Hernia Mesh Devices Recalled for Serious Health Concerns
Global health agencies have reported unacceptable failure rates for mesh products on the market. As a result, thousands of lawsuits have been filed in recent years over major health problems associated defective hernia mesh devices.
Over one million hernia repairs are performed each year in the U.S. About 800,000 of the procedures are to repair inguinal hernias and the rest are for other types of hernias. Surgeons commonly utilize surgical mesh to provide support to the weakened or damaged tissue. The majority of surgical mesh devices currently available for use are constructed from synthetic absorbable, non-absorbable or a combination of absorbable (temporary) and non-absorbable (permanent) materials.
The use of hernia mesh products may improve patient outcomes. Though despite reduced rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be recommended. Patients should talk to their surgeons about their specific health issues and possible alternatives for hernia repair.
Joe Lyon is a highly rated product liability lawyer representing plaintiffs nationwide in a wide variety of defective medical device and civil litigation claims.
Regardless of treatment, hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair recurrence rate. The use of meshes is thought to reduce dramatically the incidence of hernia recurrence. However, up to 50 percent of hernias may reoccur with an implanted device. This is commonly due to inadequate fixation during the original operation or shrinkage of the mesh. Light-weight meshes may have a higher risk due to their increased flexibility and movement.
Two-thirds of recurrences occur after three years. It is not clear if the type of mesh used has any effect on durability. All mesh products appear equally limited in effectiveness.
Based on the U.S. Food and Drug Administration’s (FDA) analysis of medical device adverse event reports and scientific literature, the most experienced adverse events for all surgical repair of hernias are pain, infection, hernia recurrence, adhesion, abdominal obstruction, bleeding, fistula, seroma, and tissue perforation.
Mesh migration after mesh inguinal hernia repair is unpredictable. A previous report has presented complications related to prosthetics in hernia repair, such as infection, contraction, rejection, and, rarely, mesh migration. Mesh migration may occur as an early or late complication after an operation
The most common adverse events following mesh hernia repair include the following:
• Hernia recurrence
• Bowel obstruction
• Mesh migration
• Mesh shrinkage (contraction)
Repair of hernias are done by either suture repair or prosthetic mesh repair. The latter is associated with a lower recurrence rate but a higher incidence of complications. The most serious complication is the development of fistula.
Fistula is a late complication of prosthetic mesh repair and is usually due to chronic erosion of bowel by mesh placed in direct contact with intestinal loops both in open and laparoscopic repairs.
Symptoms of fistulas may include the following:
• Persistent pain—throbbing and worse when sitting down.
• Skin irritation around the anus, including swelling, redness and tenderness.
• Discharge of pus or blood.
• Constipation or pain associated with bowel movements.
Mesh infection is feared because it is difficult to eradicate without removing the mesh. To make matter worse, infection can become clinically apparent many years after implantation.
Although widely used a precaution, there is no evidence that prophylaxis with antibiotics offers any protection against possible infection. Microporous meshes are at higher risk of infection because macrophages and neutrophils are unable to enter small pores.
Growing evidence in the medical field suggests that mesh removal, which is deemed necessary in many situations may cause infection, and permanent injury like chronic pelvic pain. Some estimates say nearly one in three patients who have mesh implants removed will suffer from chronic pain for years after the operation.
In severe cases, the mesh may cause infection, bowel protrusion, or even death. Despite the large numbers of post-operative complications, patients have difficulty finding doctors willing to remove the mesh.
The associated pain is not caused by simply having synthetic mesh, it’s typically the fact that the mesh is secured with stitches that sometimes become entangled with sensitive nerves. As the body begins its repair process, the mesh moves with the abdomen and over time can stretch, causing a feeling of tearing or burning pain.
An adhesion is a band of scar tissue that binds two parts of tissue together. The popularity of hernia mesh operations has led to increasing concern regarding mesh-related adhesions. Adhesions result from the fibrin exudates that follow any kind of trauma. These exudates form temporary adhesions until the fibrinolytic system absorbs the fibrin. Absorption is delayed in the presence of inflammation or foreign bodies such as mesh devices. In these situations, they develop into tissue adhesions.
All mesh implants produce adhesions, though their extent varies. Abdominal adhesions are a common complication, occurring in a majority of people who undergo abdominal or pelvic surgery. Adhesions cause the majority of small bowel obstructions in adults, and are believed to contribute to the development of chronic pelvic pain.
Symptoms of adhesion may include:
• Severe abdominal pain or cramping
• Loud bowel sounds
• Swelling of the abdomen
Attorneys claim several hernia mesh devices were not properly tested before they were marketed and distributed as safe medical instruments. Medical device companies like Ethicon, Bard and others have agreed to pay million to settle lawsuits. The companies currently face thousands of pending lawsuits.
If you have had surgery to treat a hernia using a device and you experience any signs or symptoms of recurrence of the hernia, please consult with a medical and legal expert. The Lyon Firm has experience litigating cases against medical device manufacturers.
If you or a loved one suffered an injury due to a defective hernia mesh product, and have questions about the legal remedies available to improve quality of life and medical care, contact The Lyon Firm (800) 513-2403. You will speak directly with Mr. Lyon, and he will help you answer these critical questions.