My body rejected my baha cochlear device after 9 years of successful use.The titanium abutment was surgically implanted in (b)(6) 2012 on the left side of my skull.I used the baha device without incident until (b)(6) 2021 when the entire abutment was rejected from my skull along with bloody discharge and pain.Since the original implantation, i have developed several autoimmune diseases.Prior to the implantation i was only suffering from crohn's disease.There were no tests conducted as none would have been appropriate.My body simply rejected the device.My physician and i are curious as to whether this is a common occurrence with people with autoimmune disease--to reject titanium implants.Fda safety report id # (b)(4).
|