Device statuses were verified through the Devices@FDA database, and ongoing clinical trials were reviewed at ClinicalTrials.gov.
Thread-Lifting Studies Categorized by Suture Type
Aptos threads were the first commercially available barbed sutures, using 2-0 polyprolene and bidirectional barbs with free-floating suture placement.5,19 In the first study published by Sulamanidze and colleagues5 (Aptos, Ltd., Moscow, Russia) (Table 2), 186 subjects were treated with either Aptos threads alone in the upper midface or in combination with other treatments, such as liposuction or blepharoplasty. Initial results were positive, with the only adverse event reported being thread disruption and suture extrusion in 2.5% of subjects over a 2.5-year follow-up period,4 although the outcome measures and exact percentage of subjects with a prolonged follow-up period were unspecified.
Lycka and colleagues20 studied the Aptos sutures in 350 women. Three hundred forty-eight reported positive outcomes. In the initial 7-day follow-up period, 10 reported asymmetry that was corrected with additional suture placement. Subjects retained 70% of their original results at 12 to 24 months and 60% at 36 months. Adverse events were primarily transient (Table 2), although visible threads were noted postprocedurally in 3.4% of cases.
Aptos thread complications were more recently reported in a series of 102 patients: 11 palpable thread ends with pain, 8 thread migrations, 5 infections or granulomas, and 5 instances of skin dimpling or irregularities.9,12 More serious complications such as Stensen's duct rupture, nerve damage, chronic foreign body sensation, and scarring appearing as late as 2 years after the procedure have been reported by other investigators.21–25
A continued high complication rate described in subsequent reports, including suture migration and expulsion, resulted in a decrease in popularity of usage of Aptos threads.21,26 In 2011, Sulamanidze and colleagues27 published a study in response to reported complications with Aptos threads. They retrospectively reviewed their results from 12,788 thread-lift procedures performed on 6,098 patients over 12.5 years. The authors stated that adoption of newer permutations, such as the Aptos 2 G, Aptos Needle, Aptos Needle 2 G, and Aptos Spring threads, resulted in improved outcomes and fewer complications than with the original Aptos threads, although comparative data were not presented.27 Only minor adverse events were reported (Table 2). They also cautioned that adverse effects may be operator-dependent or due to inappropriate patient selection.
In 2017, Fukaya published a study using Xtosis sutures, 0-0 polyprolene barbed sutures, which are considered to be an “Aptos analog.”8 One hundred subjects underwent 289 suture suspension procedures, and their preoperative and postoperative photographs were rated by peers. However, ratings may have been skewed as many subjects underwent additional procedures such as hyaluronic acid fillers and laser rejuvenation. Adverse events included local infection and thread extrusion (Table 2). Neither the Aptos nor Xtosis threads currently have FDA clearance.
Isse Endo Progressive Facelift Suture
In 2005, Lee and Isse28 modified the Aptos suture to place 50 unidirectional barbs distally to proximally anchor the suture in the temporalis fascia. The midface was targeted in 44 subjects, in which 10 underwent a closed approach and 34 underwent an endoscopic approach allowing for fascial suture placement. Approximately 100% of patients reported positive outcomes (Table 2). Adverse events were transient with the exception of 1 case of submalar dimpling, although the study only reported a 9-month follow-up period. The Isse Endo Progressive Facelift Suture (KMI, Inc., Anaheim, CA) does not currently have FDA clearance.
Multianchor Suspension Suture
Eremia and Willoughby29 described thread suspension of the midface with a 2-0 absorbable monofilament suture with large anchoring threads using the same absorbable monofilament sutures. These threads were made from commercially available 2-0 polydioxanone PDO and polyglyconate sutures and were thus not submitted for FDA clearance. Out of a total of 20 subjects, 6 underwent surgical facelifts assisted with anchored sutures and 14 underwent suture suspension alone. In individuals who underwent pure suspension lifts, 100% reported positive outcomes in the midface, jowls, and neck. As the sutures were absorbable, reversal of results was noted at 6-month follow-up. At 1-year follow-up, 100% of jowl and 80% to 100% of midface corrections were lost (Table 2). No adverse events were reported.
