Former FDA Advisor On LASIK Eye Surgery: 'It Should Have Never Been Approved'
NORTH TEXAS (CBSDFW.COM) - "Imagine every good thing you see today, tomorrow you don't," said Rick Rackley of Plano, who gets emotional talking about his corrective eye surgery one year ago.
The gourmet food truck owner, who loves the outdoors, wanted didn't want to wear prescription sunglasses when he was outdoors.
But he says LASIK eye surgery made his eyesight worse.
"There is substantial blurriness. It's just fuzzy," he said.
Heather Christensen of Dallas also had LASIK eye surgery eight years ago.
"For months after that I was seeing rainbows and halos around everything," she said. She didn't need glasses when she got the procedure so it frustrates her that now she does. She blames LASIK for making her eyes worse. "I was reaching 40. I was having trouble reading labels and small print," she said explaining the reason behind getting LASIK.
Both she and Rackley say they regret the surgery. "Definitely, I wouldn't t do it again," said Rackley.
"Absolutely! I would be in a much better place if I hadn't," added Christensen.
FOOD AND DRUG ADMINISTRATION: THEN AND NOW
The CBS 11 I-Team obtained nearly 500 complaints since 2015 sent to the Food and Drug Administration regarding the corrective eye procedures. They include patients reporting "halos, glares and shadows, severe dry eyes and immense pain."
But in a statement to the I-Team the FDA said, "Most patients are very pleased with the results of their refractive surgery."
"I feel a certain amount of responsibility to the say the least," said Dr. Morris Waxler.
Dr. Waxler was on the FDA team that approved Lasik in 1999.
"I am disgusted that I was part of the approval process," he said.
The former FDA advisor says the government rushed to approve the procedure because the surgeries were already being done illegally, and they needed to be regulated.
He changed his mind about the procedure in 2007 when patients complained to him about the distortions in their vision after the surgery.
"If I had known what patients told me in 2007 of all the pain and suffering, I would have said something different but I would have been tossed aside and somebody else would have been in my place," he said.
Dr. Waxler says he is "disgusted" he was part of the process.
"I've reexamined the documents, some of which I had approved, and I said this is really terrible," he said.
Dr. Waxler estimates distortions occur in one-in-five patients. He says pain and dry eyes occur even more often.
STUDIES SUPPORT LASIK SUCCESS
"The complication rate in LASIK is very low," counters Dr. Stephen Slade, of Slade and Baker Vision in Houston. He says, it's "much less than one percent."
He performed the first LASIK procedure in the United States.
"We have 20 years of experience with LASIK and close to 20 million patients, so it has been a very successful procedure."
Dr. Slade says the procedure has improved over time, seven-thousand studies support it, and while distortions occasionally occur, he says they are short term.
"We are not here so patients are guaranteed to throw away their glasses. We hope that they are less dependent on their glasses."
No matter what their opinions, everyone the I-Team talked to agreed there needs to be better communication about potential risks.
RECENT MEDIA REPORTS: SUICIDE CONNECTION?
In recent news reports - the husband of a Detroit Meteorologist said his wife committed suicide after documenting her complications from eye correction surgery. Twice, in a Facebook post, she said, "I'm struggling a little bit."
Mother Nancy Burleson can relate. She told the I-team that her son, Max Cronin, committed suicide after suffering from complications after his eye-correction surgery.
"The pain was described as having many needles sticking in his eyes." she said.
She is among many families now claiming LASIK played a role in their loved one's suicide.
Burleson said the surgery caused her son, an Army veteran, to go legally blind. She said his chronic suffering caused him to take his own life.
"They found the suicide note on him that said the doctor ruined his eyes."
She, too, blames the popular corrective and elective eye procedure.
"For not wanting to wear glasses, he lost everything," said Burleson.
Doctor Slade said there is no data that points to LASIK as a specific cause for suicide.
The FDA also tells us there is no tie to the procedure.
GOOD CANDIDATE FOR LASIK
All of the I-Team's experts agree, you need to be a good candidate for the procedure.
This includes a patient with the following:
-- an appropriate amount of near and far sightedness
-- a healthy cornea
-- no dry eyes
-- one who is medically healthy
They also recommend you find a board certified surgeon with experience and ask detailed questions about the procedure before having it done.
MUST READ: FDA'S CHECKLIST ON LASIK SURGERY
Here is the Food and Drug Administration's response to the I-Team:
"In our own continued assessment of the literature and medical device reports, the FDA continues to believe there is a reasonable assurance that approved devices used in LASIK procedures are safe and effective under the conditions of use in the labeling of the device.
