Based on the information provided we are unable to determine to what extent, if any the bard ventralex hernia patch mesh (device #1) may have caused or contributed to the events as alleged by the patient¿s attorney.The information provided alleges that the patient underwent an additional surgery to remove the ventralex hernia mesh patch which was noted by the operating surgeon to have "folded on itself." medical records are not available at this time, however, recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication.No lot number has been provided; therefore a review of the manufacturing records is not possible at this time.Should additional information be provided a supplemental emdr will be submitted.This emdr represents the bard ventralex mesh (device #1) implanted on (b)(6) 2009.An additional emdr was submitted to represent the bard composix l/p (device #2) implanted on (b)(6) 2013.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Not returned.
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The following was alleged by the patient's attorney: on (b)(6) 2009: the patient underwent surgery for repair of a recurrent incisional abdominal hernia.A bard/davol ventralex hernia patch mesh (device #1) was implanted to repair the hernia defect.On (b)(6) 2013: the patient underwent an additional surgery to remove the ventralex hernia mesh patch which was noted by the operating surgeon to have "folded on itself." on (b)(6) 2013: the patient was implanted with a bard/davol composix l/p mesh (device #2) to repair a ventral hernia defect and to replace the failed ventralex hernia mesh patch from the patient's previous surgery.On (b)(6) 2015: the patient underwent an additional surgery to repair the hernia defect and to remove the composix l/p mesh.As reported, the operating surgeon noted that the composix mesh had tracked away from its position and pulled away from the left side completely and was "balled up along the right side." and the failed composix l/p was replaced with "another mesh device." as alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective ventralex hernia patch and composix l/p hernia patch.
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