FDA ALERT regarding the use of LASER

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Based on the report made by the FDA regarding the application of the Gynecological laser in the treatments of Vaginal Tightening and Urinary Incontinence,we want to clarify some points for patient peace of mind. 

 

In the report the FDA says“...In analyzing the reports and published articles on adverse effects, we have found a large number of cases of vaginal burns, scarring, pain during intercourse, and recurrent or chronic pain….”

 

Because of these adverse effects, the FDA mentions and alerts 7 companies that market this type of equipment for these applications, which have different active elements (Co2, Erbium-YAG and Radiofrequency).It is important to note that the active element of the Lumiia SonoBeam Gyna (1940nm Diode) is not being mentioned in this report.and to guarantee that this equipment does not generate vaginal burns we attach a report(view Report) whose objective is the comparison for gynecological applications between Co2, Erbium-YAG and 1940nm diode laser equipment.

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The conclusions of the report are:

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Taking as a starting point that the use of wavelengths that have an affinity for the water molecule is a necessary and sufficient condition (this is the case of the 1940nm diode, CO2 and Erbium-YAG) as indicated above, the following can be deduced:

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1- The energy density of the 1940nm laser light turns out to be 10 times lower than that of a CO2 laser and more than 100 times lower than that of an Erbium-YAG laser.

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2- The emission of the 1940nm diode through the optical fiber is not collimated but divergent.

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3- The procedure is monitored in real time through the Gynacare HD video speculum.

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So: The SonoBeam Gyna laser minimizes the chance of scarring, burns or chronic pain in the patient.

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In our center, we work with theLumiia SonoBeam Gyna (diode laser of 1940nm) that, in addition to having less penetration and aggressiveness in the tissues, is the only one in the market that offers the possibility of directly seeing the entire procedure at the very moment of its performance through a fullHD endocamera. The equipment that the FDA places under suspicion use CO2, fractionated CO2, and Erbium-Yag.  

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To date we have not had any of the reported complications, and the results were satisfactory for the treated patients, with noticeable changes and improvement.In any case, we always clarify that we are in the presence of a medical act, and unwanted events can arise, not only with the laser, but with any procedure.But we cannot doubt the favorable effects demonstrated so far if the treatment is performed in the appropriate manner, to the indicated patient, with the correct technique, and precise knowledge.

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Probably the wake-up call from the US regulatory body will serve to order the treatment. A very aggressive advertising campaign has been carried out promoting "vaginal rejuvenation" which has spread to the point that it is offered in beauty centers and even in some cases are carried out by personnel without a degree in Medicine. 

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