This Swedish Case Regarding a Patient Complaint After Immediate Sequential Refractive Lens

This Swedish case regarding a patient complaint after Immediate Sequential Refractive Lens Exchange was published 2007 in the Swedish Medical Journal [Läkartidningen] 2007 (104) 1419-1420 Accessible at http://www.lakartidningen.se/store/articlepdf/6/6647/1419_1420.pdf

I translated the article below, please bear with any language mistakes:

“No error to perform simultaneous bilateral refractive surgery with CLE It was indiscriminate and a challenge of the complication risks to perform simultaneous intraocular surgery of the myopic patient’s both eyes, the Swedish Medical Responsibility Board (MRB) concluded and found against an ophthalmologist. The County Administrative Court (CAC) makes a completely different judgement and acquitted the doctor since the Swedish Board of Health and Welfare (SBHW) seconded an appeal. The patient, a man aged 56, saw the ophthalmologist in a private clinic because of high myopia. He was operated in both eyes through lens extraction with implantation of lens prosthesis. During surgery a rupture in the left eyes posterior capsule arose. At postoperative visit three weeks later an extensive retinal detachment with serious visual decrease in left eye was found. The patient was referred to hospital where he had surgery the following day. He filed a complaint against the ophthalmologist. The common technique for cataract The MRB stated that lens extraction is the common technique for surgical treatment of cataract. The indication is visual handicap that has a negative impact in daily life and is perceived as handicapping. Retinal detachment is a real risk connected with such treatment. The risk is significantly increased when high myopia is present or with the preoperative complication rupture of the posterior lens capsule. With cataract present it is reasonable to accept the risks with surgery. In this case the indication for surgery was high myopia with full corrected visual acuity - an indication not accepted as a [reimbursable, my insertion/BJn] medical treatment within the public financed health care. It concerns an advanced surgical intervention in fully functional eyes with full visual acuity. The operation – whose only indication is to remedy the refraction error as an alternative to continued correction with spectacles – carries significant risks for serious complications. It was therefore indiscriminate and a challenge of the complication risks to perform simultaneous intraocular surgery in both eyes. The MRB also noted other faults made by the ophthalmologist concerning the keeping of patient records and information to the patient. The ophthalmologist was warned [reprimand second to withdrawal of medical licence/BJn] Had high myopia He appealed the verdict of the MRB, meaning that it was wrong to say that the patient had full visual acuity. He was myopic minus 9 dioptres. The ophthalmologist concluded that the MRB in the first case was of the opinion that the treatment CLE (clear lens extraction) not shall be used for myopia and thereby quashed a treatment today medically recognised as routine at high myopia. Furthermore, the MRB stated that the risk for the complication that occurred was connected with the fact that the surgery was performed simultaneously in both eyes. “No odd treatment” Public financed health care has excluded all treatment for myopia. This has nothing to do with risks outweighing benefits from surgery. It is not an odd treatment only because it is not reimbursed by public health insurance, the ophthalmologist said. Within private health care this method is offered for myopia in several clinics. Faster recovery When both eyes in certain cases are operated simultaneously it means that recovery is faster. At the same time there are, according to most doctors who have been asked in this matter, no increased risks with bilateral surgery. Referring to an indicator for quality from the Swedish Board of Health and Welfare he claimed that there are reasons for simultaneous surgery for cataract and that this is in line with good medical practice. From a risk perspective there is no reason to look different upon such surgeries when performed due to high myopia. The ophthalmologist declared that risk for retinal detachment is present also at surgery for cataract and several other ophthalmological procedures. The risk is however not large and it is not larger for CLE than for other procedures. The SBHW requested a statement from its scientific expert, professor Anders Heijl, and shared his opinion that the ophthalmologist had not been acting against science and approved experience when performing the surgery through lens extraction with implantation of lens prosthesis (see separate article for the whole statement). The SBHW confirmed the MRB:s criticism towards the ophthalmologist regarding the keeping of patient records. The CAC views the case in three parts: Information, operation, and patient record keeping. It could not be confirmed which information the patient had received before the operation, and therefore the ophthalmologist cannot be found against for this part. [There is no demand for signed written informed consent before an operation in Sweden, although in the patient record it should be noted that information has been given and understood and that the patient accepts the suggested treatment/BJn] With regard to the surgical procedure the CAC points out that the MRB concluded that to perform CLE carries serious risks for severe complications. Therefore it was indiscriminate and a challenge of the complication risks to perform simultaneous intraocular surgery in both eyes. To the appeal the ophthalmologist attached documents proving that CLE today is offered at several private eye clinics and private hospitals. The SBHW has, following a statement from its scientific expert Anders Heijl, concluded that the ophthalmologist did not act against science and approved experience by using the surgical method of interest, and this pertains also to the simultaneous surgery in both eyes. The CAC states that there has been no evidence presented supporting that CLE should be connected with such risks that the procedure itself should be in conflict with science and approved experience. Further, it has not been proved that the ophthalmologist acted against science and approved experience when choosing to perform the procedure in the patient. There shall thus be no reprimand issued for this. With regard to the matter of patient record keeping, the CAC concludes that the shortcomings of the ophthalmologist motivate a disciplinary action. But taking into account that the fault has had little consequences for the patient’s safety it must be regarded as minor. Hence the ophthalmologist is also in this matter not found against.”

“The scientific expert did not share the view of the MRB: ‘The risks were not great enough to be unacceptable’ For guidance regarding the case described in the previous article the SBHW turned to its scientific expert in ophthalmology, professor Anders Heijl. He stated that CLE in this case had resulted in a serious complication, unilateral permanent visual handicap. The patient had symptoms obviously indicating retinal detachment before the vision decreased and with a faster handling of the retinal detachment the visual handicap could probably have been avoided. The MRB described CLE in negative terms. There can be different opinions about refractive surgery in general – all such procedures are operations in more or less “healthy” eyes. This does not mean that you can condemn individuals who perform this practice in an accepted manner, or that the circumstance that such procedures are not available free of cost within the public health care insurance system should be reason for criticisim of the approach, the scientific expert said. Refractive surgery is internationally performed in vast numbers, and different kinds of such surgery has been performed also in Sweden since 20 years, offered by many different health care providers, most of them but certainly not all private. Higher risk for retinal detachment CLE carries higher risks than many other refractive procedures, but is also used in eyes where the more common refractive treatments of the cornea are unsuitable. It lies in the nature of the matter that CLE is connected with a higher risk for retinal detachment than other corneal refractive procedures as well as for most cataract surgeries, exactly because the operations are performed in eyes with high myopia, as was the case in the patient discussed. It is not correct to state that the risks were to large to be acceptable in this case. CLE should in that case not be accepted in Sweden at all, but in fact these procedures are offered by at least half a dozen health care providers including the countrie’s largest eye clinic, S:t Erik’s Eye hospital in Stockholm. That the procedure was performed in both eyes simultaneously did not, according to Anders Heijl, change the risk situation in any significant way.”

In my comment (accessible at http://www.lakartidningen.se/includes/07showComments.php? articleId=6647 ) I conclude that the outcomes of this case together with the statement of the SBHW’s scientific expert indicate that immediate sequential bilateral cataract surgery must be considered an established approach, for the benefit of both patients and health care providers when performed correctly.

Björn