GalaFLEX mesh is a bioresorbable surgical mesh that has been used off-label in breast surgeries. GalaFLEX and other surgical meshes have not been FDA cleared specifically for breast procedures sometimes referred to as an “internal bra.”
In November 2023, the FDA issued a letter to health care providers about a labeling update BD made to its surgical mesh products, noting that while the agency is aware these products are frequently used in breast surgeries, their safety and effectiveness for the procedures have not been determined.
Wisner Baum continues to investigate claims related to GalaFLEX mesh and internal bra complications. Individuals who experienced serious GalaFLEX mesh side effects may be entitled to take legal action and are encouraged to contact the firm at (310) 207-3233 for a free, confidential case evaluation.
Breast mesh litigation remains in its earliest stages. To date, there has not been consolidated litigation, but individual lawsuits continue to be filed nationwide.
Lawyers continue to investigate these claims and determine whether patients were adequately informed about the potential risks of harm associated with the off-label use of the mesh in breast surgeries.
GalaFLEX mesh is a medical device manufactured by Becton, Dickinson and Company (BD). It is a knitted, bioresorbable surgical mesh made from poly-4-hydroxybutyrate (P4HB). According to the manufacturer’s website, the synthetic polymer is designed to integrate with surrounding tissue. The manufacturer further states that preclinical studies suggest it may produce new collagen. As the mesh is absorbed, it is intended to be replaced by new tissue over time. The device comes in sheets that can be cut to a precise size.
GalaFLEX mesh product line includes:
GalaFLEX is used in plastic surgery and reconstructive procedures, including breast surgeries. When used in breast surgeries, the surgical mesh is placed beneath the breast tissue or implant to support and strengthen the surrounding tissue. This technique is frequently marketed as an “internal bra,” although many patients may not realize which product was used during their surgery without obtaining a copy of the operative report.
GalaFLEX was developed by Galatea Surgical, a subsidiary of Tepha, Inc. Tepha, Inc. holds the P4HB polymer technology from which the GalaFLEX scaffold is manufactured. In July 2021, Becton, Dickinson and Company (BD) acquired Tepha, noting the company was a leading developer of P4HB, its proprietary resorbable polymer technology.
BD is among the manufacturers most frequently identified in breast mesh claims and investigations. The company also makes Phasix, another surgical mesh product, frequently used off-label in breast surgeries. BD has previously resolved mesh litigation, including 38,000 hernia mesh claims.
In May 2014, GalaFLEX was cleared through the FDA’s 510(k) pathway under clearance number K140533. The 510(k) clearance was based on the belief that GalaFLEX mesh was substantially equivalent to devices already on the market, used for the same clinical indications. This process is generally less rigorous than traditional premarket approval, which imposes stricter requirements.
According to documents provided to the FDA, the cleared indication for GalaFLEX mesh was soft tissue reinforcement in areas of weakness or void, including in plastic or reconstructive surgery. However, FDA clearance of the mesh did not include breast surgeries, such as augmentations, reconstructions, or reductions. The product is commonly used off-label for these purposes.
As noted by the FDA, it is aware of the increased use of surgical mesh in breast surgery, but the safety and effectiveness of this use have not been determined in these situations. According to legal documents, plaintiffs allege the device was promoted for use in breast surgeries despite not having breast-specific safety testing or clearance.
Some patients have reported serious complications after having GalaFLEX mesh implanted. Patients who have had GalaFLEX implanted are encouraged to keep detailed records of any side effects experienced in the days, weeks, months, and even years following surgery.
Complications from GalaFLEX mesh may be experienced shortly after surgery, such as signs of infection or seroma. Other side effects may take months or more to be identified.
Adverse event reports filed through the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database indicate patients have experienced:
In some cases, these complications have resulted in reconstruction failure and require revision or removal surgery to repair. It is important to note that the cause of a particular side effect or complication may not be readily available, as some of these issues can occur in breast surgery that has been performed without mesh.
Multiple safety concerns have been raised about GalaFLEX and other surgical meshes used in breast surgeries. Dr. Hooman Noorchashm, a professor who stated that he previously served as a medical director at BD, raised questions over the safety of GalaFLEX and other surgical mesh products. According to Dr. Noorchashm, there were hundreds of adverse event reports related to the products, enough to file a citizen petition flagging the off-label use and marketing of the devices. He also alleged that breast cancer recurrences in BD’s breast mesh clinical trials were not reported to the FDA.
While these are public allegations made by a former medical director and safety monitor at BD, they have not been resolved or proven. It is important to note, however, that in November 2023, the FDA issued a rare letter to health care providers about labeling updates BD made to its surgical mesh products. The agency noted that it was aware of the increased use of mesh, including GalaFLEX, in breast surgeries, but that the products’ safety and effectiveness for this use had not been determined.
Individuals who have suffered complications after having GalaFLEX mesh implanted during a breast procedure may be eligible to take legal action against the manufacturer. However, patients must meet certain eligibility requirements and should consult with an attorney to determine their rights and responsibilities.
General eligibility requirements for a GalaFLEX lawsuit:
Individuals who are unsure whether GalaFLEX was used during their breast procedure can request a copy of their operative report. The report should identify any medical devices or products that were used by name. If the records cannot be obtained, an attorney may help to secure and review the information to determine potential eligibility. The length of time that a patient has to file a lawsuit varies by state. Individuals are encouraged to consult with an attorney as soon as possible if they believe they may be eligible.
Wisner Baum is currently investigating GalaFLEX and other breast mesh claims for patients nationwide. The firm has extensive experience litigating defective medical device cases, including against large manufacturers. Our firm has secured billions on behalf of families throughout the country and is not afraid to hold corporations accountable for negligence or wrongdoing. Past results do not guarantee a similar outcome, and every case is different.
Consultations with the firm are free and confidential. Cases are accepted on a contingency fee basis, meaning there are no fees unless compensation is obtained on the client’s behalf. Contact Wisner Baum at (310) 207-3233 today to schedule a free, no-obligation GalaFLEX mesh lawsuit consultation.
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Patients have alleged that the manufacturer of GalaFLEX did not adequately warn them about the risks associated with the use of the mesh in breast surgeries. The mesh does not have FDA clearance for use in breast procedures, but is frequently used off-label for this purpose. Patients have alleged serious complications and are seeking compensation.
Currently, there is no surgical mesh that has received FDA clearance for breast surgery. GalaFLEX and other surgical meshes are frequently used off label for this purpose, but the safety and effectiveness of the products have not been determined by the FDA.
The manufacturer of GalaFLEX is Becton, Dickinson and Company (BD). BD acquired Tepha, which was the developer of P4HB, its proprietary resorbable polymer technology.
Many patients do not know which surgical mesh was implanted during their breast procedure. The best way to find out whether GalaFLEX or another mesh was used is by obtaining a copy of your operative report. The operative report will identify any medical devices or products that were used during the surgery.
Currently, GalaFLEX claims are in the early stages. There is no formal MDL or class action lawsuit. Individual claims, however, continue to be investigated and filed nationwide.
Patients who suffered complications after having GalaFLEX implanted during breast surgery only have a limited amount of time to file a claim. The amount of time varies by state. The best way to determine any legal deadlines that may apply to your case is by consulting with an attorney as early in the process as possible.
