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 Gore, Atrium, Covidien, Aspide, Bard and Ethicon 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 Cincinnati, Ohio product liability lawyer representing plaintiffs nationwide in a wide variety of defective medical device and hernia mesh injury claims.
Hernia Mesh Implants
High Rates of Hernia Recurrence
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.
The risk for hernia recurrence increases from repair to repair. Surgical mesh is a medical device used to provide additional support to weakened or damaged tissue. Despite reduced rates of hernia recurrence with some mesh implants, there are situations where the use of surgical mesh for hernia repair may not be recommended.
The risk of long-term mesh-related complications for mesh repairs partially offset the benefits of mesh devices. Patients in Ohio should talk to their surgeons about their specific circumstances and possible alternatives for hernia repair.
The choice of a medical strategy and surgical technique can be more important in the treatment of recurrent hernias than in other areas of hernia surgery. Repairs in recurrent hernias have to take into account the prior device or implant used, the number of times the hernia has recurred, and the type of hernias.
Hernia recurrence may occur as a result of different causes and promoting factors, though hernia signs and symptoms include typically present the same way:
- A bulge in the area on either side of the pubic bone, which becomes more obvious when upright, especially if coughing or straining
- A burning or aching sensation at the hernia bulge
- Pain or discomfort in the groin, especially when bending over, coughing or lifting
- A heavy or dragging sensation in the groin
- Weakness or pressure in the groin
- Pain and swelling around the testicles if hernia descends into scrotum
Hernia Mesh Implant Safety Risks
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, bowel blockage, bowel perforation, contraction, rejection, and, rarely, mesh migration. Mesh migration may occur as an early or late complication after an operation. The most common hernia mesh injury reports include the following:
• Hernia recurrence
• Bowel obstruction
• Mesh migration
• Mesh shrinkage (contraction)
The last thing a patient needs following a hernia mesh operation is a painful complication. But due to several models of defective hernia mesh, revision surgery and mesh injuries are relatively common.
Hernia mesh product often promote scar tissue to form, though when the scar tissue attaches itself to other tissue and organs, leading to serious complications. Intestinal obstruction can occur soon after or years after a hernia repair surgery. The intestines of patients can get blocked when a mesh implant migrates over time and embeds into tissue.
A bowel obstruction, or intestinal obstruction, describes a blockage of the intestines that prevents normal passage through the digestive tract. A tumor, inflammation, or a foreign substance like a hernia mesh product can be the cause of intestinal obstruction.
Bowel obstruction, either total or partial, can occur in the small intestine, or the large intestine or colon. A common cause of bowel obstruction is an adhesion, a type of scar sometimes initiated by hernia mesh implants.
Hernias are the second most common cause of small-bowel obstruction, either before or after a hernia repair operation. Tumors are also a leading cause. In the large intestine, about half of obstructions are caused by colorectal cancer.
Hernia Mesh Fistula
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.
Hernia Mesh Infection
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.
Hernia Mesh Injury
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.
Adhesion Risk with Hernia Implants
Hernia mesh adhesions are scar tissue resulting from hernia mesh operations and the healing process. Following hernia repair surgeries, adhesions may form in the abdomen or peritoneum. The mesh repairs usually heal quickly but when adhesions form, organs connected by the scar tissue may not function properly.
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.
X-rays do not reveal potential mesh issues or diagnose the presence of adhesions. An additional surgery is usually needed to diagnose or treat hernia mesh adhesions. However, revision surgeries carry risks and can lead to further health problems, including infection, bowel blockage, bowel perforation and chronic pain.
Adhesions may begin forming long before they are noticed by patients or doctors. Depending on the location, adhesions from defective hernia mesh devices may cause pain and affect the bowel in different ways. Even removing a defective hernia mesh product may not completely solve all health issues.
Symptoms of adhesion and hernia mesh injury may include:
• Severe abdominal pain or cramping
• Loud bowel sounds
• Swelling of the abdomen
Types of Hernias
- Inguinal: occurs in the inner groin. The most common of abdominal hernias. Sometimes muscles that attach to the pelvis leave a weakened area and if there is a stress placed on that area, the weakened tissues can allow a portion of small bowel to slide through that opening, causing pain and producing a bulge. Inguinal hernias are more likely to occur in men.
- Femoral: occurs in the upper thigh/outer groin. Femoral hernias tend to occur more frequently in women.
- Incisional: occurs through an incision or scar in the abdomen. Incisional hernias occur as a complication of abdominal surgery, where the abdominal muscles are cut to allow the surgeon to enter the abdominal cavity to operate.
- Ventral: occurs in the general abdominal/ventral wall
- Umbilical: occurs at the belly button and are very common in newborns and often do not need treatment unless complications occur. Some umbilical hernias enlarge and may require repair later in life.
- Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm
- Obturator: the least common hernia of the pelvic floor, mostly found in women who have had multiple pregnancies or who have lost significant weight.
Hernia Mesh Injury Settlement
Attorneys claim several hernia mesh devices were not properly tested before they were marketed and distributed as safe medical instruments.
The companies currently face thousands of pending hernia mesh injury 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.
Attorneys contend that some hernia mesh devices are not properly tested before they are distributed to the public as safe products. Device companies like Gore, Aspide, Ethicon, Bard, Covidien and Atrium have settled hundreds of lawsuits and currently face countless more injury claims.
If you are unsure about the mesh manufacturer and product used in your surgery and have questions about your hernia repair, contact your Ohio surgeon to obtain medical records. Contact a Cincinnati hernia mesh lawyer to discuss potential hernia mesh injury lawsuits and settlement.