Breast Mesh Lawsuits May Follow Reports of Potential “Internal Bra” Complications

Breast mesh products marketed as “internal bras” for cosmetic and reconstructive surgeries are facing increased legal scrutiny following reports of complications allegedly associated with these devices, which were never approved for breast procedures. Women across the country are reporting serious complications, including infections, chronic pain, and implant failures, which could spur a wave of lawsuits against manufacturers who allegedly promoted these products for unapproved uses despite knowing the risks.

Understanding the “Internal Bra” Technique and Its Alleged Risks

The “internal bra” technique involves using synthetic or biological mesh materials to support breast tissue during breast augmentation, reconstruction, or lift procedures. Surgeons place these mesh products beneath the breast tissue to create a hammock-like support structure meant to enhance surgical results and maintain breast shape over time.

Despite their growing popularity, these mesh products were never approved by the FDA for use in breast surgeries. In November 2023, the FDA issued a safety communication about surgical mesh products manufactured by Becton Dickinson (BD), stating that “the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

Studies Linking Breast Mesh to Potential Side Effects

Scientific research has identified numerous complications allegedly linked to breast mesh implants. A 2021 study documented a 34% complication rate among patients receiving mesh during breast procedures, with 13% ultimately requiring implant removal. Another breast mesh study published in 2024 found reoperation rates approaching 10% and implant loss in approximately 3% of cases involving synthetic mesh use in breast surgeries.

Common complications reported by patients who receive breast mesh implants include:

• Infection and chronic inflammation
• Severe pain and nerve damage
• Mesh migration or contraction
• Tissue necrosis and wound separation
• Implant failure requiring removal
• Breast deformity and asymmetry

Breast Mesh Regulatory Concerns and FDA Warnings

The FDA’s recent breast mesh safety communication raised concerns about the growing use of surgical mesh in breast procedures. The agency emphasized that while these products are “cleared for the repair and reinforcement of soft tissue where weakness exists,” their use in breast surgeries constitutes “off-label” application—a practice that occurs at a physician’s discretion but without specific FDA evaluation for safety and effectiveness in breast tissue.

Some mesh brands, including FlexHD (manufactured by Ethicon/Johnson & Johnson) and AlloMax (C.R. Bard/Becton Dickinson), have been specifically identified as having significantly higher complication rates compared to other mesh products, according to FDA documentation.

Parallels to Previous Surgical Mesh Lawsuits

Emerging complaints about alleged breast mesh complications bear striking similarities to previous mass tort actions involving surgical mesh products. Over the past decade, tens of thousands of lawsuits have been filed over alleged complications from hernia mesh and transvaginal mesh implants, resulting in billions of dollars in settlements and verdicts.

These earlier claims alleged that surgical mesh manufacturers were aware of potential complications, such as mesh shrinkage, material degradation, and inflammatory reactions, years before implementing design changes or issuing recalls. Critics argue that manufacturers should have learned from these alleged issues before promoting similar materials for breast procedures.

Alleged Surgical Mesh Side Effects

The alleged biological response to mesh implants appears consistent across different surgical applications. Whether used for hernia repair, pelvic organ support, or breast augmentation, mesh materials may potentially trigger similar complications:

• Foreign body reactions and chronic inflammation
• Mesh contraction and migration
• Tissue erosion and necrosis
• Adhesion to surrounding organs or tissues
• Pain and functional impairment

Potential Legal Claims in Breast Mesh Lawsuits

Women who pursue breast mesh lawsuits may potentially allege several forms of manufacturer wrongdoing, including:

• Promoting products for unapproved uses: Marketing mesh products specifically for breast procedures despite lacking FDA clearance for this application
• Failure to warn: Not adequately disclosing known risks associated with mesh implantation in breast tissue
• Defective design: Creating products unsuitable for long-term implantation in breast tissue
• Negligent testing: Failing to conduct appropriate safety studies before promoting products for breast surgeries
• Concealing adverse events: Allegedly downplaying or failing to report complications observed during clinical use

The breast mesh litigation is currently in the early stages, with attorneys nationwide evaluating potential claims from women who allegedly experienced complications following internal bra procedures.

Who May Qualify for Breast Mesh Litigation?

Women who underwent breast reconstruction, augmentation, or lift procedures involving mesh implants and subsequently experienced serious complications may be eligible to pursue legal action. Qualifying complications may include:

• Infections requiring medical intervention
• Chronic pain or nerve damage
• Mesh migration or contraction
• Tissue damage or necrosis
• Implant failure requiring removal
• Additional surgeries to address mesh-related problems

The litigation may encompass various mesh products used in breast procedures, including but not limited to GalaFLEX, Phasix, Strattice, FlexHD, and AlloDerm. These products are manufactured by companies including Becton Dickinson, C.R. Bard, Ethicon/Johnson & Johnson, and others.

Many Women Are Unaware of Potential Breast Mesh Risks

For the approximately 400,000 women who undergo breast reconstruction or augmentation surgeries annually in the United States, the use of unapproved breast mesh products represents a potential health risk. Many patients report they were never informed that the mesh used in their procedures lacked specific FDA clearance for breast applications.

The breast mesh controversy highlights ongoing concerns about medical device regulation and the responsibilities of manufacturers to ensure patient safety, particularly when promoting products for “off-label” uses beyond their approved applications. As breast mesh lawsuits emerge, they may provide both compensation for allegedly affected women and important safeguards for future patients considering breast procedures.