[58977144]
Caller had a granuloma reaction to a class three (3) medical device called silikon 1000 approved by fda for detachment retina but some doctors use this device as a dermal filler off label, and market this product on a website called "realself" in a cosmetic form. Caller met with a doctor who is an ent and a general facial surgeon who performed three procedures with the device. The first procedure was done in (b)(6) 2014. In (b)(6) 2014 the second treatment was given, and the third treatment occurred on (b)(6) 2014 which caused the granuloma reaction. Caller went for a followup about a month later in (b)(6) 2014 after experiencing chronic pain, swelling of the eyes, discomfort, disfigurement, and heaviness in the eyes. The outcome of the meeting was that he would require a surgery where the doctor would have an incision on the top and bottom of the affected areas to correct the problem. After the meeting with the doctor he was advised to see an ocular specialist. He met with two ocular specialists and they did not agree with the corrective treatment because it may cause further problems to his eyes. He was diagnosed with edema, overcorrection or possibly reaction. Caller believed the doctor engaged him in misinformation semantics and ad hoc procedures that do not exist and deceptive tactics. He believes the website did not have sufficient information about the device and believe is a false advertisement. He wants fda to intervene so others will not go through what he has gone through with this device and the doctor.
Patient Sequence No: 1, Text Type: D, B5