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Dermal Fillers (HA, CaHa, PMMA, Collagen) English Consent Form

INTENDED USE / INDICATIONS

Bellafill is indicated for the correction of nasolabial folds and moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.

Bellafill®

Bellafill is an FDA-approved dermal filler made of sterile polymethylmethacrylate (PMMA) microspheres in a purified bovine collagen gel carrier.

How Bellafill Works

Bellafill is a dual-acting injectable dermal filler that provides both immediate and long-lasting correction by stimulating the patient’s own collagen. When Bellafill is injected, the PMMA microspheres and collagen gel carrier provide immediate correction. Over time, the collagen gel carrier dissipates and the PMMA microspheres provide a “scaffold” that supports natural collagen production.

Most patients can expect to maintain the level of correction they see early after treatment. However, every patient is unique and it is recommended to begin with a conservative amount of Bellafill and continue with touch-up treatments as needed to achieve optimal results. Optimal correction may take several syringes and/or treatment sessions. Discussion of number of syringes and treatment sessions that will be required, along with associated costs related to treatment(s), should take place prior to any treatment.

Skin Test

Four weeks before your first treatment, you will receive a “Bellafill Skin Test” to confirm that you are not sensitive to the bovine collagen contained in Bellafill. During this skin test, a very small amount of bovine collagen (0.1 cc) will be injected under the skin of your forearm. You should observe the skin test site daily during the 4-week test period and notify your provider immediately if any effects indicative of a positive or equivocal response are observed or if systemic effects are experienced.

A positive response consists of redness of any degree, induration, tenderness, and swelling, with or without itching. An equivocal response is one in which there is no localized skin reaction, but the patient does elicit a possible systemic reaction such as a rash, aching joints, or aching muscles that occurs at any time during the 4-week observation period.

Bellafill Skin Test results will be reviewed by your provider after the 4-week observation period. If it is negative, you may then receive Bellafill treatment.

Procedure Description

Prior to Bellafill treatment, local anesthetic may be administered for pain control. Bellafill also contains lidocaine to minimize treatment discomfort. Then, one or more injections of Bellafill will be placed under the surface of the skin. Your provider may gently massage the skin immediately after injection and may place ice or cooling packs over injection points.

As stated above, additional touch-up injections at intervals of at least 2 weeks may be required to achieve the desired correction. The interval at which touch-up injections are needed depends on the nature of the defect, the amount of Bellafill injected, the site of placement, and the dynamics at the corrected sites.

CONTRAINDICATIONS

  • Bellafill is contraindicated for patients displaying a positive response to the required Bellafill Skin Test. Refer to the Bellafill Skin Test Instructions for Use for complete instructions for administration and evaluation of the Skin Test.
  • Bellafill is contraindicated for patients with severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies.
  • Bellafill contains lidocaine and is contraindicated for patients with known lidocaine hypersensitivity.
  • Bellafill contains bovine collagen and is contraindicated for patients with a history of allergies to any bovine collagen products, including but not limited to injectable collagen, collagen implants, hemostatic sponges, and collagen-based sutures, because these patients are likely to have hypersensitivity to the bovine collagen in Bellafill.
  • Bellafill is contraindicated for patients undergoing or planning to undergo desensitization injections to meat products, as these injections can contain bovine collagen.
  • Bellafill is contraindicated for patients with bleeding disorders.
  • Bellafill is contraindicated for use in lip augmentation and injection into the vermilion or the wet mucosa of the lip.
  • Bellafill should not be used in patients with known susceptibility to keloid formation or hypertrophic scarring.

