In this episode, four guests share their diverse perspectives on LASIK eye surgery. This procedure surgically changes the shape of the cornea with the goal of helping people see better, ideally without eyeglasses or contact lenses. Experts estimate that ophthalmologists perform about 700,000 of these in the US each year. Most patients are satisfied with the outcomes. As with all surgeries, however, there are risks. What do we know about them?
The FDA first approved the laser devices for this procedure in 1999. (LASIK is an acronym for Laser-Assisted In Situ Keratomileusis.) At that time, Dr. Morris Waxler was Branch Chief for the agency. By 2011, Dr. Waxler had changed his mind about the safety of the procedure. Consequently, he petitioned the FDA to issue a Public Health Advisory regarding LASIK-related injuries. He explains his thinking in this interview.
More than 20 years ago, Paula Cofer had refractive surgery. It seemed that it would be a good fit with her active lifestyle, which included scuba diving. Her results were disastrous, however. She was left with pain and impaired vision, especially in low light. Ms. Cofer tells her story, including her testimony to the FDA and her experience as the Patient Representative at an advisory panel meeting for the agency in 2008.
Dr. Edward Boshnick, an optometrist in private practice in Miami, Florida, specializes in helping people who are struggling with the results of their LASIK eye surgery. Some have severe dry eye, while others have persistent pain or visual abnormalities. In most cases, Dr. Boshnick provides them with special scleral lenses that provide the cornea with constant moisture. They may also help correct vision distorted by a weakened cornea. Dr. Boshnick describes his approach with passion.
Dr. Alan Carlson of Duke University School of Medicine is very familiar with LASIK eye surgery. In the course of his career, he has performed more of these procedures than anyone else at his institution. He points out, however, that he has also sent more patients away without surgery than anyone else. Dr. Carlson, who does not currently perform this procedure, offers his viewpoint on the proposed guideline changes from the FDA. In addition, he discusses his conservative perspective on who can get the most benefit from LASIK–people such as military personnel, police or elite athletes for whom glasses or even contact lenses might be a hazard. He also outlines eye conditions such as glaucoma that could make refractive surgery riskier.
In the interests of providing the fullest possible range of viewpoints for our listeners, our producer approached the Refractive Surgery Council, a group of ophthalmologists who regularly perform LASIK eye surgery.
February 24, 2023:
Statement from The Refractive Surgery Council (RSC) for The People’s Pharmacy with Joe and Terry Graedon
LASIK is both safe and effective for those who are good candidates, a fact the FDA has reaffirmed repeatedly. In fact, the FDA’s own independent clinical study, PROWL, reported very high levels of patient satisfaction between 96 and 99 percent.
The risks and side effects from LASIK are very well understood based upon an enormous volume of clinical data amassed over 25+ years and more than 7,000 studies.
The FDA understands LASIK is safe and effective for those who are good candidates. In July 2022, the FDA said it had “issued a draft guidance to help ensure that information is available to patients and healthcare professionals to clearly communicate the benefits and risks of LASIK devices.”
Patients should be presented with the facts about the risks and benefits of any procedure, which should reflect the clinical, evidenced-based experience. For a patient to make a well-informed decision, both the risks and the benefits must be carefully articulated and understood.
Importantly, RSC believes it is the doctor’s role to discuss whether any patient, considering their individual needs and medical conditions, is a candidate for any medical treatment, including LASIK surgery. Patients considering LASIK are encouraged to do their own independent research, using credible, clinically accurate, and updated sources of information, such as the resources provided by RSC and the American Academy of Ophthalmology, and have a thorough discussion with their doctor to help inform their decisions. Achieving informed consent is the work of the doctor-patient relationship and each surgeon is required to provide patients with an informed consent form to review and sign.
LASIK devices have continued to incorporate advances, improvements, and refinements since the FDA began its post-market LASIK surveillance activity in 2008 resulting in a significantly improved risk profile. According to the FDA’s Total Product Life Cycle database, the number of adverse events reported with LASIK surgery is low and has declined each year from 2018 to 2021, an indication that modern technology and techniques have improved what is already a safe and effective procedure.
The Refractive Surgery Council (RSC) was created in 2010 through a collaboration of the American Society of Cataract and Refractive Surgery (ASCRS) and refractive device manufacturers working together to provide a comprehensive, independent source for patient education. As a leading authority, RSC offers individuals researching laser vision correction procedures medically reviewed and clinically accurate information to help make confident, informed decisions about vision correction procedures. For RSC’s full response to the FDA’s Draft Guidance, please visit https://www.regulations.gov/comment/FDA-2022-D-1253-0468.
HELPFUL TAKEAWAY POINTS FOR THOSE EVALUATING WHETHER LASIK IS RIGHT FOR THEM:
1. Ask yourself what you want out of LASIK. Are you active and your glasses get in the way? Are contact lenses bothering you?
2. Thoroughly research everything from how LASIK works to recovery, risks, and potential complications, and then write down your questions.
3. Make an appointment with a board-certified ophthalmologist for a thorough medical evaluation. Share your full health history including your medications and health conditions.
4. Discuss your specific risks with your surgeon so you understand what to expect if you should be one of the rare few who have a complication, the treatment protocols, and how you and your eye doctor will work together to ensure your best outcome.
5. Once your questions are answered and you understand you are a good candidate, take time to thoroughly review, discuss, and sign the informed consent with your surgeon. You shouldn’t feel rushed or pressured through this important step.
Morris Waxler, PhD, was the Branch Chief at the FDA from 1996 to 2000 who oversaw the original approval of the devices used for LASIK surgery in the USA. Soon coming to believe that the real risks associated with these devices are far higher than the FDA would have originally approved, and that important data had been distorted or withheld, on January 6, 2011 Dr. Waxler petitioned the Food and Drug Administration (FDA) to issue a Public Health Advisory to halt the epidemic of LASIK injuries.
Paula Cofer suffered life-long complications from LASIK surgery nearly 23 years ago. Since that time she has devoted herself to educating prospective LASIK patients on the risks and long-term consequences of LASIK and advocating for LASIK patients with bad outcomes. In 2008, she served as the Patient Representative at an FDA advisory panel meeting on LASIK issues. In 2014, she started the LASIK COMPLICATIONS SUPPORT GROUP on Facebook, which currently has close to 8,000 members.
Edward Boshnick, OD, maintains a cutting-edge practice in Miami, FL, devoted to the restoration of vision and comfort lost from LASIK damage as a result of refractive eye surgery (including LASIK and radial keratotomy), keratoconus, corneal transplant surgery, pellucid marginal degeneration, extreme dry eye, corneal dystrophies, corneal trauma and Stevens-Johnson Syndrome. Dr. Boshnick has been a clinical investigator for both the FDA and several major contact lens manufacturers for over 20 years. His website is https://eyefreedom.com/
Alan N. Carlson, MD, serves as Professor of Ophthalmology at Duke University School of Medicine, specializing in cataract, refractive and corneal surgery. Dr. Carlson was selected among the top 6 refractive surgeons in university settings and is an active member in over a dozen professional societies and one of the most experienced anterior segment surgeons in the country having performed over 52,500 successful surgical procedures, including 18,500 LASER vision correction procedures in his ophthalmic career. Dr. Carlson has conducted over 55 television and radio interviews and performed the first televised LASIK procedure in this region.