Open Letter to Director Timothy Ulatowski

Open Letter to Director Timothy Ulatowski
Posted 7/13/2009

June 27, 2009

Timothy A. Ulatowski, Director
Office of Compliance
Food and Drug Administration
Center for Devices and Radiological Health
9200 Corporate Blvd.
Rockville, MD 20850

Dear Mr. Ulatowski,

The recent FDA warning to consumers regarding Zicam cold products emphasized the seriousness of loss of smell and its effect on quality of life. But for years, the FDA has ignored the pleadings of patients who needlessly suffered visual impairment by LASIK eye surgery devices.

You need only consult readily available information already in FDA databases – for example the FDA Maude database of LASIK-related adverse events to see that LASIK eye surgery is exposing the public to unreasonable risk. There are hundreds of patient reports of chronic, debilitating dry eyes and incapacitating visual impairment after LASIK. Yet the FDA continues to fail to act on these reports by allowing these devices to remain on the market.

Is it the FDA’s position that the sense of smell has a greater impact on quality of life than sight? Can the FDA say that vision is less important to public health and safety than a sense of smell?

The LASIK industry is actively engaged in cover-up of the problems associated with LASIK surgery. The LASIK industry diverts attention away from emerging problems of LASIK such as LASIK-induced dry eye disease and night vision problems by feeding the media statistics about LASIK ‘satisfaction rates’ and patients achieving 20/20 vision for short periods of time after surgery. The LASIK industry doesn’t like to talk about night vision impairment and intractable dry eyes which may be debilitating and permanent after LASIK. The LASIK industry doesn’t want to discuss how poor quality (distorted) 20/20 vision after LASIK can be a waking nightmare for patients with LASIK-induced irregular astigmatism. And only in the alternate universe of ‘The LASIK Industry Money Machine’ is severe dry eyes merely a “side effect” and not a serious health concern.

None of the information in this letter is news to the leaders in the Center for Devices and Radiological Health (CDRH) and the Division of Ophthalmic and ENT Devices. You know about the hundreds of MedWatch reports related to LASIK injuries. You know about petitions to withdraw the approval of LASIK. You know that data submitted in the applications for FDA-approval of LASIK devices confirms that roughly 20 percent of patients experience dry eyes and night vision disturbances persisting beyond the endpoint of the clinical trials. You know that the body of medical literature demonstrates high incidence of dry eyes and night vision disturbances after LASIK. You know about LASIK-related suicides.

If Zicam can lead to loss of smell, then I believe the FDA took the proper action by issuing a warning to consumers. However, it is incomprehensible that the FDA would warn consumers to stop using a cold product due to risk of smell loss, yet fail to take swift action to protect the public from devices demonstrated to cause permanent impairment to the eyes of 20 percent or more of patients who undergo the LASIK procedure.

I implore you to explain the FDA’s position on this matter.