What Was in the Recent FDA Statement?
You might have heard about a statement issued by the FDA last week that several news outlets and medical experts have reported on. What is unclear about the statement is what, exactly, is driving it, but it seems to be more of an issue with the manufacturer’s marketing claims than the device itself. The manufacturer, Cynosure, reached out to us in email on Aug. 2:
“The letter received by Hologic did not question the safety of the device but did question some of the claims located on our website…. As a leader in women’s health, Hologic [the company that owns Cynosure] has a strong track record of developing products based on science and clinical evidence as well as meeting our regulatory obligations and so we take the contents of this letter seriously…We share the same goals as FDA – clinically strong products that improve patient lives and are marketed responsibly.” Kevin Thornal, president, Cynosure
Continuing to Offer the Procedure
The FDA statement to Cynosure does not affect Medical Aesthetics. We will continue to offer this life-changing procedure that has worked so well for so many Dallas clients.
“Like any medical procedure, results vary,” says Dr. Eisenberg. “But nearly all of our MonaLisa Touch patients are overwhelmingly happy and satisfied. So satisfied, in fact, that they have referred people to us and given their own video testimony. Anecdotally speaking, the procedure is a gamechanger.”
If you have questions or would like to schedule a consultation: