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RFAL studies show real benefits

Article-RFAL studies show real benefits

Key iconKey Points

  • Early results of clinical trials studying BodyTite demonstrate high patient satisfaction rates
  • Expert says best reshaping results have been seen in breast area in male and female patients

Cosmetic surgeons in the United States are awaiting Food and Drug Administration (FDA) approval for Invasix's BodyTite, a radiofrequency-assisted liposuction (RFAL) device. Many expect clearance to be granted this year, in part because of the early positive data.

Guillermo Blugerman, M.D., director of Clinica B&S de Excelencia en Cirugia Plastica, Buenos Aires, Argentina, heads one of the sites conducting these clinical trials. The clinic has performed more than 350 RFAL procedures. "We find that with this new technology, we can obtain faster results in a better way, mainly through the distribution of the heating process," Dr. Blugerman says.

Patients have been equally pleased with the results. "The patient satisfaction rate is very high," Dr. Blugerman says. The few patients who have undergone previous liposuction procedures, such as laser lipolysis, found the radiofrequency procedure more effective, he adds.

Dr. Blugerman says he has seen the best reshaping results in the breast area, both in male and female reduction procedures. Other areas where the device has been used include the neck, bra line, upper arms, stomach, inner thighs and inner knees. And though they are tighter areas of the body, the hips and outer thighs can also undergo RFAL for patients who want less bruising, swelling and pain. Men can treat the gut and love handles.

When comparing RFAL to laser liposuction (SmartLipo, Cynosure), Dr. Blugerman says he has seen faster procedures and quicker results with the former. In one study that has yet to be published, SmartLipo and BodyTite procedures were performed simultaneously 10 times. "We needed half of the time with the BodyTite as with the SmartLipo," Dr. Blugerman says.

Recovery, in terms of healing, was found to be similar, but RFAL patients showed a quicker improvement in skin contraction and aesthetics. "They look better in a shorter time," Dr. Blugerman says.

However, only appropriate candidates should undergo the procedure, and their expectations should be managed. "Roughly 10 to 20 percent of the abdominoplasty patients can be done with BodyTite. If you overindicate the procedure, you will have unhappy patients," Dr. Blugerman says.

The primary hazards have been burns and seromas, but the risk for both has been minimal. "At the beginning, we believed that we would probably find more liquid collection in the tissue, but we haven't found any difference in this aspect," Dr. Blugerman says.

Burns are more likely in inexperienced hands. "If you don't have good control of the handpiece and the parameters, you can burn the skin," Dr. Blugerman says. Proper training can help to avoid this danger. Blugerman says he recommends hands-on training, observation and a slow approach for surgeons performing the first 10 procedures.

"As with every new technique, you need a learning curve to avoid problems," he says. This should not, however, discourage surgeons from adding RFAL to their practice. "In this competitive market, to maintain your position, you need to introduce new devices when they are available for the patients," he says.

DISCLOSURES:
Dr. Blugerman conducts studies to submit to the FDA and lectures about the BodyTite system for Invasix, but he holds no contract with the company and receives only travel expenses for his work.

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