For many people with a hernia, surgical repair is not necessary. For people requiring surgical repair of a hernia with mesh, their complications after surgery are more disastrous than the hernia itself. Atrium manufactured the first omega 3 fatty acid mesh. The C-Qur hernia mesh utilizes a layer of Omega 3 fatty acid on the mesh. The intent of the Omega 3 fatty acid coating is to prevent adhesions after the initial implantation. Following implantation, the body should slowly absorb the Omega 3 fatty acid layer of the mesh. However, the body can not always absorb the Omega 3 fatty acid coating of the C-Qur mesh. The Omega 3 fatty acid layer also has a tendency of peeling off of the C-Qur mesh prematurely. Complications with the Omega 3 fatty acid mesh has caused severe organ damage, infection, and pain in numerous individuals nationwide.
Omega 3 Fatty Acid Mesh Complications
The omega 3 fatty acid mesh must be removed within one year of implantation in an alarmingly high number of patients. Some patients require mesh removal within weeks of implantation due to the severe side effects. Most patients experience pain as the first symptom of an omega 3 fatty acid mesh adverse reaction. The Omega 3 fatty acid coating causes the body to initiate an immune response. Immune reactions cause pain, warmth and rash to the skin closest to the mesh.
In 2013, a physician reported to the FDA that a patient developed a rash in the exact shape of the C-Qur mesh. In 2014, a patient reported that they experienced hives, rash, and redness after implantation of the C-Qur hernia mesh. In 2015, another physician reported a patient experienced severe pain with a purple and blue discoloration post implant. In 2016, yet another physician reported to the FDA that a patient developed a rash after implanting the C-Qur mesh. The rash was still present eight months post implant.
Omega 3 Fatty Acid Mesh Packaging Problems Leads to a Class II Recall
A class II recall against the C-Qur hernia mesh took effect due to the Omega 3 fatty acid layer. The Omega 3 fatty acid coating would strongly adhere to the package if exposed to high humidity. The recall did not mandate that physicians not use the C-qur hernia mesh. The recall merely warned physicians to check for the Omega 3 fatty acid layer before implanting. A class I recall would be necessary to completely pull the C-Qur hernia mesh from the market. Class I recalls are for medical devices that predictably could cause serious health problems or death. If the Omega 3 Fatty acid layer peels, serious health problems will result. The C-Qur hernia mesh should have been subject to a class I recall.
The ineffective recall resulted in a physician reporting to the FDA that he implanted half a piece of the plastic lining in a patient. Another physician reported implanting the C-Qur mesh intact and then reopening the patient three days later to find the Omega 3 fatty acid layer resting on the bowel. A third physician reported the coating falling off while he attempted to tack the mesh in place. The FDA and our hernia mesh attorneys continue to receive reports on the C-Qur Omega 3 fatty acid mesh.
Have you experienced hernia mesh complications? If so, contact the Hollis Law Firm today for a free C-Qur hernia mesh lawsuit review. Our experienced legal staff reviews every case individually, free of charge. All consultations are risk-free and confidential. Visit our general hernia mesh lawsuit page for more information on dangerous hernia meshes.