Are there Contraindications I should know about?

Prodefine Retouch must not be used:

1. For injections in the periorbital zone (eyelids, under eye bags); for injections in blood vessels; for augmentations of the mammary tissue or for bone, tendon, ligament or muscle implants.
2. Must not be administered to patients with previous or current autoimmune diseases or being treated with immunotherapeutic drugs; proven tendency to form hypertrophic scars or keloids or pigmentation disorders; multiple serious allergies; infections and inflammatory processes in situ or near the area being treated; coagulation disorders; recognised hypersensitivity to hyaluronic acid.
3. Must not be used by women who are pregnant, nursing or on people under the age of 18.

What are the Warnings I Should Understand About?

In performing the injection procedure, there is a potential risk that the material gets inadvertently injected into the blood vessels. In rare cases, this could cause vascular occlusion, abscess, necrosis or embolic phenomena. To ensure that the needle is not inside a blood vessel during normal use of the medical device, lightly aspirate with the syringe before proceeding with the injection. PRODEFINE Retouch was packaged to be used on one patient only and within the same session. Do not re-use. Do not use PRODEFINE Retouch in combination with other injectable products or mix it with other preparations before use. Do not use PRODEFINE Retouch when the skin shows redness, swelling or changes in pigmentation; do not use PRODEFINE Retouch with inflammation, infection or fever in progress. Patients taking medications to slow blood clotting may present with bruising or significant bleeding at the injection site. Patients taking anticoagulant medication should stop taking it, in agreement with their doctor, at least 14 days before getting PRODEFINE Retouch injections.

What Precautions Should My Doctor Advise Me?

Only use Prodefine Retouch in compliance with the instructions for use. Do not use on patients with ongoing infections or inflammatory processes near or at the injection site. It is recommended not to use Prodefine Retouch in areas where other implants have been performed and not to use it at the same time as any other injectable product.

What Possible Adverse Reactions Should I be Made Aware of?

Following the use of Prodefine Retouch, some injection-related adverse reactions may occur, which include pain, itching, altered pigmentation and tissue density in the area of the injection site and which normally resolve spontaneously within a week. Sometimes small oedemas may appear, which reabsorb in few days. Adverse reactions related to the use of the product, in consideration of the bibliographic studies of the existing literature and the scientific knowledge of the producer at the date of issue of this leaflet, can include inflammatory reactions, itching, pain to the touch after injection lasting up to a week at most; bleeding or hematoma in rare cases; follicular papules-pustules that may form up to 4 weeks after treatment, allergic reactions to hyaluronic acid; hardening or appearance of nodules at the injection sites; in very rare cases, granulomas or significant inflammatory reactions, wheals, necrosis, urticaria, which can appear even after several months.

In extremely rare cases, injection-related adverse events may occur, such as bacterial infection, abscess formation, tissue necrosis, or even blindness, in case the product is accidentally injected into a blood vessel.

If any unusual symptoms occur after the injection, such as severe pain, unusual swelling, redness, or tenderness at the injection site, or any other symptoms that concern you, you should contact your doctor immediately.

It is essential to report any adverse reactions or side effects associated with the use of Prodefine Retouch to your doctor or directly to AQ Skin Solutions. For full safety information, please refer to the package insert or leaflet, or visit AQProdefine.com.

Regulations and usage circumstances for the product vary from market to market and the content on this page is not intended for US audiences. You should not use this information to treat a health problem or diagnose a disease without consulting with a qualified healthcare provider. This website is designed for informational purpose only.