This is an informed consent document that has been prepared to help inform you concerning PDO Thread Lift Procedure, its risks, and alternative treatments. It is important that you read this information carefully and completely.
INDICATIONS OF USE:
ON or OFF LABEL USE only concerns marketing & promotional material for a product. Physicians are free to use any medical device for any purpose, even a use that the FDA has not approved. PDO threads are to be used in soft tissue approximation where the use of absorbable sutures is appropriate.
Alternative forms of non-surgical and surgical management consist of facelift, Nd:YAG Laser, full-face CO2 Laser, dermal fillers, or chemical peels. Risks and potential complications are associated with alternative forms of treatment. Every procedure involves a certain amount of risk, and it is important that you understand the risks involved. An individual's choice to undergo a procedure is based on the comparison of the risk to the potential benefit. Although the majority of patients do not experience these complications, you should discuss each of them with your practitioner to make sure you understand the risks, potential complications, and consequences.