7 Major Companies Face 'Internal Bra' Mesh Lawsuits After FDA Warning

FDA Warning Sparks Wave of Internal Bra Mesh Litigation

A growing number of women are filing lawsuits against major medical device manufacturers following FDA warnings about the use of surgical mesh in breast procedures, commonly known as "internal bra" surgery [2]. The FDA released a safety communication in November 2023, emphasizing that no surgical mesh products are cleared or approved for use in breast surgeries [3]. This warning has prompted lawyers to investigate claims against seven major manufacturers for allegedly promoting mesh products for unapproved breast surgeries while understating serious risks [4].

Major Manufacturers Under Legal Scrutiny

Several prominent medical device companies are now facing potential litigation related to their mesh products used in breast surgeries [5]. The manufacturers under review include Becton Dickinson and Company (BD), C.R. Bard, Ethicon, Allergan/LifeCell, and Integra LifeSciences [6]. Specific products mentioned in the investigations include GalaFLEX Scaffold and Phasix Mesh from BD, AlloMax from C.R. Bard/BD, FlexHD from MTF Biologics, Strattice from Allergan/LifeCell, DuraSorb from Integra LifeSciences, and AlloDerm from Allergan/LifeCell [7].

Off-Label Use Creates Legal Liability

The core of these lawsuits centers on the fact that the FDA has not approved any surgical mesh products for use in breast surgery, including augmentation, reconstruction, or lift procedures [8]. This means any use of mesh in these procedures is considered "off-label" use. Lawsuits allege that manufacturers failed to adequately test the safety and efficacy of mesh used in the breast, failed to warn patients and doctors about the risks of complications, and improperly marketed the devices for non-approved uses in breast surgery [9].

Alarming Complication Rates Drive Legal Action

Scientific studies reveal concerning complication rates that are fueling the litigation. A 2021 study found a total complication rate of 34% within six months of breast surgery with mesh, with about 13% of patients requiring implant removal [10]. A 2024 review found reoperation rates near 10% and implant loss in roughly 3% of cases associated with synthetic mesh use in breast surgeries [11]. A 2023 meta-analysis found infection rates of approximately 5%, seroma around 5%, skin necrosis approximately 5.5%, and implant loss around 4% [12].

Extensive Range of Documented Complications

Women who have undergone internal bra mesh procedures have reported a wide range of serious complications [2]. These include infection, chronic pain, mesh migration, wound dehiscence (separation), hemorrhage, adhesions (scar tissue), hematoma, inflammation, mesh extruding from tissues, recurrence of soft tissue defects, seroma (fluid buildup), tissue necrosis, implant loss, nerve damage, scarring or deformity, capsular contracture, need for reoperation, and reconstruction failure [3].

Massive Patient Population at Risk

The scope of potential harm is significant given the number of breast surgeries performed annually in the United States. There are approximately 100,000 breast reconstruction surgeries and more than 300,000 breast augmentation surgeries per year in the US [4]. Women who have undergone breast augmentation, breast lift procedures, implant-based breast reconstruction, or revision surgeries using surgical mesh may be affected by these complications [5].

Company Response and Label Updates

In response to growing concerns, the FDA announced label updates in 2023 to synthetic bra mesh made by Becton, Dickinson and Company (BD) [6]. 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 [7]. Additionally, in December 2025, several plastic surgeons issued internal-bra warnings cautioning that mesh products used in breast lifts and augmentations may offer little proven benefit while exposing patients to serious risks, including infection, inflammation, deformity and failed reconstruction [8].

Early Stage Litigation with Billion-Dollar Precedent

As of early 2026, no breast mesh class action lawsuit has been filed, nor has a formal multidistrict litigation (MDL) been established to coordinate proceedings for internal bra claims [9]. Internal bra lawsuit claims are in the early stages, and there have been no settlements or jury verdicts yet [10]. However, prior hernia mesh settlements provide insight into potential compensation levels. C.R. Bard settled nearly 40,000 hernia mesh claims in 2024 for an estimated $1 billion or more [11].

Legal Investigation Continues

Lawyers are currently accepting clients and gathering evidence to file claims against the manufacturers [12]. The allegations focus on the manufacturers' promotion of mesh for unapproved breast surgeries, understated risks, and inadequate warnings that were only updated after years of patient complications. The legal teams are also asserting that manufacturers marketed these products for breast surgery without adequate testing [2].