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General product and regulatory information only. This page is not medical advice; questions about a specific patient or repair belong with the treating surgeon.
Short answer
Surgical mesh is a medical device used to give extra support to weakened or damaged tissue. Under 21 CFR 878.3300 it is a metallic or polymeric screen implanted to reinforce soft tissue or bone, and it is a Class II device. The same term covers hernia mesh, orthopedic mesh and transvaginal mesh, which FDA regulates differently.
What is surgical mesh? Definition and scope
The federal classification regulation defines surgical mesh as “a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists.” Its examples are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery. FDA’s hernia page describes the same device in plainer terms: mesh provides additional support to weakened or damaged tissue, and most devices on the market are made from synthetic materials or animal tissue.
Two points follow from the definition. Mesh is not only a hernia product, because the regulation names orthopedic uses. And the regulation describes mesh by function and material, not by dimensions, so it sets no standard sizes.
How surgical mesh is used in practice
FDA states that surgeons often use mesh to strengthen a hernia repair and reduce the rate of recurrence. FDA lists pain, infection, recurrence and seroma as common complications of all hernia repairs, and adds migration or shrinkage (contraction) of the mesh itself as a mesh-specific concern. FDA advises patients to discuss their own circumstances with their surgeons. This page does not describe how a repair is performed.
Types of surgical mesh
FDA’s hernia page and the CFR support three ways to sort mesh. They are ways to describe a product, not a ranking.
| Axis | Options named by FDA or the CFR | What the source says |
|---|---|---|
| Material origin | Synthetic, or animal-derived | Synthetic mesh comes in knitted mesh or non-knitted sheet forms. Animal-derived mesh is processed and disinfected, is absorbable, and is mostly from pig or cow. |
| Material class in the CFR | Metallic, or polymeric | 21 CFR 878.3300 covers both, including metallic mesh used in orthopedic surgery. |
| Absorbable vs non-absorbable | Absorbable, non-absorbable, or a combination | Absorbable mesh is absorbed and loses strength over time and is not intended for long-term reinforcement. Non-absorbable mesh remains in the body indefinitely, though it may degrade somewhat over time. |
For the same absorbable and non-absorbable distinction in another product family, see the CASRAI comparison of absorbable and non-absorbable sutures.
Surgical mesh sizes
Neither 21 CFR 878.3300 nor FDA’s hernia page gives a size table. Dimensions are a property of each individual product, so any size comparison has to come from that product’s own labeling.
Where it matters for labs, clinics and supply decisions: one term, three regulatory situations
The term covers more than one regulatory situation, and that changes what “surgical mesh” means in a supply or regulatory context.
| Use | Regulatory status per FDA and the CFR |
|---|---|
| Hernia and orthopedic mesh (21 CFR 878.3300) | Class II. |
| Mesh for transvaginal repair of pelvic organ prolapse | FDA reclassified it into Class III on January 5, 2016, which requires a premarket approval (PMA) application. On April 16, 2019 FDA ordered two manufacturers to stop selling and distributing their products after their PMAs were declined because the data did not give reasonable assurance of safety and effectiveness. |
| Mini-slings for stress urinary incontinence (SUI) | FDA’s page describes no order restricting SUI mesh, and the advisory panel recommended that mesh for SUI remain in Class II. |
To see how the Class II and Class III pathways differ, read 510(k) vs PMA and the guide to FDA device regulation, classification, 510(k) and PMA. For product identification, unique device identification explains how a specific product is labeled in FDA’s systems, and what is a medical device gives the wider definition.
Common misunderstandings
“Surgical mesh is only for hernias.”
The regulation’s own examples include orthopedic acetabular and cement restrictor mesh, and FDA also regulates mesh for pelvic organ prolapse.
“All mesh is permanent.”
FDA distinguishes absorbable mesh, which loses strength over time, from non-absorbable mesh, which stays in the body indefinitely.
“All vaginal mesh was banned.”
The 2019 stop-sale order concerned two manufacturers’ products for transvaginal repair of pelvic organ prolapse. FDA’s page does not describe an order restricting mesh for stress urinary incontinence.
FAQ
What is surgical mesh?
A medical device that supports weakened or damaged tissue. The CFR defines it as a metallic or polymeric screen implanted to reinforce soft tissue or bone where weakness exists.
What are the types of surgical mesh?
FDA sorts mesh by origin (synthetic or animal-derived) and by whether it is absorbable, non-absorbable or a combination. The CFR also covers metallic mesh.
What sizes does surgical mesh come in?
The classification regulation and FDA’s hernia page set no standard sizes. Sizes are specific to each product.
Is surgical mesh FDA regulated?
Yes. Hernia and orthopedic mesh is Class II under 21 CFR 878.3300. Transvaginal mesh for pelvic organ prolapse is Class III.
Sources
- 21 CFR 878.3300, Surgical mesh https://www.ecfr.gov/current/title-21/part-878/section-878.3300 (checked 2026-10-30).
- FDA, Surgical Mesh for Hernia Repair, https://www.fda.gov/medical-devices/implants-and-prosthetics/surgical-mesh-used-hernia-repair (checked 2026-10-30).
- FDA, FDA’s Activities: Urogynecologic Surgical Mesh, https://www.fda.gov/medical-devices/urogynecologic-surgical-mesh-implants/fdas-activities-urogynecologic-surgical-mesh (checked 2026-10-30).
