Breast Mesh and ‘Internal Bra’ Lawsuit Investigation

Attorneys working with ClassAction.org are looking to file lawsuits on behalf of people who were injured by internal bra mesh placed during breast reconstruction, augmentation, reduction and lift procedures.

Reports have begun to emerge of complications that could be associated with breast mesh, which is increasingly being used during breast surgeries in what is sometimes referred to as the “internal bra” technique. Specifically, patients have reported experiencing infection, fluid buildup, tissue death, mesh migration or exposure, chronic pain and failure of the mesh or implants. Many times, these complications require additional surgeries (called revision procedures) and can result in the removal of the implants or mesh.

The Food and Drug Administration (FDA) has warned that surgical mesh products, including GalaFLEX, Phasix Mesh and others, have not been cleared or approved by the agency for use in breast surgery, and attorneys are now investigating whether lawsuits can be filed claiming the manufacturers failed to properly test the mesh for safety and efficacy, promoted it for off-label use in breast surgeries and failed to warn patients about the risks.

Lawsuits could potentially hold mesh manufacturers responsible for the harm caused to patients and help them recover money for medical expenses, pain and suffering, emotional distress, physical disfigurement, lost wages and more.

What Is Breast Mesh and the ‘Internal Bra’?

Surgical mesh is a medical device used to help reinforce weak or damaged soft tissue. Though it was originally developed and approved for hernia repair, mesh has increasingly been sold to cosmetic surgeons for use in breast surgeries—including breast reconstruction after a mastectomy, breast augmentation or reduction, or breast lifts—especially in conjunction with implants.

The use of breast mesh in this context is sometimes described as placing an “internal bra” or using the “internal bra technique” because the mesh is placed under the breast tissue or implant to provide additional support within the breast. In the internal bra procedure, breast mesh is inserted through an incision and secured to the chest wall or other stronger parts of the breast, forming what’s been described as a scaffold into which new tissue grows as the body heals.

Internal bras are often marketed as able to prolong the results of a breast surgery and prevent or address ptosis (drooping), “bottoming out” and implant migration.

However, surgical mesh has never been approved by the FDA for use in breast surgeries, and the agency has issued warnings to healthcare providers stressing that its safety and efficacy for such a use has not been determined.

November 2023 FDA Warning on BD Mesh Products

In November 2023, the U.S. Food and Drug Administration (FDA) issued a letter to healthcare providers informing them that the labels for Becton, Dickinson and Company (BD) mesh products, including GalaFLEX mesh and Phasix mesh, had been updated with certain warnings and precautions.

The FDA said it was aware that the use of mesh for breast surgery has been increasing but that its safety and efficacy for such a purpose has not been determined by the agency.

According to the breast mesh FDA letter, no surgical mesh products have been cleared or approved by the FDA for use in breast surgery.

The agency urged healthcare providers to read and follow the updated labeling for the following BD breast mesh products:

• 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 Lite Scaffold
• GalaFLEX Scaffold
• GalaFLEX 3D Scaffold
• GalaFLEX 3DR Scaffold

Despite the FDA warning, no Phasix mesh recall or other breast mesh recall has been issued. However, if you experienced Phasix or GalaFLEX mesh complications, you may be able to take action. Keep reading to learn more about your eligibility to file a GalaFLEX lawsuit or Phasix Mesh lawsuit.

Reported Internal Bra Complications and Injuries

Studies have reported various breast mesh complications and internal bra side effects, including the following:

• Infection
• Mesh migration or displacement
• Mesh or reconstruction failure
• Delayed wound healing
• Chronic pain or nerve damage
• Seroma (fluid buildup under the skin)
• Hematoma (blood pooling under the skin)
• Capsular contracture (tightening of scar tissue around the implant, which can cause pain, hardening and a distorted appearance)
• Tissue death (necrosis)
• Tissue erosion
• Visible mesh

In some cases, breast mesh complications can result in additional surgeries, including removal of the mesh and implants.

In fact, one 2024 review of 19 studies involving synthetic mesh breast reconstruction surgeries found that reoperation was performed in roughly 10% of cases.

Some surgeons and healthcare professionals have cited an increased risk of complications and the potential for internal mesh bra side effects in explaining why they choose not to use breast mesh in their procedures. Their stated concerns include a higher risk of infection due to the body reacting to the mesh as a foreign material and the fact that if breast mesh complications arise, the mesh can be difficult to remove given its integration with surrounding tissue. Some doctors have also noted that the long-term effects of breast mesh are not fully known.

If you’ve experienced GalaFLEX mesh side effects or complications with another type of breast mesh, you may be able to take legal action. Fill out the form on this page to learn more about filing an internal bra lawsuit.

Who May Qualify for a Breast Mesh Lawsuit?

