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Breast Mesh Lawsuits

Maybe you had breast reconstruction after cancer. Maybe it was a lift, reduction, augmentation, gynecomastia correction, or chest surgery. And maybe something has not been right since, which resulted in another surgery – or recommendation for another surgery – to address those issues: pain that has not gone away, unusual hardening, mesh migration, or problems with healing.

You may have been told to give it time. Pain can be part of healing. Scar tissue can cause hardening. Not every difficult recovery means something went wrong.

The current breast mesh litigation involves allegations about surgical mesh and scaffolds used to provide support during breast procedures, sometimes described as an “internal bra.”

Plaintiffs allege that Becton, Dickinson and Company, or BD, marketed certain resorbable mesh products for use in breast surgery without conducting a clinical study establishing that they were safe and effective for that particular use. Lawsuits also allege that the material may not always absorb as represented and may be associated with complications reported by some patients.

Those are allegations. They have not been established as fact by a court.

The FDA’s position is separate and important.

In a November 9, 2023 letter to health care providers, the FDA stated:

“There are no surgical mesh products cleared or approved by the FDA for use in breast surgery, including in augmentation or reconstruction.”

The FDA further noted “the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

The products identified in the FDA letter are cleared “for the repair and reinforcement of soft tissue where weakness exists.”

They are not cleared or approved by the FDA for use in breast surgery.

That distinction is central to the litigation now being investigated.

Which Products Did the FDA Name?

The FDA’s November 2023 letter identified nine BD products:

Both the Phasix and GalaFLEX product families use poly-4-hydroxybutyrate, or P4HB. The material is made by fermentation, is designed to absorb over time, and is not derived from human or animal tissue.

That last distinction matters.

This investigation concerns non-biologic surgical mesh. Products such as AlloDerm, which is made from human donor tissue, and Strattice, which is derived from pig tissue, generally fall outside RDCY’s breast mesh investigation described on this page.

If you have no idea which product was used, that is not unusual. The records can answer the question.

What Problems Are Being Reported?

People bringing breast mesh claims have had explant, or revision, surgery completed, scheduled, or recommended due to complications including:

Nerve damage
Hematoma
Infection or abscess (BUT see below)
Mesh or reconstruction failure
Mesh migration or displacement
Scar tissue formation that is irregular or excessive
Seromas (fluid buildup)
Skin necrosis
Visible mesh

These are conditions reported in claims. They should not be read as a statement that breast mesh caused any particular patient’s condition.

Capsular contracture may also be relevant in some cases. It refers to scar tissue tightening around a breast implant, so it does not apply to every breast or chest procedure.

If you are experiencing pain, swelling, infection, hardening, changes in the surgical area, or another medical problem, talk to your treating physician. A legal review is not a substitute for medical care.

Find Out Whether Mesh Was Used

Breast mesh may have been used during procedures including:

Reconstruction after mastectomy
Breast augmentation
Breast reduction
Breast lift
Gynecomastia correction
Chest masculinization and other gender-affirming chest surgery
Revision surgery

If you are having problems after breast or chest surgery, the first useful question is whether surgical mesh was used at all.

What was put in my body during the surgery?

Some patients learn only later that surgical mesh or a surgical scaffold was used to provide internal support. That does not mean the mesh caused your symptoms. It does mean you have good reason to find out whether mesh was used and, if so, which product.

Start with your operative report. This is the surgeon’s account of what happened during the procedure and may identify the mesh or scaffold by name.

If the operative report does not give you a clear answer, other records may.

Look for:

An implant card or product sticker
An itemized surgical or facility invoice
Manufacturer registration or warranty paperwork
The surgical facility’s implant log

Do not be surprised if you cannot find everything in one place.

For procedures performed at an ambulatory surgical center, records may be divided among the surgeon’s office, the surgical facility, and sometimes an anesthesia group. Older practices may have closed or moved their records.

That can make the process frustrating. It does not necessarily make the answer unavailable.

If you have none of these records, you can still call us. We can talk through where your procedure took place, approximately when it occurred, what has happened since, and where the records are likely to be.

Finding out what was used is part of the investigation.

A free consultation with RDCY is the first step toward holding negligent parties accountable and ensuring that your rights are protected throughout the mass tort litigation process. Call (561) 516-5168 or contact Rafferty Domnick Cunningham & Yaffa online.

Who May Have a Breast Mesh Claim?

There is no reliable way to determine that from a checklist alone.

A potential case may warrant review when non-biologic mesh or a scaffold was used during breast or chest surgery and the patient later experienced a significant complication, particularly when revision or explant surgery has occurred or is being considered.

But there are many variations.

You may not know what product was used.

Your surgery may have happened years ago.

You may have had an early infection that could have several possible causes.

You may have symptoms but no recommendation for another surgery yet.

Those are reasons to look more closely at the records, not reasons to make assumptions about whether you have a case.

When you call Rafferty Domnick Cunningham & Yaffa, we will ask some basic questions: what procedure you had, approximately when and where it happened, what has changed since, whether your surgeon has discussed revision or explant surgery, and what records you already have.

If you have nothing, we can tell you where to begin.

If the facts do not appear to fit the litigation we are investigating, we will tell you that rather than simply signing you up.

