Colorado Dangerous Drugs & Medical Devices

Defective Hernia Mesh – Denver Dangerous Medical Devices Attorney

Defective Mesh - Burg SimpsonBurg Simpson attorneys are investigating claims for injuries related to the implantation of hernia mesh in hernia repair procedures. Complications that can result from failure of defective hernia mesh include severe pain, adhesions, bowel obstruction, organ obstruction or perforation, fistula, and infection. When complications occur, patients can require surgery to remove the hernia mesh.

Hernia mesh is a medical device used in surgery to repair hernias and is sometimes referred to as a hernia screen or hernia patch. Surgeons do not use hernia mesh in every hernia repair surgery, but when it is used the mesh is intended to prevent or reduce the risk of recurrence of a hernia. Because hernia repair surgery is the most common in the country, hundreds of thousands of patients are implanted with this mesh each year.

Hernia mesh is made of synthetic or biologic materials, or a combination of the two, and often has a coating made from fatty acids or similar materials that act as a barrier to separate the mesh material from tissue and organs.

Complications from Defective Hernia Mesh

Defective hernia mesh can cause many complications that result from failure of the mesh product to properly perform in the human body.  These complications can result in medical problems including:

  • Severe pain in the abdomen, groin, testes, or upper thigh;
  • Bowel obstruction;
  • Organ obstruction or perforation;
  • Adhesions, or bands of scar tissue between abdominal organs and other tissue;
  • Fistula, or formation of a tunnel between the intestinal tract or stomach and other tissue;
  • Severe infection or abscess; and/or
  • Need for surgery to remove mesh or treat complications.

What is a Hernia?

Hernias develop when pressure pushes an organ or tissue through weakened or torn areas of muscle or connective tissue. The cause of this pressure can include obesity, physical exertion or heavy lifting, diarrhea or constipation, coughing and sneezing. Additionally, individuals who smoke, who have poor nutrition, and who have had prior surgery may be at greater risk of developing a hernia.

Hernias commonly occur in the abdominal wall but can also occur in other areas of the body, including the groin area in both men and women. Common types of hernias include:

  • Inguinal hernia: occurs in the groin area, common in men.
  • Femoral hernia: occurs in the groin area or upper thigh, common in women.
  • Incisional hernia: emerges through an incision from prior surgery.
  • Ventral hernia: occurs in the abdominal/ventral wall.
  • Umbilical hernia: occurs at the belly button.
  • Hiatal hernia: occurs in the abdomen, along the upper stomach or diaphragm.

Additional Information

Treatment options for hernias include both surgical and non-surgical options. Surgery is not always required if a hernia is not causing complications or symptoms. Depending on the severity of the hernia, some doctors recommend observation instead of surgery if the hernia does not cause a significant amount of pain and does not grow or cause other complications.

If surgery is performed, the surgery may be either laparoscopic or an open surgery. Laparoscopic surgery is performed by making several small incisions through which surgical instruments are inserted to perform the hernia repair. Open surgery involves a larger incision. Both laparoscopic and open hernia repair surgeries can be performed with or without the use of surgical mesh.

Hernia mesh is surgical mesh or patch is used to provide additional support or reinforcement to the weakened or damaged tissue. Surgical mesh can be made of either synthetic materials or animal tissue. Synthetic, or man-made, hernia mesh can be made from a variety of materials such as polypropylene. Synthetic mesh can either be uncoated or coated with materials such as fatty acids or other polymers that are intended to prevent the mesh from adhering to tissue or organs in the body.

Defective hernia mesh can cause many complications that result from failure of the mesh product to properly perform in the human body. These complications can result in medical problems including:

  • Severe pain in the abdomen, groin, testes, or upper thigh;
  • Bowel obstruction;
  • Organ obstruction or perforation;
  • Adhesions or bands of scar tissue between abdominal organs and tissue hernia;
  • Fistula (formation of a tunnel between the skin and the intestinal tract or stomach);
  • Severe infection or abscess; and/or
  • Need for surgery to remove mesh or treat complications.

The FDA monitors the safety of all medical devices sold in the United States by reviewing reports of adverse events that it receives from the medical community, patients, device manufacturers, and other sources. The FDA monitors adverse event report information regarding hernia mesh products.

On April 7, 2016, the FDA published an informational article on its website called Hernia Surgical Mesh Implants. The FDA warned the public about complications that could result from the use of hernia mesh in hernia repair procedures that have been reported, including “pain, infection, hernia recurrence, adhesion, and bowel obstruction.” The FDA also explained that hernia mesh could cause other complications resulting from “mesh migration and mesh shrinkage (contraction).”

On May 25, 2016, Ethicon, a subsidiary of Johnson & Johnson, recalled its Physiomesh® flexible composite mesh and issued an Urgent Field Safety Notice. This safety notice advised the medical community that the product would no longer be sold because of the higher than expected rate of reoperation and hernia recurrence.

There are numerous hernia mesh products that are available for use by surgeons in the United States. Complications have been reported for hernia mesh products manufactured by a number of different companies including:

  • Atrium/Maquet;
  • Bard/Davol;
  • Ethicon/Johnson & Johnson; and
  • Covidien.

If you or a loved one has suffered complications from defective hernia mesh, fill out the Free Case Evaluation form now to discuss your hernia mesh case with a Burg Simpson Drug Attorney.

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