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Thread: FDA Bulletin............Laser surgery risky

  1. #1
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    FDA Bulletin............Laser surgery risky

    The procedure promises freedom from contact lenses and glasses. Which? claim it can mean ‘gambling’ one’s sight.
    Picture: Getty Images



    NHS steers clear of laser eye surgery after review fails to answer concerns

    ALISON HARDIE
    HEALTH CORRESPONDENT


    LASER eye surgery to correct short-sightedness will not be offered by the NHS because of concerns over the procedure’s safety, it emerged yesterday.

    A year-long review has concluded that "current evidence" on the treatment’s effects cannot justify widespread use in the health service.

    The procedure, which actress Courteney Cox Arquette as well as the Scots actor Ewan McGregor have undergone, pledges "freedom" from wearing glasses or contact lenses.

    Private companies charging up to £3,000 for "cosmetic" eye surgery to correct myopia have grown rapidly in Britain.

    However, Westminster’s medical watchdog, the National Institute for Clinical Excellence (NICE), conducted the review into the procedure known as LASIK.

    The institute voiced concerns about the lack of reliable clinical information concerning the number of patients reporting adverse after-effects.

    NICE’s findings will be studied by health officials in Scotland, who are likely to follow the review’s conclusions.

    Professor Bruce Campbell, the chairman of NICE’s interventional procedures advisory committee, said yesterday there was "very little information" about how many people are harmed as a result of LASIK.

    He said: "LASIK offers improvement to people who have mild or moderate trouble with their vision.

    "This is a problem that can easily be corrected by spectacles or contact lenses, so any risk of damage to the eye by LASIK is a real concern.

    "Although many people have undergone LASIK treatment there is very little information available about how many are harmed as a result."

    He added: "We know that vision gets worse in a few people after LASIK and eye specialists are also concerned about the effects of thinning of the cornea of the eye in the long term.

    "We need to know more about these potential problems."

    In its draft report, NICE concludes "current evidence does not appear adequate to support its use without special arrangements for consent and for audit and research".

    As myopia can be corrected safely with spectacles or contact lenses, NICE says an alternative treatment "must have excellent safety to be suitable for use".

    Laser surgery, which was first introduced in the UK in 1989 in the form of PRK (photo refractive keratectomy) costs about £2,000 to £3,000 and is performed on about 100,000 people each year in Britain.

    The celebrities Cindy Crawford, Nicole Kidman, Barry Manilow and Mimi Rogers are all also reported to have undergone the procedure.

    LASIK is the most popular type on offer, where a flap about one-third of the thickness of the cornea is cut and the bed underneath reshaped using the laser beam. The flap is then put back into place.

    Last year, the medical journal Ophthalmology said the failure rate for eye surgery was one in ten, not the one in 1,000 figure widely advertised.

    The Medical Defence Union, Britain’s largest insurer for doctors, said negligence claims involving laser eye surgery more than doubled among its members since 1998.

    Which?, the organisation formerly known as the Consumers’ Association, has warned that people having the surgery are "gambling with their sight".

    It found that some clinics did not highlight possible side-effects until after patients had signed up for treatment.

  2. #2
    Master OptiBoarder rbaker's Avatar
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    Citation

    Chris,

    Where is the FDA bulletin? Can you please provide a citation on posted article. Many thanks.
    Dick

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    Answer.............................

    Quote Originally Posted by rbaker
    Chris,

    Where is the FDA bulletin? Can you please provide a citation on posted article. Many thanks.
    Dick
    I get the daily FDA Bulletin, look if there is anything related to our interest, either copy and if there is a link, I follow the link which I did in this case:


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    Quote Originally Posted by rbaker
    Where is the FDA bulletin? Can you please provide a citation on posted article.
    I agree that the title of the thread is a bit misleading.

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    Copyright © 2004 by Washington Business Information, Inc./FDAnews. All rights reserved.
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    If you need to contact us please call toll free (inside U.S.) (888) 838-5578 or +1 (703) 538-7600.
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    FDAnews.com [http://www.fdanews.com/] is not affiliated with the U.S. Food and Drug Adminstration [http://www.fda.gov/]. FDAnews.com is not a governmental agency, nor does it have any regulatory power. FDAnews.com is a for profit company that sells reports, books, tapes, CDs, and other materials and services to those in the medical and pharmaceutical industries. Given that most people think about the U.S. Food and Drug Administration, not FDAnews, when they see or hear the acronym “FDA”, the title of this tread (i.e. “FDA Bulletin............Laser surgery risky”) is misleading.

  7. #7
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    very misleading. send yourself a ticking off e-mail as is your norm

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    Despite the fact that it wasn't the FDA that said it (in contrast to the thread title) the NICE report will have considerable impact in the UK. Rumour has it that it will not be published as scheduled on the 15th, however.

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