(b)(4).
(b)(6).
It should be noted that the gore dualmesh® 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 laparoscopic incisional hernia repair on (b)(6) 2012 whereby a gore dualmesh® plus biomaterial and gore dualmesh® biomaterial devices were implanted.
The complaint alleges that on (b)(6) 2014, an additional procedure was performed whereby the gore devices were explanted.
It was reported the patient alleges the following injuries: chronic open draining wound, mesh infection, mesh removal, small bowel resection, dense adhesions, fistulized bowel.
Additional event specific information and medical records have been requested.
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