Do we really want an already "Corrupt FDA" having complete control over Medical Devices, especially after seeing that they gave the FDA Approval to LASIK (a surgery even Dr. Oz is warning you to NOT get...stating 1 in 5 eyes is having permanent dry eye and other injuries??"
What's next that the Ophthalmic Eye Industry is pushing and why is it NOT in your best interests to believe what they tell you??
What are ICL's and why should you be worried when your Ophthalmologist or their commissioned clerk tries to push them on you?
What is an ICL lens implant and why is the industry
now pushing this instead of pushing LASIK?
"You may not put it in your eye, but it meets the guidance". ~ Marian Macsai-Kaplan, M.D., Ophthalmologist and FDA Advisor
"When you start talking about intraocular procedures you are now adding a whole new layer of risks." ~ Dr. Richard Duffey. Source
IMPORTANT: If you experienced problems related to implantable contact lenses, the FDA wants to hear from you. File a MedWatch report with the FDA online. Alternatively, you may call FDA at 1-800-FDA-1088 to report by telephone, or download a copy of thepaper form and either fax it to 1-800-FDA-0178 or mail it using the postage-paid addressed form. Read implantable lens injury reports filed with the FDA (enter product code MTA, select a date range, and click search).
They go by many names. Phakic intraocular lenses ("phakic" meaning your natural lens remains in the eye) is the generic term for these lenses; however, lens manufacturers and eye surgeons gave the lenses shiny new marketing terms. "Implantable Contact Lens" sounds reasonably safe, right?
So, what's this web page doing on a site about LASIK complications? Good question! We're often asked about alternatives to LASIK. Many eye surgeons have begun offering implantable lenses to their patients who are afraid of LASIK or have been found to be an unsuitable candidate for LASIK. But are they safer? Read on to learn why we don't recommend having these dangerous lenses implanted inside your eyes.
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What are implantable contact lenses?
From the FDA website: Phakic intraocular lenses, or phakic lenses, are lenses made of plastic or silicone that are implanted into the eye permanently to reduce a person's need for glasses or contact lenses. Phakic refers to the fact that the lens is implanted into the eye without removing the eye's natural lens. During phakic lens implantation surgery, a small incision is made in the front of the eye. The phakic lens is inserted through the incision and placed just in front of or just behind the iris.
Are implantable contact lenses FDA-approved?
Currently, there are two phakic intraocular lenses approved in the U.S., the STAAR Surgical Company's Visian Myopia Implantable Collamer Lens (MICL) and Advanced Medical Optics, Inc. (AMO)'s Verisyse (also known as Ophtec's Artisan) iris-fixated phakic intraocular lens (IOL). The Visian Toric ICL is currently under review by the FDA.
The Visian ICL is a posterior chamber collamer lens that was approved by the FDA in 2005. It requires patients to undergo peripheral iridotomy, which is a hole in the iris made with a laser. This is necessary to ensure that fluid flows properly from the back chamber to the front chamber of the eye to prevent a buildup of pressure within the eye after surgery. The lens comes in four sizes, which may present a challenge for the surgeon in selecting the appropriate lens for the patient's eye. Implanting the wrong size may lead to serious complications. Read the Visian Patient Information Booklet
The Verisyse lens received FDA-approval in 2004. It is marketed internationally as the Artisan lens by Ophtec and distributed in the U. S. by AMO under the name Verisyse. The Verisyse/Artisan lens is implanted in the anterior chamber of the eye behind the cornea and attached to the front of the iris, and is visible. Implantation of the lens requires a relatively large incision and stitches. Read the Verisyse/Artisan Patient Information Booklet
Doesn't FDA approval mean it's safe?
There have been countless FDA-approved drugs and medical devices which were later recalled or withdrawn from the market after serious problems, even deaths, were reported. Moreover, in 2008 a group of FDA scientists accused agency officials of approving unsafe medical devices to appease industry. Read story
Industry pressure was key in FDA's approval of LASIK, according to former FDA official turned whistleblower Morris Waxler, PhD. As chief scientist, Waxler oversaw early clinical trials review for FDA-approval of LASIK. He now asserts that the approval was a mistake. Read story.
What are the risks of implantable lenses? The most serious risks of implantable lenses include the following:
Corneal endothelial cell loss, which may lead to need for corneal transplant.
• From page 7 of the Verisyse/Artisan Patient Information Booklet: (content reorganized for clarity).
"The endothelium is a layer of cells which lines the undersurface of the cornea, and it regulates corneal water content. The endothelium works as a pump, removing excess water as it is absorbed into the stroma [middle portion of the cornea], the surface behind the epithelium. If the water content isn't regulated, the stroma could become saturated, resulting in a hazy and opaque appearance, which would reduce vision.
"Corneal edema occurs when the cornea takes on more water than-it can absorb, which means the cornea swells and becomes less transparent. Endothelial cells play a role in keeping the cornea healthy. The available 3-year data from the clinical study indicates a continual steady loss of endothelial cells of -1.8% per year and this rate has not been established as safe. If endothelial cell loss continues at the rate of 1.8% per year, 39% of patients are expected to lose 50% of their corneal endothelial cells within 25 years of implantation. The long-term effect on the cornea's health of a 50% loss in comeal endothelial cells is unknown. However, if too many cells are lost you may need a corneal transplant. Therefore, it is very important that your endothelial cell density is periodically monitored.
