(b)(4).
(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: ¿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 laparoscopic incisional hernia repair on (b)(6) 2002 whereby a gore dualmesh® plus biomaterial was implanted.
The complaint alleges that on (b)(6) 2005, an additional procedure was performed whereby explant of the gore device was performed.
It was reported the patient alleges the following injuries: removal of mesh, revision surgery, dense adhesions to small bowel, loss of consortium.
Additional event specific information was not provided.
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