Hernia Meshes Have Been Recalled For Varying Reasons Since 2005.

Surgical mesh is a medical product that provides additional support to weakened or damaged tissue during hernia surgeries. In many cases, the surgical mesh was fast-tracked through the U.S. Food and Drug Administration’s (FDA) 510(k) approval process. This process allows a manufacturer to bypass the usual testing required before product approval by asserting the device is “substantially similar” to a device already on the market.  Under this process, the emphasis is on the equivalence of a product to an existing product, the “dedicated device,” not on the safety or effectiveness of the new product.

Problems under this fast-track process arise when the new product is different from the predicate device.  These differences can arise from the type of material used for the mesh, or variances in the use of the hernia mesh vs the predicate device.

The FDA has issued recalls of certain hernia mesh products for various reasons, including:

• Mislabeling of package documentation;
• Design defects;
• Manufacturing defects; and
• Use of counterfeit materials

These recalls followed warnings by the FDA to manufacturers that mesh implants were potentially causing harmful and dangerous side effects. Manufacturers continued to sell surgical mesh despite the published warnings.

Common Complications Associated with Recalled Mesh

Hernia mesh complications can arise soon after surgery or be delayed,  months, or sometimes year after surgery. These complications are most commonly associated with mesh migration (when mesh moves from its original implant location) and from mesh contraction (when mesh shrinks in the body).

Common complications associated with recalled mesh are:

• Chronic and severe pain
• Infection
• Hernia recurrence
• Adhesion to the bowel wall
• Obstruction of the large or small intestines
• Perforation of the intestines
• Mesh migration
• Mesh shrinkage
• Fistulae (Abnormal connections between internal organs, intestines, or blood vessels)

What to Do if You Have Complications from Hernia Mesh.

You may have a claim against the manufacturer if you have complications from hernia mesh. The claim can include compensation for medical expenses, lost wages and diminished earning capacity, pain and suffering,  mental anguish, and permanent disabilities, impairment or disfigurement. By completing the form below, we can start a complimentary preliminary investigation to see if you qualify for a claim. No fees or litigation expenses are charged unless we win your case. If no recovery is obtained, you are not charged anything for the services provided by our office.