Product liability partner Jill Paterson discusses the lack of regulation in the corrective eye surgery sector

Since the introduction of laser eye surgery around 20 years ago, there has been a surge in high street providers willing to deliver the treatment. Whilst the treatment is growing in popularity the industry remains largely unregulated which worries many experts.

Surgical risk

There have been remarkable advances in technology and surgical technique over the past 20 years.  Despite this there are risks linked to laser eye surgery, as with any surgery. These can include health problems that have a detrimental effect on people’s quality of life such as  poor night vision, double vision, foggy vision, chronic eyelid inflammation, dry eyes and infection.

Patients need to be provided with a full risk assessment so that  they can make an informed decision about the treatment they receive. Whilst serious long-term complications are rare, patients deserve to know the potential adverse outcomes they could face.

Customer experience

In a Which? Undercover investigation carried out in 2014 the consumer watchdog found that a third of visits to high street eye clinics were rated poor, with Optical Express faring particularly badly .

Which? sent researchers to clinics to see whether the advice being given was sufficient and discovered that one third of providers significantly down played the risks associated with surgery.  

Hard sell

It’s no secret that a salesperson will use ‘any trick in the book’ to secure a sale. However, if that salesperson was selling a medical procedure, you would expect the position to be different, wouldn’t you?

A confidential 10 page training manual from high street provider Optical Express leaked last year, revealed the ‘hard sell tactics’ encouraged to ensure bookings. The manual advised sales staff to look for a ‘nugget’, a personal connection, to be shared with the Optometrist as “a good nugget can be the difference between a booker and a thinker”. It has been reported that the manual prioritises sales of treatments over and above ensuring that the risks are explained fully in each individual case.

Regulation of eye surgery

Initial concerns about regulation of the industry were raised in Parliament in 2005.  Disturbingly, there is no legal requirement for a surgeon to be qualified or experienced in this field of surgery. The Royal College of Ophthalmologists introduced a certificate in laser surgery, but it is reported that only half of practising surgeons have it. There are further concerns about the number of surgical operations an individual surgeon undertakes in one day, with as many as 17-20 being carried out, which in turn puts time pressures on assessments, pre-op procedures, operations and aftercare.

The Regulation of Refractive Eye Surgery Bill was read in Parliament by John McDonnell MP in November 2013, which suggested implementing the following changes:   

  1. All surgeons practising laser eye surgery to be qualified, certificated and assessed regularly.
  2. The surgeon to be available for the initial assessment, operation, post op care & discharge.
  3. The success rates of individual surgeons and clinics to be published.
  4. High pressure sales techniques to be made illegal.
  5. A legal requirement for companies and surgeons to provide full information, in an easy to understand form, on all risks to patients.
  6. A 7-day cooling off period, enforceable in law, between the initial decision and final consent.
  7. Heavier sanctions for breaches of advertising standards and mis-selling.
  8. Guaranteed aftercare and, if things go wrong, remedial action at the expense of the company, not the individual.
  9. A compensation scheme for individuals who suffer loss and damage as a result of such actions.

More than 12 months later the industry still remains largely unregulated. Given the longstanding and growing concerns, it is clear that the laser eye industry requires statutory regulation.  With the increase of complications associated with contact lens use, many people are now looking to have laser eye corrective surgery and it is imperative that stricter regulation of the eye care industry is introduced as quickly as possible.