The attorneys want to speak with anyone who:

• Had a breast reconstruction, augmentation, reduction or mastopexy (breast lift) in 2016 or later;
• Had a mesh product (internal bra) placed during the surgery; and 
• Had a revision procedure performed or scheduled, or had a consultation about a breast mesh revision, due to complications from the surgery.

The attorneys are not accepting claims at this time for injuries involving acellular dermal matrix products (e.g., AlloDerm, FlexHD or Strattice). However, you may be able to file a GalaFLEX lawsuit or Phasix Mesh lawsuit if you received either of these two popular breast mesh products.

If you’re not sure which mesh you received, you don’t need to find out before getting in touch with one of the attorneys we work with. This information can typically be found in your medical records, and if your attorney thinks you may have a case, they can request your medical records on your behalf to verify what type of mesh was used.

Fill out the form on this page to get in touch with a breast mesh attorney or legal representative and learn more about your eligibility to file a breast mesh lawsuit.

Is This a Class Action Lawsuit?

No, this is not a class action lawsuit. Instead, attorneys working with ClassAction.org are handling breast mesh lawsuits on an individual basis, meaning you will hire your own attorney who will file an internal bra mesh lawsuit on your behalf. This is because the attorneys believe the injuries and other harm potentially caused by breast mesh are serious enough to warrant individual action.

Class action lawsuits are typically filed on behalf of a large group of individuals who have suffered a comparatively small harm, such as purchasing a falsely advertised product. In these situations, the case is only financially viable if handled collectively, as the cost of separate lawsuits for affected individuals would outweigh any potential recovery.

Learn more about the difference between class action lawsuits and individual injury lawsuits here.

What’s Involved in Filing a Breast Mesh Lawsuit?

If you decide to pursue an internal bra mesh lawsuit, the attorney you hire will first need to gather some relevant information and documents from you or on your behalf. This may include:

• Basic contact information
• Details about the procedure you underwent that involved the use of breast mesh
• When and where you received this procedure
• Medical records detailing what type of breast mesh was used, any complications experienced and, if applicable, any subsequent treatment and/or revision procedure(s)
• Information about how the breast mesh injury has affected your life

After your attorney has gathered enough information and documentation, they will begin drafting a complaint. A complaint is a legal document that, when filed, officially begins your lawsuit. Yours will contain information such as who you are suing (the defendants), how and why your injuries occurred and why you believe the defendants are responsible.

For example, your breast mesh lawsuit may allege that:

• The mesh manufacturer failed to inform doctors and patients about the risks associated with the mesh or the way it was used in your procedure
• The manufacturer failed to properly test the mesh to ensure its safety and efficacy for breast surgeries
• The manufacturer marketed the mesh for a purpose or procedure for which it was not FDA-approved
• The implantation of the mesh directly led you to develop an infection, pain, a deformity, tissue loss or other issues, some of which may have required additional surgeries to repair

Once your internal bra lawsuit has been filed with the court, your attorneys will go back and forth with the defendants’ attorneys to try to resolve the case. Generally, a case will either settle, be dismissed or go to trial (though jury trials are increasingly rare in civil cases).

During this process, which may take months or even years, the attorneys may:

• Attend court hearings
• File memos, responses, exhibits, motions, briefs and other documents with the court
• Consult with medical experts
• Issue subpoenas
• Engage in discovery, a formal exchange of information that may involve taking depositions

It should be noted that in some cases, often in those involving harmful medical devices, similar lawsuits may be consolidated into one court before one judge to help efficiently manage the litigation, ensure consistent rulings and save time and money for everyone involved. This kind of consolidated action is known as multidistrict litigation, which involves the court appointing a group of qualified attorneys to coordinate pre-trial proceedings and help resolve the case as a whole.

As the multidistrict litigation proceeds, a handful of the involved lawsuits may be selected to proceed as “bellwether trials,” meaning they serve as test runs to see if juries tend to side with the defendants or with the plaintiffs. For example, if the defendants lose all or most of the bellwether trials, they may decide to reach a global settlement to avoid the risk and uncertainty of jury trials in the remaining lawsuits. If the defendants win more of the bellwether trials, a settlement may not be established.

You can learn more about multidistrict litigation here.

How Much Does a Breast Mesh Lawyer Cost?

Attorneys working with ClassAction.org are handling breast mesh lawsuits on a contingency fee basis—which means if they don’t win your case, you don’t pay. In a successful lawsuit, the attorneys will take a percentage of your breast mesh settlement or jury award as their payment.

What Could I Recover from a Breast Mesh Lawsuit?

An internal bra lawsuit could potentially seek money for any injuries or damage caused to the patient by the allegedly harmful product, including the following:

• Medical bills, including the costs of the initial breast surgery and any revision surgeries
• Pain and suffering
• Emotional distress
• Permanent disfigurement
• Lost wages

Mesh Lawsuit Settlements and Verdicts

Some of the same companies that make breast mesh have been sued over other surgical mesh devices that allegedly caused injuries and complications.

