Product identification records for the alleged gore device were not provided.
Therefore, a review of the manufacturing records could not be performed.
It should be noted that the gore® dualmesh® biomaterial instructions for use 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 incisional hernia repair on (b)(6) 2010 whereby a gore® dualmesh® biomaterial was implanted.
The complaint alleges that on (b)(6) 2010, an additional procedure occurred whereby the gore device was explanted.
It was reported the patient alleges the following injuries: chronic pain, adhesion, hernia recurrence, mesh erosion and swelling abdomen.
Additional event specific information was not provided.
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