Contour Threads, which were patented as Featherlift Extended Aptos Length Threads (Surgical Specialties, Corp., Reading, PA) but are unique from the original Aptos threads, are 2-0 polyprolene sutures with a central segment of unidirectional barbs that are anchored proximally. They were cleared by the FDA in October 2004 for mid and lower facial rejuvenation. In 2008, an anonymous satisfaction questionnaire was mailed to 20 female patients who had undergone the ContourLift with a minimum follow-up of 6 months.1 Average patient satisfaction with the procedure was 6.9 (1 = completely unsatisfied and 10 = extremely satisfied) and patient-reported improvement in facial laxity averaged 6.6 of 10 (1 = no improvement and 10 = dramatic improvement). Improvement between preprocedural and postprocedural photographs was also independently rated by physicians with an average overall score of 4.6.1 Only transient adverse effects were reported (Table 2).
A retrospective study was performed in 2009 by Abraham and colleagues of 33 subjects: 10 underwent thread-lifts alone with Contour Threads, and 23 underwent thread-lifting with additional rejuvenation procedures. Results were compared with 10 patients who underwent non–thread-lift rejuvenation only.3 Non–thread-lift rejuvenation procedures consisted of blepharoplasty, 35% trichloroacetic acid peels, lipectomy, lipotransfer, and calcium-hydroxylapatite injection. Subjects were followed from 12 to 31 months (average 21 months), and postoperative results were graded by blinded physicians. The thread-only group received an average score of 0.2 to 0.5 (0 = no improvement and 3 = considerable improvement) (Table 2), in comparison with 0.5 to 1.4 and 1.8 to 2.3 for thread-lifting with additional procedures and non–thread-lift rejuvenation, respectively. Skin dimpling and visible knots were reported, with 3 subjects requiring postprocedural thread removal.
Another retrospective study published by Garvey and colleagues30 in 2009 investigated the outcomes of Contour Threads in 72 female subjects, 54 of whom underwent thread-lifts only of the jowls, midface, upper face, and neck. The other subjects received thread-lifts in combination with procedures such as blepharoplasty and jowl-lift. Complications were reported in 64.8%, although adverse events described were mostly minor (Table 2). Furthermore, 42.3% underwent revisional surgery at an average of 8.4 months, and 11.3% required thread removal due to palpable knots or suture extrusion.
In 2010, Rachel and colleagues31 conducted a retrospective study of 29 subjects who underwent barbed contour thread-lifts (Angiotech Pharmaceuticals, Vancouver, BC) with a follow-up of 1 to 25 months (average 12 months). Recurrence of laxity was reported within 8 weeks in 14% and within 6 months in 45%. Sixty-nine percent described adverse effects (Table 2), and 59% required additional surgery during follow-up.
As with Aptos threads, the increasing number of reports detailing complications resulting from Contour Threads resulted in their discontinuation. In the United States, Contour Threads lost FDA clearance regarding the technique used in the thread-lift; however, the sutures themselves still have FDA clearance for midface suspension surgery, specifically the Featherlift Extended Aptos Length Threads (Surgical Specialties, Corp) and the Featherlift Extended Aptos Threads (Kim Kolster Methods, Inc., Corona, CA).
