Although still not FDA approved, the agency considered a full contraindication and a Black Box Warning for ESI’s due to reports of serious adverse medical events including death during the 2014 AADPAC advisory hearings. The FDA also ruled that fluoroscopy did NOT reduce risk. In fact an advisory panel voted 14 to 7 to initiate a full CONTRAINDICATION for CESI’s but the FDA overturned their decision without explanation.
Although still not FDA approved, the agency considered a full contraindication and a Black Box Warning for ESI’s due to reports of serious adverse medical events including death during the 2014 AADPAC advisory hearings. The FDA also ruled that fluoroscopy did NOT reduce risk. In fact an advisory panel voted 14 to 7 to initiate a full CONTRAINDICATION for CESI’s but the FDA overturned their decision without explanation.
Can these injections create more room for nerves in the spinal canal?