FDA, Studies Flag Breast Mesh Dangers: “Internal Bra” Implant Lawsuits on the Horizon
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Following FDA warnings and studies flagging internal bra implant complications, lawyers are beginning to file lawsuits for nerve damage, infection, mesh extrusion or erosion, reconstruction failure and other complications.
So-called “internal bra” techniques utilize mesh as a scaffold within the breast tissue to lift the breasts and reinforce the tissue.
In late 2023, the FDA issued a rare direct warning to practitioners, clarifying that no surgical mesh product — synthetic or biologic — should be used for breast augmentation, reconstruction or lifting. The agency also announced that GalaFLEX maker Becton, Dickinson and Company updated its warnings and precautions to reflect complications and off-label mesh use concerns.
Major brands like GalaFLEX, Phasix, AlloMax, and FlexHD have been widely adopted for internal bra surgeries, despite lacking explicit FDA clearance for mesh in breast implant surgeries.
“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 attorney at Flint Cooper, told Consumer Notice.
Reported Mesh Injuries and Studies
According to current studies, more than 100,000 breast reconstruction cases and 300,000 augmentations take place annually in the U.S. Mesh-related injury rates are emerging as concerns for women who may be considering breast surgery.
Complications linked to internal bras run the gamut: persistent pain, infection, mesh migration, wound breakdown, hemorrhage, adhesions, hematoma, mesh extrusion and soft tissue recurrence have all surfaced in medical literature.
According to a 2021 clinical review, over one-third of mesh recipients experienced complications. Delayed healing, fluid build-up and tissue death were common within the first six months. About 13% required the implants to be removed.
A separate analysis in 2024 placed reoperation risk near 10% and outright implant loss at roughly 3%, with some mesh brands faring worse than others for infection and surgical failures.
Doctor and Safety Advocate: “Nothing Okay About It”
Long before lawsuits began, safety concerns around GalaFLEX and other mesh types were raised by Dr. Hooman Noorchashm, a professor at Northeastern University’s Amy J. Reed Medical Device Safety Collaborative.
While briefly serving as BD’s Medical Director, Noorchashm reported that breast cancer recurrences in the company’s breast mesh clinical trials were withheld from FDA notice, and hundreds of adverse event reports lacked critical details about harm to recipients.
“They wanted me to handle about 400 or 500 adverse event reports,” he recalled. “I wasn’t going to sit there and rubber-stamp them … There was nothing okay about it.”
Noorchashm’s concerns led him to file citizen petitions flagging off-label marketing and unauthorized mesh experimentation with GalaFLEX products.
Allegations and Next Steps in Litigation
The core allegations echo past device injury lawsuits: manufacturers pushed mesh for breast surgeries not sanctioned by regulators, understated risks in promotional materials, and delivered warning updates only after years of complaints and complications from patients nationwide.
“Anyone who has suffered complications that appear to be related to mesh used in the surgical process should contact an attorney to see if they qualify for legal assistance,” Miracle said.
