No conclusions can be made.The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient including disability, pain, bleeding and subsequent surgical intervention; however, no details have been provided.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Should additional information be provided, a supplemental emdr will be submitted.Not returned.
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Per the attorney: on (b)(6) 2018 the patient was diagnosed with incarcerated incisional ventral hernia.On (b)(6) 2019 the patient underwent ventral incisional herniorrhaphy with implant of a small ventralex patch in the preperitoneal space to repair the hernia.On (b)(6) 2019 the patient was traveling and started to experience extreme pain and profuse bleeding in the abdominal area.The patient visited the er and was told that surgery was required to remove the mesh.On (b)(6) 2019 the patient underwent removal of mesh.Attorney alleges that the patient had mental and physical suffering from significant pain, disfigurement, injuries, pain and suffering and other damages.It is also alleged that the patient is at elevated risk of hernia recurrence following the removal of mesh.It is also alleged that the patient experienced emotional distress and the device was defective.
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