ALT 0.00% 0.1¢ analytica limited

Does this mean the end for this stock?, page-2

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    No. The FDA recently warned against vaginal laser treatments as being unsafe and potentially harmful. Extract from the FDA statement from July 30 2018 below:


    We’ve recently become aware of a growing number of manufacturers marketing “vaginal rejuvenation” devices to women and claiming these procedures will treat conditions and symptoms related to menopause, urinary incontinence or sexual function. The procedures use lasers and other energy-based devices to destroy or reshape vaginal tissue. These products have serious risks and don’t have adequate evidence to support their use for these purposes. We are deeply concerned women are being harmed.
    As part of our efforts to promote women’s health, the FDA has cleared or approved laser and energy-based devices for the treatment of serious conditions like the destruction of abnormal or pre-cancerous cervical or vaginal tissue, as well as condylomas (genital warts). But the safety and effectiveness of these devices hasn’t been evaluated or confirmed by the FDA for “vaginal rejuvenation.” In addition to the deceptive health claims being made with respect to these uses, the “vaginal rejuvenation” procedures have serious risks. In some cases, these devices are being marketed for this use to women who have completed treatment for breast cancer and are experiencing symptoms caused by early menopause. The deceptive marketing of a dangerous procedure with no proven benefit, including to women who’ve been treated for cancer, is egregious.
    In reviewing adverse event reports and published literature, we have found numerous cases of vaginal burns, scarring, pain during sexual intercourse, and recurring or chronic pain.
    We haven’t reviewed or approved these devices for use in such procedures. Thus, the full extent of the risks is unknown. But these reports indicate these procedures can cause serious harm.
    Today, we’re warning women and their healthcare providers that the FDA has serious concerns about the use of these devices to treat gynecological conditions beyond those for which the devices have been approved or cleared.
    We recently notified seven device manufacturers of our concerns about inappropriate marketing of their devices for “vaginal rejuvenation” procedures. They are: Alma Lasers, BTL Industries, Cynosure, InMode, Sciton, Thermigen and  Venus Concept. We requested that the manufacturers address our concerns within 30 days. If our concerns are not addressed, then the FDA will consider what next actions, including potential enforcement actions, are appropriate. This matter has the full attention of our professional staff.
    The deceptive marketing of unproven treatments may not only cause injuries but may also keep some patients from accessing appropriate, recognized therapies to treat severe medical conditions. These products may be particularly appealing to women who may not be candidates for certain FDA-approved treatments to relieve vaginal dryness, and thus are seeking alternative, non-hormonal options. Women considering treatment for vaginal symptoms should speak to their doctor about the potential and known benefits and risks of all available treatment options. FDA is committed to helping advance the development of safe, effective treatment options for these conditions.
 
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