Facial Thread-Lift Loses Approval of FDA

By Margarita Nahapetyan

Very popular type of face lift, a technique called the facial thread lift, recently has lost the approval from the Food and Drug Administration (FDA). The surgery, that involves insertion of barbed threads under the skin in order to tighten lax tissue, has been referred to as cutting-edge procedure with no cutting edges. It has been considered as an easier and less invasive way to rid the face and neck of undesirable wrinkles.

However, a study of patients who underwent the surgery, has showed that there was only short-term improvement in their appearance, with many of them experiencing serious problems with it, including indentations, bunching, dimpling, visible knots, broken threads and facial asymmetry. Investigators also claim the threads can cause extensive scarring making them difficult to remove.

The Food and Drug Administration approved the Contour Thread-lift system in 2005, wrote in the report Dr. Rima F. Abraham of Albany Medical College, New York and her fellow colleagues. And while FDA canceled its approval after reports describing problematic issues, the experts say that the similar products are still available, and the procedure is still used by many.

In order to collect the objective information on the risks and benefits of thread lift procedure, the investigators examined 33 patients who underwent the surgery. Out of all patients, 23 reported to have other surgical interventions as well, whereas ten patients had just facial thread lifts. For a comparison, there was one more, control group of 10 more individuals who had some other types of plastic surgery.

Four plastic surgery experts, who were not aware which procedure the participants of the study had gone through, had to rate the "aesthetic improvement" for each patient on a scale from zero, which meant no improvement, up to three, that would mean considerable improvement. Thirty days after the surgery, improvements were observed in all the patients. However, at follow-up, which ranged from one year to 31 months and with the average time of 21 months, the group of participants who had just a thread lift, received the lowest scores, with average improvement rates ranging from 0.2 to 0.5. The investigators found that among individuals who had thread lifts in combination with other procedures, scores varied from 0.5 to 1.4, whereas for the group of patients that only had traditional procedures, scores ranged from 1.5 to 2.3.

Dr. Abraham and her team came to the conclusion that thread lifts do not provide patients with long-lasting results because they do not change the shift in facial volumes that happens with aging. In addition, they noted that excess skin that is left over after facial tightening is left in place. The results that were observed one month after the thread lifting surgery were more likely because of swelling and skin inflammation, the experts explained. Among complications associated with thread lifts seen in the study, were visible knots and dimpling of the skin. Three patients had to have a thread removed.

The researchers caution that thread lifts are linked to a high risk of complications, while extensive scarring may make it hard to remove the threads, which is, in turn, problematic because research has indicated that up to 20 per cent of patients need a repeat surgery. "Given these findings, as well as the measurable risk of adverse events and patient discomfort, we cannot justify further use of this procedure for facial rejuvenation," Dr. Abraham and her colleagues concluded.

SOURCE: Archives of Facial Plastic Surgery, the edition of May/June, 2009.