Double vision, dry eyes, difficulty driving at night… patients considering having Lasik surgery should be better informed about the risks of the operation, suggests the Food and Drug Administration, Health Canada’s counterpart in the United States . In Quebec too, people would have liked to know more about the possible complications before undergoing the operation.
“I had to say bye to my life before,” sighs Gabrielle Bernier, 26.
In January 2019, the young woman underwent an operation to treat myopia. “I have had good eyesight since the operation. That’s not the problem. It’s the pain,” she explains. “It’s as if I had knives in my eyes. It’s like being stuck with needles 24 hours a day, 7 days a week.”
Mme Bernier complains that the staff at Lasik MD, one of the clinics performing Lasik surgery, misinformed her of the risks of eye surgery. She also says the clinic minimized her pain when it started two years after her operation. To understand what was happening to her, the young woman consulted a doctor in Boston who diagnosed her with a rare disease called corneal neuralgia.
For most patients, nerves severed during Lasik surgery regenerate on their own in six months or less. Gabrielle Bernier’s nerves never healed.
I can’t be in the sun for long, in the wind, in the air conditioning, in front of the computer, I can’t wear makeup.
Gabrielle Bernier
Gabrielle Bernier quit her job as a financial advisor because she couldn’t tolerate her computer screen anymore. At the height of the pain, she considered suicide.
A guide to informing the public
The testimony of Mr.me Bernier is far from being the only one in the genre. In the United States, the Food and Drug Administration (FDA) is working on a guide for the Lasik industry to better inform patients of the benefits and risks of surgery. The text, still at the draft stage, was highlighted by the New York Times in December and is available on the FDA website.
The American agency lists, in a 29-page document, a series of possible complications after a Lasik intervention such as dry eyes, the appearance of halos, double vision, discharge from the eyes and slight discomfort which disappears for the most in less than six months.
“In some patients, the pain may never go away and may be resistant to treatment,” however, qualifies the outline in a sentence highlighted in bold.
Some patients have been reported to have suffered from severe depression or suicidal tendencies which they attribute to complications from the procedure.
Excerpt from Food and Drug Administration document
The FDA approved Lasik surgery in 1999. In 2019, one of the experts who served on the FDA committee that approved Lasik in the United States said in a CBS network interview that he regretted his vote and that the operation should “absolutely” be withdrawn, given the possible complications.
In Quebec, a patient filed a class action lawsuit against Lasik MD in 2019 because the company allegedly failed to inform its customers of the risks associated with vision correction surgery. However, the Superior Court did not authorize the action because the plaintiff had exceeded the three-year period after the appearance of his first symptoms. The judge also ruled that this patient’s case was special and could not be extended to all Lasik MD clients.
Clinics that operate “by volume”
The Dr Languis Michaud is not surprised that the FDA is looking into the Lasik industry. “I applaud this four-handed initiative,” says the optometrist, who sometimes treats patients who are dissatisfied with their Lasik operation at the University of Montreal’s optometry clinic.
” [Au Québec], there are centers that work very well, that inform their patients and leave time to reflect. But unfortunately, there are also centers that operate by volume and which conceal or minimize the risks,” explains the man who is director of the optometry department at the University of Montreal. Note that the Dr Michaud refrained from naming any clinic by name in the interview.
The optometrist maintains that the eligibility of candidates varies from one center to another. A person may be refused in one clinic, but accepted in another. Clients have also been offered surgery within hours of their first clinic visit, leaving little time for reflection, he adds.
In some centers, the patient meets the surgeon for the first time when he is below the machine, both eyes strapped. I don’t call that informed consent.
The Dr Languis Michaud, optometrist
In an email sent to The Presse, Lasik MD claims that the satisfaction rate of Lasik clients is between 96% and 99%, citing an American study. The FDA talks about a 95% satisfaction rate on its website.
The company also claims that only 1% of its patients use eye drops more than a year after surgery. The FDA indicates instead that 17% of patients use drops, five years after the operation. The US agency says that 2% of patients have difficulties that prevent them from going about their daily activities, six months after their operation. There are no statistics on the Lasik MD site about this.
“The number of procedures we have performed at Lasik MD over the past 20 years [plus d’un million] allowed us to collect clinical data that differs from statistics [de la FDA] explains Jessica Lukian Papineau, Senior Director at Lasik MD. She recalls that the scientific literature has shown, for 25 years, that Lasik is “safe and effective”.
“While all medical procedures carry some degree of risk, complications of a surgical nature related to Lasik are rare. They occur in less than 1% of cases, and the vast majority of them are treatable,” she continues.
Mme Lukian Papineau also ensures that patients at Lasik MD are made aware of the risks of surgery from their first preoperative meeting. A 32-page information booklet is given to each candidate. “Lasik MD takes patient education very seriously. We believe it is important that all of our patients understand the risks, benefits and possible side effects of the procedure they are considering, as before any other medical treatment. We talk to patients about different aspects of Lasik at several points before they decide to have the procedure,” she explains.
Minimized risks?
Charles-Antoine Masson, he had the impression that the risks were minimized when he presented himself in a Lasik MD clinic. “They don’t insist on it, and the dry eye, they say it is fixed with drops”, says the one who had surgery in May 2021 because he was tired of having fog. in the glasses.
Since his operation, his eyes have been so dry that on four occasions, his eyelids have torn pieces of his cornea. The pain becomes unbearable, prevents him from working and forces him to multiply visits to the clinic to cure his eyes.
Every day since his operation, he has had to put in drops, which cost him $80 a month (his pharmacist has just found him a brand that is partially reimbursable by his insurance).
And every day since May 2021, he wonders if Lasik MD has played with the statistics regarding possible complications. “Was there a lack of transparency? Do they consider that I only have slight complications? Do they include me in their statistics? “, he wonders.
“If the risks of dry eye had been better explained to me, I would certainly have thought more than 10 minutes before having the operation,” he says, bitterly.
Health Canada says it “monitors” adverse reactions to laser surgery devices, including “monitoring” complaints. “When risks to patients are identified, Health Canada does not hesitate to take appropriate measures, if necessary, to protect the health and safety of Canadians,” wrote the Canadian agency in an email.
What is LASIK?
Lasik can treat visual disorders such as myopia, hyperopia, astigmatism and presbyopia by modifying the shape of the cornea. To achieve this, the surgeon incises a very thin layer of the cornea called the flap, then removes a variable amount of tissue depending on the patient. The corneal flap is then put back in place and the healing of the eye begins. The operation lasts about ten minutes. In Canada, Lasik has been practiced since the mid-1990s. Lasik MD is one of the clinics that performs this type of surgery.
Some definitions
- Myopia: difficulty seeing at a distance
- Hyperopia: difficulty seeing up close
- Astigmatism: distorted vision of objects at a distance
- Presbyopia: inability to clearly distinguish nearby objects