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On November 9, 2023, the FDA issued a Letter to Health Care Providers regarding surgical mesh products manufactured by Becton, Dickinson and Company (BD). The letter did not recall any products.
It did something arguably more significant for the women who received these devices: it confirmed in writing that no surgical mesh product has ever been cleared or approved by the FDA for use in breast surgery, including breast augmentation, breast reconstruction, or breast lifts.
BD's mesh products, including its Phasix and GalaFLEX product lines, were FDA-cleared for general soft tissue reinforcement, not specifically for breast surgery. The FDA observed a significant increase in surgeons using these products during breast reconstruction and breast augmentation procedures despite that limitation. The agency issued the letter to ensure physicians understood that the safety and effectiveness of these products in breast surgery had never been established through the clinical evidence the FDA requires for that specific indication.
The updated labeling applied to a wide range of BD products commonly discussed in active breast mesh litigation:
Each of these products was cleared for repairing and reinforcing soft tissue where weakness exists in general surgical contexts. None of them were evaluated or approved for use in breast procedures.
The agency's statement is direct and applies beyond BD products alone. There are currently no surgical mesh products cleared or approved by the FDA for use in breast surgery, including breast augmentation or breast reconstruction. Surgeons may legally use medical devices off-label, meaning for purposes outside their official FDA clearance, if they believe doing so is medically appropriate. But the FDA has not determined that BD mesh products, or any surgical mesh, are safe and effective specifically for breast applications.
The communication is frequently misunderstood, so it is worth being precise about its limits. The FDA did not recall BD mesh products. It did not ban surgeons from using them in breast procedures. It did not order hospitals to remove already implanted mesh. The agency specifically stated it is not recommending reoperation or removal of implanted surgical mesh in patients who are not experiencing symptoms.
What the FDA did require was updated product labeling. Following discussions with the agency, BD revised its labeling to clarify that the products were not evaluated for breast surgery and that safety and effectiveness for breast reconstruction have not been established. The agency also noted that its 2019 General and Plastic Surgery Devices Panel recommendations remain unchanged, reflecting continued concern about the absence of sufficient clinical evidence years after that review took place.
For women filing breast mesh claims, the FDA's letter from November 2023 provides publicly available regulatory evidence to support the key allegations in active cases. The letter confirms several facts that plaintiffs cite directly:
The warning itself does not establish manufacturer liability on its own. It does not prove that any individual patient's complications were caused by the mesh. What it provides is regulatory confirmation that the off-label use of these products in breast surgery proceeded for years without the clinical evidence that would normally accompany a breast-specific medical device, and that manufacturers continued to benefit from that use without securing that evidence themselves.
Women who received mesh during breast procedures have reported a range of complications, including infection, seroma, chronic pain, implant failure, tissue damage, capsular contracture, mesh exposure, delayed wound healing, and the need for reoperation. The FDA's letter did not conclude that BD products cause these complications, but it emphasized the need for further clinical evaluation specifically because these reports continued to surface as off-label use increased.
If you received a BD mesh product, including Phasix or GalaFLEX, during a breast reconstruction, augmentation, or lift procedure and later developed complications, you may have grounds for a breast mesh claim. Our team has spent more than 35 years helping patients determine whether they have a viable claim and connecting those who qualify with attorneys prepared to represent them. Reach out today for a free and confidential case evaluation.