Breast Mesh Problems Prompted FDA Warnings Over Off-Label Use

Officials have warned that “internal bra” mesh used in breast surgery has been linked to higher rates of infection, implant loss, tissue breakdown and revision surgery.

Despite FDA warnings dating back to 2021, manufacturers have continued to sell mesh implants as “internal bras” for breast reconstruction and augmentation procedures, even though the products have never been approved as safe or effective for use during breast surgery, and have been linked to reports of painful injuries and complications.

Over the past several years, mesh scaffolds like Phasix, GalaFLEX, Strattice and similar products have been widely used by plastic surgeons to reinforce weakened breast tissue and improve implant positioning. These products were originally cleared through the 510(k) pathway for soft-tissue reinforcement in hernia repair, but were later adopted in breast procedures without formal FDA review or clinical trials specific to the breast.

Without any breast-specific approval, manufacturers began selling mesh to plastic surgeons for its supposed cosmetic and structural benefits, which in return were used for breast augmentations and reconstructive surgeries.

Now, as studies document higher rates of infection, implant displacement and revision surgery tied to these internal bra techniques, those early FDA warnings are being reconsidered as a direct reflection of what the clinical data is showing.

The agency made its stance clear years ago that no mesh device has been approved for breast implantation, and that all use in reconstruction or augmentation is off-label. Yet manufacturers continued presenting these products as internal support systems, allowing an unapproved application to gain widespread acceptance, despite a lack of breast-focused safety evaluation.

As more women report complications and undergo revision surgeries, many are now seeking legal representation and exploring potential breast mesh lawsuits, alleging that manufacturers continued selling these devices being used for internal bra procedures despite FDA warnings and no approval for use in breast tissue.

FDA Warnings About Breast Mesh Risks

In parallel with emerging clinical evidence, the U.S. Food and Drug Administration (FDA) has issued multiple safety communications highlighting the lack of approval for breast mesh products and the rising reports of adverse outcomes tied to their off-label use in breast reconstruction and cosmetic surgery.

FDA Safety Communication on Acellular Dermal Matrices

In March 2021, the FDA issued a Safety Communication directed at biologic mesh materials known as acellular dermal matrices (ADMs), which had rapidly become common in post-mastectomy reconstruction.

Following a mastectomy, many women undergo implant-based breast reconstruction to restore breast shape after cancer surgery. To support the implant and reduce visible rippling or collapse, surgeons began inserting acellular dermal matrix mesh between the skin and implant as a structural layer. These biologic grafts were used as a way to improve cosmetic outcomes, provide soft-tissue coverage, and create a stronger pocket for the implant to sit in.

As a result, ADMs quickly became a common mesh option in post-mastectomy breast reconstruction, even though they were never formally approved by the FDA for implantation in breast tissue.

In the FDA’s notice, the agency indicated that products like Strattice, AlloMax, FlexHD and similar grafts were being implanted to support breast implants following cancer surgery, despite never receiving FDA approval for that purpose.

Based on internal adverse event data, published clinical outcomes, and reports submitted to the FDA’s MAUDE database, the agency found that:

• Infection and implant loss rates were elevated in reconstructions involving biologic mesh
• Reoperations were more frequent when these materials were used, compared to traditional techniques
• Mesh performance varied significantly depending on how the material was processed and where it was implanted

The FDA reiterated that no acellular dermal matrices (ADMs) or synthetic mesh products are approved or cleared for breast surgery, and that their use in this context remains off-label.

GalaFlex and Phasix Mesh Warning Label Updates

In November 2023, the FDA issued a Letter to Health Care Providers after Becton, Dickinson and Company (BD) updated the labeling on several of its mesh implants to include new warnings and precautionary language.

While the updated labels acknowledged reports of mesh being used in breast procedures, the FDA made it clear that these changes did not reflect any new approval or clearance for breast surgery.

According to the agency, none of the BD mesh products have been evaluated or authorized for use in breast tissue, despite their increased use among plastic surgeons as internal support implants. The FDA stated:

“The FDA is aware of increased use of surgical mesh products in breast surgery. However, the safety and effectiveness of surgical mesh in breast surgery, including in augmentation or reconstruction, has not been determined by the FDA.”

The agency cautioned surgeons not to rely on the device’s soft-tissue reinforcement clearance, originally granted for hernia repair and similar procedures, as justification for breast use. Instead, providers were instructed to review the updated labeling carefully, disclose the off-label status to patients, and report any mesh-related injuries or revision surgeries through the MedWatch surveillance system.

The FDA’s notice specifically referenced the following BD mesh products:

• GalaFLEX 3D Scaffold
• GalaFLEX 3DR Scaffold
• Phasix Mesh
• Phasix ST Mesh
• Phasix Plug and Patch
• Phasix ST Mesh with Open Positioning System (OPS)
• Phasix ST Mesh with Echo 2 Positioning System
• GalaFLEX Lite Scaffold
• GalaFLEX Scaffold

Breast augmentation remains one of the most frequently performed cosmetic surgeries in the United States, with hundreds of thousands of women undergoing implant procedures every year. Critics now claims that as demand grew, manufacturers capitalized on an opportunity to expand mesh use beyond medical reconstruction and into the far larger cosmetic market.

However, this strategy, which critics say prioritized market expansion over patient safety, has now led a growing number of injured women to seek legal representation and pursue compensation for mesh-related complications.

As reports of internal bra mesh complications continue to rise, lawyers are now investigating breast mesh lawsuits against manufacturers who sold these devices to surgeons, who in return used them for breast reconstruction and augmentation without FDA approval or long-term safety data.

Claims are being reviewed for women implanted with breast mesh products who later suffered infections, mesh migration, implant failure, chronic pain, or required revision surgery, alleging that manufacturers failed to warn about the risks of implanting mesh in breast tissue and misled surgeons about its safety.