Internal Bra Lawsuit

Internal bra lawsuits may be filed by women who were injured by breast mesh side effects like infections, tissue damage, reconstruction failure, needing another surgery, and more.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Internal Bra injury cases in all 50 states. If you or somebody you know was injured by an internal bra or breast mesh implant, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.

What is an Internal Bra?

Plastic surgeons and influencers are hyping the “internal bra,” a new type of cosmetic surgery in which surgical mesh is used to support sagging breast tissue or artificial breast implants.

Doctors claim that adding mesh will produce longer-lasting, more natural results — but do these unproven benefits actually outweigh the added costs and risk of severe side effects?

Is Internal Bra Surgery Safe?

Internal bra surgery with breast mesh is NOT approved by the FDA, but in recent years the use of mesh in breast surgery has grown increasingly popular. Surgeons now commonly use mesh in breast surgeries, including plastic surgeries like the “internal bra” and other types of breast surgeries.

The FDA has issued several safety warnings about potential complications when mesh is used in breast surgery, but surgeons may not be fully informing their patients about the risk of severe side effects from internal bra surgery.

Can I File an Internal Bra Lawsuit?

If you have an internal bra, or breast mesh surgery, you may be able to file a lawsuit if you experienced complications, such as:

Severe infection
Disfigurement
Unnatural breast shape
Nerve damage (reduced sensitivity)
Scar tissue
Numbness or loss of sensation
Breastfeeding complications
Chronic pain
Needed another surgery (revision surgery to remove the mesh or repair other breast injuries)
And other serious complications

Types of Internal Bra Mesh Implants

The internal bra is a cosmetic procedure that uses “breast mesh” or “bra mesh implants.” This surgery involves implantation of a flexible mesh-like material under the breast, which acts like a hammock or sling to support sagging breast tissues, or hold the weight of artificial implants.

Breast Mesh Surgeries

Breast mesh is commonly used in a variety of breast surgeries, including:

“Internal bra” cosmetic surgery
Breast lift (mastopexy)
Breast augmentation with mesh (often called an “internal bra” under artificial breast implants)
Implant-based breast reconstructive surgery following a mastectomy (surgery to remove the breasts, usually due to breast cancer)
Breast reduction surgery

Why Do Doctors Use Breast Mesh?

Doctors who use mesh in “internal bra” surgeries will commonly tell women that it will help support their weakened breast tissue (or breast implants), and improve cosmetic outcomes by keeping the breast and/or implant in the correct position and proper shape during the healing process, thus creating a more lifted, longer-lasting, and symmetrical appearance.

Breast Mesh Is Not Approved by FDA

The problem is that many women may have no idea that the use of mesh in breast surgery has not been FDA-approved, and the risks may outweigh the benefits — especially women who suffer complications or need another surgery due to infections, tissue damage, or breast reconstruction failure.

Nerve Damage After Internal Bra Surgery

Breast mesh has also been linked to nerve damage, which can have a devastating impact on a woman’s quality of life.

Nerve damage in the breast may result in a loss of sensation or numbness, chronic pain or discomfort due to mesh used in internal bra surgery. In a lawsuit for internal bra injuries, this type of injury could also result in “loss of consortium” claims from the victim’s spouse due to a loss of companionship, affection, or sexual intimacy.

Can I File a Lawsuit for Internal Bra Side Effects?

Women who were injured by internal bras are now seeking legal advice from a lawyer who can help them file a lawsuit or join a class action against the manufacturers who hyped up these products and failed to provide adequate warnings about the risk of severe injuries.

Examples of Surgical Mesh Products

Some examples of surgical mesh products include:

GalaFLEX (Becton Dickinson / BD / Galatea Surgical)
Phasix (C.R. Bard / Becton Dickinson)
Strattice (Allergan / LifeCell Corporation)
AlloDerm (Allergan / LifeCell Corporation)
DuraSorb (Integra LifeSciences)
FlexHD (Ethicon / Johnson & Johnson)
SurgiMend (C.R. Bard / Becton Dickinson)
AlloMax (C.R. Bard / Becton Dickinson)
And more

What is Dermal Matrix Mesh (ADM)?

Acellular Dermal Matrix (ADM) is a type of biological surgical mesh that is commonly used “off-label” for internal bra breast surgery to provide support for weakened tissues. The FDA has approved ADM mesh for hernia repair surgeries, but it is not approved for internal bras or any other breast surgery.

Types of Dermal Matrix Breast Mesh

There are a wide range of ADM products on the market. They can be created from human skin (such as FlexHD, AlloMax, AlloDerm) or animal skin (such as SurgiMend). The skin is sterilized and processed to remove the cells, leaving behind a support structure of natural connective tissue that acts as a scaffold for new tissues to grow. The mesh is supposed to slowly dissolve.

