The Food and Drug Administration is weighing whether or not surgeons should provide additional warnings about the risks of Lasik , a popular corrective eye-sight surgery.

In a draft guidance from July, the agency suggested that individuals should become explicitly informed concerning the dangers of dry eye, problems driving at night, visual disturbances – or other rare but more serious side effects related to the particular surgery.

PHOTO: A woman has glasses on in an undated stock photo.

STOCK PHOTO/Getty Images

The FDA is still finalizing the guidance. If implemented, companies would end up being asked to create a checklist associated with possible risks and surgeons would be asked to go through that checklist with patients in order to ensure they understand the particular possible dangers and benefits of the procedure.

An FOOD AND DRUG ADMINISTRATION spokesperson said in the statement, “The FDA issued a draft guidance in July 2022 that recommends content and formatting for patient labeling information with regard to laser-assisted within situ keratomileusis (LASIK) devices. As part of the guidance process, this document was published in the Federal Register, giving the public an opportunity to comment. The remark period regarding the draft guidance recently closed on November 25, 2022. With the comment period now closed, the FDA is now reviewing plus considering comments for the final guidance. The particular timeline intended for the last guidance issuing is dependent on a number of factors and we cannot provide a firm timeline at this point. ”

The American Academy of Opthalmology weighed within on the proposed assistance and raised concerns regarding the checklist.

“Much of the content presented is important for that knowledgeable consent process but it is presented with insufficient depth and nuance, ” stated Dr. Stephen McLeod, CEO of the particular academy. “The academy’s position is that effective informed consent is a process of shared information and decision-making that occurs between the physician plus the patient. Risks and benefits do not exist in a vacuum, and for them to be meaningful rather than abstract, they must be interpreted plus discussed in the context of a specific patient. We are also concerned that will there are several statements that are not well supported by the latest evidence, and some that have actually been disproved. ”

According in order to the FDA , Lasik is a procedure intended to reduce a person’s dependency on glasses or contact lenses. The particular agency said that the surgery is one of the particular most commonly performed and estimated that nearly 600, 000 Lasik surgeries are carried out each year.

Within a video , the agency summarizes some risks to the particular procedure, stating that “Lasik is not to get everyone. ”

The newly drafted guidance succeeds two previous FOOD AND DRUG ADMINISTRATION measures upon disclosing the risks of Lasik surgery.

PHOTO: A woman visits an optometrist in an undated stock photo.

SHARE PHOTO/Getty Pictures

In May 2009, the FDA released a letter to eye care professionals providing them with important information about promoting and advertising Lasik after receiving complaints that consumers were not told from the risks associated with the procedure.

Two years later, the FDA issued the second letter “to remind eye care professionals of their legal responsibility to provide balanced information about medical products, inch including disclosing risk info in vision care professionals’ promotional material.

Editor’s Picks

In 2017, after the agency reportedly received complaints about side effects from the surgery, through dry attention to more serious stories of chronic eyesight pain, it commissioned studies to investigate whether patients were being adequately educated about dangers, as well as clear benefits.

The 2022 draft guidance suggests that manufacturers and cosmetic surgeons should explicitly walk sufferers through a “checklist” that includes clear warnings plus benefits.

The particular drafted Laser eye surgery “checklist” includes part associated with the following.

Six months after surgery:

  • Up to 27% of patients experience dry eyes symptoms
  • About 41% associated with patients may experience visible symptoms such as glare, halos, starbursts or double images
  • Around 4% of patients may have “very” or even “extremely” bothersome symptoms
  • Around 2% of patients might have “a lot associated with difficulty” when not wearing glasses or contacts

Five years after surgical treatment:

  1. About 17% of patients still used eye drops pertaining to dry eyes
  2. Fewer than 2% associated with patients nevertheless notice some visual disturbance
  3. About 8% of individuals have trouble driving in night
  4. There are rare (fewer than 1%) reports of severe, constant pain

Leave a Reply

Your email address will not be published. Required fields are marked *