(b)(6).
It should be noted that the gore® dualmesh® plus biomaterial instructions for use includes warnings and addresses the following adverse reactions among others: ¿strict aseptic techniques should be followed.
If an infection develops, it should be treated aggressively.
An unresolved infection may require removal of the material.
¿ ¿possible adverse reactions with the use of any tissue deficiency prosthesis may include, but are not limited to, contamination, infection, inflammation, adhesion, fistula formation, seroma formation, hematoma, and recurrence.
¿.
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It was reported to gore that the patient underwent open ventral hernia repair on (b)(6) 2001 whereby a gore® dualmesh® plus biomaterial was implanted.
It was reported the patient was additionally implanted with a gore® dualmesh® plus biomaterial on (b)(6) 2003.
The complaint alleges that on (b)(6) 2005, an additional procedure occurred whereby the gore device was explanted.
It was reported the patient alleges the following injuries: removal of meshes, additional surgery, lysis of adhesions.
Additional event specific information was not provided.
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