WARNINGS

  • The safety of Bellafill when used within 6 months of collagen, botulinum toxin, or other wrinkle therapies has not been studied.
  • A Bellafill Skin Test must be administered and evaluated prior to injection of Bellafill. Patients demonstrating a positive Skin Test or 2 equivocal Skin Tests should not be considered candidates for treatment. Patients demonstrating an anti-bovine collagen serum IgG level outside of the normal range at baseline also should not be considered candidates for treatment. A negative Skin Test does not preclude the possibility of the patient subsequently developing a delayed hypersensitivity response to Bellafill following treatment exposure. Refer to the Bellafill Skin Test Instructions for Use for complete instructions for administration and evaluation of the Skin Test.
  • Use of Bellafill at specific sites in which an active inflammatory process (skin eruptions such as cysts, pimples rashes, or hives) or infection is present should be deferred until the inflammatory process has been controlled.
  • Introduction of product into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. 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. Immediately stop the injection if a patient exhibits any of the following symptoms, including changes in vision, signs of a stroke, blanching of the skin, or unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and possibly evaluation by an appropriate health care practitioner specialist should an intravascular injection occur.
  • Bellafill is not indicated for use in the periocular area (e.g. tear trough), as the effects of injection in this location have not been studied. The following adverse events including, but not limited to, lumps, swelling, granulomas and vision loss due to vascular occlusion have been reported in the postmarket surveillance data with off-label injection in the periocular area.

PRECAUTIONS

  • Bellafill contains non-absorbable PMMA microspheres. Implantation is permanent and will not be reversed without physical removal.
  • The safety of Bellafill for use during pregnancy and in breastfeeding females has not been established.
  • Bellafill is packaged in a sealed tray containing individual treatment syringes with sterile needles for single patient use, packaged in a box. The tip of the syringe is sealed with a Winged cap. Do not use if the seal on the tray lid or syringe is broken or removed. Do not re-sterilize.
  • The safety of injecting greater amounts than 3.5 cc per treatment site or 8.9 cc overall has not been established.
  • The safety and effectiveness of Bellafill for the treatment of non-distensible atrophic acne scars has not been established. The use of Bellafill for ice pick or sinus tract scars has not been studied.
  • The safety and effectiveness of Bellafill for nasolabial fold wrinkles and cheek acne scars have not been established in patients under the age of 21 years. There is limited information on the safety of Bellafill in patients less than 36 years of age. In the pivotal Acne Scar Study of Bellafill, the incidence of injection site reactions in subjects less than 36 years old (30 subjects) was similar to the incidence in subjects above the age of 36 (113 subjects). The majority of these injection site reactions were mild in severity.
  • The safety in patients with known susceptibility to hyperpigmentation, keloid formation, and hypertrophic scarring has not been studied. Formation of hyperpigmentation, keloids, or hypertrophic scars may occur after dermal filler injections including Bellafill. In the pivotal Acne Scar Study of Bellafill, the incidence and severity of adverse events in 34 subjects with Fitzpatrick Skin Types V and VI was similar to that reported in 109 patients with Fitzpatrick Skin types I-IV and no unique adverse events associated with these patient subgroups were observed.
  • As with all transcutaneous procedures, Bellafill injection carries a risk of infection. The usual precautions associated with injectable materials should be followed.
  • The safety of Bellafill in patients on immunosuppressive therapy or with connective tissue disorders has not been established, however these patients may have an increased susceptibility or hypersensitivity response and/or accelerated clearance of Bellafill. Therefore, caution should be used when treating these patients, including consideration for further skin testing.
  • Bruising or bleeding may occur at Bellafill injection sites. Use of Bellafill in patients who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation within 3 weeks preceding treatment has not been studied.
  • Patients should minimize exposure of the treated area to excessive sun, UV-lamp exposure, and extreme cold weather at least until any initial swelling and redness has resolved.
  • If laser treatment, chemical peeling, or any other procedure based on active dermal response is considered after treatment with Bellafill, there is a possible risk of eliciting an inflammatory reaction at the injection site. This also applies if Bellafill is administered before the skin has healed completely after such a procedure.
  • The use of Bellafill in anatomical spaces other than the dermis for correction of nasolabial folds and for acne scars on the cheek has not been studied. Refer to the Clinical Studies section in the Bellafill Instructions for Use for more information on injection sites that have been studied.
  • The use of Bellafill in patients with thin or flaccid skin has not been studied and the cosmetic results for these patients are unknown.
  • Long-term safety and effectiveness of Bellafill beyond five years has not been established.
  • In order to minimize the risks of potential complications, this product should only be used by health care practitioners who have appropriate training, experience, and who are knowledgeable about the anatomy at and around the site of injection.
  • Health care practitioners are encouraged to discuss all potential risks of soft tissue injection with their patients prior to treatment and ensure that patients are aware of signs and symptoms of potential complications.
  • 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.
  • Bellafill has an opaque, off-white appearance. In the event that the content of a syringe shows signs of separation and/or appears clear (like water), do not use the syringe and notify Suneva Medical immediately. In the US or Canada, call 844-235-5234. Outside of the US or Canada, call +1-858-550-9999.
  • Bellafill should not be mixed with other products before injection.
  • Bellafill was formerly known as ArteFill®.

