ThermiGen Says it will Voluntarily Discontinue Certain Claims for ‘ThermiVa’ Device Following Challenge from Viveve

New York, NY – March 28, 2017 – ThermiGen, LLC., said it has voluntarily and permanently discontinued certain advertising claims for the company’s ThermiVa medical device.

The claims at issue were challenged before the National Advertising Division by Viveve, Inc.

NAD is an investigative unit of the advertising industry’s system of self-regulation. It is administered by the Council of Better Business Bureaus.

ThermiVa is a radio-frequency device cleared for sale by the Food and Drug Administration in 2013 for use in certain dermatological and general surgical procedures.

Viveve challenged claims that included:

  • The ThermiVa device treats urinary incontinence, overactive bladder, urgency, and frequency, doing so with just one treatment.
  • The ThermiVa device treats bladder dropping or fallen bladders.
  • The ThermiVa device causes regeneration of nervous tissue in and around the vagina.
  • The ThermiVa device treats the effects of menopause.
  • The ThermiVa device “immediately shrinks tissues.”

The challenger also took issue with before-and-after photographs of vaginal treatment with the ThermiVa device, video animation of before-and-after results of vaginal treatment with the ThermiVa device and testimonial claims regarding the use of the ThermiVa device.

During the course of the proceeding, the advertiser made a written voluntary commitment to NAD to permanently discontinue the challenged claims, including challenged before-and-after photographs and videos and to permanently cease the distribution of any marketing materials containing the challenged claims to customers or physicians.

The advertiser also promised to make efforts to instruct any customer or physicians that, to the extent they may have used the challenged claims in connection with their own marketing, they may no longer do so.

In reliance on the advertiser’s representation that the challenged claims have been permanently discontinued, NAD did not review these claims on their merits.  The voluntarily discontinued claims will be treated, for compliance purposes, as though NAD recommended their discontinuance and the advertiser agreed to comply.

Note: A recommendation by NAD to modify or discontinue a claim is not a finding of wrongdoing and an advertiser’s voluntary discontinuance or modification of claims should not be construed as an admission of impropriety. It is the policy of NAD not to endorse any company, product, or service. Decisions finding that advertising claims have been substantiated should not be construed as endorsements.