clarified that FDA clearance for soft-tissue reinforcement does not mean a product is approved specifically for breast surgery. The FDA also emphasized the importance of discussing product indications, available clinical data, and potential risks with patients considering procedures involving mesh.

2025–2026 Breast Mesh Litigation Expands, and Manufacturer Practices Face Scrutiny

One of the most important issues emerging in breast mesh litigation is the significance of the FDA’s November 2023 communication regarding updated labeling for certain surgical mesh products, including products manufactured by Becton Dickinson and its subsidiaries.

For patients pursuing claims, the timing of these labeling changes has become a central issue. Plaintiffs may argue that manufacturers knew their products were being used extensively in breast procedures but failed to provide adequate breast-specific warnings regarding potential risks.

Manufacturers, however, may argue that surgeons independently selected these products for off-label use and that FDA clearance for soft-tissue reinforcement did not prevent physicians from using their medical judgment in other procedures.

As litigation develops, courts will likely examine questions such as:

• What did manufacturers know about the extent of breast-related use before the FDA labeling updates?
• Did companies provide physicians with sufficient information about potential risks associated with breast implantation?
• Were existing warnings focused on general soft-tissue reinforcement rather than the unique challenges of breast tissue and implant procedures?
• Could additional warnings or safety information have affected physician decision-making or patient consent?

Why Hire Freese & Goss

Being forced to deal with body-altering complications, unexpected surgeries, and unanswered questions because a corporation chased profits is devastating.

Holding massive medical device companies accountable requires more than general legal advice. It demands a team that has already gone to trial against these exact corporate defense teams and won. 

At Freese & Goss, we didn’t just join the fight against defective meshes; we helped lead it, securing first-of-their-kind verdicts including a $73.4 million victory in transvaginal mesh litigation. We know the corporate playbooks, we understand the complex medicine behind foreign-body reactions, and we have the resources and experience to stand up against large corporations. 

Call us directly today at (214) 761-6623 or fill out our online form to speak with our team.

Breast Mesh Injury Lawsuit FAQs