I had Lasik on 7/14/06 after receiving a flyer from Eyecare Medical Group in Portland, Maine, telling me to "Throw Away my Glasses or Contact Lenses" and that Lasik was "Safe and Effective" and no, there was no mention of risks on the flyer. Within days of the surgery I developed severe dry eye that then spiraled into a full blown and severe case of blepharitis. My surgeon's nurse had only told me that any dry eye would last "a few weeks or maybe 3 months". End of discussion. I was handed an IC document, conveniently called "permission to perform surgery" to read after just having my eyes dilated and was never given a copy. Of course, the IC document was never referred to again. I had not even met my surgeon nor was any testing done at that point.
After I got my records, I realized that there was nothing in either the informed consent document or video referring to dry eyes, either severe or permanent despite warnings right on the LADARVISION website that specifically warned of this risk for women with my medical conditions and pre-existing symptoms. By the way, it took me almost a full year to realize that the ghosting, starbursts and halos at night could be from my 7.4mm pupils despite the LADARVISION warning that pupils exceeding the maximum 6.5 treatment zone would be at increased risk for visual aberrations. And no, I did not receive the manufacturer's patient information booklet from my surgeon as required. I had to find it on-line.
Fast forward to my complaint with the State of Maine Board of licensure in September 06. I filed a complaint about the lack of informed consent and their IC process to the Maine BOLIM (Board of Licensure in Medicine) and to the American Academy of Ophthalmology.
In my physician's response to my September 06 complaint to the BOLIM he states categorically that I was "adequately informed of the risks" and that since I was nearsighted, I could have read the IC document with dilated pupils (I guess he also forgot I was presbyopic). The BOLIM dismissed my complaint almost immediately.
Apparently, it is OK with he State of Maine to dilate a patient's eyes, hand them a document they can't read and call it by a misleading name and never even give them a copy.
However, the AAO determined that there was sufficient evidence to support my complaint and after almost full year of investigation by the Ethics Committee of AAO, including having my Lasik records reviewed at the Bascom Palmer Eye Institute, my surgeon was issued a formal reprimand for a lack of informed consent, inadequate screening and a failure to provide warnings of side effects that a "reasonable patient would find objectionable". Trust me when I tell you that this does not happen often.
After repeated letters and emails to the Governor of Maine, John Baldacci, The BOLIM and The Office of Professional and Financial Regulation who oversees the BOLIM, I received a rather hostile letter from the Executive Director of the BOLIM, Mr. Randall Manning, stating that the BOLIM would NOT take further action.
Shortly after, I then received an email telling me that the BOLIM had reconsidered as "new" evidence compelled them to do so. My surgeon was issued an LOG (letter of guidance). This is not considered "discipline" as the BOLIM stated that the evidence did not rise to that level. That opinion despite an IC document and video that clearly did not contain all of the risks and side effect of Lasik eye surgery. My surgeon had informed me in a letter subsequent to my complaint being closed with the State that "after I had brought this oversight to their attention" in September 06, his practice had revised both their IC document and video. When I asked the BOLIM which version of the IC document and video he had included in his initial response, they refused to answer me and still have not done so to this day. After all, none of his statements in his initial response to the BOLIM were supported by documentation and my medical records actually contradicted some of his statements.
My surgeon's license renewal was due in October 08. The renewal application requires that a physician report any reprimands from any peer association. When I asked the BOLIM if my surgeon had complied, they informed me that he had not. After several months of "investigation" they accepted my surgeon's response that he did not realize he was required to submit this and that "he would endeavor to improve". The BOLIM also acknowledged that by this time they did have an actual copy of the sanction from the AAO in their possession. But again, all they did was issue a letter of guidance. The BOLIM knows my surgeon lied to them on his initial response to my complaint and they know he was found responsible by his highly educated peers for performing surgery without adequate informed consent and adequate preoperative screening and they do nothing. They have gone to great lengths to try and shut me up and the double speak was simply astounding.
Obviously, this is a synopsis of events over the last 3 years. The volume of letters and emails is enormous and the time it would take for me to capture the exact sequence of events and compile all the supporting documentation could be weeks. I have included the two LOG's from the state of Maine. I have a copy of the sanction from the AAO but am not ready to release that at this time.
Oh yes, I also asked my surgeon for the model # of the LADARVISION4000 they were using and documentation of his self proclaimed "10% re-treatment rate" when I found out about it's terrible history and the FDA recalls but he refused to supply it. Just as Alcon very quietly dumped the LADARVISION for the Wavelight, so did my surgeon's practice. Just another of the "dirty little secrets of Lasik".
I don't believe there is anyone at the FDA who really cares that the overwhelming majority of Lasik surgeons act with impunity and seemingly with no oversight but for anyone at the FDA to suggest that state medical boards and/or medical malpractice is the answer are woefully naive and misinformed or in collusion with medical lobbyists and medical malpractice carriers. With all I've heard and seen recently about the FDA, the very questionable approval process for Lasik and what smacks of the FDA scrambling to cover up after Mr. Waxler's recent statements, I doubt very much that the FDA will do anything. Even my 80 year old mother told me recently that she would no longer take at face value anything "FDA approved" and I concur.
By the way, I still wear glasses (oh yes, I was undercorrected from the start but was advised by several other Lasik surgeons that an "enhancement was too risky") I still have dry eyes and my night vision is terrible. I avoid driving after dark whenever possible and never to any place that I am not totally familiar with.
Thank you for listening.