Risks Associated With Laser Treatments
FDA approval and the CE mark
The US Food and Drug Administration (FDA) is responsible for evaluating new medical devices and determining if these devices are safe for consumers in the US.
This body is internationally known for its standards and their evaluation of medical devices may be seen as an independent benchmark of these instruments. The same applies to the European CE markThe European CE mark, formerly called the EC mark, is a mandatory marking for products sold in the European Economic Area (EEA) since 1993. The CE mark is the manufacturer's declaration that a product meets the requirements of the applicable EC directives. CE originally stood for Communauté Européenne, French for European Community..
Prior to receiving FDA approval or to obtain a European CE mark, each laser manufacturer is required to sponsor a study with several surgeons and hundreds of patients, using the same technique and following the results obtained on those patients for several years. The FDA closely examines and audits the charts and results before approval. All the lasers are held to the same standard, so it really is an ‘apples with apples’ comparison. While Doctor Smith may say his results are better than Doctor Jones, there really is no proof like a formal FDA study. Visit the FDA WebsiteFDA is the abbreviation for the US Food and Drug Administration. The FDA tests and approves various foods, drugs, medicines and medical equipment to ensure that they meet minimum requirements and standards. Such reports are available on the FDA website. See www.fda.gov. to see for yourself.
The FDA, through their scrutiny of equipment, makes recommendations concerning certain risks and contra-indications that may exist by using these devices. For your information and easy reference, we thought it well to include these viewpoints below about laser treatments.
The Risks and Contra-indications of Corrective Laser Treatments
As in the case of any other major surgery, corrective laser treatments has certain risks associated with the procedure. Dr Potgieter, who is a highly-experienced laser surgeon, can answer your questions about the risks and possible side effects of laser treatments.
Every FDA-approved laser used in vision correction has various risks and complications associated with them. But all lasers approved for laser treatments include the risks of ‘dry eye’ syndrome which, depending on which procedure is used, can be severe; the possible need for glasses or contact lenses after the treatment; possible debilitating visual symptoms after the procedure, that may include halos, glare, starbursts and double vision and, in extreme cases, loss of vision.
Laser treatments are considered contra-indicated in pregnant or nursing women and in patients with Collagen vascularThis implies one of the tissue types of which blood vessels are constructed in the body., auto-immune or immune deficiency diseasesThese diseases describe a group of diseases that are caused by an impaired or inappropriate immune reaction in the body., as well as keratoconusKeratoconus is an eye condition that causes the cornea to spontaneously bulge outward, like the tip of a rugby ball. It causes very high levels of myopia and astigmatism. See Eye Diseases – Keratoconus. or suspected keratoconus. Patients currently taking Ro-accutaneMedication often used in the treatment of acnea., CordaroneMedication used in the treatment of cardiac arythmias. and HexaroneMedication used in the treatment of cardiac arythmias. are also considered contra-indicated for laser treatments.
Fortunately, the risks are low and the rewards are high. Nevertheless, there are people who have lost some of their sight due to laser treatments. A good estimate of such cases is one in 10 000. Several laser surgeons from all over South Africa have sent patients who have experienced complications to our clinic for specialised care. The experience we have gained from these complex cases translates into better results for our own patients!
You can have peace of mind when you choose a laser surgeon who is chosen time and time again to take care of the complicated cases of other surgeons!
You will be asked to review and sign an Informed Consent statement before the treatment.