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LASIK Surgery to Undergo FDA Review

Mar 18, 2008 | Parker Waichman Alonso LLP

US health regulators plan to review whether LASIK—laser-assisted in situ keratomileusis— surgery is actually improving patients' lives. Last month, in response to patient complaints, the US Food and Drug Administration (FDA) discussed plans to organize a large, national study to examine the relationship between LASIK complications and quality of life issues, including psychological problems such as depression. According to Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, those discussions have now led to plans for a public meeting to talk about the issue. Schultz said a number of concerns have been raised concerning patient satisfaction with the LASIK vision correction procedure.

Schultz did not give a date when the meeting will occur.  Companies that could be affected by such a meeting include LASIK device makers such as Advanced Medical Optics Inc. and LASIK providers such as TLC Vision Corp and LCA-Vision Inc.  "Obviously, it's a technology that has caught on and is used very, very widely.  And there have been questions raised in terms of ... quality of life and what does it actually do for the patient as opposed to the technology itself," Schultz said adding that the meeting will focus on the quality of patients' lives following surgery. Although FDA spokeswoman Karen Riley said the meeting date has not been made public, some analysts have said it could happen as early as next month.  Meanwhile, the agency's eye-related panel has tentatively scheduled meetings for April 24-25, May 15-16, September 18-19, and November 20-21.

When patients undergo vision-correcting laser eye surgery, such as LASIK, they sign a release form with an extensive list of risks.    Known complications can include dry eyes, glare, double vision, an increased risk of corneal inflammation or infection, and blindness. However, researchers and former patients say a potential complication is not mentioned -- depression leading to suicide.

In July 2007, the FDA responded to petitions from an individual requesting that LASIK procedures be stopped and for a withdrawal of their approval. The agency responded by saying the LASIK devices were safe and effective but advisory panel discussions "could complement" its other safety monitoring.  "The post-market information found within our databases, regarding the devices mentioned in your petitions, does not suggest that at this time, there are adverse events that are unanticipated or occurring at an unexpected rate," the FDA said then.

In a research note, analyst Larry Biegelsen—from Wachovia Capital Markets—said the planned FDA meeting could result in a couple of different outcomes.  Either doubt could be cast on affected companies because of an uncertain outcome or it "could ultimately be positive for companies" if the panelists decide the surgery does helps patients, especially those which were done with newer technologies, he said.

In 2006, the FDA began to look into LASIK complications and quality-of-life issues and determined more research was needed.  A task force including representatives of the National Eye Institute and the National Institutes of Health has since formed to design a large study to be conducted by laser eye surgeons across the country.