PDO Threads Patient Information

Secret Illusion Pressed PDO Threads

TGA registration number 351866 made by Hyundae Meditech Co Ltd Model numbers FML 18122G185 and FML 1870G162 Secret Illusion Threads are re-absorbable threads made from pressed polydioxanone (PDO) which has been safely used for more than 30 years in plastic surgery, gastroenterology, urology, gynaecology and ophthalmology for sutures. Not everyone wants to undergo facelift surgery and often dermal fillers are not enough to achieve the best level of facial rejuvenation as they have too much volume to be used in large quantities. Threads are now a viable alternative to lift and re-aligning sagging tissue. Thread lifting was first described by Buttkewitz, in 1956, using nylon. The procedure has been popularised since 1999 by Dr M Sulamanidze who used notched polypropylene which he called APTOS (Anti-PTOSIS) threads.  Absorbable polydioxanone (PDO) lifting threads have been developed as in Korea since 2010. Several manufacturers including Hyundae, which make Secret Illusion, are offering pressed (as opposed to cut threads) which have an advantage in being five times stronger (ie 5kg breaking strain) making breakages uncommon. The threads are priced much more economically than existing threads registered with Australian and NZ TGA making the procedure cost effective. Threads are inserted via an 18G cannula and are folded back at the end so no exit hole is made, thus eliminating dimpling and the swept back look resulting from older thread procedures. PDO is absorbable, lasting approximately 6 months in the tissues, which means potential problems such as biofilms, granuloma formation and migration are rare and only temporary as the foreign material is removed. Similarly to poly-L-lactic acid threads PDO also has a collagen stimulating function on breakdown, thus causing lifting to last for approximately 12 months. The threads are removable at any stage after insertion so any unwanted effects such as infection, dimpling, asymmetry or discomfort may be immediately rectified. As the threads are inserted via a blunt cannula the risk of arterial or nerve damage is small and also would only be temporary. The mid-face is the main area treated so initially the temple area is suffused with a local anesthetic (LA) injection containing adrenalin. It is best if the patient waits 15 minutes after this for the adrenalin to work to reduce the chance of bruising. Approximately 10% of patients may find the anaesthetic gives then an upper eyelid droop or problems closing their lower lid. This last for the maximum of 3 hours and is no cause for concern and will not prevent safe driving home. 15 minutes after LA injection the area if sterilized with a chlorhexidine antiseptic, then, with the patient lying flat, an 18G needle is used to make three small entrance holes adjacent to the ear and then threads are inserted into the mid-face. The procedure takes about 5 minutes per side to insert 2- 4 threads. The procedure is moderately uncomfortable but in sensitive patients more anaesthetic (plus or minus ‘laughing gas’) may be used. (It is possible to make the procedure totally painless with a facial nerve block but this cause drooping  for several hours so most patients prefer not too.) After the procedure the lifting effect is immediately apparent, although in some patients there may be some slight asymmetry due to an imbalanced effect of the LA. This imbalance will wear off after the maximum of 3 hours. Significant bruising (>3 days and not manageable with camouflage makeup) is uncommon except in those taking blood thinners (such as fish oils). It is normal to experience some pulling for the first 3-4 days but uncommon for this to last more than a week. Tenderness over the insertion point adjacent to the ear is also common for up to 4 days but should not require more than mild analgesia. It may be best to avoid very chewy foods for the first 2 days and avoid any dental procedures for a week. Any asymmetry after say 10 days may be managed with a further thread or a little hyaluronic acid (HA) filler (this should not be required in more than 10% of patients). The lift procedure is twice as effective as HA fillers and last twice as long. Secret Illusion PDO Thread Potential Side Effects Summary Long term >6 months Very rare as threads dissolve in the tissues and the inserting cannula is blunt Medium term <4 weeks Discomfort to a maximum of 4 weeks (<0.1%)* patients Asymmetry <1% patients (fix with further threads) Thread protrusion with local inflammation (<0.1%) (fix with excision of thread end) Thread breakage  (<0.1%) patients (fix with further threads) Infection (<0.1%) patients (may require drainage of pus/antibiotics/thread removal) Temporary nerve weakness or sensation alteration (<0.005%) Short term <1week Drooping of eyelid or face from local anaesthetic with duration of a maximum 3 hours (<10%) Tightness and moderate discomfort over the injection sites for up to 3 days (<30%) Visible tension line along thread for up to 3 days (<10%) Puckering of the skin along the thread for up to a week (<10% )  (fix by pulling on the skin in both directions at 90 o to the line of the thread) Localised mild bruising (<5%) More severe haematoma (<0.1%) Asymmetry (<2%) (fix with further threads) Insufficient tissue lifting  (<5%) (fix with further threads) What if I experience a side effect? If you have a side effect then contact your treating practitioner. If you have a side effect of more than 4 weeks contact your practitioner and Kosmedical on info@kosmedical.com.au If you have a side effect of more than 6 months then you may report this to Kosmedical and the TGA on www.tga.gov.au Contraindications There are no contraindications to treatment other than allergy to PDO material (very rare). Very thin faced patients are more likely to show thread tension lines and patients with excessive fat or lax facial  skin may have less than optimal lifting due to excess tissue.  Patients on blood thinners or with clotting disorders are more likely to bruise.  There are no contraindications to Xrays, CT, EMR scans, radio-surgical devices etc. or use of dermal fillers or botulinum toxin post treatment. Very little residual material is left in the tissue so no long term consequences are expected for this. Follow-up In the absence of complications no follow up is required although further threads may be indicated from 3-6 moths after their insertion. The benefits of treatment are expected to last at least 12 months. Conclusions Pressed PDO threads offer a safe, cost effective method of lifting of the mid-face lifting (*The term <0.1% percent means that it occurs less than in 1 of 1000 people treated)  

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                    (Version 1 30 Nov 2021)                            

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