Internal Bra (Breast Mesh) Lawsuit

People who had surgery such as the internal bra technique using surgical mesh and suffered complications may qualify to file a breast mesh lawsuit for compensation. The breast mesh lawsuit alleges that mesh makers failed to warn about the risks of using mesh in breast surgeries, including infection, mesh failure and erosion.

The lawsuit also alleges that implant makers marketed their products for off-label use in breast surgery even though the FDA did not approve them for this use.

“There are approximately 100,000 breast reconstruction surgeries per year and 300,000 … augmentation surgeries a year in the U.S. … Mesh is used in what is often referred to as the ‘internal bra’ procedure. People are seeking legal advice because of injuries suffered as a result of the use of mesh in these procedures,” Trent B. Miracle, a mass tort and product liability lawyer with Flint Cooper, told Drugwatch.

Breast mesh is a specialized material used during breast reconstruction (after mastectomy), augmentation and revision/mastopexy procedures to provide internal support for tissue and implants.

The technique surgeons use to insert mesh into the breast is often called the internal bra technique. Like a bra, the mesh goes under the breast or over the breast to support tissue and maintain shape.

Individuals may qualify to file a breast mesh lawsuit if they received an internal bra mesh implant during breast reconstruction, augmentation or revision surgery and experienced serious complications or injuries that required surgery to fix.

Each case is different, so make sure to consult a licensed attorney to see if you qualify to file an internal bra lawsuit.

Mesh Complications & Warning Signs

Infection is a serious concern for mesh as the body may react to the foreign material, resulting in. One of the main complications and warning signs of mesh problems is. Serious infections may require reoperation and removal.

Some studies have found higher complication rates in breast surgeries with mesh, especially with ADM. These include higher incidences of seroma, infection, skin necrosis and implant loss.

Call your doctor right away if you have signs of an infection. These include elevated temperature, redness or swelling, severe breast pain or discharge from the incisions.

You should also call your doctor if you experience fatigue or feel unwell, as these can also be general signs of internal bra mesh complications.

In severe cases, you may need to undergo revision or implant removal surgery because of mesh complications. A 2024 Aesthetic Surgery Journal Open Forum study found reoperation rates as high as 10%. Implant loss occurred in about 3% of patients when synthetic mesh was used in breast reconstruction.

Evidence Needed to Start a Claim

To start an internal bra mesh claim, you’ll need to gather evidence. This includes proof you received a breast mesh implant, proof of your injuries and documentation of the damages you suffered.

Your lawyer can tell you exactly what evidence you will need for your individual claim.

How to Find Out Which Mesh You Received

You can find out which mesh you received by looking at your surgery records for device stickers, a Unique Device Identifier (UDI) and device lot number. Pathology records or imaging reports may also help.

In some cases, you may be able to access certain records to print out from your provider’s patient portal.

The FDA has released multiple safety communications about the use of ADM or mesh in breast surgeries. The agency hasn’t approved mesh for use in breast surgeries, including the internal bra technique.

Internal bra mesh products were allowed on the market through the 510(k) “clearance” process and were cleared for general soft-tissue support — not specifically for breast procedures. This is an important point for breast mesh lawsuits because the 510(k) only requires the demonstration of “substantial equivalence” to an existing product. It isn’t proof of safety and effectiveness in breast-specific applications.

In 2021, the agency issued a communication warning that some brands of ADM (may have significantly higher risks of complications than others — specifically FlexHD and AlloMax.

Breast Mesh Recalls & Label Updates

There hasn’t been a recall specifically for breast mesh. But, in 2023, the FDA announced label updates to synthetic bra mesh made by Becton, Dickinson and Company (BD). The company updated the warnings and precautions on the labels of several of its mesh products that are popular for breast surgeries.

The company reiterated that these products are cleared for the repair and reinforcement of soft tissue where weakness exists and that BD’s mesh devices haven’t been studied for use in breast reconstructive surgeries.

Mesh brands under legal investigation in potential internal bra lawsuits include meshes and ADMs produced by BD/C.R. Bard, Integra LifeSciences and Allergan/LifeCell.

DuroSorb and GalaFLEX are two of the most popular meshes used in internal bra surgeries. There is a good chance you may have received one of these brands if you’ve undergone the procedure.

You should be able to see the brand of mesh you received in your medical records. Your lawyer may help you find this information if you can’t. Even if you didn’t have one of these breast mesh brands, you should still call an attorney to see if you qualify for an internal bra lawsuit.

Since there haven’t been any breast mesh settlements yet, it’s impossible to determine exactly what these cases could be worth.

However, prior hernia mesh settlements might provide a comparison. These include C.R. Bard’s 2024 hernia mesh settlement to resolve nearly 40,000 claims for an estimated $1 billion or more. But comparisons to other mesh settlements can be misleading because breast mesh litigation has its own unique factors, injuries and legal considerations that could influence outcomes.

Typically, lawyers will have a better idea of case value after bellwether test trial jury verdicts or individual settlements have been offered. This can take a few years to determine.

Remember, there is no guaranteed settlement amount, and each claim has its own unique value. You can talk to your lawyer about potential settlement values.