Hernia Surgical Mesh Implants | FDA

Video Hernia mesh what is it

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

what is a hernia?

A hernia occurs when an organ, intestine, or fatty tissue pushes through a hole or weak spot in the surrounding muscle or connective tissue. hernias often occur in the abdominal wall. Sometimes a hernia can be visible as an external bulge, especially when you strain or push.

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 navel
  • hiatal: occurs within the abdomen, along the upper part of the 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 muscle weakness is present at birth, but more often it occurs later in life. Anything that causes increased abdominal pressure can cause a hernia, including obesity, heavy lifting, 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 a million hernia repairs are performed in the us each year. uu. approximately 800,000 are to repair inguinal hernias and the rest for other types of hernias.1

    • non-surgical
      • watchful waiting: Your surgeon will look at the hernia and make sure it doesn’t get bigger or cause problems . Although surgery is the only treatment that can repair hernias, many surgical procedures are elective for inguinal hernias in adults. Watchful waiting is an option for people who do not have complications or symptoms with their hernias, and if it is recommended by your surgeon.
      • surgical
        • laparoscopic: The surgeon makes several small incisions in the abdomen that allow surgical tools to be inserted 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 repairs the area of ​​weak muscle. open repair can be performed with or without surgical mesh. open repair using non-mesh sutures is known as primary closure. primary closure is used to repair inguinal hernias in infants, small hernias, strangulated or infected hernias.
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          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 hernia repairs; by 2000, non-mesh repairs accounted for less than 10% of groin hernia repair techniques.

          The use of surgical mesh can also improve patient outcomes by reducing operative time and minimizing recovery time. however, recovery time depends on the type of hernia, the surgical approach, and the patient’s condition before and after surgery.

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

          Despite low recurrence rates, there are situations in which the use of surgical mesh for hernia repair is not recommended. patients should discuss their specific circumstances and their best options and alternatives for hernia repair with their surgeons.

          surgical mesh

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

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          Surgical mesh made from synthetic materials can be found in the form of woven mesh or non-woven sheet. the synthetic materials used may be absorbable, non-absorbable, or a combination of absorbable and non-absorbable materials.

          Animal-derived meshes are made from animal tissue, such as intestine or skin, that has been processed and disinfected to make it suitable for use as an implanted device. These meshes of animal origin are absorbable. Most of the tissue used to produce these mesh implants comes from a porcine (swine) or cow (bovine) source.

          Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide a permanent reinforcement to the repaired hernia. the 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.

          complications of hernia repair surgery

          According to FDA analysis of medical device adverse event reports and peer-reviewed scientific literature, the most common adverse events for all surgical hernia repairs (with or without mesh) are pain, infection, recurrence of the hernia, scar tissue that joins the tissues (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels or intestines (fistula), accumulation of fluid at the surgical site (seroma) and a hole in neighboring tissues or organs (perforation).

          The most common adverse events after mesh hernia repair are pain, infection, hernia recurrence, adherence, and bowel obstruction. Some other potential adverse events that can occur after mesh hernia repair are mesh migration and mesh shrinkage.

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          many complications related to hernia repair with surgical mesh that were reported to the fda were 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 removed mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the leading cause of bowel perforation and obstruction complications.

          Please see the recall notices here for more information if you have recalled the mesh. For more information on recalled products, visit the FDA Medical Device Recall website. please visit the doctor’s office & database of radiation-emitting devices to search for a specific type of surgical mesh.

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

          1rutkow, i.m. (2003). Demographic and Socioeconomic Aspects of Hernia Repair in the United States in 2003. North American Surgical Clinics; 83(5):1045-51, v-vi.

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

          other resources

          • hernia: medlineplus
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