Risks of widespread laser eye surgical procedure could also be MUCH increased than claimed

Patients are not being warned about the debilitating risks of laser eye surgery, which can leave some in agonising pain and even suicidal, experts have warned.

Each year an estimated 100,000 Britons opt for the £4,000 procedure which promises to correct vision, allowing people to ditch their spectacles and contact lenses for good.

Yet specialist eye surgeons have told The Mail on Sunday the op, in which a laser is used to cut and reshape the front of the eyeball, can cause permanent scarring and leave some ­suffering an excruciating ‘burning’ sensation. 

Most private clinics offering laser eye surgery insist in advertising materials that serious problems are rare, with fewer than one per cent of patients suffering issues.

However, while the procedure is safe for the majority of people, recent research carried out by US health officials suggests the number of those who do experience painful symptoms is likely to be significantly higher than previously assumed.

Some studies have concluded as many as a third of patients who undergo the most popular form of laser eye surgery – LASIK (laser-assisted in situ keratomileusis) – experience long-term side-effects. Support groups for laser eye surgery patients in the UK and US have a combined 16,000 members, many of whom claim they’ve suffered symptoms ranging from double vision to chronic pain and severe light sensitivity.

Campaigners say they’ve heard from ‘hundreds’ of patients who have contemplated suicide as a result of these debilitating problems.

And The Mail On Sunday has learned of a 60-year-old mother-of-one, who killed herself earlier this year after developing painful laser eye surgery side-effects. Kim Hybarger was told her eyes had been ‘butchered’ by the LASIK surgery she underwent in 2006, leaving her unable to see properly and in agonising pain. Her devastated husband Charlie said the former nurse ‘couldn’t live with what she was seeing’ any longer.

Despite these shocking findings, experts say that the UK health regulator is failing to ensure that all patients who are offered the treatment are warned of its potentially life-altering complications.

The Medicines and Healthcare products Regulatory Agency (MHRA), which ensures the safety of medical procedures, does not require private clinics by law to provide a complete list of the risks of the procedure. This means these laser eye surgery firms can decide for themselves what risks to tell patients about.

During this investigation, we found some popular high street laser eye ­surgery clinics boasted of between a 99.2 per cent and 100 per cent LASIK success rate on their ­websites – and did not mention potential long-term side-effects.

Laser eye surgery patients who spoke to The Mail on Sunday described being handed a consent form that outlined the risks of the surgery just minutes before they went into the operating theatre.

Some had already had numbing eye drops applied when they were asked to sign on a dotted line that they could barely see – let alone make out the small text above.

Almost none had met their surgeon before the day of surgery – instead speaking to them briefly on the phone. And all said that if they had been made aware of the potential outcomes beforehand, they would not have gone through with the procedure.

Victoria Ball, 38, from Cornwall, had laser eye surgery in 2022 to fix her long-sightedness. ‘I was told it went well but when I woke up the next morning I couldn’t see anything,’ she said.

‘For the first six weeks it was hell. I now suffer from severely dry eyes and I’ve become shortsighted. I never used to wear ­contact lenses before because my vision wasn’t bad enough but now I rely on them.’

Victoria said the only warning she was given about potential side-effects was a single page consent form, which ­mentioned a handful of adverse outcomes including temporary dry eyes, visual disturbances and night vision problems – but said these were very rare.

After she returned to the clinic to complain about the issues with her sight, Victoria was offered a second procedure. This time, the consent form was more than 20 pages. ‘Seeing all those risks now clearly outlined, I just couldn’t go through with it,’ she explained.

‘And if I’d seen them before, I definitely wouldn’t have ever decided to have the procedure done in the first place.’ 

Campaigner Sasha Rodoy says regulators need to do more to ensure patients are properly informed of the complications before ­undergoing laser eye surgery.

Since suffering horrific side-effects from laser surgery in 2011, Ms Rodoy has lobbied for Government regulation through her foundation My Beautiful Eyes. In 2013, she advised MPs on a bill that was put forward in Parliament, which sought to ­regulate the laser eye surgery industry.

