01/24/2011
Reprinted with permission from www.fdaweb.com

As FDA continues to dither in the face of new data challenging the safety of vision-enhancing LASIK eye surgery, a new report to be published next week by the German technology innovator BioShape Holding will support an immediate ban on the procedure. Adding to data in a petition for an immediate ban from former CDRH LASIK review chief Morris Waxler, the company says it has developed a unique device that measures the topography of the eye during refractive laser treatment and its research has shown “that LASIK in general is too dangerous to be allowed,” according to co-founder Daniel Kluting in an email to FDA Webview.

“The problem is that the LASIK cut brings problems to the structure of the eyes,” Kluting writes. “Because we have the only measuring device that is able to measure the topometry of the eyes with resolution of a few microns, we can look deeper into microeffects than anybody else. One of the major questions in research is, what is the cornea built of? From our research it seems to be that it consists of tissue layers with a tensive strain to all sides. Think about cutting in something like that!”

The permanence of the never-healing corneal flap cut is a major concern in Waxler’s petition, which last week was still deep in a queue in the Commissioner’s Office, awaiting a decision on whether or not to even accept it for consideration. In less than a year, Waxler has hardened his position from tolerating LASIK’s continuation to petitioning the agency for a complete ban and vowing to seek FDA Office of Criminal Investigations focus on laser makers who allegedly hid LASIK safety issues.

Moreover, it has been 16 silent months since former CDRH compliance director Tim Ulatowski launched a mini-blizzard of Warning Letters to LASIK ambulatory surgical facilities over their failure to file MDR reports and peppered the industry with advice to include risk information in their ads — with no further word from him or his successor, Steve Silverman, about agency follow-through, if any.

During the ensuing inactivity, injured LASIK victim and activist Dean Kantis says he has sent the agency “hundreds” of violative LASIK ads “that do not list all known risks and side effects … And the FDA continues to do NOTHING to discipline them. Why is it when I turn on the TV, every prescription drug commercial has 30 seconds of warnings yet when it comes to elective LASIK ads on TV or radio, there isn’t one word mentioned of the warnings?”

FDA’s ingrained unresponsiveness on the LASIK safety issue may be well illustrated by its failure to respond to a cogent 9/13/09, heavily documented 14-page letter from LASIK Surgery Watch to CDRH director Jeff Shuren describing the risks of the procedure and contending that “FDA has been grossly negligent and has placed patients’ interests secondary to interests of surgeons and medical device manufacturers.” The organization said 1/23 that none of its letters to the agency had brought responses.

Kluting’s email says that “from our point of view we would like to see LASIK stopped immediately. Then the laser manufacturers need to do some basic research on eyes [to] probably come up with a completely new way how to do refractive surgery. During the last 7 years the laser industry knew the problems, but did not want to go through the process of basic research combined with the [stopping] of LASIK. Right now with LASIK the cornea is damaged, the only good thing is that the cornea excuses a lot and the eye is still able to see. Nearly all risks of LASIK are because the procedure is not safe. It’s not because of the patient or a misfortune.

“We have just a measuring device. Our goal was to measure the ablation during refractive surgery to avoid using nomograms and be more precise. We did clinical trials with one of the large players on the market. But we found out that first all surgeons and the industry need to understand the eye better. We have a couple of ideas how refractive surgery can be in the future, but till now … laser manufacturers avoid … [talking] with us. Even those we made the clinical trials with, 8 years ago. It’s easier to leave the moneymaking machine LASIK turned on than to go through the struggle of development.

“So we went into the market of scleral lenses and wait for the refractive market to wake up. All patients who got hurt by LASIK since mid-2005 could have been prevented.”

BioShape’s new report next week is expected to update and supersede its 2005 report on the same subject, Complications of Refractive Laser Surgery.

In a comment to FDA Webview, former FDA medical device compliance director Larry R. Pilot, who has been deeply involved in the LASIK issue with injured patients, called FDA’s management of its regulatory program for LASIK “a clear dereliction of duty and responsibility to the concept of ‘protection of the public health’.

While there may be valid applications for LASIK eye surgery,” Pilot continued, “the vast majority of uses involve risks to the patient/customer that are often unknown until after the fact. The FDA/CDRH has failed incredibly to monitor post market experience through its mandatory MDR program. For just this program alone, the potential for patient protection was there for years, yet the CDRH deliberately ignored the responsibility to inspect or review the performance of any of the possible thousands of user facilities which were in absolute violation of law and regulation.

“Current and past FDA/CDRH employees shared this liability and should have been/should be punished for their failures. … I agree that the optimal approach to reporting is to have the FDA/CDRH enforce the MDR requirement applicable to user facilities. From the outset of my involvement with this LASIK issue, I have repeatedly emphasized this fact. It took two years for the FDA to display some movement, but more is needed.”

Asked to comment on this story, FDA press officer Karen Riley replied: “We cannot comment on the specifics of the German report, as we have not received or reviewed it. As you well know, FDA continues to monitor the safety and effectiveness of all devices, including the lasers approved for LASIK. In October of last year we provided a brief update on our role in a three-part study of LASIK that is still in the beginning phases. It is a project that we hope will yield additional insights about this procedure. Stay tuned.”