In 2020, C.R. Bard and parent company Becton, Dickinson and Company (the maker of GalaFLEX and Phasix Mesh) reached a $60 million settlement to resolve litigation over pelvic mesh, also called transvaginal mesh, which was used to treat stress urinary incontinence and pelvic organ prolapse. According to the litigation, filed by the attorneys general of 48 states and the District of Columbia, C.R. Bard knew about and failed to warn doctors and patients about the potential for serious complications associated with pelvic mesh, including mesh erosion, pain during sexual intercourse and voiding dysfunction. In 2019, the FDA banned the sale of all mesh products for use in pelvic organ prolapse repair following reports of complications.

In 2019, Johnson & Johnson agreed to pay $117 million to resolve litigation over its pelvic mesh devices. The company and its Ethicon unit faced thousands of lawsuits filed by women who claimed they were injured by the company’s transvaginal mesh. Similarly, Boston Scientific reached a $189 million vaginal mesh lawsuit settlement in 2021, agreeing as part of the settlement to “describe more accurately to consumers the safety and risks” of surgical mesh.

In 2024, Becton, Dickinson and Company agreed to settle 38,000 lawsuits filed by people who claimed to have been injured by its hernia mesh devices, with payouts to take place over the course of several years. The settlement came after four hernia mesh lawsuits went to trial, with three of the plaintiffs securing verdicts of $255,000, $500,000 and $4.8 million, respectively. The company prevailed in the other trial.

Breast Mesh Lawsuit FAQs

What is an internal bra?

An “internal bra” is a technique used in breast surgeries that involves placing breast mesh, including products like GalaFLEX, Phasix Mesh and DuraSorb, under the breast tissue as a type of internal support. An internal bra procedure may be performed as part of a breast lift, reconstruction or augmentation, especially in situations where the skin is thought to be too thin or stretched to provide enough support on its own.

What is breast mesh?

Breast mesh is a medical device made from synthetic or biological material that is used to reinforce weakened soft tissue. Surgeons are increasingly using mesh in breast augmentation, reduction, reconstruction and lift procedures. It is typically placed under the lower pole of the breast and anchored to stronger surrounding areas (such as the chest wall) to support the breast tissue and/or implants during the healing process and either remains within the breast or is absorbed by the body.

What is GalaFLEX?

GalaFLEX is a breast mesh product made from poly-4-hydroxybutyrate (P4HB), an absorbable biologically derived polymer. It is commonly used in breast lift, breast augmentation, breast reconstruction and revision surgeries, acting as a scaffold or lattice to support the breast as new tissue grows into the mesh.  

What are the complications of breast mesh?

Breast mesh complications may include infection, delayed wound healing, mesh migration or displacement, tissue erosion or necrosis, seroma formation, hematoma, capsular contracture, chronic pain, visible mesh, and removal of the mesh or implants.

Can I sue for capsular contracture?

Capsular contracture has been reported as a potential complication of breast mesh. If you experienced capsular contracture or other complications after having a breast lift, breast reduction, breast reconstruction or breast augmentation with mesh in 2016 or later and then sought or had revision surgery performed, you may be eligible to file a mesh lawsuit. Fill out the form on this page to learn more.

Is mesh approved for breast surgery?

The FDA has clarified that no breast mesh product, including GalaFLEX and Phasix Mesh, has been approved for use in breast surgery. The agency has warned that these products have been used off-label by cosmetic surgeons even though the FDA has never determined their safety and efficacy for such procedures.

What brand of breast implants are being recalled?

No breast mesh recall has been issued yet. In November 2023, the FDA warned that certain breast mesh devices, including GalaFLEX and Phasix Mesh, had their labeling updated to include certain warnings and precautions for healthcare providers. The agency noted that no breast mesh products have been approved for use in breast surgery.

How do I know if I had mesh?

Information about your breast surgery, including whether breast mesh was used and what type of mesh was used, should be included in your medical records. An attorney should be able to request your medical records on your behalf to help determine whether you are eligible to file a mesh surgery lawsuit.

Do I have to know the manufacturer?

You do not need to know the manufacturer of your breast mesh before speaking with an attorney or legal representative. If the attorney believes you may have a case, they can request your medical records on your behalf to find out which company manufactured the breast mesh used in your surgery.

What is the average payout for a mesh lawsuit?

Since the breast mesh investigation and litigation is still in its early stages, there have not been any settlements or jury verdicts yet. However, factors that could influence how much your mesh implant lawsuit is worth may include the severity of your injuries, whether you needed one or multiple revision surgeries, the duration of your pain and suffering, the impact on your life and the extent of your financial losses, including medical expenses and lost wages.

Injured by Breast Mesh? Take Action

After you fill out the form, a breast mesh attorney or legal representative may reach out to you directly to ask you some questions and explain more about what’s involved with filing an internal bra lawsuit. It costs nothing to fill out the form or speak with someone, and you’re not obligated to take legal action if you decide not to.

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