The United States Food & Drug Administration (FDA) reports that surgical meshes continue to serve as “the system of choice for hernia repair,” with a “lower rate of recurrence” than non-mesh-based hernia repairs. However, the organization also affirms that mesh usage does not represent the “optimum method” of hernia repair.
Drawbacks relate mostly to the chemical structure of the mesh, which can yield adverse effects like infection, adhesion, and bowel obstruction. The FDA report on this topic indicates the need for a more ideal mesh construction with improved biocompatibility.
Adverse Effects Resulting From Mesh-Based Hernia Repairs
Hernia patients with mesh-based hernia repairs report several adverse effects. The most common dangers of hernia mesh include:
- Perforation – Mesh punches a hole in bowels or in a neighboring organ
- Migration – Mesh ventures throughout the body
- Adhesion – Scar-like tissue forms, resulting in organs, body tissue, and muscle sticking together
- Obstruction – Mesh results in blockage of the large or small intestine
- Contraction – Mesh collapses on itself and no longer covers the targeted hernia area
- Fistula – Two organs or the intestinal tract connect abnormally, ultimately causing leakage into the body cavity or via the skin
Complications Linked to Recalled Mesh Used for Hernia Repair
The FDA has received thousands of reports about complications arising from surgical-mesh-based hernia repairs. Recalled mesh, in particular, has consistently caused complications in hernia repair patients, thousands of which are now suing manufacturers for compensation for their injuries.
The most commonly reported hernia-mesh-related complications resulting from recalled mesh include:
Among all the reports consumers made to the FDA regarding bowel perforation and obstruction, recalled mesh consistently appears as the number-one cause of these complications.
Determining if Your Mesh Has Been Recalled
The Tosi & Rose team will check with your surgeon or with the facility where they conducted your mesh hernia repair surgery. Either should be able to refer to your medical record to reveal which specific brand of mesh was used in your operation, as well as the name of the mesh manufacturer.
Your lawyer will check if your hernia mesh manufacturer is one that is involved in the multi-district lawsuits.
Hernia Mesh Defects Resulting in FDA Recalls
Hernia mesh products have shown themselves to serve up a broad range of complications, a great many of which result from the manufacturers' defective designs and use of inferior, cost-saving materials.
Because the FDA had already approved similar hernia mesh products, the agency ushered an onslaught of “me-too,” or “new and improved” mesh products through a quick approval process. Unfortunately, these medical devices did not undergo the otherwise tight scrutiny of traditional FDA testing, and consumers have been paying the price. As growing numbers of patients began to report medical problems brought on by hernia meshes, the FDA started to issue recalls of products from a large variety of mesh manufacturers. The reasons for these recalls include:
- Mesh ring falls apart, creating bowel perforations and other complications (manufacturer, C.R. Bard)
- Mesh loses laminate coating (manufacturer, Ethicon Inc.)
- Improper packaging (manufacturer, Atrium Medical Corporation)
Examples of Hernia Meshes Subject to Lawsuits Due to Product Defects
When the hernia mesh market showcased itself as the lucrative new “it” medical device, manufacturers raced to the manufacturing line, often touting “new and improved” products to position themselves as the medical device to buy for hernia repairs.
Unfortunately, the speedy development came at the cost of quality research and design, resulting in mesh breakages that either invited hernia recurrence and/or created even further injury to the hernia repair patients. For example:
C-Qur (Atrium Medical)
Patients who had this hernia mesh implanted suffered almost immediate adverse reactions and severe side effects to the purified pharmaceutical-grade fish oil that the manufacturer used as a gel coating on this mesh (intended to prevent adhesion). Patients who managed to tolerate the fish oil coating also suffered repercussions from the implants. The coating eventually detached from the mesh, causing internal organ damage.
Composix Kugel Mesh (Bard Davol)
This mesh design featured a built-in recoil ring that enabled the mesh to fold up during insertion, then open up after the mesh was positioned behind the incision. Unfortunately, the ring would break apart and end up puncturing internal organs as it traveled throughout the body.
Proceed by Ethicon (Johnson & Johnson)
Ethicon manufactured a lightweight, polypropylene mesh then coated it with oxidized regenerated cellulose to further protect the patient from mesh injury. To make the device resorbable, the manufacturer radiated it, causing the underlying mesh polymer to degrade. Oftentimes, the entire device shrunk, disintegrated, and traveled throughout the body of the patient.
Physiomesh by Ethicon (Johnson & Johnson)
This product was riddled with manufacturing defects that caused premature breakdown and/or disintegration of the device. Furthermore, the mesh folded over after being implanted, and patients suffered adhesion of the mesh to their bowels. Finally, while still in their packaging, the meshes were even discovered to tear and become perforated. Manufacturers voluntarily recalled this hernia mesh in 2016.
A Mass Tort Attorney Can Help You File a Hernia Mesh Claim or Lawsuit
If you have detected symptoms of complications from your hernia mesh repair, you may be entitled to compensation. A hernia mesh lawsuit lawyer from Tosi & Rose can be able to help. Call us today at 888-311-8292 for a free, no-obligation consultation.