FDA Warns Against Using At-Home Dermal Filler ‘Pens’

fda warns against using at home dermal filler pens

Sumary of FDA Warns Against Using At-Home Dermal Filler ‘Pens’:

  • These pen devices use high pressure to force dermal filler into the body without a needle.
  • She directs the Office of Surgical and Infection Control Devices in FDA’s Center for Devices and Radiological Health.
  • Seeking to bypass more expensive — but much safer — injections from trained professionals, some consumers are using the over-the-counter devices to reduce wrinkles, increase lip volume or change the shape of the nose.
  • But Ashar said her agency “is warning the public and health care professionals not to use needle-free devices such as hyaluron pens for injection of hyaluronic acid or other lip and facial fillers, collectively and commonly referred to as dermal fillers or fillers.
  • ” “These unapproved needle-free devices and fillers are often sold directly to customers online, bypassing consultation with a licensed health care provider, a critical safety measure for patients to make informed decisions about their personal health,” she said.
  • Then stick to procedures done in a clinical setting by licensed health care providers using FDA-approved fillers with needles or cannulas (thin tubes), the FDA advised.
  • “The FDA is monitoring online platforms for these unapproved needle-free devices as well as dermal fillers intended for use with needle-free injection devices,” Romo said.
  • ” Uneven, unsightly results can occur because the pen devices simply aren’t precise enough, he explained.

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