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Breast mesh implants promoted as “internal bra” supports have become the subject of legal and regulatory scrutiny. Not cleared for this use by the FDA, the mesh implants have been linked to higher rates of infections, reoperation and implant failure.

“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.

The “internal bra” technique uses synthetic or biologic mesh in combination with other breast surgeries to lift breasts and enhance results.

But in November 2023, the FDA released a safety communication emphasizing that no surgical mesh products — including those manufactured by Becton Dickinson (BD), C.R. Bard (also a part of BD), Ethicon/Johnson & Johnson and other major medical device companies — are cleared or approved for use in breast surgeries.

Despite this, mesh products have seen increased off-label use for internal bra techniques in breast surgeries with implants.

There are approximately 100,000 breast reconstruction surgeries per year and more than 300,000 breast augmentation surgeries per year in the US. The use of breast mesh in these procedures could put people at risk of higher complication rates.

Complications Linked to Breast Mesh

There is a long list of complications linked to internal bra mesh. These include infection, pain, mesh migration, wound dehiscence (separation), hemorrhage, adhesions (scar tissue), hematoma, inflammation, mesh extruding from the tissues and recurrence of soft tissue defects.

A 2021 study found that delayed wound healing, infections, hematomas, seromas (pockets of fluid) and tissue necrosis were among the complications that occurred within six months of breast surgery with mesh. The total complication rate per patient was 34%. About 13% of patients had to have their implants removed.

In some cases, complications occurred up to three years after the initial surgery.

A 2024 review published in Aesthetic Surgery Journal Open Forum found reoperation rates near 10% and implant loss in roughly 3% of cases associated with synthetic mesh use in breast surgeries.

Some mesh brands, such as FlexHD (Ethicon/Johnson & Johnson) and AlloMax (C.R. Bard/Becton Dickinson), have been found to have higher complication rates than other mesh brands, according to the FDA.

Citizen Petitions Raise Safety, Off-Label Marketing Concerns About GalaFLEX

Before buzz about potential injury lawsuits, Dr. Hooman Noorchashm, a research professor and co-director of the Amy J. Reed Medical Device Safety Collaborative at Northeastern University School of Law, had already been raising concerns about the off-label marketing and safety of the GalaFLEX internal bra techniques for breast surgery.

Noorchashm previously worked as medical director and safety monitor for BD, the maker of GalaFLEX.

While working in this capacity, Noorchashm raised concerns about using these mesh devices, which were biochemically active, in women who had breast cancer. He also found out that some women in BD’s trials had breast cancer recurrence, but none of these recurrence instances were reported to the FDA as required. 

After he told the company his concerns about internal bra mesh and other issues he saw at BD, the company fired him, Noorchashm said.

That didn’t stop him from trying to raise alarms. He filed a series of citizen petitions with the FDA that flagged BD and Galatea Surgical for promoting off-label marketing of GalaFLEX and Phasix and using human subjects for experimentation with these devices without proper formal authorization from the FDA.

Allegations in Emerging Breast Mesh Lawsuits

Allegations in breast mesh internal bra lawsuits mirror those from past mass torts over medical device safety, including promoting mesh for unapproved uses, failing to warn of risks and downplaying reported injuries.

“Mesh has historically caused complications when used in various surgical procedures,” Miracle told Drugwatch. “In light of this, the FDA has gone out of its way to confirm it hasn’t made any determination about the safety of surgical mesh in breast surgery, including in augmentation or reconstruction.”

Recently added warnings and notifications by the FDA may have come too late for some women.

For example, GalaFLEX was first cleared for marketing in 2014, but it wasn’t until 2023 that BD updated its labeling to include warnings and precautions.

Internal bra lawsuits are in the early stages. Those who suffered complications after internal bra procedures and are interested in learning more about lawsuits should contact a licensed attorney to find out if they qualify.