Hernia mesh is a medical device used during surgical repair to provide structural reinforcement to weakened tissue, typically where an organ or tissue protrudes through a muscle wall. The mesh acts as a scaffold, supporting the repair and significantly reducing the likelihood of the hernia returning, which was common with older techniques using only stitches. Most hernia repair surgeries in the United States now use mesh, which can be made from synthetic materials like polypropylene or from animal tissue. Despite its widespread use, numerous devices have been subject to regulatory action, including recalls, due to patient complications and failures.
Distinguishing Recalls from Safety Alerts
The Food and Drug Administration (FDA) uses different actions to address issues with medical devices already on the market. A “recall” is the removal or correction of a product, often voluntarily initiated by the manufacturer, intended to reduce a health risk or remedy a violation. The FDA classifies recalls into three classes based on the degree of health hazard.
Recall Classifications
A Class I recall is the most serious, indicating a reasonable probability that using the product will cause serious adverse health consequences or death. Class II recalls, which have been the most common for hernia mesh, suggest the product may cause temporary or medically reversible adverse health consequences. A Class III recall is the least severe, meaning the product is not likely to cause adverse health consequences. In contrast, a “Safety Alert” or “Warning Letter” notifies the public or healthcare professionals about a potential problem without mandating the product’s removal.
Specific Recalled Hernia Mesh Products
Between 2005 and 2021, manufacturers recalled over 211,000 units of hernia mesh due to safety concerns and defects.
The C.R. Bard Composix Kugel Mesh Patch was subject to a significant Class I recall between 2005 and 2007. This recall occurred because the memory recoil ring, designed to help the patch open, could break after implantation, leading to serious internal injuries such as bowel perforation.
Atrium Medical faced multiple Class II recalls for its C-QUR Mesh product line, including the C-QUR V-Patch and C-QUR TacShield, around 2013. These products, which feature an omega-3 fatty acid coating, were recalled primarily due to packaging issues that compromised the product’s sterility and adherence properties. The FDA also issued a warning letter to Atrium in 2012 regarding inadequate sterilization processes at the manufacturing facility.
Ethicon, a subsidiary of Johnson & Johnson, was involved in multiple Class II recalls of its Proceed Surgical Mesh between 2006 and 2014. Issues often related to delamination, where the mesh layers separated, or packaging defects that compromised sterility. Additionally, Ethicon initiated a voluntary market withdrawal of its Physiomesh Flexible Composite Mesh in 2016 due to higher-than-expected rates of recurrence and reoperation compared to other mesh products.
Covidien (now Medtronic) issued Class II recalls for certain models of its Parietex mesh. These recalls included investigations into mesh failure leading to recurrence and packaging errors where the incorrect device was placed inside the package. The volume of recalled mesh units from major companies highlights a pattern of device failure across the industry.
Underlying Causes of Mesh Recall
Recalls stem from fundamental flaws in material composition, device design, or manufacturing quality control. A major underlying issue is the body’s reaction to the mesh material, particularly polypropylene, a synthetic plastic used in many devices. The body often perceives polypropylene as a foreign object, triggering a chronic inflammatory response.
This inflammation can lead to mesh shrinkage or contraction, where the mesh reduces significantly in size after implantation. Shrinkage pulls on surrounding tissues, causing chronic pain, and is a factor the FDA has acknowledged in connection with complications. Material degradation is another concern, where synthetic components stiffen and lose structural integrity when exposed to the body’s internal environment.
Design flaws and failures in securement or erosion can result in mesh migration, where the device moves from its intended placement. Migration and chronic inflammation can lead to serious complications, including:
- Bowel obstruction
- Adhesion formation
- Perforation of nearby organs
Patient Steps After a Device Recall
If you are concerned about a possible recall, the first step is to contact the surgeon who performed the procedure or your primary care physician. These professionals can review surgical records to identify the exact make, model, and manufacturer of the implanted device. Obtaining this specific information is necessary to determine if the device is among the recalled products.
Patients should monitor themselves for signs of potential mesh failure, which can manifest months or years after the initial surgery. Symptoms include chronic or worsening pain at the surgical site, signs of infection like fever or warmth, or digestive issues such as bowel obstruction. Any change in physical condition should be promptly reported to a doctor.
The decision to remove a mesh that is causing complications requires a careful discussion with your surgeon about the risks and benefits of explantation surgery. Revision surgery is often more complex than the original procedure, and your doctor will consider the severity of your symptoms and the potential for hernia recurrence without the mesh.