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| NEWS


news T


he AmericAn Society for Aesthetic Plastic Surgery (ASAPS) has announced that many consumers are still unaware of the risks associated with aesthetic procedures performed


by unlicensed practitioners. reports from Las Vegas and


Philadelphia document unsuspecting patients suffering from pain and disfigurement and in the two cases, death, when women had their buttocks injected with


unknown


substances. injectable fillers to enhance the bust, hips, buttocks or face are frequently administered in non‑clinical settings by amateur or unlicensed


practitioners.


Unsuspecting patients have been injected with materials such as silicone, baby oil, and those with no safety or efficacy record. 'We desperately need more consumer education on this topic ... Patients may be lured in by


Lexington International, LLC has announced the successful completion of two clinical studies of the HairMax LaserComb, proving the efficacy and safety of three new devices for the treatment of androgenetic alopecia. The analysis showed that 95.4% of participants experienced hair growth. Furthermore, the average increases in hair count for participants in the


A round-up of news stories in the aesthetic and anti-ageing medicine industry


phoNy procEdurEWArNiNg


ASApS warns of the dangers and risks of procedures performed by unlicensed practitioners


inexpensive prices and unrealistic claims. Patients think they are getting a bargain, but they are actually putting their health and lives at risk and they may not even know it,' saidfelmontf.eaves, iii, President of the Aesthetic Society. Patients can make safe choices when seeking cosmetic procedures by selecting qualified physicians who perform or oversee procedures in appropriate settings. in most cases, cosmetic


procedures offered in non‑medical settings, such as homes, hotels and beauty salons are not performed by qualified individuals and may involve the use of illegal or unknown substances. Patients should never choose a doctor solely on


the basis of lower cost. 'We hear very sad and frustrating


stories of patients being taken advantage of by phony doctors and illegal procedures. Patients are being scammed and exposed to great harm,' said Dr eaves.


Advancements in oral implants


New materials and technologies offer implant dentistry to more patients. Fibre-reinforced composite is a new material that promises advantages for use in oral and craniofacial applications, as well as orthopaedics.. A study published in the Journal of


Oral Implantology compared fibre-reinforced composite and titanium implants. Researchers analysed how the materials affect stress and strain on the implant and bone tissue. They also compared interfacial stresses between the materials under 3 directions of load. Distribution of stress and strain


to the jawbone is significantly changed after reconstruction with oral implants. How an implant using fibre-reinforced composite reacts has not yet been well biomechanical


tested. This connection


between implant and bone can be different for each patient and is hard to measure. This study used a three- dimensional finite element model constructed from a mandibular bone and an implant to test these materials. Although variances were observed for both, the composite performed well.


NEW MILESTONES IN HAIR GROWTH AND FDA CLEARANCE two double-blind,


HairMax LaserComb group was 20.4 hairs/cm2


, which is considered


medically and scientifically significant. None of the participants in the studies experienced any serious side-effects. Based in part on submission of clinical results, the FDA Granted Class II Clearance 510(k) K103368 of these medical devices for sale in the USA for the 'Treatment of Hair Loss and


Promotion of Hair Growth' in males. The


device-controlled multi-centre


studies were conducted by Zoe Draelos, David Goldberg, Michael Jarrett, and Abe Mercadis, under Good Clinical Practice guidelines and Institutional Review Board approval. Submission of these data was a major component of the FDA filing and was a key factor in the


agency's decision to clear the HairMax LaserComb. The clearance further validates the HairMax as a non-drug option for treating hereditary hair loss in males. Since 2001, Lexington has


completed a total of seven clinical studies with 460 subjects and all of the studies have demonstrated the efficacy and safety of the HairMax LaserComb.


prime-journal.com | May 2011 ❚ 9


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