Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling

While medtech industry stakeholders are asking the US Food and Drug Administration (FDA) to limit requirements in its guidance on hernia mesh labeling, patient and physician groups argue the guidance doesn’t go far enough to address patient safety.

Industry advocates say the requirements may be too burdensome and asked for a phase-in period. Still, others want more details so that surgeons better understand the product and patients know the potential risks.

In recent years, FDA has recorded thousands of adverse events associated with the use of hernia mesh, including patient deaths. In response, the agency published draft guidance in June suggesting manufacturers include additional information about the products, such as their material and intended use, on the label. Since then, several stakeholders have written to the agency regarding the proposed guidance.

Medtech industry

The Medical Device Manufacturers Association (MDMA) argued that it's not clear if the proposed guidance will significantly help the medical community or if surgeons will find it useful enough to affect patient outcomes. The group argued that healthcare providers already understand the key properties of the products they use in their practice, and additional requirements, such as adding mechanical and physical properties, and method of fixation, are unlikely to affect what product they choose for surgery.

“Additional requirements to the package labeling run the risk of being overlooked as the carton box is often discarded in a different room and the packaging that contains the mesh product is often small and does not lend itself to providing such information in a readable manner,” said MDMA. “We believe it would be more effective to include a QR code on the package labeling (secondary packaging/commercial box).”

MDMA argued that adding a scannable QR code would allow healthcare providers to not only have access to the electronic instructions for use (eIFU) but also prevent surgeons from having to open the packaging to pull out the paper instructions, which could compromise the sterility of the mesh. The group added that it would also mean less use of the carcinogenic gas ethylene oxide (EtO), which is most commonly used to sterilize the devices and their container.

FDA has been working with industry and other stakeholders for the past few years to reduce the amount of EtO that the medtech industry uses to clean their products for market.

If FDA goes ahead with the guidance as written, MDMA asked that it limit the information to "critical aspects of the device" such as the material the mesh is made of, its source, and density.

"Properties relating to the surgical use of the device (anatomic site of application, method of fixation, etc.) should be left to the Instructions for Use where more detailed information can be presented to the healthcare provider," said MDMA. "Usage information, if required on package labeling, will affect a manufacturer’s ability to utilize one package for multiple markets (for instance, if anatomic site of application is different in various regions due to different regulatory approvals).

"Further, global products would require translations of this information, providing a challenge, particularly for smaller device packaging," the group added. "New SKUs and/or different packaging would be needed to accommodate the proposed package labeling changes. Such a burden would likely increase costs to providers and patients."

MDMA said it was unclear what level of detail should be included in the label to identify the source of any biological/animal-derived materials. The group asked the agency to state that manufacturers are only required to provide a high level of detail to avoid potentially divulging proprietary information. It also said FDA’s need to include the anatomic site of the hernia repair in the label is unclear, noting that a device can be used for multiple sites.

“A more appropriate inclusion, and one relevant to safety, may be whether the device is intended to be utilized in contact with viscera (i.e., intraperitoneally) or if such contact should be avoided,” said MDMA. “The intended anatomic location of product placement is captured in the indications for use and additional information throughout the product’s Instructions for Use.”

MDMA asked FDA to allow manufacturers to phase in the guidance requirements at least five years after or when a new 510(k) is granted after the guidance is finalized. The group said it would give global health authorities time to evaluate the changes and their impact on review timelines and product classification.

Patient and physician advocates

By contrast, some patient and physician advocacy organizations asked FDA to add more requirements to the proposed guidance. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGE) noted that most surgeons currently learn about surgical mesh properties from medical device representatives, creating a point-of-care knowledge gap. The group said it is concerned surgeons may implant meshes without sufficient knowledge about the characteristics of the devices and asked the agency to ensure better labeling requirements. It also noted that it is often impractical for the surgeon to contact the manufacturer representative during a procedure to clarify mesh-specific properties, which could also delay surgery.

"We believe that providing clear, standardized labeling for mesh products, surgeons and surgical staff will be able to better identify the best suited product for any given patient outcomes," said SAGE. "This will, in turn, allow for better product selection and prevent implant errors which can lead to unintended adverse events in our patients."

SAGE asked FDA to require the guidance to ask manufacturers to include specific details on biological tissue-derived mesh, permanent synthetic mesh, and resorbable synthetic mesh.

"We believe these minor changes to point-of-care labeling can help minimize implant errors by facilitating optimal mesh selection leading to enhanced patient safety and overall improved care for a large surgical population," said the group.

The National Center for Health Research (NCHR) also wrote to FDA stating it agrees with the guidance's objectives and the need for labeling changes because certain products have led to injuries and death. The group, however, argued that the proposed guidance is inadequate because it doesn't require manufacturers to include essential warnings or examples in the labeling on how the use of certain mesh has led to adverse events.

"Even more important than the inadequate description of possible adverse events in the guidance, the current labeling and proposed new labeling do not provide any information about the frequency of any of the common adverse events that the FDA lists (adhesions, recurrence, pain, and infection) and fails to mention the frequency or types of very serious adverse events that have been reported in the research literature or the adverse events on FDA’s website," said NCHR. "These serious adverse events as reported on the FDA website are not specific to any specific company’s mesh products, and that is one of the reasons why labels with concise and easily understandable descriptions of the different mesh products are unlikely to substantially reduce the incidence of adverse events."

Guidance comments

Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling

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