Risk Management

CO2 Laser Skin Resurfacing: Watch Out for Marketing Liability

By Joe F. Arterberry, MD, and Paul Weber, JD

Argus, February 1997

Skin resurfacing with the CO₂ laser is a relatively complex surgical innovation that has captured the attention of the medical community and the public. Much of the public’s fascination can be traced to aggressive marketing of the procedure, which has led many patients to expect superb results without side effects. Unfortunately, such results are not always achievable despite optimal surgical technique and attentive post-treatment care.

The combination of aggressive marketing and high patient expectations sets the stage for costly litigation when patients suffer real or perceived complications following CO₂ laser resurfacing. The most likely allegations relate to inadequate training resulting in suboptimal performance of the procedure, lack of informed consent, and inadequate laser precautions.

In their haste to sell ophthalmologists very expensive laser systems, manufacturers and sales representatives may not emphasize the substantial amount of education and training necessary to perform this procedure properly. At a minimum, education and training should include:

• A solid foundation in the basic science of lasers and laser interaction with tissues.
• An understanding of skin anatomy and wound healing.
• Didactic courses on specific types of CO₂ laser delivery systems.
• Initial CO₂ resurfacing surgical experience under a preceptor or proctor.
• A laser safety course.

The laser operative team also should have proper training and adhere to stringent laser safety precautions, including:

• Following fire precautions (e.g., avoiding alcohol-based prep solutions and topical, flammable anesthetic agents, etc.).
• Wearing glasses with sideshields or goggles.
• Using dulled metallic corneal shields and dulled low- or nonreflective metallic surgical instruments to prevent specular reflections and to protect tissues from accidental photoablation.
• Using an approved smoke evacuator to remove a potentially infectious laser plume.

All documentation of CO₂ laser education, training and safety courses attended by the ophthalmologist and staff should be kept on file. Continuing education is equally important in this area since the technology and the procedures related to it are relatively new and constantly evolving.

Prior to coming to the ophthalmologist’s office, the patient may already have been misinformed about this procedure by glitzy newspaper and magazine ads or television infomercials touting only the benefits of CO₂ laser skin resurfacing. It is the ophthalmologist’s responsibility to determine the patient’s prior knowledge and understanding of this procedure and to give patients accurate and current information regarding its risks, benefits and alternatives. Some of this information can be provided by non-ophthalmologists; however, the responsibility for securing informed consent from the patient cannot be delegated. Commercial videotapes and educational materials are available to begin the informed consent process, and OMIC has developed an informed consent document for CO₂ laser skin resurfacing that can be requested by fax from OMIC’s Risk Management Department at 415-771-7087. It must be emphasized that these videos, brochures and informed consent documents are no substitute for an ophthalmologist’s detailed discussion with the patient. The fact that this discussion took place should be documented by the physician either on the informed consent document or in the patient’s chart.

Patients need to understand that while the initial results of CO₂ laser skin resurfacing have been very promising, long-term results or effects are currently indeterminate. For instance, with every pass of the CO₂ laser spot, a quantifiable thickness of skin is ablated, ranging from 50-150 microns depending upon the laser parameters used, and a varying thickness of dermis is thermally damaged. Therefore, pending completion of clinical studies, it may be prudent to inform heliotropes or “sun-worshippers” about the increased risk of or susceptibility to developing cutaneous malignancies subsequent to their “resurfacing.”

Ophthalmologists who advertise CO₂ laser skin resurfacing need to be particularly careful about how they characterize this procedure. It is difficult to defend in court the ophthalmologist who advertises and markets the procedure as “safe,” “quick,” “effective,” or “gentle” if a patient has one of the known complications of the procedure. Should a lawsuit arise against an ophthalmologist who improperly advertises, a jury could determine that the misleading statements in the advertisements outweigh the force and effect of a thorough discussion of the risks by the ophthalmologist.

In conclusion, if the ophthalmologist approaches CO₂ laser resurfacing methodically and with a compulsive attention to detail and concern for the patient’s well-being, the surgical risk should be minimized.