Jenny Ha, a Senior Associate on the Personal Injury and Clinical Negligence Team, discusses lens replacement surgery and the regulatory and legal challenges surrounding informed consent in the medical sector.

Lens replacement surgery, also known as refractive lens exchange (RLE), is the now commonplace medical procedure for replacing the natural eye lens with a prosthetic alternate, or intraocular lens (IOL), in circumstances where the natural lens loses opacity and normal vision is impaired to an extent that a patient no longer considers to be tolerable. Initially developed as a treatment for cataracts, the procedure is now increasingly offered to individuals without cataracts but as a vision correction procedure – it is widely marketed as being a safe and effective solution for people seeking to be free from glasses and contact lenses and is frequently sold on the promise that the outcome can restore almost 20/20 vision. Specifically, it is appealing to those over 40 where age-related wear has caused a diminution in the eyes’ ability to focus on objects close-up.

The surgery has grown in popularity, but costs approximately £3,000 to £4,000 per eye. There are also increasing concerns about the potential risks of the surgery and more significantly, the adequacy of the information given out by providers about possibly adverse consequences, and the shortcomings in the process of obtaining properly informed consent from the patient to the procedure. Many patients report they were not made adequately aware of the various possible complications, some of which are permanent and irreversible. Given the complexity of the process and its inherent potential dangers, is it fair or reasonable to expect untrained individuals to be conducting their own due diligence before asking themselves ‘is it worth it?’

Understanding the Risks of Lens Replacement Surgery

As with any surgical procedure, lens replacement surgery is not risk free and that is not restricted to the danger of a post-procedure infection. There are other possible complications, which can include the following:

Retinal Detachment: A serious complication, which can lead to permanent blindness if the detachment is not tackled by corrective surgical intervention fast enough. Some patients may present with an enhanced risk of Retinal Detachment even before the surgery.

Glare and Visual Disturbances: Halo effects, and increased sensitivity to glare around lights, particularly at night, can create real difficulties with night driving. These are common side effects of lens replacement surgery and often dismissed by practitioners as ‘temporary” with eventual resolution over several months, but that is not always the case. If these disturbances do not resolve, they cannot be corrected by further surgery. For some, these effects lead to serious and permanent impairment to the patient’s quality of life.

Posterior Capsule Opacification (PCO): This occurs if the membrane behind the artificial lens becomes cloudy. Practitioners generally suggest that the effect can be fixed quickly by a laser procedure known as YAG capsulotomy, but that secondary process cannot resolve other complications.

Loss of Focus, Depth Perception, and Contrast Sensitivity: Many individuals go for this type of surgery in the mistaken belief that it can potentially restore the full functionality of a young natural lens, but that is not so. An artificial fixed focus lens may restore clearer vision and brighter colours, but it will not replicate original functionality in terms of the ability to adjust focus, manage depth or contrast. Many patients who go into this surgery without that full appreciation of what it can and cannot do are then disappointed to find out only after the procedure, that they still require glasses, and do not have the youthful vision they had planned for. Many say that had they known that they would not be glasses free after all, they would never have put themselves thought it or wasted their money.

Informed Consent

The patients we meet repeatedly report that the marketing of the procedure sells the notion of a permanent fix and a freedom from glasses. They complain that they were not fully informed about the process of lens replacement surgery, its limits, and that they had little or no discussion of the downside. We are often told that the risks and possible complications were downplayed by those selling or promoting the product, and those assisting in the procedure. Another main complaint is that any discussion happens on the day and having already turned up for the procedure, little or no time is given for questions or reflection on what can be a large amount of information or booklets handed to them by the clinics on the day.

Patients have a clear right to understand not just the benefits of a procedure, but also its potential drawbacks. Given that this surgery is mainly an ‘elective’ surgery, and for many a purely voluntary choice, there should an enhanced level of transparency around risks and complications, expected recovery times, the future use of glasses, and what the patient might experience. Informed consent should be more than a generic brochure and a signature on a tick box questionnaire and consent form. If the medical practitioner has not created the environment for true understanding, has failed to take the time to understand the specific needs and hopes of the patient and address them, the signature on the form will not protect him or his clinic from a potential suit – particularly so where private practitioners derive a direct financial incentive to perform each elective surgery for personal gain. The priority of looking to the Patients’ personal best interest remains the foremost consideration for any procedure.

Regulatory and Legal Implications

Regulation of the sector is governed by the Care Quality Commission who have responsibility for clinics meeting basic standards of practice, and the General Medical Counsel which monitors and oversees medical and ethical practice. However, those regulators do not control or restrict the general marketing activities of private clinics and content, nor do they issue general information to the public on complications of individual processes and procedures or warnings they may have issued to surgeries, clinics, or practitioners. The public is still largely expected to look to their own personal protection, conduct their own research, and rely upon their own due diligence before committing.

While lens replacement surgery has benefits and has helped many people achieve better vision and freedom from glasses, it is not a magic solution and does not necessarily result in a glasses-free future, free from issue. No procedure is risk-free, and the consent process does not often give all of the information patients would want.

Patients have taken to various platforms highlighting their experiences and outcomes following surgery and prospective patients should review commentary and if in doubt, seek more than one opinion and more than one consult, beyond those simply marketing their wares.

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