No conclusion can be made.It is alleged that the patient was implanted with 3 bard devices in 2014.As alleged since approximately eight (8) months post implant the patient continues to experience multiple postoperative symptoms.Although the medical records provided were limited information states constipation, diarrhea and pain were due to diverticulitis.The medical records also included an office note from the patient's md indicating a left side (device #2) recurrent hernia.As reported, there has been no surgical procedure performed to date.Recurrence is a known inherent risk of hernia repair surgery and is listed in the instructions-for-use as a possible complication.A lot number was not provided; without a lot number a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.This emdr represents device #2 additional emdrs were submitted to represent device #1 and device #3.Remains implanted.
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The following was reported to davol and is based on information provided by contact: it is alleged that on (b)(6) 2014 the patient was implanted with three bard mesh devices.As alleged a ventralex st mesh (device #1) was placed for the repair of an umbilical hernia and two 3dmax mesh (device #2 and device #3) were placed for bilateral repair in the groin area.As reported about 8 months after the implant procedure, the patient experienced abdominal pain and constipation.Due to these symptoms the patient went to the hospital where he was diagnosed with a bowel obstruction.Reportedly the patient is having significant issues with his bowels, experiences urinary retention and has been to numerous doctors over the years about his issues.The contact reports the mesh has moved in the patient's stomach which is causing all of his issues.As alleged the patient is experiencing a golf ball-like appearance in the area of the implant (device #2), pain, swelling, trouble with the digestion process, pain in the area which radiates to the neck, lower back pain, trouble going to the bathroom, nerve involvement, and impingement on the small intestine which shows ¿strings¿.As reported the patient has to eat salads or else he gets ill.The patient has consulted with a surgeon who wants more information about the mesh he had implanted before removing the mesh from the patient.The following is based on medical records provided by contact: on (b)(6) 2017 office visit patient diagnosed with constipation, diarrhea and pain due to diverticulitis.On (b)(6) 2019 office note from the patient's md indicates a left side (device #2) recurrent hernia with recommendation to have a laparoscopic repair of the hernia.As reported, there has been no surgical procedure performed to date.
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