A hernia is a condition that occurs when pressure forces a portion of the intestine, an organ, or fatty tissue to push through a weakened area of the surrounding muscle or connective tissue. Pressure can come from many sources such as heavy lifting, persistent sneezing or coughing, pregnancy, obesity, or even diarrhea or constipation. Similarly, several things can cause a weakening of the muscle or connective tissue including prior surgery, poor nutrition, and smoking. Other hernia risk factors include heredity, cystic fibrosis, and standing for long periods of time on a regular basis.
Common types of hernias include Inguinal (inner groin), Femoral (upper thigh/outer groin), Incisional (following a surgical incision in the abdomen), Ventral (abdominal/ventral wall), Umbilical (belly button), and Hiatal (inside the abdomen, along the upper stomach/diaphragm).
Hernia symptoms include nausea, vomiting, and pain. Hernias may bulge out and become visible outside the body, especially when the affected area is strained. Hernias can also cause blood flow to an affected organ to become restricted or blocked, which can result in secondary organ damage.
Hernia repairs are common. More than one million hernia repairs are performed each year in the U.S., either through traditional open surgery or laparoscopically. Hernia mesh is used in both open and laparoscopic surgeries, and is intended to prevent recurrence of the hernia by reinforcing the area where the intestine, organ, or fatty tissue is protruding. Hernia mesh devices can be made from synthetic materials or animal tissue and can be absorbable, non-absorbable or a combination of absorbable and non-absorbable materials.
Several complications and adverse events related to hernia mesh have been reported to the U.S. Food and Drug Administration (“FDA”). These complications include severe and persistent pain, infection, hernia recurrence, mesh shrinkage or migration, fistula formation, bowel adhesion, obstruction, or perforation, sepsis, injuries to nearby nerves and blood vessels, and organ damage such as organ puncture or rupture. Many patients who suffer one or more of these injuries require mesh revision/removal surgery, surgery to remove a portion of the bowel or other injured organ, and/or a colostomy.
Many of these reported injuries are from patients whose hernias were repaired with mesh products that have since been recalled or taken off the market. For example, eight different models of Kugel mesh were recalled by the FDA in 2006 and 2007. Since then, thousands of lawsuits have been filed by patients who allege they were injured when a Kugel mesh device broke and caused severe bowel perforations or other serious injuries. In 2011, C.R. Bard agreed to a $184 million settlement involving 2,000 individuals who were implanted with Composix Kugel hernia mesh manufactured in 2004 & 2005. Many more Kugel mesh injury lawsuits are still in progress.
Similarly, Proceed mesh, which is manufactured by Ethicon, a subsidiary of Johnson & Johnson, was recalled by the FDA in 2005 after several patients reported that the device disintegrated inside the body, resulting in severe infections. Patients implanted with Proceed surgical mesh have also reported serious adhesions and fissures caused by device malfunctions.
C-Qur hernia mesh has been the subject of both an FDA warning letter and a recall. In 2012, after inspecting the manufacturing facilities of then C-Qur manufacturer, Atrium Medical Corporation, a division of MAQUET Medical Systems, the FDA issued a warning letter stating that Atrium had failed to adequately respond to multiple sterility violations and complaints of infections associated with C-Qur hernia mesh. Later, in 2013, the FDA announced a Class II recall of the C-Qur V-Patch mesh, after reports revealed that the coating on the mesh could peel off and adhere to the inner packaging liner. Several lawsuits have been filed by patients who were implanted with C-Qur mesh and suffered from infection and other serious injuries. Court documents allege that the coating on the mesh peeled off after being implanted and caused serious injuries.
Although not recalled by the FDA, Physiomesh Flexible Composite Mesh, also manufactured by Ethicon, was voluntarily pulled from the market in May 2016. Ethicon sent an urgent field safety notice to hospitals and doctors directing them to stop using Physiomesh Composite and immediately return any unused product. Several studies have associated Physiomesh Composite with a range of complications, including recurrent hernias that may require additional surgery to repair. Ethicon has even admitted that the design of Physiomesh Composite caused it to fail at a higher rate than other similar products.
Additional hernia mesh products that have been linked to serious injuries include Sepramesh, 3DMax, and PerFix, which are manufactured by C.R. Bard. Although Sepramesh has not been recalled, at least 50 adverse event reports regarding Sepramesh have been filed with the FDA. Both the 3DMax and PerFix devices have been linked to severe and often untreatable testicular pain and, in some men, these devices have reportedly attached to the spermatic cord, putting them at risk of testicular loss if hernia mesh removal is needed.
Lawsuits involving hernia mesh medical devices are being filed by patients who were injured after being implanted with a hernia mesh product. These lawsuits allege that the hernia mesh products involved were defectively designed and are causing unnecessary repairs and injuries that would not have occurred if a safer mesh product or sutures had been utilized instead.
If you or a loved one has experienced any adverse side effects after being implanted with hernia mesh, you may be entitled to compensation. The attorneys at Canepa Riedy Abele are currently offering free case evaluations to patients who have been harmed by hernia mesh. To learn more about your legal options, please contact us for a free consultation.