Featherlift Silhouette Sutures (Kolster Methods, Inc., Corona, CA) are 3-0 polypropylene sutures with absorbable cones cleared by the FDA for midface rejuvenation and jawline definition by fixating the cheek subdermis in an elevated position.32 They are anchored proximally in the temporal fascia and then reinforced with polyprolene mesh. de Benito and colleagues treated 316 subjects over 2 years with an 18-month follow-up period, 294 of which underwent thread-lifts only. Minor adverse events were reported (Table 2), although 2 individuals required revisional surgery for asymmetry and 1 patient required thread removal.32
In 2008, Gamboa and Vasconez33 studied thread-lift outcomes using Silhouette Lifts (Silhouette Lift, Inc., Irvine, CA) in 17 subjects; these threads also currently have FDA clearance for midface suspension surgery. At 9 months, 90% reported they were very satisfied, and 10% reported they were moderately satisfied. Approximately 5.6% required a revisional procedure. Only minor adverse events were reported (Table 2).
Given the complications reported with nonabsorbable barbed sutures, absorbable thread-lifts have recently gained popularity. Several studies in Asia have been published using PDO threads. In the United States, the Quill Knotless Tissue-Closure Device and Synthetic Absorbable Barbed Suture (Quill Medical, Inc., Research Triangle Park, NC) are absorbable barbed PDO threads cleared by the FDA for soft-tissue closure. In 2015, Suh and colleagues34 published a study investigating the use of absorbable bidirectional barbed PDO threads in conjunction with a novel knotless PDO thread device. Thirty-one subjects underwent thread-lifts of the midface and were given an oral cephalosporin for 5 days afterward, with a 24-week follow-up period. Postprocedural photographs were evaluated by both subjects and independent physicians at 24-week follow-up. Eighty-seven percent of patients considered their results to be satisfactory. Physician ratings were excellent or good in 70.9% regarding skin texture improvement and in 54.9% regarding lifting. Only transient adverse events were reported (Table 2).
In 2017, Kim and colleagues35 published a similar study using 1-0 to 2-0 unidirectional barbed PDO threads (Youngs Lift; Y. Jacobs Medical, Seoul, Korea) in 31 subjects. Ultrasonography and a 3-dimensional scanner were used to evaluate postprocedural changes in mean dermal thickness and midfacial volume, respectively. Approximately 86.3% of patients reported at least moderate satisfaction with the procedure after 3 months. At 3-month follow-up, midfacial volume decreased by 7.6, and dermal thickness increased from 1.30 to 1.87 mm; at 7 months, average volume decreased by 8.7, and dermal thickness was stable at 1.89 mm. Only transient adverse events were described (Table 2).
Kang and colleagues36 examined a vertical PDO thread-lift (VOV-LIFT; GLK International, Seoul, Korea) technique with a retrospective analysis of 39 subjects. Follow-up photographs were rated by independent physicians. At 6-month follow-up, 89.7% patients reported their results to be satisfactory, whereas physician rating of outcomes was “improved” in 88.2%. Mostly transient adverse effects were described, with 1 patient reporting thread extrusion (Table 2).
Lee and colleagues37 published a study in 2017 with similarly high patient satisfaction scores and limited adverse events (Table 2). Thirty-five subjects underwent thread-lifts with PDO sutures followed by oral antibiotics, and 94.3% were satisfied with their outcomes with a mean follow-up period of 1 year. Independent physicians evaluated preprocedural and postprocedural photographs and rated 100% of subjects as improved.
Other PDO barbed sutures currently available in the United States include PDS Barbed Sutures (Ethicon, Inc., Somerville, NJ) and the Contour Thread Synthetic Absorbable PDO Barbed Suture (Surgical Specialties, Corp); however, these, including the Quill Synthetic Absorbable Barbed Suture, have FDA clearance for soft-tissue approximation and not specifically for midface suspension.
