(b)(4).
The plus antimicrobial product coating contains silver carbonate [approximately 800 micrograms per cubic centimeter of product (g/cm3)], and chlorhexidine diacetate [approximately 1600 micrograms per cubic centimeter of product (g/cm3)].
The gore® dualmesh® plus biomaterial instructions for use also states: ¿strict aseptic techniques should be followed.
If an infection develops, it should be treated aggressively.
An unresolved infection may require removal of the material.
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(4)2007 whereby a gore® dualmesh® plus biomaterial was implanted.
The complaint alleges that on (b)(6) 2020, an additional procedure occurred whereby the gore device was explanted.
It was reported the patient alleges the following injuries: recurrence, dense adhesions, mesh shrinkage, mesh erosion, pain and suffering.
Additional event specific information was not provided.
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