Erchonia Corporation took on this project for two reasons, one to prove that low-level lasers (3LT®) can influence pain along with reducing swelling and edema and the second to substantiate our position on depth of penetration. Erchonia Corporation has never agreed with the prevailing “depth of penetration theory,” and has proven through Rodrigo Neira, MD and Erchonia Corporation's ground-breaking research on abdominal MRI, that a 635nM laser could emulsify fat deep into the abdominal fat. (Ref: AACS 2003).
Laser Breast Augmentation patients were asked to participate in a study using real and placebo lasers. Through random selection, half the patients were placed in a control or real laser treated group and the other half placed in the placebo group. The procedure consisted of cutting a half moon in the areola complex (nipple), the muscle was pulled back and a pocket was created on the chest wall. The implant was then put into place and the muscle pulled over the implant. Once in place, the implant was inflated to the desired size and the nipple was then sewed back together.
The medical laser had to deal with the pain of creating the pocket, stretching the muscle to put the implant in and then cutting and sewing the skin back together. Lazed patients were compared to placebo treated patients on a self-reported pain scale of 1 to 100. Patients rated their pain levels throughout the process and when tabulated showed the Erchonia laser to be 77% more effective than the placebo. The phenomenal results of the Laser Enhanced Breast Augmentation™ study has proven through 105 patients that low-level lasers have an effect on pain deep into the body when compared to placebo.
Prior to beginning this study in 2005, it was submitted to the FDA and an IRB for evaluation and approval. The results of the study were submitted to the FDA for market clearance in August 2007. We expect the market clearance letter in December 2007. An article depicting the clinical study and results has been submitted for publication and is expected to be published in 2008. An abstract has been provided.