Poly-L-Lactic Acid Threads
Recently, interest has grown in PLLA threads, in particular due to their potential collagen-stimulating properties.38 However, a known complication with PLLA injections is the formation of subcutaneous nodules and late-onset granulomas.39 Other devices made of PLLA such as screws and pins have been described to have delayed inflammatory reactions.38 A study was published by Sarigul Guduk and colleagues40 using newly developed PLLA suture with bidirectional poly lactide/glycolide (PLGA) copolymer cones designed for lifting the eyebrows, lower neck, jaw, and cheek called the Silhouette Instalift (Silhouette Lift, Inc., Westwood, MA), also known as Silhouette Soft or Lift. Results may last from 12 to 18 months. These threads differ from previous iterations of thread-lifts in that they use cones rather than barbs and are cleared by the FDA for temporary midface suspension targeting the elevation of the cheek subdermis, in contrast to PDO threads. One hundred forty-eight subjects underwent thread-lifts with these PLLA/PLGA threads with the goal of lifting the cheeks, cheekbones, eyebrows, neck, and lower jaw. The purpose of the study was to assess the safety rather than efficacy of these threads; patients were followed over a median of 22 months. Mostly transient adverse outcomes reported; 1 subject experienced persistent skin dimpling, requiring subsequent subcision (Table 2).
A small pilot study was performed using Silhouette Instalift threads in 20 women for improving jawline contour.41 Six-month and 1-year post-treatment photographs were rated by blinded physicians using the Global Aesthetic Improvement Scale (GAIS). At 6-month follow-up, 75% of patients were considered to be improved, and 55% were rated as improved at 1-year follow-up. Patient satisfaction was also rated as low, medium, or high. Seventy percent of patients reported high or medium satisfaction. Result duration was also rated at less than or greater than 6 months, with 55% achieving results lasting over 6 months. Only transient adverse events were reported, although there was 1 incidence of postprocedural infection (Table 2).
Thread-lifting is one of many minimally invasive rejuvenation procedures that have been growing in popularity. As interest in specific cosmetic procedures is often driven by patient demand and company marketing rather than supportive objective clinical data, it is crucial for health care providers to critically analyze novel materials and techniques to provide cutting-edge care that is also safe and beneficial to patients.42,43
Suture suspensions performed with nonabsorbable sutures are fraught with many drawbacks.44,45 High complication and revision rates were reported, although revisions are not necessarily an anomaly for cosmetic procedures. As importantly, it has been postulated that the transient initial improvement in outcomes may be due to local inflammation and edema rather than the thread-lift itself.9,46,47 An additional concern regarding nonabsorbable barbs is that their removal can be difficult, often leaving residual fragments that continue to be symptomatic. Finally, the long-term ramifications of SMAS scarring are uncertain.48
Although the physicians who patented Aptos threads argued that the complication rate is significantly operator-dependent, a necessary goal of the development of a successful minimally invasive technique is ease of implementation and widespread adoption. As several barbed sutures were initially FDA cleared and then withdrawn from the market due to adverse effects, it important to always exercise appropriate skepticism and caution when adopting any early techniques.
Recently, interest in thread-lifts has again increased with absorbable threads. Numerous studies have been published demonstrating positive outcomes and rare complications using PDO thread, which is degraded in the body approximately within 4 to 6 months. PDO and PLLA are known to be collagen stimulants and are postulated to stimulate a long-term benefit in rejuvenation.15,38 However, the published studies have had short follow-up times and have yet to provide much objective data regarding long-term benefit, although Kim and colleagues35 did use 3D scanners and ultrasonography to evaluate skin thickness and lifting. As with nonabsorbable sutures, it has also been argued that short-term improvement observed may be the result of local edema and inflammation rather than structural change, particularly as laboratory studies investigating the long-term persistence of increased fibrous tissue after suture placement have not been conclusive.1,9,24,45,48–50
