Hernia Mesh Products Involved

  • Ethicon:
  • Physiomesh
  • Proceed
  • Proceed Ventral Patch
  • Prolene 3D Patch
  • Prolene Hernia System
  • Covidien/Medtronic:(Formerly Tyco)
  • Parietex
  • Parietex Composite
  • Parietex Composite Open Skirt
  • Parietex Composite Parastomal
  • Parietex Composite Hiatal
  • Parietex Composite Ventral Patch
  • Parietex Easegrip
  • Parietex Lightweight
  • Parietex Plug & Patch
  • Parietex ProGrip
  • Parietene
  • Parietene Composite
  • Parietene Macroporus
  • Parietene Progrip
  • Surgipro
  • Surgipro Plug & Patch
  • Symbotex
  • Bard/ Davol
  • Visilex
  • Composix
  • Composix EX
  • Composix Kugel
  • Curasoft
  • Dulex
  • MK Patch
  • Parastomal Patch
  • Spermatex
  • 3D Max
  • 3DMax Light
  • Bard Mesh
  • Bard Pre-Shape/Keyhole
  • Sepramesh
  • Perfix Plug
  • Perfix Light
  • Ventralex
  • Ventralex ST
  • Atrium-Maquet-Getinge:
  • C-Qur Centrifx
  • C-Qur FX
  • C-Qur Mesh
  • C-Qur Mosaic
  • C-Qur Edge
  • C-Qur TacShield
  • C-Qur Lite Mesh V-Patch
  • C-Qur Mesh V-Patch
  • Prolite Mesh
  • ProLite Ultra Mesh
  • ProLoop Mesh
  • Gore
  • Dual Mesh
  • Dual Mesh
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Hernia Mesh Failure

Hernias have a high risk of re-opening (called recurrence). To reduce this risk, most surgeons stitch in a mesh patch or plug to help reinforce muscles and connective tissues. They can be synthetic or non-synthetic, permanent or absorbable. Some patches work better than others. For example, Physiomesh was withdrawn from the market due to higher rates of recurrence.

Certain hernia mesh patch products can shrink, shrivel, and migrate, causing damage to nearby organs. Adhesions — or the development of scar-like tissue that causes organs, muscle, and body tissue to stick together sometimes occur. Irritation or abrasions from the mesh can cause a hole in the bowel or neighboring organs. Many of the newer synthetic meshes were rushed through the Food and Drug Administration’s (FDA) 510(k) process — which is a fast-track review, based on devices that are deemed to be similar to an already approved medical device.

Millions of hernia surgeries have utilized mesh implants and the failure rate is estimated to be as high as 12-30%. In some hernia mesh cases, the side effects that indicate a problem can take years to emerge.

In fact, hernia mesh failure symptoms may occur beyond five years after the device is implanted, according to a recent study published in JAMA Surgery. The researchers found that the rate of hernia mesh problems increased over the five-year period after a patient receives hernia mesh surgery. Many patients required hernia mesh revision surgery to treat hernia mesh complications.

From 2005 to 2007, C.R. Bard and Davol issued three recalls for Composix Kugel Mesh patches because the “memory recoil ring” can break and cause a bowel perforations or intestinal fistula. In June 2010, another Class 1 recall was issued for counterfeit hernia mesh sold under the C.R. Bard or Davol brand-name.

In July 2013, Atrium recalled most of their C-QUR Hernia Mesh implants because high humidity could cause the fish oil gel coating to peel off and stick to the inside of the package.

In May 2016, Ethicon recalled all unused stock of Physiomesh in Europe and Australia, but only issued a “market withdrawal” in the United States.

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