A hernia occurs when part of an organ or tissue pushes through the wall of the body cavity containing it. This frequently happens when a weak spot in the muscles or connective tissue of the pelvic or abdominal wall allows for the intestines to protrude through.
Hernias corrected by surgery can have a high recurrence rate. Since the 1980s, surgeons have increasingly relied on hernia mesh in an attempt to strengthen surgical repairs and prevent recurrences.
Some recent hernia meshes have been linked with increased risk of infections, adhesion, perforation or obstruction of the bowels, mesh migration, or a higher-than-expected rate of hernia recurrences requiring hospitalization and further surgeries.
For a free consultation and more information about your legal options, please contact us today.
If you have suffered severe mesh complications requiring hospitalization or corrective surgery due to problems with the mesh used in your hernia repair surgery, you may be entitled to compensation for medical costs and other expenses. Weitz & Luxenberg offers a free consultation to help you understand your legal options.
Complications Occurring with Hernia Mesh
Collectively hundreds of adverse events have been reported to the U.S. Food and Drug Administration (FDA) related to several types of hernia mesh, including Atrium Medical’s C-QUR, certain types of Bard mesh such as the PerFix, 3DMax, Ventralex ST, Sepramesh IP Composite, Composix E/X, and Ethicon Inc.’s Physiomesh Flexible Composite Mesh.
All of the above meshes were approved through the FDA’s 510(k) process. Manufacturers using this method do not have to provide safety or efficacy data to the FDA through clinical trials; they only have to show the new product is “substantially equivalent” to another device that the FDA has already approved
Complications from Ethicon Physiomesh Flexible Composite Mesh, Atrium’s C-QUR meshes, and several types of Bard hernia meshes have frequently required additional surgeries.
These complications have included:
Severe or chronic pain
Adhesion of the mesh to bowels
Perforation of the intestines
Migration from the surgical site
Seromas – pockets of fluid that build up under the skin
Weitz & Luxenberg wants to hear from people who have developed any of the above conditions following surgery in which C-QUR meshes, certain Bard meshes, or Ethicon’s Physiomesh Flexible Composite mesh were used. The firm also wants to talk to people who have had revision surgery to correct problems related to these hernia meshes and to people who have been advised by their doctor to have corrective surgery.
Atrium C-QUR Problems Reported to the FDA
Physicians or patients implanted with Atrium C-QUR mesh have reported the need for additional surgery to the FDA MAUDE (Manufacturer and User Facility Device Experience) adverse events database.
In one case, the patient reported that a surgeon had to remove previously healthy tissue, including previously healthy muscle tissue, because of the damage done by the C-QUR mesh, with the patient subsequently developing a life-threatening infection requiring prolonged hospitalization. In another case, the MAUDE report stated that the patient’s C-QUR mesh had “totally detached” and partially blocked and “strangled” the colon after the mesh was implanted.
In one case, the patient reported that a surgeon had to remove previously healthy tissue, including previously healthy muscle tissue, because of the damage done by the C-QUR mesh, with the patient subsequently developing a life-threatening infection requiring prolonged hospitalization.
Doctors have also reported infections or reactions after implanting C-QUR meshes in patients. One patient reported to the FDA Maude database that the patient’s surgeon stated that the area around the mesh “looked like a bomb went off” after the surgeon attempted surgery to remove the C-QUR mesh.
Physiomesh Flexible Composite Mesh
Within months of first approving Physiomesh Flexible Composite Mesh, the FDA began receiving multiple reports of failures and recurring hernias requiring doctors to perform additional surgeries.
In 2014, researchers with the Polish Hernia Study Group terminated a clinical trial involving Physiomesh and the Bard Ventralight ST due to severe adverse events. There was a high rate of hernias recurring and reoperations were necessary. In 2016, large hernia registries in Germany and Denmark also reported higher-than-average failure rates for the mesh.
In May, 2016, Ethicon removed Physiomesh Flexible Composite Mesh for laparoscopic surgeries from the global market. The device removal decision affected only the Physiomesh Composite Mesh, and not the Open Flexible Composite Physiomesh.
If you have required hospitalization, revision surgery, or experienced pain or other symptoms related to problems with Ethicon’s Physiomesh Flexible Composite Mesh, speaking with an attorney can help you understand your legal options. Weitz & Luxenberg’s Drug and Medical Device Unit is prepared to help you.
We would feel privileged to assist you. For a free consultation and more information about your legal options, please contact us today.
Between 2009 and 2013, the FDA conducted four separate inspections of the New Hampshire facility where Atrium manufactured C-QUR hernia mesh. Each time, inspectors found violations of federal regulations.
During one inspection, the FDA noted Atrium had failed “to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specification…”
During one inspection, the FDA noted Atrium had failed “to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specification…” As an example, the FDA mentioned complaints of C-QUR mesh product infections that were closed without obtaining the pending sample culture results regarding the infections.
After the FDA sought a permanent injunction against Atrium in 2015, the parties entered into a Consent Decree of Permanent Injunction in which Atrium agreed to pay $6 million in equitable disgorgement and agreed to shut down production lines until Atrium complied with the specific federal regulations and stipulations specified the Consent Decree.
Physiomesh Flexible Composite Mesh Complaints
By late 2016, six years after the FDA first approved Physiomesh Flexible Composite Mesh, hundreds of reports on the mesh were filed with the FDA’s MAUDE database of adverse events.
A review of those complaints shows repeated references to Physiomesh failing in ways that allowed hernias to recur. These cases frequently required revision surgery to remove and replace the faulty mesh.
Other complications of Physiomesh Flexible Composite Mesh listed in the FDA database include:
If you suffered complications such as infection, mesh failure, pain, bowel perforation or obstructions, or other conditions related to C-QUR, certain Bard, or Physiomesh Flexible Composite Mesh following hernia surgery, you may be entitled to compensation.
Weitz & Luxenberg has 30 years of experience litigating complex medical cases and has been instrumental in securing billions of dollars in verdicts and settlements for patients harmed by faulty medical devices.
While past performance is no guarantee of future success, Weitz & Luxenberg has the background and resources necessary to seek justice if you have suffered complications from defective medical products.
For a free consultation, call us at (877) 680-3753 or fill out the contact form on this page and one of our representatives will be in contact with you shortly.