By Abby Van Voorhees, MD, May 01, 2015
In this month’s Acta Eruditorum column, Physician Editor Abby S. Van Voorhees, MD, talks with Mathew Avram, MD, about his two recent articles, “FDA MAUDE data on complications with lasers, light sources, and energy-based devices” in Lasers in Surgery and Medicine and “Increased risk of litigation associated with laser surgery by nonphysician operators” in JAMA Dermatology.
Dr. Van Voorhees: Let’s start with your recent paper on the review of complications associated with lasers, light sources, and energy-based devices. All would agree that the use of non-invasive procedures has become increasingly popular, so understanding the risks associated with these procedures is of paramount importance. Let’s start by your telling us what database you utilized for your study.
Dr. Avram: We used the Manufacturer and User Facility Device Experience (MAUDE) database. This is the primary database with which the FDA gathers complications with medical devices. It is generated by reports by patients, physicians, and industry. MAUDE is an important database because it’s the largest one devoted to complications with lasers, light sources, and energy-based devices within the field of dermatology. Therefore it was important for us to take a look at the incidence of these complications and side effects and seek to determine which were the most common, and which were surprising, in order to educate physicians and non-physicians using these devices as to the relative risks associated with treating patients.
Dr. Van Voorhees: What did you find were the most common adverse events seen overall? Are there differences between the various types of instruments?
Dr. Avram: Laser hair removal had the most adverse events. This isn’t surprising because laser hair removal is the most common use of lasers in medicine. Depending on the devices, the wavelengths, or the light source devices that were being used, there were differences in the reported adverse side effects. This can be attributed to the design of the devices as well as the inappropriate use of these devices. It can be difficult to determine whether it’s the device or the operator that’s at fault.
Dr. Van Voorhees: Did any one type of laser or light source have more medical device reports (MDRs) than the others? Is there any specific treatment type that had a greater risk?
Dr. Avram: We didn’t find red flags with regard to the different devices. The most important take-away from our review of the database is that there were a number of side effects for these devices related to dermatologic treatment, thus, it’s important to be aware that all of them carry some degree of side effects. While some of the devices have more inherent risk than others, it’s important to note that the inappropriate use of any of these devices, particularly in the hands of operators with less training and skill in the field, leads to a particularly high risk for adverse side effects.
Dr. Van Voorhees: How reliable is this data? Are physicians reporting their complications reliably?
Dr. Avram: While it’s a large and important database due to the sheer volume of reports within it, there are important limitations. First, it’s based on the reports of physicians, operators, and industry. It’s fair to say that many operators of these devices do not report all of the adverse side effects that occur. This alone detracts from the overall value of the data. Further, the reports vary with regard to their detail; unfortunately, some have little detail regarding the precise source of the side effect. Nevertheless, MAUDE is an important database to examine — it encompasses a huge number of treatments and is the largest registry of reported side effects in our field. It is crucial for understanding the methods for employing best practices for patient safety and avoiding common side effects with the use of lasers, light sources, and energy-based devices. [pagebreak]
Dr. Van Voorhees: Now let’s switch to talking about your paper on trends seen associated with the use of laser surgery. You mention that the number of cases performed by non-physicians has expanded over the past decade or so. Has this change been substantial? Do you see it continuing?
Dr. Avram: The change in the proportion of non-physician operator (NPO) litigation has been explosive over a short period of time. There has been a tremendous increase in litigation against NPOs due to injuries that have occurred as a result of laser, light source, and energy-based device treatments of skin conditions. This trend is particularly alarming because it comes at a time when there are great differences as to the degree of government regulation regarding who can operate these devices and what supervision, if any, is required. These differences are governed by state law.
Dr. Van Voorhees: Who qualifies as an NPO? Were there differences among different non-physicians?
Dr. Avram: Any non-physician would fall into this classification, whether a nurse practitioner or physician assistant or an aesthetician or electrologist. In the legal database we queried, sometimes it was difficult to tease out the details. The information was not robust enough to generate reliable data differentiating among different types of NPOs.
Dr. Van Voorhees: Is the increase in litigation especially true with any specific types of laser procedures?
Dr. Avram: The most common source of injury is laser hair removal. This is in part true because it’s the most common use of lasers in medicine. But it’s important to note that the proportion of injuries that are happening within laser hair removal among NPOs is significantly out of proportion to the number of procedures that NPOs are performing. In other words, the trends for increasing litigation are not solely related to the fact that there are more of these procedures being performed; the growth in litigation is disproportionately taking place in situations where NPOs are performing the procedures. More people are getting injured and they’re suing.
Dr. Van Voorhees: As more physicians delegate these procedures to NPOs has there been a correlation in lawsuits?
Dr. Avram: There’s been an increase in the number of lawsuits as physicians have delegated these procedures. It’s important to note, though, that the largest growth in litigation associated with these procedures being delegated is among NPOs performing these procedures in non-traditional medical settings, such as medispas, where the amount of supervision, if any, is less than that found in a traditional physician’s office or hospital. That’s where we’re seeing the biggest growth.
To be clear, these injuries are happening in all settings. They’re happening with dermatologists and plastic surgeons performing these procedures themselves. They’re happening more frequently when delegated to NPOs performing these procedures under supervision in medical practices. But they’re happening most commonly — alarmingly, but perhaps not surprisingly — in situations where there is less medical supervision, i.e., non-traditional settings such as medispas, where the amount of supervision is limited.
Dr. Avram is director of the Dermatology Laser and Cosmetic Center at Massachusetts General Hospital. His articles appeared in Lasers in Surgery and Medicine (2015 Feb;47(2):133-40. doi: 10.1002/lsm.22328. Epub 2015 Feb 4) and JAMA Dermatology (2014 Apr;150(4):407-11. doi: 10.1001/jamadermatol.2013.7117).