1) Is there a recent study or review about Lasik complications done by the FDA?
We collaborated with the National Eye Institute (NEI) and the Department of Defense (DoD) to conduct the LASIK Quality of Life Collaboration Project [fda.gov] (LQOLCP). The project produced a web-based questionnaire with new scales that can be used to more thoroughly assess symptoms before surgery and to monitor patients for visual symptoms as well as satisfaction after surgery. Note that the objective of these studies was not to specifically assess complications. The FDA made the questionnaire publicly available. Researchers, patients, and providers now have a well-defined tool to guide medical decisions and use in future research. Manufacturers can use the questionnaire to gather valid scientific evidence related to patient-reported outcomes that they can include in their device submissions. The questionnaire can be used during clinical care to assess candidates before LASIK surgery and monitor them for visual symptoms after LASIK surgery, and to research the rate and impact of symptoms following the procedure. We encourage the ophthalmic community to take up the charge to investigate the predictors of debilitating visual symptoms following LASIK, taking advantage of the development work conducted for the PROWL questionnaire.
2) Is there data on Lasik complications like blurriness, halos, dry eyes?
Initial estimates of the rates of symptoms and their impact from the Patient Reported Outcomes with LASIK (PROWL) studies, which were part of LQOLCP, can be found at https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2587831
3) I would like to request the most recent guideline from the FDA regarding Lasik surgeries?
The FDA does not regulate the practice of medicine, and we do not have any guidelines on how LASIK surgery should be performed. However, we do have a list of FDA-approved LASIK lasers on our web site. Each approved laser includes the device's labeling (including patient information and instructions for use). The labeling, Summary of Safety and Effectiveness Data, and Approval Order can be found at the link for each device.
4) How does the FDA ensure the patients getting Lasik have all the information on risks?
We continue to recommend that patients considering the LASIK procedure should thoroughly discuss the benefits and risks of the procedure with their health care professional. Besides the patient labeling for each device, the FDA has made a significant amount of consumer-focused information available on its website about LASIK, including the risks https://www.fda.gov/medical-devices/lasik/what-are-risks-and-how-can-i-find-right-doctor-me.
6) What is the FDA doing currently to address the issues with Lasik complications such as dry eye, blurriness, halos, streaks and symptoms such as that?
Most patients are very pleased with the results of their refractive surgery. However, like any other medical procedure, there are risks involved. That's why it is important for patients to understand the limitations and possible complications of refractive surgery, including symptoms. The FDA has made a significant amount of consumer-focused information available on its website about the benefits, risks and expected outcomes associated with LASIK. We have made the PROWL questionnaire publicly available and encourage its use. We continue to monitor the safety of LASIK lasers, including reports of symptoms, which can be reported to FDA at the following link https://www.accessdata.fda.gov/scripts/medwatch/
7) Is suicide considered a rare complication of Lasik?
We take all reports of adverse events very seriously. Complaints or adverse event reports do not necessarily directly indicate a faulty or defective medical device, and adverse event reports alone cannot be used to establish causality or rates of event occurrence. We have information about when LASIK may not be right for a patient here. Patients considering the LASIK procedure should thoroughly discuss the benefits and risks of the procedure and whether it is right for them with their health care professional.
8) If yes, how is the FDA monitoring suicides that are linked to Lasik surgery?
Each year, the FDA receives several hundred thousand medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions. MDRs are one of the post-market surveillance tools the FDA uses to monitor device performance, detect potential device-related safety issues and contribute to benefit-risk assessments of these products.
Mandatory reporters (i.e., manufacturers, device user facilities, and importers) are required to submit certain types of reports for adverse events and product problems to the FDA about medical devices. In addition, the FDA also encourages health care professionals, patients, caregivers and consumers to submit voluntary reports about serious adverse events that may be associated with a medical device, as well as use errors, product quality issues, and therapeutic failures. These reports, along with data from other sources, can provide critical information that helps improve patient safety.
MDRs submitted to the FDA are only one source we use to monitor marketed medical devices. These reports may contribute to the detection of potential device-related safety issues as well as to the benefit-risk assessments of these devices. While such reports are a valuable source of information, this type of reporting system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified or biased data. Confirming whether a device actually caused a specific event can be difficult based solely on information provided in a given report. Additionally, we may receive multiple reports related to the same event making it difficult to determine actual numbers of events.
Besides MDRS, FDA reviews regular reports on device performance required from manufacturers. Other sources we use to monitor marketed medical devices include scientific literature, professional society meetings and patient forums. When appropriate, the FDA employs a targeted, risk-based approach to address specific device areas of concern. "
