Hernia Mesh

KEY POINTS

• Surgical mesh is a medical device that provides necessary support to weakened or damaged tissue in the body. Around the world, there are a wide range of surgical meshes indicated for use in hernia repair surgery. These meshes are sold by a number of different manufacturers, and each is unique in its design and characteristics.
• Modern hernia mesh revolutionized the surgical treatment of abdominal wall and inguinal hernias, allowing tension-free repairs, reducing recurrence rates and decreasing the need for reoperation, compared to suture herniorrhaphy. Today, hernia mesh is widely used in the vast majority of abdominal wall and inguinal hernia repairs. Many consider use of mesh as the ‘gold standard’ treatment.^1,2,3,4,5
• Medtronic has a diverse portfolio of innovative hernia mesh products that offer surgeons the opportunity to select the mesh that is best suited for their patient’s condition and individual needs.
• Over the past two decades, Medtronic’s hernia mesh products have been used safely and effectively in millions of hernia repair procedures. Several post-market clinical studies performed under real-world conditions with Medtronic hernia meshes have reported rates of complications consistent with those associated with hernia repair procedures.^6,7,8,9,10
• Medtronic stands behind the safety and efficacy of its hernia mesh products. Medtronic is confident that its hernia mesh products are safe and effective when used as intended. We continually monitor the safety of our products and take all potential safety issues seriously.

Overview

1. Hernia Is a Common and Potentially Serious Medical Condition
   
   A hernia occurs when an internal organ bulges through a weak area of surrounding muscle or connective tissue. Hernias frequently cause pain and also may be associated with other symptoms. Left untreated, hernia tissue may become trapped (“incarcerated hernia”) or the blood supply to the hernia tissue may be cut off (“strangulated hernia”), a surgical emergency that can result in permanent disability or even death. It is estimated that more than 20 million hernias are repaired each year worldwide.¹¹


2. Modern Hernia Mesh Revolutionized Hernia Repair Surgery
   
   Hernia mesh products were first introduced in the mid-1940’s, revolutionizing the field of hernia surgery. Over the past six decades, a large body of scientific evidence has established that the use of mesh strengthens hernia surgical repair, significantly reduces the rate of hernia recurrence, and decreases the need for reoperation. Clinical studies also suggest that mesh surgical repair improve patient outcomes and reduces recovery times, compared to traditional suture repair techniques. For these reasons, most surgeons use mesh to repair the vast majority of abdominal wall hernias.¹²


3. Medtronic Hernia Mesh Products Are Thoroughly Tested Prior to Marketing
   
   All Medtronic hernia meshes are thoroughly tested during development and manufacturing to evaluate and ensure product performance and biocompatibility during their intended use. Before being legally marketed in the United States, Medtronic has to submit a 510(k) application that includes several testing data per state-of-the-art recognized standards for review by experts at the FDA. Regulatory agencies from several global jurisdictions also perform periodic inspections of our facility and actively conduct technical and clinical data reviews intended to verify that our devices are both safe and effective for their intended use.

PRODUCT ADVISORY
Information on this site should not be used as a substitute for talking with your doctor. Always consult your doctor about diagnosis and treatment information.

See also:

• Safe and Responsible Product Development
• Responsible Promotion and Compliance
• Medical Device Labeling
• Medical Device Regulations