Kingston, New York MedMal Lawyer Relays FDA Warning: Optometrists Need to Disclosure EVERYTHING Related to LASIK!

Recently the FDA issued a letter to eye care professionals regarding the promotion and advertising of FDA-approved lasers used during refractive procedures such as LASIK. This letter was spurred by constant notifications to the FDA regarding improper promotion and advertising practices by optometrists. Particularly, the FDA harped on the inadequacy of risk information in their advertising and promoting of these procedures.

In 2009 the FDA issued similar letter to providers. However, the FDA is still reporting that they are receiving reports of misleading advertising and improper promotion of laser surgery. These misleading advertisements generally downplay the dangers of the eye surgery.

The FDA remarks that "[i]t is critical to disclose risk information appropriately and effectively to consumers in all advertisements and promotional materials concerning restricted devices, including the consequences that may result from the devices' use. Advertisements and promotional materials that do not include appropriate risk information may be misleading." Further, the FDA cited to various federal statutes under the United States Code which regulate restricted devices, such as lasers. One of the statutes provided that if the labeling or advertising is false or misleading, it is misbranded, which depends on whether labeling or advertising omits important information related to the device's limitations and risks.

In conclusion, the FDA proclaims that this will improve public health because patients can make better decisions. There are signs that this time the FDA is taking this more seriously, as they have set up a special website for consumers to report continuing problems by providers.

Of course this can also lead to medical malpractice lawsuits due to the complications that might arise, when the surgeons do not adequately provide these warnings. In fact, back in 2009 when the FDA issued the first warning, there were a slew of successful lawsuits brought.

Do you know of someone who had surgery on their eyes and had complications? Your eyes are important! Please do not hesitate and contact me immediately to know your rights! I welcome your phone call on my toll-free cell at 1-866-889-6882 or you can drop me an e-mail at jfisher@mmolaw.net. You are always welcome to request my FREE book, The Seven Deadly Mistakes of Malpractice Victims, at the home page of my website at www.protectingpatientrights.com.

Fun fact-did you know that LASIK stands for laser-assisted in-situ keratomileusis?