There are a number Covidien hernia mesh implants that appear to be poorly designed. While some mesh implants effectively treat hernias, others can cause complications that often lead to additional surgeries. Below is a list of Covidien mesh implants that GSP is investigating:
Parietex Composite (PCO)
Parietex Plug and Patch
The universe of hernia mesh implants is comprised of many different types of products that are made from different materials, utilize different substances as layers of film, have different pore sizes, use different attachment mechanisms, and come in a variety of shapes and sizes. All of these variables play a factor in the safety and effectiveness of these implants and many of them were never tested for safety and effectiveness before being marketed for use in hernia surgeries.
For instance, Parietex mesh is made from polyester and has a layer of collagen film that disintegrates over time and fails to protect against exposure to the polyester material. This, along with its rough edges, leads to perforation of surrounding organs and tissues, infections, and dense bowel adhesions. The lightweight version of this mesh with large pores also has problems with the mesh implant failing as a result of it breaking or tearing.
Covidien’s Symbotex Composite mesh is similarly made from polyester textile and covered with absorbable hydrophilic film on both sides. The layer of film on this product consists of collagen from porcine origin and glycerol. This mesh implant claims to provide long term reinforcement of soft tissues while the absorbable film minimizes tissue attachment to the mesh in the event of direct contact with the viscera. Similar problems have been seen with this implant as those described with the Parietex implant.
The Paritex ProGrip mesh has a unique design consisting of thousands of microgrips that replace the need for alternative tacks or sutures. The fixation of this mesh is akin to that of velcro. Once this implant is placed it cannot be moved. This type of inflexible fixation leads to tearing, fraying and unraveling of the mesh which can cause incredible pain, perforation of surrounding tissue and organs, and a pulling or tugging sensation. Some have reported a foreign body response with this implant.
The Parietex Plug and Patch system is a plug-like design made from mesh. This implant is specifically indicated for the treatment of groin hernia defects used in an open approach. The World Guidelines for Groin Hernia Management have warned against the use of plug repair techniques because they are associated with higher rates of migration and erosion.
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