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The devices are not created to work on large areas or for reshaping procedures such as those performed during vaginal rejuvenation. "We are deeply concerned women are being harmed", Gottlieb said.

The FDA noted in a safety alert issued Monday that vaginal "rejuvenation" often is used to describe nonsurgical procedures meant to treat symptoms such as vaginal laxity, atrophy or dryness, and pain during intercourse or urination.

"The deceptive marketing of a unsafe procedure with no proven benefit, including to women who've been treated for cancer, is egregious", Gottlieb added. 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. Needless to say that the FDA has yet to review, let alone recommend, these procedures.

Such treatments, however, might lead to adverse effects, according to the Food and Drug Administration - including vaginal burns, scarring, and increased pain during sexual activity.

"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", said FDA commissioner Scott Gottlieb in a statement.

Hologic's (HOLX +1.7%) Cynosure unit is one of seven manufacturers warned by the FDA over their marketing of energy-based devices, including lasers, for "vaginal rejuvenation", an unapproved indication.

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The laser devices used in vaginal rejuvenation are cleared for some medical uses.

The agency has notified the firms, including Alma Lasers, BTL Aesthetics, BTL Industries, InMode, Sciton and Thermigen, that they have 30 days to respond to its questions about their marketing practices for the unapproved use. The administration says if the companies fail to address the issue within the notice period, it will take "potential enforcement actions".

"In addition to the deceptive health claims being made with respect to these uses, the "vaginal rejuvenation" procedures have serious risks", Gottlieb said. Parent company Hologic, Inc. said it is aware of the FDA warning.

The agency posted copies of letters it sent to manufacturers of the MonaLisa Touch, Femilift, Venus Fiore RF Ablation System and other devices, telling them to stop promoting them for the rejuvenation procedure.

The new laser and ultrasound devices are being marketed as safer, but the FDA said they could be harmful. "We are evaluating the letter in full and will collaborate with the agency to ensure all product communications adhere to regulatory requirements". We encourage those who've had an adverse event associated with the use of these devices to report their problem to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Discuss the benefits and risks of all available treatment options for vaginal symptoms with your health care provider.


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