Synthetic Mesh for Internal Bra Surgery

There are also several types of synthetic surgical mesh products that surgeons are using for internal bra surgery (such as GalaFLEX or DuraSorb). These products are made of a medical-grade plastic material that is placed under the breast tissue. The mesh is supposed to provide a scaffold for tissue growth, and then gradually dissolve when the healing process is complete.

What is Breast Mesh?

Breast mesh looks like a thin, flexible sheet of material that is shaped like a hammock, sling, or scaffold to support breast tissue. The mesh may be used with or without an artificial breast implant in various surgeries.

When it is used along with a breast implant, the surgeon places the mesh under the implant like a sling or hammock, and secures the mesh against the chest wall. The mesh holds the weight of the implant to prevent sagging.

Breast mesh is designed to slowly dissolve over the next 6-24 months, depending on the type of product, as the body slowly replaces it with natural collagen and scar-tissue. This is advertised to produce more “natural-looking” and “longer-lasting results” compared to skin-tightening procedures alone.

Breast Lifts

Breast mesh is also used to enhance the effects of a “breast lift.” Plastic surgeons use a combination of mesh and sutures to connect tissues and correct sagging breasts, or to fix the placement of drooping artificial implants.

Breast Reconstruction Surgery

Breast mesh is also commonly used “off-label” for breast reconstruction surgery in women who have had a mastectomy (surgery to remove the breast). There are several methods for reconstructing the breast after a mastectomy, and it is not always necessary to use mesh. Even so, it is becoming increasingly common for surgeons to routinely use a combination of a breast implant and surgical mesh in breast reconstructive surgery.

What Are Off-Label Surgeries?

Surgeons are allowed to use surgical mesh in breast surgeries, even though this use is not included in the FDA-approved labeling. This is called an “off-label” use. Patients should know that it carries risks because the procedure has not been thoroughly studied for safety or evaluated by the FDA.

Doctors are supposed to use their medical expertise to decide when the “off-label” use of a medical device or implant will provide the best outcome for the patient. The problem is that without adequate studies to rely on, doctors may not be able to make an unbiased, well-informed decision about what is best.

Internal Bra Problems May Not Be Fully Understood for Years

If there is an increased risk of severe side effects when mesh is used for internal bra surgery, the problem may not be obvious right away. It could be years before researchers raise the alarm by publishing studies based on real-world data, the FDA issues safety warnings based on reports of injuries, and manufacturers announce recalls for high-risk devices. By that time, many women will be living with the long-term consequences of a mesh implant.

FDA Warning for BD Breast Mesh Products

In November 2023, the FDA published a letter to health care providers about BD Mesh Products, including:

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, and
GalaFLEX Lite Scaffold
GalaFLEX Scaffold
GalaFLEX 3D Scaffold
GalaFLEX 3DR Scaffold

The FDA has only approved BD surgical mesh products for the repair and reinforcement of soft tissue where weakness exists.

The FDA is aware that BD mesh is being increasingly used off-label for breast surgeries, but “the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

FDA Warning About Higher Risk of Complications from FlexHD and AlloMax Mesh

In March 2021, the FDA published a Safety Communication to warn about a higher risk of complications for Acellular Dermal Matrix (ADM), which is a type of surgical mesh used in implant-based breast reconstruction.

The FDA said patient-level data suggests that two products — FlexDH and AlloMax — may have a higher risk of complications. The data showed “significantly higher complication rates of explantation (implant removal), reoperation and infection in patients with FlexHD and AlloMax brands of ADM two years following surgery.”

How Can a Lawsuit Help?

Women who were injured by side effects of internal bra surgery may be eligible to file a lawsuit or join a class action.

These lawsuits will typically seek a settlement or financial compensation for the victim’s pain and suffering, medical expenses, lost income, decreased quality of life, and other serious injuries.

Surgical Mesh Lawsuits

It is important to speak with an attorney who is experienced in mesh implant lawsuits. Thousands of mesh lawsuits have already been filed against manufacturers of products like vaginal mesh and hernia mesh.

Some of these lawsuits have ended in settlements or multi-million dollar jury verdicts, but most mesh lawsuits are currently consolidated in Multi-District Litigation (MDL) for pre-trial proceedings.

All of these mesh lawsuits accuse manufacturers of failing to adequately warn patients and doctors about risks like chronic pain, infection, nerve damage, needing another surgery, and other severe complications.

Do I Have an Internal Bra Lawsuit?

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