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Most breast mesh litigation to date has involved products sold by Becton, Dickinson and Company, also known as BD, following the FDA’s November 2023 safety communication seeking label updates for multiple of its product lines.
The BD products covered by the FDA's labeling update include:
Both GalaFLEX and Phasix products are cleared for soft tissue reinforcement but are not FDA-cleared or approved specifically for breast surgery. The FDA required updated labeling after observing an increase in off-label use during breast reconstruction, augmentation, breast lift, and internal bra procedures.
Other manufacturers have also made surgical mesh used in breast procedures, including RTI Surgical and TELA Bio, which produces reinforced tissue matrices used in reconstructive procedures. Breast reconstruction has also involved biologic matrices derived from human, porcine, or bovine tissue, which differ from synthetic mesh in both materials and regulatory pathways.
The FDA stopped short of recalling any of these products or recommending removal in asymptomatic patients. Being named in a lawsuit doesn't automatically mean a product is defective or that a manufacturer bears liability, since each case is assessed individually.
An important step in evaluating any potential claim is identifying the specific manufacturer, product name, and implantation date, all of which can often be found in operative reports, implant logs, or device stickers in the medical chart.
Our team has over 35 years of experience handling defective medical device cases and can review your records. If you suffered complications after a breast procedure involving surgical mesh, we'll determine whether you qualify to file a breast mesh claim. Contact Atraxia Law today to get your case evaluated for free.