The consultation is confidential.

This Is a Product Claim, Not a Claim Against Your Surgeon

For some people, this is an important distinction.

A claim about the device is not a claim against your surgeon.

The breast mesh litigation discussed here concerns the companies that designed, manufactured, and marketed the products and what plaintiffs allege those companies represented about their use in breast surgery.

Your surgeon may have used a product that was legally on the market and cleared by the FDA “for the repair and reinforcement of soft tissue where weakness exists.”

The questions being investigated concern the product and its manufacturer.

You do not have to accuse your surgeon of wrongdoing in order to ask whether you may have a product liability claim.

What Records Should You Keep?

You do not need to build the case yourself. But if you already have records, keep them.

Particularly useful documents may include your operative report, implant card or product stickers, surgical invoices, pre- and post-operative photographs or imaging, follow-up records, and records from any revision procedure.

If you undergo revision or explant surgery, the records documenting what was removed can be especially important.

Physical material removed during surgery may also become evidence. If another operation is being planned, you can tell your attorney and treating physician beforehand so the question of preserving relevant material can be addressed.

The medical decision about whether to undergo surgery remains between you and your doctor.

How Long Do I Have to Bring a Breast Mesh Claim?

There is no single nationwide deadline.

The answer may depend on where your surgery occurred, where you live, when you learned that a product may have been involved, and which state’s law applies.

But the surgery date does not necessarily answer the question. It’s more important to seek the advice of an attorney rather than trying to calculate the deadline yourself:

Timing is something we check, not something you should assume.

If you had surgery years ago but only recently learned that mesh may have been used, tell us both dates.

What Compensation May Be Available?

Depending on the facts and applicable law, a product liability claim may seek compensation for losses such as:

Medical treatment and future medical care
Revision or explant surgery
Lost income and diminished earning capacity
Out-of-pocket expenses
Pain and suffering
Disfigurement
Loss of enjoyment of life

Wrongful death claims may involve additional damages available to surviving family members under the law that applies to the case.

The value of an individual claim depends on the medical evidence, the nature and duration of the injury, future treatment needs, financial losses, and other circumstances.

That cannot responsibly be determined from a web page or an initial checklist.

How Rafferty Domnick Cunningham & Yaffa Investigates Breast Mesh Cases

For many people, the first job is simply reconstructing what happened.

We start by identifying the product. That can mean reviewing the operative report, implant documentation, invoices, surgical-center records, and other materials that show what was actually used.

Then we look at the medical history: what happened after surgery, when symptoms began, what treatment followed, and whether another operation has occurred or is being considered.

Where appropriate, medical experts can help evaluate the records and the relationship between the product, the procedure, and the complications being reported.

We also examine the law that applies to the particular claim and the deadlines that may govern it.

You do not need to arrive knowing the manufacturer, product name, lot number, or legal theory.

That’s what the investigation is for.

Frequently Asked Questions About Breast Mesh Lawsuits

How do I know if mesh was used during my breast surgery?

Start with your operative report. If that does not answer the question, look for an implant card or product sticker, itemized surgical invoice, manufacturer paperwork, or the surgical facility’s implant log.

If you do not have any of these documents, Rafferty Domnick Cunningham & Yaffa can help you determine which records to request.

Is GalaFLEX FDA approved for breast surgery?

No. The FDA has stated: “There are no surgical mesh products cleared or approved by the FDA for use in breast surgery, including in augmentation or reconstruction.”

GalaFLEX products are cleared for “the repair and reinforcement of soft tissue where weakness exists.”

Those are different things.

What does “internal bra” mean?

“Internal bra” is an informal term used to describe mesh or a scaffold placed inside the breast to provide additional support during certain surgical procedures.

It is not an FDA-cleared indication or regulatory term.

Do I need to have revision surgery before calling?

No.

If revision or explant surgery has already happened, is scheduled, or has been discussed with your doctor, tell us. We can review the circumstances and determine what additional information may be needed.

Is this a lawsuit against my surgeon?

The product liability claims discussed on this page concern the companies responsible for designing, manufacturing, and marketing the product, not a claim that your surgeon committed malpractice.

Different facts can raise different legal issues, but you do not need to accuse your surgeon of wrongdoing to have a potential breast mesh product claim reviewed.

Should I have the mesh removed?

That is a medical decision for you and your doctor.

The FDA has stated that it “is not recommending reoperation or removal of implanted surgical mesh in asymptomatic patients.”

That statement concerns patients without symptoms. If you are experiencing symptoms, discuss them and your treatment options with your physician.

Rafferty Domnick Cunningham & Yaffa does not advise patients for or against surgery.

Related Information

You Don’t Need to Know Whether You Have a Breast Mesh Lawsuit Before You Call

You may not even know whether you have breast mesh.

That’s okay.

Tell us what surgery you had, when you had it, and what has happened since. If your surgeon is discussing another operation, tell us that too.

From there, we can help determine what records exist, whether one of the products involved in this investigation was used, and whether your circumstances warrant a closer legal review.

You do not have to figure out the case before asking for help.

Rafferty Domnick Cunningham & Yaffa is based in Palm Beach Gardens and reviews potential breast mesh claims nationwide.

The consultation is free.