Some months have passed now since a letter requesting clarification regarding vaginal treatments with various energy systems was sent by the FDA to some American distributors, including Cynosure Inc., MonaLisa Touch distributor in the USA and Canada.
Beyond this letter, some assessments have been released regarding presumed risks of the above -mentioned systems, without – in our opinion -deep familiarity of vaginal treatment procedures.
To unpack all the misunderstandings, we have to say that the letter sent by the FDA to Cynosure Inc. is based in an interpretation of the FDA’s rules regarding the possibility to publicise MonaLisa treatment in American territory. The differing interpretation between Cynosure and the FDA has led to various meetings between the two organisations, meetings which will flow into a mutual agreement between what can and cannot be said in publicity for the procedure.
Beyond this necessary clarification, we must note:
1. The SmartXide Touch system with the MonaLisa Touch scanner has not been banned from sales by the FDA. From the time of the FDA’s notice, last 30 July, to the present, many MonaLisa Touch systems have been ordered and delivered in the United States.
2. The request for clarifications on the FDA’s part has nothing to do with the quality of the treatment, as the thousands of professionals who use MonaLisa regularly all know well, just like the now millions of patients who have benefitted from this treatment.
3. The evaluation regarding the presumed risks of MonaLisa Touch continues to be an assessment which we interpret to be personal and confused among the, by now, dozens of offers which have tried to emulate the treatment we offer.
As we know very well, MonaLisa Touch is not an esoteric procedure but rather rests on a solid, uncontestable scientific base, and it is used by major university and hospital institutions in the
four corners of the world, with efficacy and safety that have few equals. The presumed hundreds of serious side effects do not exist, as one can easily verify consulting the designated sites online
which the same FDA makes available for all patients.
In these months DEKA has avoided comment through declarations regarding its own counterdeductions and arguments because we believe that all this fuss has no foundation, and that for our account speak all the women who have received a new life for their intimacy from MonaLisa Touch, with complete relief and in complete safety. This is our strength and it is the strength which
will always accompany MonaLisa Touch.
DEKA does not fear those who think MonaLisa Touch is ineffective or even dangerous; we know it is not true, and we have demonstrated it.
Mauro Galli
International Sales and Marketing Director DEKA
