In this age of www.high-tech-wonder.scam, it is the pizzaz surrounding high tech science that wins the day. People want to have, and to believe, in high technology. So what is the latest high tech wonder the government agencies are approving for permanent hair reduction today?

In 1999, around the time that ThermoLase was announcing its exit from the hair removal business, MW Medical, Inc., of Arizona, announced it had received clearance from the U.S. Food and Drug Administration (FDA) to begin marketing its Microwave Delivery System, Model MM-300 device. The first clinical trails were begun two years prior to that, but the only thing Hair Route has been able to find out about this so-called microwave system of hair removal comes from an Oct. 1998 statement by the Company’s CEO, Paul E. Banko. “We don’t know for sure that it will work, but we think it will, based on what we’ve seen so far.”

Apparently (and we know nothing for certain), MW applies a certain cream, and a cooling gas to the patient’s skin to help avoid burning. The microwave — funneled from a standard microwave generator through a specially designed handpiece — is applied either in a dime-sized spot or in a “paint brush” style, to a depth of 4 mm - 5 mm. The Company said they found that the depth stops growth in the follicle without burning the skin. “It’s hard to funnel microwave,” Mr. Banko said. “It doesn’t like to curve.”

So how does this system work without cooking everything under the skin? In another news release, in May 1999, announcing approval to conduct Phase II trials with the treatment of spider veins, MW’s chief scientist, Dr. Robert Spertell, said the microwaves “work by generating heat, that causes the small blood vessels making up spider veins to coagulate and eventually fade. The effectiveness is a result of the greater than two-fold absorption of microwave energy by blood as compared to skin.”

Didn’t the laser companies go out of their way — when designing their hair removal systems — to avoid absorption by blood? So we are compelled to ask, in the case of microwave hair removal, what damage is done under the skin in addition to that being done to the hair follicle?

Trying to determine the effectiveness of microwave epilation from the information given to the media in press releases has been exceedingly difficult. As to how the device actually “cooks” the hairs, and whether or not the system works (i.e. effectively destroys hairs permanently) is far from clear. The only information from the Company that comes close to an answer is in a statement by Dr. Spertell: “We found significant hair clearance sustained for three months at near the highest dose. We can’t conclude that it’s more effective (than available laser hair removal systems), because we haven’t tested enough patients. But this indicates that it has the desired level of effectiveness.”

So, the only thing we can find out and know for sure, is that it is no more effective than lasers, which might explain the basis for MW Medical’s 510(k) submission to the FDA as being “substantially equivalent to [an unknown device] for the purpose of the removal of unwanted, non-facial body hair.”

The real problem (our Y2K bug) is not the manufacturers of these devices but the institutions like FDA — that were created to protect the public — who are becoming no more than rubber stamping departments for our industry.

A defining example of this is shown by a statement made by Linda Kahan, Deputy Director for Regulations and Policy for the FDA’s Center for Devices and Radiological Health on January 5, 2000. In responding to a challenge of the FDA’s apparent exemption of galvanic tweezers from it’s Final Ruling that states all tweezers effect only temporary hair removal. Kahan said that because claims for permanent and long-term hair removal appeared in their 510(k)s, and that the clearances were granted, the “FDA does not believe that there is sufficient justification to change the regulatory status of these devices, or to take immediate regulatory action against manufacturers using the words ‘permanent’ or ‘long-term’ in their promotion and advertising materials.”

So, just what is “sufficient justification,” anyway?