Safety information

Safety information/IFU

Important safety information for the Molderm® range of fillers and bio-stimulating products.

  • Do not use if known allergy or hypersensitivity to hyaluronic acid fillers.
  • Do not use if you have porphyria, bleeding disorder, and/or active skin disease such as inflammation, infection, or tumors, in or near the intended injection site, or if you are taking thrombolytics or anticoagulants.
  • There are several precautions that are important to discuss with your healthcare professional prior to treatment. Inform your healthcare professional if any of the following apply:
    • You have pre-existing pigmented dark lower eyelid circles, thin skin and pre-existing tendency toward edema formation as treatment of the lower periorbital region may not be suitable.
    • You are taking immunosuppressants as treatment may not be suitable.
    • You have a tendency to form hypertrophic scars or any other healing disorder.
    • You have herpes viral infection as injection procedures can lead to reactivation of latent or subclinical herpes viral infections.
    • You are using substances that affect platelet function, such as aspirin and nonsteroidal anti-inflammatory drugs. As with any injection procedure, using these medications may increase your risk of bruising or bleeding at the injection site.
    • A laser treatment, chemical peel, or any other procedure based on active dermal response is performed before or after the treatment. There is a possible risk of eliciting an inflammatory reaction at the implant site.
  • Rare but serious adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage, leading to stroke, skin necrosis, and damage to underlying facial structures.
  • Injection-related adverse events such as bruising, erythema, itching, swelling, pain, and tenderness may occur. These side effects generally resolve spontaneously within one week after injection. Other potential side effects can occur with dermal filler injections. You should discuss the potential treatment risks with your healthcare professional.
  • After the treatment, exposure of the treated area to heat (sunbathing, sauna, steam baths, etc.) or extreme cold should be avoided until any signs of local inflammation have disappeared.
  • Discuss all potential risks with your healthcare professional prior to treatment.

This is only a partial list of safety information. For complete product and safety information, select the product below.

HA DERMAL FILLERS

BIO-STIMULATION

WORLD WIDE DISTRIBUTION

Molderm® is distributed via and ONLY by an exclusive distribution network to ensure the same quality and identity, shared values and concept, no matter where you are located. You only have the opportunity to order your Molderm® products from the distributor who is responsible for the territory you are located in.