Breast mesh claims for injured consumers

What makes a breast mesh claim eligible

Thousands of women underwent breast reconstruction, augmentation, breast lifts, and internal bra procedures during which surgeons implanted surgical mesh products to provide internal support. What many of those women were never told is that no surgical mesh product has ever been cleared or approved by the FDA specifically for breast surgery. The manufacturers whose products were used in these procedures marketed them for soft-tissue reinforcement and allowed widespread adoption in breast procedures without conducting breast-specific safety testing or disclosing the risks that came with that use.

Women who developed serious complications after breast mesh implantation are now filing lawsuits alleging that manufacturers failed to warn them, promoted products for uses the FDA never sanctioned, and placed revenue ahead of patient safety. If you received surgical mesh during a breast procedure and later experienced complications, contact Atraxia Law today for a free and confidential case evaluation.

Because breast mesh litigation has not yet been consolidated into a federal MDL, eligibility is evaluated case by case rather than against standardized court criteria. Most plaintiff firms look for the following:

• The claimant underwent breast reconstruction, augmentation, a breast lift, an internal bra procedure, or implant revision surgery in which surgical mesh was implanted
• A qualifying product was used, confirmed through operative reports or implant records
• Serious complications developed after implantation, including infection, chronic pain, capsular contracture, implant loss, mesh exposure, or cosmetic deformity
• Complications required additional medical treatment such as revision surgery, mesh or implant removal, hospitalization, or reconstructive correction
• Medical records link the injury to the implanted mesh rather than to an unrelated condition
• The claim falls within the applicable statute of limitations, which in many states begins when the patient knew or reasonably should have known the injury was related to the mesh

Factors that tend to strengthen a claim include not being informed that the mesh lacked FDA clearance for breast surgery, permanent scarring or disfigurement, substantial medical expenses or lost income, and ongoing chronic pain or functional limitations.

Why was no surgical mesh ever approved for breast surgery?

The FDA has repeatedly stated that no surgical mesh product has been cleared or approved for breast reconstruction, breast augmentation, mastopexy, or internal bra procedures. Most of the products now at the center of active legal investigations entered the market through the FDA's 510(k) clearance pathway for general soft-tissue reinforcement, a process that does not require breast-specific clinical trials demonstrating long-term safety in that application.

In March 2021, the FDA issued a safety communication identifying data showing that certain acellular dermal matrix products used in implant-based breast reconstruction, including FlexHD and AlloMax, had significantly higher rates of infection, reoperation, and implant removal compared to alternatives. In November 2023, the FDA went further, requiring Becton Dickinson to update warning labels for GalaFLEX, GalaFLEX Lite, Phasix, and Phasix ST to state explicitly that the safety and effectiveness of these products in breast surgery had not been established.

Plaintiffs argue that manufacturers knew their products were being widely used in breast procedures, collected the revenue that use generated, and failed to push for the breast-specific studies or warnings that would have informed surgeons and patients of the real risks involved.

The products most frequently named in legal investigations

Legal investigations currently focus on the following mesh products used in breast procedures:

• GalaFLEX and GalaFLEX Lite (Tepha Inc.)
• Phasix Mesh and Phasix ST (Becton Dickinson)
• AlloDerm (LifeCell Corporation)
• FlexHD (MTF Biologics)
• AlloMax (RTI Surgical)
• Strattice (AbbVie)
• SurgiMend

Operative reports and implant records are typically needed to confirm which product was used and to establish the connection between the device and the complications that followed.

Complications that form the basis of active claims

Courts evaluating breast mesh claims are prioritizing cases where implantation led to documented medical harm requiring additional treatment. The complications most commonly reported by plaintiffs include:

• Surgical-site, deep tissue, or implant infections requiring antibiotics, hospitalization, or implant removal
• Seroma formation requires drainage procedures or additional surgery
• Capsular contracture causes pain, hardening, or distortion of the breast
• Mesh exposure through tissue or wound breakdown requires corrective procedures
• Chronic breast or chest wall pain persisting after the original procedure
• Implant displacement, structural mesh failure, or recurrent sagging
• Tissue necrosis requiring additional surgical intervention
• Permanent cosmetic deformity following mesh failure or removal

Claims are generally strongest when complications require revision surgery, mesh or implant removal, hospitalization, or long-term wound care, and when medical records document the connection between the implanted product and the injury.

Where the litigation stands now

Breast mesh litigation is in the early filing phase. No federal MDL exists yet, no bellwether trials have occurred, and no nationwide settlement program has been established. Individual lawsuits are accelerating across multiple jurisdictions as more women come forward with complications from internal bra procedures and breast reconstruction surgeries performed over the past decade.

Mass tort observers increasingly compare the current state of breast mesh litigation to hernia mesh and transvaginal mesh litigation before those cases were consolidated and produced billions in settlements. The FDA's November 2023 labeling action gave plaintiff firms the regulatory foundation to move, and the pace of new filings is increasing. Women who act now are entering the litigation at its earliest and most accessible stage.

Atraxia Law can evaluate your breast mesh claim

If you received surgical mesh during a breast procedure and later developed an infection, chronic pain, capsular contracture, implant loss, or required revision surgery, you may have a product liability claim against the manufacturer whose product was used. At Atraxia Law, we conduct the rigorous clinical screening of medical records needed to assess whether your situation meets the evidentiary threshold that active cases require. We evaluate the merits of your claim and connect you with a litigation attorney prepared to represent you against the manufacturers whose products caused this harm.