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Bard XenMatrix Surgical Mesh Recalled Over Toxic Levels of Bacteria

Medical advances have made amazing things possible. Prosthetics can help those who are missing limbs to become mobile again. Medical devices can help hearts beat regularly. Animal tissue can help skin and organs to regrow or heal.

In addition to their potential to help a lot of people, these advancements have also shown the potential to harm a great deal of people. Strict oversight is needed to ensure the safety of these products and treatments. Using animal tissue in medical treatment, in particular, requires a great deal of scrutiny as the live tissue has the potential to cause a number of side effects.

One device made from animal tissue, the XenMatrix Surgical Mesh, had to be recalled because it could not meet regulatory guidelines for safe levels of toxins. Thousands of people who used the mesh may have been exposed to dangerous levels of bacteria as a result.

The Facts: XenMatrix Surgical Mesh

  • XenMatrix Surgical Mesh is designed to treat hernias and repair abdominal walls. It is manufactured by Davol Inc., a subsidiary of C.R. Bard.
  • Pig tissue is used to create the XenMatrix Surgical Mesh, and some lots were found to contain endotoxins, bacteria that can lead to potentially deadly infection.
  • Davol announced a recall of the XenMatrix Surgical Mesh in January 2011, explaining that it could not assure that the mesh met the regulatory guidelines for toxins released by dead bacteria.
  • Two months later, the FDA categorized the recall as a "Class 1 Recall" for the potential of the product to lead to serious injury or death.

Bard XenMatrix Surgical Mesh Recall

The XenMatrix Surgical Mesh is a collagen matrix patch that incorporates pig tissue. It is used to treat hernias and ruptures in the abdominal wall. Davol acquired the mesh in 2009 from Brennan Medical.

Davol issued its recall of the XenMatrix Surgical Mesh in January 2011, explaining that testing could not assure that the mesh met FDA guidelines for toxins released by the dead bacteria. Some lots were found to contain bacteria levels exceeding these guidelines.

Endotoxins are bacteria that can cause toxicity in the human body, leading to conditions such as bacterial meningitis and meningococcal disease, which causes sepsis. Symptoms of these conditions can include:

  • Fever
  • Headache
  • Nausea and vomiting
  • Fatigue
  • Stiff neck
  • Sensitivity to light
  • Bruising

Seizures can also accompany these conditions in some patients.

Davol said that there were no consumer complaints about the XenMatrix Surgical Mesh at the time of the recall.

In March 2011, the FDA announced that it would classify the recall as a "Class 1 Recall" because of the potentially serious or deadly side effects of the device.

North Carolina Bard XenMatrix Surgical Mesh Lawyers

Davol has had a troubling history with its surgical meshes and medical devices. The company also recalled its Composix Kugel Hernia Mesh patch (link to our page) in 2005, 2006 and 2007 over a faulty mechanism.

We are currently not accepting new cases on this defective medical product. If you wish to have a lawyer represent you and you do not have another lawyer in mind, we suggest you call North Carolina Bar Association Referral Service. The number is 1-800-662-7660. Without charging a fee, they should be able to put you in touch with another attorney.