The overall evidence regarding thread-lifts is weak. Studies have had short follow-up periods and no standardized protocol, with most studies following subjects for less than a year and no studies with longer than a 3-year follow-up. Many studies also investigated outcomes of thread-lifts in combination with other rejuvenation procedures without a control group. In regards to outcomes, few studies reported objective procedural outcomes or used widely accepted patient-reported outcome measures. Although subjects reported high satisfaction rates with thread-lifting, more granular data using psychometrically validated outcome measures (e.g., the FACE-Q) could help physicians better evaluate and tailor future iterations of devices for maximum subject satisfaction.51
There will likely remain a role of thread-lifting in facial rejuvenation as technology continues to improve. Suture suspensions with barbed threads can be a very effective technique in the appropriate patient. New suture materials promoting collagen growth and better understanding of the vectors of aging will likely lead to additional improvements in efficacy. Thread-lifting may also be a helpful tool for other cosmetic concerns, such as acne scarring. A recent study by Oh and colleagues52 found elastic threads to be effective in the treatment of gluteal ptosis,52 and there has been recent growing interest in using PLLA sutures for thread-lifting, although current evidence is lacking. Although there exist several barbed PDO sutures on the market, they are only cleared by the FDA for soft-tissue approximation, versus the Silhouette Instalift PLLA/PLGA sutures, which are cleared for midface suspension. A recently completed clinical trial investigated the use of 3-0 V-Loc 180 barbed sutures (Surgical Devices; Tycho Healthcare Group LP, New Haven, CT), composed of an absorbable copolymer of glycolic acid and trimethylene carbonate, in anchoring retaining ligaments to the temporal fascia as a different approach to the thread-lift.53
At this point, it is prudent for physicians to fully inform patients of the limited supportive evidence for thread-lifts, realistic expectations of outcomes, and potential adverse events. Although the future of nonabsorbable thread-lifting seems promising, dermatologists must take caution and learn from the authors' experience with previously marketed but subsequently failed cosmetic interventions before widely adopting novel techniques.
Thread-lifting has been a commonly practiced aesthetic procedure for facial rejuvenation over the past few decades, although protocols vary widely. Robust data do not currently exist for thread-lifting outcomes, although smaller scale studies have been published and indicate promise. Although initial methods using nonabsorbable suture possessed a frequent complication and revision rate, newer published methods using absorbable sutures have shown positive preliminary data regarding safety and efficacy. Further multicenter studies with standardized protocols, including suture type and number of sutures, larger sample sizes, extended follow-up times, and outcome measures are needed to better evaluate efficacy, safety, and optimal treatment regimens.
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24. Beer K. Delayed complications from thread-lifting: report of a case, discussion of treatment options, and consideration of implications for future technology. Dermatol Surg 2008;34:1120–3; discussion 1123.
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43. Teitelbaum S. Enthusiasm versus data: how does an aesthetic procedure become “hot”? Aesthet Surg J 2006;26:51–3.
44. Yoo KH, Kim WS, Hong CK, Kim BJ. Chronic inflammatory reaction after thread lifting: delayed unusual complication of nonabsorbable thread. Dermatol Surg 2015;41:510–3.
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46. Jang HJ, Lee WS, Hwang K, Park JH, et al. Effect of cog threads under rat skin. Dermatol Surg 2005;31:1639–44; discussion 1644.
47. Van Winkle W Jr, Hastings JC, Barker E, Hines D, et al. Effect of suture materials on healing skin wounds. Surg Gynecol Obstet 1975;140:7–12.
48. Stark GB, Bannasch H. The “golden thread lift”: radiologic findings. Aesthetic Plast Surg 2007;31:206–8.
49. Jeong S, Ma YR, Park YG. Histopathological study of frontalis suspension materials. Jpn J Ophthalmol 2000;44:171–4.
50. Kirsch WM, Zhu YH, Steckel R, Concepcion W, et al. In vivo remodeling of surgically constructed vascular anastomoses: nonpenetrating, arcuate-legged clips versus standard suture. Ann N Y Acad Sci 2002;961:284–7.
51. Pusic AL, Klassen AF, Scott AM, Cano SJ. Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients. Clin Plast Surg 2013;40:249–60.
© 2019 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
52. Oh CH, Jang SB, Kang CM, Shim JS. Buttock lifting using elastic thread (elasticum((R))) with a new classification of gluteal ptosis. Aesthetic Plast Surg 2018;42:1050–8.