Corneal inlay surgery: What you should know
The U.S. Food and Drug Administration is currently reviewing corneal inlays and their surgical applications. Specifically, the agency is determining whether corneal inlays are safe and effective. As any Illinois medical malpractice lawyer would know, it is important for consumers to understand that new medical procedures carry risks. This is especially true for surgical devices and implants, as problems with such products may lead to severe injuries.
What is corneal inlay surgery?
According to the National Public Radio Science Desk, corneal inlay surgery is an eye procedure that may eliminate the need for reading glasses. Corneal inlay implants act as artificial pupils and are used to treat presbyopia. This common eye condition, also known as farsightedness, affects a person’s ability to focus on close objects.
Complications
All surgeries carry some risks, as any Illinois medical malpractice lawyer knows. The American Academy of Ophthalmology notes that several complications have been associated with corneal inlay surgeries. These include chronic dry eyes, which stem from damaged corneal nerves. Degraded vision quality, blurry vision and other vision problems may also result from these surgeries.
These problems have been revealed through trial studies in the U.S. In addition, some complications have been identified through data from Europe, where corneal inlay implants have been legal since 2011.
FDA review
According to NPR, there are several types of corneal inlay implants currently in development for U.S. markets. One of these, called KAMRA, is under review by the FDA. KAMRA’s manufacturer asserts that the device is highly effective and produces results with a surgery less invasive than LASIK. However, the FDA has raised some questions about these claims.
The company states that its corneal inlay surgery trials produced positive results for 83 percent of participants. The FDA advisory panel, however, noted that these figures excluded 44 patients. The majority of these participants stated that KAMRA did not improve their vision as well as expected. The inclusion of these 44 patients would have reduced the company’s efficacy figures to 75.8 percent.
Potential impact on Illinois residents
The University of Illinois’ College of Medicine notes that presbyopia is a very common condition. In fact, 4 million people develop it every year in the United States alone. Should the FDA approve corneal inlay surgeries, a large number of people could opt for the procedure. If any of these patients suffer injuries as a result, they may be entitled to compensation. Those who find themselves injured by a medical procedure may want to consult an Illinois medical malpractice lawyer. An attorney may help these patients determine whether malpractice litigation is a good option for them.