[1757011]
(b)(6) hosp/eye clinic. Dr (b)(6) performed surgery on pt that was medically unnecessary because pt was already blind in left eye. The surgery was with the use of silicone oil which was not approved for use in the united states until (b)(6) 2007. There was no fda approved use of silicone at this time, therefore, it could not be used as 'off label'. The only such way to obtain would be black market. Dr (b)(6) wasn't on the fda list to perform any experimental surgeries which such list does exist since 1965. Dr (b)(6) was not experienced to perform such surgery, because he had never done such before this one. He did not know what the complications, or damages would be. He did state that if left in too long it would cause damage but he did not know what those were. On (b)(6) 1984, dr (b)(6) and duke did another surgery to remove the silicone oil. It was not discovered until (b)(6) 2010 during surgery that the silicone oil was still in the eye. And over the yrs it caused glaucoma. Cataracts, severe pain due to pressure. It caused the eye to shrink. And it cause the sclera to become so thin, you could see through it. It was also discovered that two objects, which the lab reported to be foam were left in the eye. (b)(6) risk mgmt feels they did nothing wrong. Dr (b)(6) wrote a book about the use of silicone oil for retina detachment whereas he states that he does not recommend the use of silicone oil, because the risks are too high and the risk out weighs the benefit. Dates of use: (b)(6) 1985 -- (b)(6) 2010. Diagnosis or reason for use: retina detachment. Event abated after use stopped or dose reduced: no. Event reappeared after reintroduction: yes. Practice of medicine not dqrs.
Patient Sequence No: 1, Text Type: D, B5