Evolence was withdrawn from the U.S. market in November of 2009.

The U.S. Food and Drug Administration approved Evolence, a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds, in June of 2008.

Patients with known hypersensitivity to any collagen products or planning to undergo desensitization injections to porcine products should not use Evolence, as these injections can contain porcine collagen.

Evolence is injected into the mid-to-deep dermis. The most common side effects of Evolence injections are usually injection-site related and include mild swelling, redness, and pain. Other rare side effects include the development of small areas of firmness under the skin at the treated sites that may be noticed when the areas are pressed upon.

What is Evolence?

Evolence was withdrawn from the U.S. market in November of 2009.

Evolence collagen filler is a porcine collagen gel implant composed of 3.5% (35 mg/mL) homogenous Type I collagen that was extracted and purified from porcine tendons and suspended in phosphate-buffered saline (PBS) and which has been cross-linked with ribose-mediated technology. Evolence collagen is cross-linked through its patented Glymatrix Technology using the natural sugar, D-Ribose.

Evolence is supplied as a single-use, prefilled syringe.

Contraindictions:

Evolence was withdrawn from the U.S. market in November of 2009.

Evolence Collagen Filler is contraindicated in the following:

• Patients with known hypersensitivity to any collagen products or planning to undergo desensitization injections to porcine products, as these injections can contain porcine collagen.

• Patients with a history of anaphylactic reactions or history or presence of severe recurrent allergic reactions.

• Evolence Collagen Filler should not be implanted in spaces other than the dermis of the face.

• Evolence Collagen Filler should not be implanted in patients with bleeding disorders.

Evolence was withdrawn from the U.S. market in November of 2009.

• Local necrosis is a rare event, which has been observed following other collagen implantation and may occur following injections to the glabella. It is thought to result from the injury, obstruction, or compromise of blood vessels.
• Patients with a history of dietary porcine allergy should be carefully examined before porcine collagen injections, since it is possible that the collagen component of the porcine material may be causing the allergy.
• Avoid injecting Evolence into blood vessels as collagen can initiate platelet aggregation and may cause vascular occlusion and localized infarction or embolic phenomena.
• Use of Evolence at specific sites in which infections or active inflammatory reaction is present, should be deferred until the underlined process has been controlled.
• Injection site reactions (e.g., swelling, redness, tenderness, or pain) to Evolence have been observed as consisting mainly of short-term minor or moderate inflammatory symptoms starting early after treatment and with less than 7 days duration. Refer to the adverse reactions section for details.
• Delayed onset inflammatory papules have been reported following the use of dermal fillers. Inflammatory papules (solid, raised skin lesions less than 1 cm in diameter) that may occur rarely should be considered and treated as a soft tissue infection.

Precautions

Evolence was withdrawn from the U.S. market in November of 2009.

The following precautions must be observed:

• STERILE CONTENT. The prefilled syringe is intended for single patient use. Do not resterilize. Do not use if the package is opened or damaged.
• As with all transcutaneous procedures, injection of Evolence carries a risk of infection. The usual precautions associated with injectable material should be followed.
• Bruising or bleeding may occur at Evolence injection sites. Patients using substances, which may reduce coagulation, such as aspirin and nonsteroidal anti-inflammatory drugs, may experience increased bruising or bleeding at injection sites as experienced with any injection.
• The safety and effectiveness of Evolence for the treatment of anatomic regions other than facial wrinkles and nasolabial folds has not been established in controlled clinical studies.
• The safety and efficacy of Evolence for lip augmentation has not been established.
• The safety of usage in breast augmentation or injection into bone, tendon, ligament or muscle has not been established in controlled clinical studies.
• Evolence should be used with caution in patients on immunosuppressive therapy.
• The safety of Evolence in pregnant or breastfeeding females, as well as in patients under 18 years of age has not been established.
• The safety of Evolence with concomitant dermal therapies such as epilation, UV radiation, or laser, mechanical or chemical peeling procedures has not been evaluated in controlled clinical trials, therefore there are no data available on the potential for site inflammatory reaction.
• Injection of Evolence into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
• Patients should minimize exposure of the treated areas to excessive sun, UV lamp exposure and extreme hot or cold weather for the first 24-48 hours following treatment.
• Based on preclinical studies the use of Evolence in individual patients shall be limited to 10 ml over a one year period. The safety of injecting greater amounts has not been established. In clinical trials using a split face design, patients were injected with up to approximately 4 mL of Evolence in a single injection site over a one year time period.
• The safety of Evolence in patients susceptible to keloid formation, hyperpigmentation and hypertrophic scarring has not been established.
• Long term safety and effectiveness of Evolence beyond one year have not been investigated in clinical trials.
• After use, treatment syringes and needles may be potential biohazards. Handle accordingly and dispose of in accordance with accepted medical practice and applicable local, state, and federal requirements.
• Evolence should not be mixed with other products before implantation of the device.
• Evolence is a yellowish, homogenous, opaque gel. In the event that a syringe contains material exhibiting separation between solid and liquid, or change of color, do not use the syringe.