It called for a legal requirement that companies provide a full and comprehensive list of risks to patients, which they should be given a week to consider before making their decision.

It also aimed to mandate that the laser eye surgery industry ­regularly publish safety data that would reveal how often the procedure was a success or led to severe side-effects. Since most laser eye surgery procedures take place in private clinics, much of this ­crucial information is currently unavailable to the public.

Although the bill did not receive a second hearing, Ms Rodoy – who suffers from extremely dry eyes and severe light sensitivity – hopes to see an updated version put forward in Parliament again.

‘I was in no way informed of the risks before my surgery,’ she said. ‘If I had been warned at any point that I would lose my near vision I never would have gone through with it.

‘I speak with new patients every week who say they weren’t properly informed of the risks and are now left with devastating consequences. Hundreds of people who have contacted me over the years say they’ve contemplated or even attempted suicide as a result.

‘We need guidelines that ensure surgeons are discussing with and explaining to patients side-effects they could experience.’

Laser eye surgery was developed to treat vision problems including long-sightedness, short-sightedness and astigmatism.

LASIK involves cutting a flap in the eye with a laser and reshaping the cornea – the eye’s clear, protective layer – with another laser.

First approved in the 1990s, the surgery takes under ten minutes, so patients can return home the same day. Many organisations, such as the American Refractive Surgery Council (a group of laser eye clinicians), claim fewer than one per cent of patients experience side-effects.

However, more recent data suggests laser eye surgery may be riskier than previously thought.

Two years ago, the US Food and Drug Administration (FDA) released worrying new guidance on the procedure. Outlining a litany of potential problems from the surgery – including a risk of permanent double vision, persistent eye pain and even suicide – the FDA told doctors that prospective patients must be warned of the dangers.

The FDA has received over 700 complaints of severe pain after laser eye surgery, including symptoms described by women as ‘worse than childbirth’.

In one clinical trial from 2017, FDA researchers found that nearly half of participants reported ‘new visual symptoms’ including glare, halos and ­starbursts after their surgeries.

The FDA also warned in its ­guidance that nearly one in five of patients still needed eye drops daily to combat dry eye symptoms more than five years after their surgeries. Experts say this frequency of side-effects related to laser eye surgery is unsurprising as the procedure involves permanently damaging the eyeball.

Dr Cynthia MacKay, clinical professor of ophthalmology at Columbia University, claims that, often, the millions of cornea nerves cut during LASIK surgery never grow back properly.

‘Although the nerves are gone right after the surgery – meaning patients usually don’t feel any pain – they begin to grow back in the weeks following,’ she said.

‘But this regrowth can happen in a chaotic, disorganised fashion. And that’s when the pain starts.’

In some cases, LASIK can ­trigger a complication called ­corneal ectasia, which occurs when the damaged cornea bulges outwards. Left untreated, it can lead to severe vision problems including blindness. Under close examination, clinicians report that many patients with corneal ectasia have visible stretch marks on their eyeballs and white dots where the cornea has detached (see image, left).

Dr Morris Waxler, one of the FDA’s vision scientists who first approved LASIK, says he regrets playing a part in the process.

Dr Waxler carried out ­analysis of industry data and concluded roughly a third of patients experienced chronic eye pain after LASIK. ‘If I’d been more knowledgeable about the procedure at the time, I never would have voted to approve it,’ he told The Mail on Sunday.

‘Many surgeons who I’ve met won’t have LASIK themselves but are happy to recommend it,’ he said. ‘Surgeons are supposed to provide informed consent.

‘But the documents they provide are totally lacking in information that would help a layperson understand what’s happening to their eyes.’ Experts also warn part of the problem is many patients are offered LASIK ­surgery when they would be b­etter suited to a different ­procedure. Another version, called LASEK (laser epithelial keratomileusis), does not involving cutting the cornea.

