FDA to Crackdown on Non-FDA Cleared PDO Threads

Emphasis and Focus are Users who Administer PDO Threads to Patients

The FDA has recently announced that it will start to crackdown on the illegal importation and the administration by healthcare professionals of non-FDA Cleared devices including PDO Threads. A spokesman for the agency further commented that “it will be increasingly difficult to stop the various channels that people can acquire these non-FDA Cleared devices so the emphasis will be on the physician or healthcare professional administering these unapproved devices”. In essence, the FDA cannot regulate third party resellers (i.e., Amazon, Alibaba) and internet stores from bringing in non-FDA PDO Threads so the FDA will pursue the persons administering these procedures instead.

Cosmetic threads are medical sutures that are commonly used in cosmetic surgeries which are placed directly into the skin with the help of a needle to lift and rejuvenate skin. The contouring threads market categorizes its threads by barb threads, smooth threads, screw threads or cone threads. Threads can be made of different fabric types such as polypropylene threads, polydioxanone (PDO) threads, polylactic acid (PLA) threads or caprolactone threads. Thread sutures are used to accomplish many body contouring treatments like a breast lift, skin rejuvenation, ptosis, and others. Contour threads are used in cosmetic/plastic surgery to vertically lift facial tissues that have drooped or sunken with age. The "ptosis" or descent of facial tissues with aging is a universal phenomenon to which cosmetic facial surgery is directed. Areas where facial skin laxity are attached and elevated onto the barbed threads and stays elevated because of the barbs within the thread and later due to collagen remodeling allowing the skin to stay elevated. The result is patient gets a "facelift", without any scalpel work and without any removal of skin. Because the thread procedure is minimally invasive and maintaining effectiveness of the cosmetic threads is key, patients are asked to do repetitive procedures to sustain a particular look.

Cosmetic thread-based cosmetic surgeries are extremely popular among adults between ages 30-55. Initially cosmetic thread procedures were not widespread among cosmetic surgeons and healthcare professionals because of lack of marketing for the threads and unawareness of benefits of the threads. As time goes on, many medical practitioners are seeing the plethora of advantages that contouring threads bring. Due to the rising fashion industry and its influence on cosmetic surgery, the cosmetic threads market has doubled over recent years. The growth of the cosmetic threads market vastly depends on the adaption rate of the treatments by healthcare professionals. This can be a slow process because the goal of healthcare professionals is to protect well-being of the patients first. It can take time for professionals to get accustomed to new methods of practice before feeling comfortable to perform on a patient. Another factor that will determine the growth of this market is cost effectiveness of the thread procedures. Treatment affordability will in most cases determine if a market is allowed to flourish or not since the prices determine the size of market that is being broadcasted to. The fact that cosmetic threads are minimally invasive compared to Botox or dermal fillers and is extremely safe is a huge selling point. The advantages of a thread lift treatment will most certainly guarantee the market of cosmetic threads will continue to grow.

Penalties for using non-FDA Cleared Devices may include warnings, surrender of present products, penalties, and possible oversight by State Medical Boards which can be harsh in certain states. The other issue facing practitioners is the possible issue of non-coverage by malpractice insurance companies for the use of non-FDA medical devices especially when these devices are implanted within the patients. This is why Illari Threads, LLC offers the training for both new and existing PDO Thread users where we present the standard-of-care, latest accepted protocols, and compliance issues in comparison within other competitors or weekend seminar companies who use mid-levels for their training.