"Based on the data obtained from the clinical study of the ARTISAN® Phakic IOL, it is impossible to predict the effect that this IOL will have on the corneal endothelium."
• From pages 11 and 13-14 of the Visian Patient Information Booklet:
Complications After 1st Week: loss of cells from the back surface of the cornea responsible for the cornea remaining clear (endothelial cell loss, 8.9% at 3 years).
WARNINGS: The long-term effects on the corneal endothelium have not been established. You should be aware of potential risk of corneal edema (swelling) possibly requiring corneal transplantation. Periodic checks of your endothelium are recommended to monitor the long-term health of the cornea.
• From page 115 of FDA Presentation: Mar. 14, 2014, which states that the post-approval study of the Visian myopia implantable collamer lens demonstrated endothelial cell loss of 11% at 5 years. Six percent of eyes had endothelial cell loss greater than 30%.
• Ocular Surgery News U.S. Edition, November 25, 2010: "The Air Force has not begun using phakic IOLs in any of our men and women in uniform, and we are waiting for additional long-term safety data regarding endothelial cell loss before we will begin using the lenses in our personnel". – Charles Reilly, MD, Lt. Col, USAF. Link to source
• This 2011 literature review found that cataract was the most common complication of posterior chamber intraocular lenses, reported at a rate of 5.2% of eyes implanted. Of those, 43.4% were reported within 1 year, 15.4% between 1 and 3 years, and 35.3% three or more years after after ICL implantation. Cataract surgery was carried out in 27.9% of eyes with induced cataracts.
• Visian phakic intraocular lens shown to lead to development of cataracts over time. Source: Schmidinger G, et al. Long-term changes in posterior chamber phakic intraocular collamer lens vaulting in myopic patients. Ophthalmology. 2010 Aug;117(8):1506-11. Link to abstract
• "But ocular trauma can cause the PIOL to shift, become dislodged, and even come into contact with the crystalline lens and induce a cataract. The most common traumas that Dr. Devgan has seen in these patients are due to airbag injuries during car accidents." Daly, Rich. "Long-term strategy for phakic IOLs." EyeWorld. March, 2014. Link to article
• Early acute intraocular pressure increase is reported frequently after phakic IOL implantation. Pupillary block glaucoma can occur due to occlusion of aqueous flow between the lens and the iris. This is a dangerous situation which may lead to permanent vision loss if not detected and remedied immediately. In this small study, pupillary block glaucoma occurred in 5.8% eyes within the first postoperative day.
• A retrospective study of Martínez-Castillo and colleagues (2005) with follow-up of 64.3 ± 10.35 months shows an incidence of retinal detachment of 2.7%, occuring from 1 to 70 months after implantation of posterior chamber implantable lenses. Link to abstract
• In a 2011 study by Parkhurt and colleagues, 3% of post-ICL eyes reported halos significant enough to require treatment with a glaucoma medication to constrict the pupil. (Source: Parkhurst G, et al. Phakic Intraocular Lens Implantation in United States Military Warfighters: A Retrospective Analysis of Early Clinical Outcomes of the Visian ICL. J Refract Surg. Vol. 27, No. 7, 2011)
What about large pupils and implantable lenses?
Complaints of night vision problems and visual disturbances have plagued the refractive surgery industry from the beginning. Implantable lenses are no different. The FDA website says you are probably not a good candidate for phakic lenses if you have large pupils. (Keep in mind, the FDA works hand in glove with eye surgeons whose livelihoods are dependent upon selling unnecessary surgery.) We would say you are definitely not a good candidate for phakic lenses if you have large pupils.
How large is too large?
Generally speaking, if your dark-adapted pupil diameter exceeds the diameter of the lens optic diameter, you're not a good candidate.
The Visian ICL labeling states that the lens features an optic diameter with an overall diameter that varies with dioptric power; the smallest being 4.9 mm/12.1 mm and the largest 5.8 mm/13.7 mm.
The Verisyse lens is available in 5 mm and 6 mm optic diameters, according to the company's website.
You're going to have to ask some probing questions of your eye surgeon to determine if your pupil size makes you a poor candidate. Be sure to have your pupils measured in the dark after a period of dark adaptation, and repeat this measurement on a different day.
Links to more information about implantable lenses:
10/3/2003 FDA Ophthalmic Devices Panel meeting review of premarket application of Visian Myopia ICL - Read transcript
2/5/2004 FDA Ophthalmic Devices Panel meeting review of premarket application of Artisan Phakic IOL - Read transcript
3/14/2014 FDA Ophthalmic Devices Panel meeting review of premarket application of Visian Toric ICL - Read transcript; Meeting materials
Follow the latest research on PubMed.gov.
Igarashi, et al. Eight-Year Follow-up of Posterior Chamber Phakic Intraocular Lens Implantation for Moderate to High Myopia. Am J Ophthalmol. 2014 Mar;157(3):532-539. Link to abstract
Disclaimer: The information contained on this web site is presented for the purpose of warning people about complications of LASIK, implantable lenses, and other forms of refractive surgery prior to surgery. Patients experiencing problems should seek the advice of a physician.
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