Hologic Stops Marketing TempSure Vitalia Devices In Wake Of FDA Vaginal Rejuvenation Warning

Published on September 26, 2018 by Laurie Villanueva

Hologic has decided to suspend sales and distribution of TempSure Vitalia handpieces, less than two months after the U.S. Food & Drug Administration (FDA) issued a warning for so-called vaginal rejuvenation devices.

Sales of MonaLisa Touch to Continue

Tempsure Vitalia hand-pieces are marketed by Hologic’s Cynosure division, one of several companies that received FDA letters concerning the possible “inappropriate marketing” of laser-based devices for vaginal rejuvenation.

While the FDA letter to Cynosure did not mention TempSur Vitalia, it specifically named the company’s MonaLisa Touch laser. Yet sales of MonaLisa Touch will continue.

According to MDDI Online, the decision to abandon TempSur Vitalia and stick with MonaLisa Touch likely came down to clinical evidence and frequency of use.

The TempSure Vitalia System is typically used for “vaginal laxity”, while MonaLisa Touch is more often used for vaginal dryness. What’s more, TempSure Vitalia was only introduced to the North American market last July.

FDA Warning on Unapproved Vaginal Rejuvenation Devices

The FDA has cautioned doctors not to use laser and other energy-based devices like the MonaLisa Touch for vaginal rejuvenation, including procedures referred to as “designer vaginoplasty,” “revirgination” or “G-spot amplification”.

“These products have serious risks and don’t have adequate evidence to support their use for these purposes,” the FDA commissioner said in a statement dated July 30th. “We are deeply concerned women are being harmed.”

Complications reported to the agency in relation to vaginal rejuvenation devices include:

  • Severe vaginal burns
  • Vaginal scarring
  • Pain during sexual intercourse
  • Recurring/chronic vaginal pain

Of note, lasers and other energy-based devices have never been approved by the FDA for vaginal rejuvenation, and were only approved for the treatment of abnormal or precancerous cervical or vaginal tissue, genital warts, and other serious conditions.

FDA Encourages Women to Report Vaginal Rejuvenation Injuries & Complications

“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,” the FDA said. “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.

Women who’ve suffered injuries and complications related to vaginal rejuvenation are encouraged report their experience to MedWatch, the FDA Safety Information and Adverse Event Reporting program.

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