PowerFill

PowerFill is a filler developed in the laboratory of Regen Biotech Inc. in South Korea and is certified by international associations. The main component of PowerFill is Polylactic acid (PLA), which is commonly used in the medical industry. This filler is used to fill soft tissue deficiencies, increase volume, and correct the shape of certain body parts. The effects of the treatment can last for up to 5 years. Once the filler has dissolved, which occurs within 1.5-2 years, the effects continue due to the formation of a strong collagen matrix.

PowerFill is a highly efficient and long-lasting filler that is composed of Polylactic acid (PLA). The product is made of hypoallergenic and biodegradable materials, and it is primarily used for increasing volume and correcting the shape of body and intimate zones.

Application Areas

:

• Buttock

• Male genital

Main Ingredients:

PDLLA (Poly-D,L-Lactide Acid)

– Make sure and check whether the product package is damaged or broken.

– Check any deformation in the outside of the product or foreign materials attached to this product.

– Before use this product, doctors should fully understand this instruction guide.

– All the suspension procedures of this product should be done under the aseptic condition in the environment free from microorganism contamination.

1. After remove the cap of the vial, wipe its rubber stopper with an antiseptic. When the aluminum cap or rubber stopper of the vial is damaged, do not use.

2. Connect an 18 G sterile needle to a 10 milliliter(ml) sterile, single-use syringe. After drawing sterile Water For Injection(WFI) into the 10 ml syringe, slowly add all the sterile WFI into the vial (8ml for PowerFill-V1000).

3. After fully shaking the vial till the sterile WFI is mixed well with PowerFill, leave the reconstituted solution in the vial for about 30 minutes.

4. The reconstituted solution must be immediately used.

After reconstitution, any non-used or remaining reconstituted solution must be discarded.

5. Just before treatment to patients, shake the reconstituted solution for better suspension.

6. At the time of treatment to patients, wipe the rubber stopper of the vial with antiseptic, use a 17 G sterile needle by connecting it to a 10 ml disposable sterile syringe, and withdraw 10 ml suspension from the vial.

7. At the time of treatment to patients, use a 17 G sterile cannula needle or an 18 G sterile needle on a case-by-case treatment purpose.

1. Before injecting this product to patients, explain precisely to the patients about the indications and cautions to use the product (for example, prohibitions, warnings, general notice, possible side effects or adverse events), and injection methods.

2. Before treatment with this product, for sterilization and anesthesia, sterilize the penile area with Potadine solution, cover the sterilized area with a surgical drape with hole and make the penis to be exposed, and inject an adequate amount of one percent lidocaine around the penopubic junction of the penis.

3. There is no particular standardized treatment method with this product. It is important to have enough conversation between the doctor and the patient in order to shape a penis that the patient wants.

4. The treatment technique with this product may vary depending on doctors. By slightly pulling the penis forwards, inject the reconstituted solution to be spread thinly and evenly if possible, and try to keep balance overall.

5. The order or procedure of injecting sites may vary depending on doctors. If possible, inject around the penopubic junction toward the sulcus coronalis of the penis between Dartos fascia and Buck’s fascia, and make a shape while injection.

6. After injection of this product, the final molding is very important in order to enhance the degree of completion in the outer appearance.

7. During the treatment, the injection into the corpus cavernosum and blood vessel must be prohibited. Be careful not to put pressure on the area of urethra.

8. At the time of treatment to patients, use a 17 G sterile cannula needle or an 18 G sterile needle on a case-by-case treatment purpose.

9. At the time of treatment to patients, the appropriate solution amount for treatment may vary depending on what kinds of shapes the patient wants. For a shape of silicone ring, it is enough to inject 10 cc. For overall enlargement of the penis, it needs 20 cc to 30 cc. However, at the first stage of injection, in order to prevent or reduce any possible side effects due to over-injection, it is better not to inject over 20 cc at the first trial.

10. The additional injection of this product can be done after about one month from the last treatment.

11. The treatment of this product is the injection of the diluted solution.

Thus, before treatment, notify the patients that physiological erection and pressure may cause some irregular shape in the outer appearance of penis, and that sometimes unbalanced cases in the penis may occur.

12. After treatment, fix the treated area with compression bandage (Coban) for about five days.

13. After treatment, the doctor prescribes an oral medication for three days including an antibiotic and analgesic.

14. The patient can take a shower after three days from treatment. Sexual intercourse may be possible after three weeks from treatment although some discomfort might be accompanied at the beginning.