Medical Devices

Hernia Surgical Mesh Implants

In this website, the FDA describes hernias, the different treatment options to repair hernias and recommendations for patients that are considering surgery for their hernias. The FDA wants to help patients make informed decisions about their health care and to facilitate a discussion between patients and their surgeons.

What is a Hernia?

A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Hernias often occur at the abdominal wall.  Sometimes a hernia can be visible as an external bulge particularly when straining or bearing down.

Types of Hernias

The most common types of hernias are:

  • Inguinal: occurs in the inner groin
  • Femoral: occurs in the upper thigh/outer groin
  • Incisional: occurs through an incision or scar in the abdomen
  • Ventral: occurs in the general abdominal/ventral wall
  • Umbilical: occurs at the belly button
  • Hiatal: occurs inside the abdomen, along the upper stomach/diaphragm

Causes of Hernias

Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue. The pressure pushes an organ or tissue through the opening or weak spot. Sometimes the muscle weakness is present at birth but more often it occurs later in life. Anything that causes an increase in abdominal pressure can cause a hernia, including obesity, lifting heavy objects, diarrhea or constipation, or persistent coughing or sneezing. Poor nutrition, smoking, and overexertion can weaken muscles and contribute to the likelihood of a hernia.

Treatment Options for Hernias

Hernia repairs are common—more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias and the rest are for other types of hernias.1

  • Non-Surgical
    • Watchful Waiting - Your surgeon will watch the hernia and make sure that it is not getting larger or causing problems. Although surgery is the only treatment that can repair hernias, many surgical procedures are elective for adult inguinal hernias. Watchful waiting is an option for people who do not have complications or symptoms with their hernias, and if recommended by their surgeon.
  • Surgical
    • Laparoscopic - The surgeon makes several small incisions in the abdomen that allow surgical tools into the openings to repair the hernia. Laparoscopic surgery can be performed with or without surgical mesh.
    • Open Repair - The surgeon makes an incision near the hernia and the weak muscle area is repaired. Open repair can be done with or without surgical mesh. Open repair that uses sutures without mesh is referred to as primary closure. Primary closure is used to repair inguinal hernias in infants, small hernias, strangulated or infected hernias.

Hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair and reduce the rate of recurrence. Since the 1980s, there has been an increase in mesh-based hernia repairs—by 2000, non-mesh repairs represented less than 10% of groin hernia repair techniques.

The use of surgical mesh may also improve patient outcomes through decreased operative time and minimized recovery time. However, recovery time depends on the type of hernia, the surgical approach, and the patient’s condition both before and after surgery.

Information found in medical literature has consistently demonstrated a reduced hernia recurrence rate when surgical mesh is used to repair the hernia compared to hernia repair without surgical mesh. For example, inguinal hernia recurrence is higher with open repair using sutures (primary closure) than with mesh repair2.

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 circumstances and their best options and alternatives for hernia repair.

Surgical Mesh

Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue. The majority of surgical mesh devices currently available for use are constructed from synthetic materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be absorbable, non-absorbable or a combination of absorbable and non-absorbable materials.

Animal-derived mesh are made of animal tissue, such as intestine or skin, that has been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine) source.

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement to the repaired hernia. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.

Hernia Repair Surgery Complications

Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).

The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).

Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.

Please refer to the recall notices here and here for more information if you have recalled mesh. For more information on the recalled products, please visit the FDA Medical Device Recall website. Please visit the Medical & Radiation Emitting Device Database to search a specific type of surgical mesh.

If you are unsure about the specific mesh manufacturer and brand used in your surgery and have questions about your hernia repair, contact your surgeon or the facility where your surgery was performed to obtain the information from your medical record. 

 

 



1Rutkow, I.M. (2003). Demographic and Socieconomic Aspects of Hernia Repair in the United States in 2003. Surgical Clinics of North America; 83(5):1045-51, v-vi.  

2. http://www.facs.org/public_info/operation/brochures/hernrep.pdf

Page Last Updated: 11/16/2012
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