Jeffrey Frentzen

What about primum non nocere?

At a recent meeting of aesthetic practitioners, I heard a story about a physician who helped to create and invariably became the media spokesman for a new laser-based device.

Even though the device had been approved for a certain use by the FDA, the physician employed the device for an off-label use that had no scientific data to support the doctor’s claim.

At that same meeting, during a demonstration of a new device for cosmetic uses, a surgeon explained to me that the device, which the vendor claims will “burn fat” via light, uses a frequency that does not burn fat (or anything else).

However, several prominent media-savvy plastic and cosmetic surgeons have promoted this device on the national scene, touting its ability to burn fat.

Aesthetic practitioners who appear in print, radio, television, Internet, or other mass media are to be held to a higher ethical standard than every other practitioner in the field.

Is this rule of thumb applied 100% in the field? No.

Plastic and cosmetic surgeons who use the media as a promotional tool are at greatest risk to fall into the trap of endorsing products/devices or procedures that may violate medicine’s “do not harm” primal directive.

I say “may” because this is a cautionary tale as opposed to an indictment of mistaken or misguided surgeons—or of the industry. The temptation for some physicians in the media to endorse products publicly is a phenomenon that affects only a small percentage of all aesthetic practitioners.

In order to be effective in the media, this brand of physician must posses a unique combination of excellent communication skills, physical poise, and “acting ability”/showmanship—qualities that are not easy to find among most physicians. Many within that small group pursue the media spotlight and also manage to run an active medical practice.

My message here is addressed to that small group. It is a group that is increasing in number every year. In the current explosion of new media outlets—especially niche-oriented channels on cable television—more surgeons and other practitioners are performing in the media circus.

They are also performing a valuable service to all. The citizenry needs to be educated more thoroughly on matters of plastic surgery, to combat the wave of corporate propaganda in the aesthetic industry that relentlessly pushes the boundaries of credulity.

A CHANGING LANDSCAPE

What’s the big problem with endorsing products? Nothing, as long as the endorser understands that he or she will be held to a higher ethical standard than other practitioners.

Why is this a problem now? Aside from the growing number of practitioners getting involved, there have been recent rumblings out of the FDA of regulatory rule changes for the approval of medical devices.

In recent years, the FDA has been openly criticized for relaxing its standards. This is symptomatic of an overall push within the federal government to deregulate and relieve manufacturers of having to strictly adhere to arduous safety standards.

The FDA is now reviewing its regulatory process after issuing a self-critical report that said top regulators bowed to outside political pressure when approving a knee device in 2008.

The agency released a 120-page report in August that offered insight into how the FDA will improve its ethics. The report says the agency will aim to better define what devices can and can’t access the 510(k) approval process and when applications would require medical evidence. The recommendations will be open for public comment until mid-October before any are put in practice, possibly in the coming months.

A similar, more individual-based review process should be high on the to-do lists of any plastic or cosmetic surgeon who talks in the media on matters of surgery, products, or aesthetic devices.

The responsibility for doing the right thing on the airwaves is paramount.

I know one physician who is an expert in testing new medical devices for the aesthetic industry. He is so good at it that the manufacturers desire his approval, but he is tenacious and unwilling to take a manufacturer’s claims to heart unless he has exhausted all attempts to debunk.

That’s the spirit!