Instead, an alcohol solution is applied to the eyeballs. This loosens the thin layer of cells on the eye’s surface, called the ­epithelium, which is then removed by hand. Once this layer is out of the way, the laser can be used to reshape the cornea.

A special contact lens is inserted following the procedure to protect the eye while the epithelium heals – which usually takes a week. LASEK tends to be more painful than LASIK, and the eyeball takes longer to heal.

However, experts claim it leads to fewer complications, which is why it is recommended for people with an especially thin cornea or other existing eye conditions.

But doctors have told this newspaper that High Street clinics in the UK are more likely to suggest LASIK to patients. ‘LASIK is what they prefer because it’s quicker and less ­painful, with fewer ­complaints from patients at first,’ says Dr Robert MacLaren, professor of ophthalmology at the University of Oxford.

Alice Bentley says she was approved for laser eye surgery without being informed of the complications. She had the ­procedure five years ago. ‘I didn’t think I’d be a good candidate as I’d had quite a drastic change in my prescription the year before,’ the 28-year-old ­commercial manager from King’s Lynn explained.

Patients are often told not to get eye surgery after a new glasses prescription because the shape of their cornea may still be changing. ‘I mentioned that I already suffered from dry eyes as well,’ says Alice.

‘But the clinician told me I was definitely suitable for LASIK and promised me a life without glasses. Just a few months after the surgery, however, I was wearing glasses again – and in a lot of pain. Now I have to go on multiple walks during the working day because I’m in so much agony staring at a screen.

‘Even just a slightly bright day makes my eyes incredibly sore.’

Software engineer Ian ­Waghorne, 51, had a similar experience when he received LASIK surgery from a high street clinic in 2017. The dad-of-two, who lives in Cheshire, said: ‘I was told I was an ideal candidate, despite telling the clinician that I had previously been told I had dry eyes.

‘I regret signing that consent form without properly reading it but I felt I was being rushed and didn’t suspect there would be anything on it that the doctor hadn’t already discussed with me.

‘Later on, I discovered that my surgeon had written in his notes that I was at “high risk” of dry eyes and that I should never have been given the surgery at all.

‘Day to day is a cocktail of eye drops, hot compresses and ointments at night. When I go to sleep I wake up with dry, sore eyes that feel like they’re full of grit.

‘I’ve tried to commit suicide twice and the second time I nearly succeeded.’

The MHRA said manufacturers of medical devices should supply information on risks. The Royal College of ­Ophthalmologists said it was not a regulatory body and it was the duty of the General Medical Council to regulate ­doctors and the Care Quality ­Commission to regulate care providers. The GMC and CQC were approached for comment.

‘Kim could no longer live with what she was seeing’

Kim Hybarger, 60, took her own life on Mother’s Day of this year, after suffering through almost two decades of debilitating eye pain and blurred vision.

Kim’s husband of 40 years, Charlie, says her death in May (the date of Mother’s Day in the US) was directly linked to her botched LASIK surgery.

‘She couldn’t live with what she was seeing,’ he said. ‘She would tell me that she couldn’t get any peace.’

Kim, who worked as a nurse in their hometown of Cleveland, Tennessee, had already undergone a radial keratotomy – an outdated eye operation that cuts deep incisions into the cornea to flatten it – when she was approved for LASIK surgery in 2006.

However, this was unsuccessful and so she decided to get LASIK as well.

According to Charlie, a maintenance technician, this second procedure triggered a series of debilitating side-effects including double vision, light sensitivity and distorted vision.

Kim’s eyes were also extremely dry and felt, in her words, ‘like leather’.

When the couple travelled to Miami to get special lenses fitted so that Kim could see again, the ophthalmologist examining her eyes was aghast.

‘He told us that her eyes had been butchered,’ Charlie said.

And when Kim’s eyesight again began to deteriorate earlier this year, the mum-of-one could no longer cope.

‘Doctors may tell you that just one per cent of people have bad results but if that’s you or your family, then your life may be ruined,’ said Charlie. ‘LASIK destroyed my wife.’