POTENTIAL SIDE EFFECTS

Possible complications of Bellafill treatment include redness, swelling, bruising, pain, itching, lumps/bumps, tenderness, discoloration, sensitivity, infection, fatigue, and muscle aches. Please see below for more information regarding the adverse events that were observed in Bellafill clinical trials.

Nasolabial Fold Clinical Trial:

Adverse events, including those attributed and not attributed to treatment, reported in Bellafill subjects at an incidence of 1% or greater were: lumpiness at injection area more than 1 month after injection (4.6%), persistent swelling or redness (3.5%), increased sensitivity (1.8%), rash/itching more than 48 hours after injection (1.4%).

No systemic adverse events were reported at an incidence of 1% or greater. One severe adverse event (granuloma or enlargement where Bellafill was injected) and 14 moderate adverse events (persistent swelling or redness, lumpiness at injection site more than 1 month after injection, blurred vision, flu-like symptoms, abscess, granuloma or enlargement where Bellafill was injected, alopecia areata) were reported for Bellafill subjects. Nine severe adverse events (lumpiness at injection site more than 1 month after injection, abscess, infection, granuloma or enlargement of the implant, sensitization reactions, increased sensitivity, persistent swelling or redness), and 12 moderate adverse events (persistent swelling or redness, rash, itching more than 48 hours after injection, sensitization reactions, lumpiness at injection site more than 1 month after injection, visibility of the puncture area, abscess) were reported for Control subjects.

Local adverse events reported in Bellafill subjects at an incidence of less than 1% in US studies, whether or not they were determined to be related to Bellafill, were sensitization reactions, abscess, visibility of the puncture area, blurred vision, flu-like symptoms, recurrence of existing herpes labialis, granuloma or enlargement where Bellafill was injected, acneiform lesions, occasional tenderness, redness and visible capillaries, alopecia areata, and dry skin. Systemic adverse events reported at an incidence of less than 1% were mild chest congestion and fainting. One subject was diagnosed with breast cancer, determined by the investigator not to be related to Bellafill.

For Control subjects, local adverse events reported at an incidence of less than 1%, whether or not they were determined to be related to Control treatment, were increased sensitivity, flu-like symptoms, granuloma or enlargement where Control treatment was injected, infection, and acneiform reaction. One subject died of trauma unrelated to Control treatment.

Acne Scar Clinical Trial:

Physician-diagnosed adverse events, including those attributed and not attributed to treatment, reported in Bellafill subjects at an incidence of 1% or greater were: injection site reactions (4.2%), tenderness (3.5%), nasopharyngitis (2.8%), injection site bruising (2.1%), injection site pain (2.1%), swelling (2.1%), arthralgia (1.4%), back pain (1.4%), contact dermatitis (1.4%), fatigue (1.4%), flu-like illness (1.4%), rash (1.4%), sinusitis (1.4%).

Five serious adverse events were noted during the study: cholecystitis, lower-back nerve impingement, recurrence of breast cancer, West Nilemeningitis, and exacerbation of depression. None were deemed related to study treatment. There were no deaths during the study.

Adverse events of special interest were followed separately for the study. These included hyper- and hypopigmentation, hypertrophic scarring or keloid formation, and the appearance of granulomas. None of these adverse events were reported.

POST-CARE RECOMMENDATIONS

IMPORTANT: Please also review the product label in consultation with your treating physician.

 

Additional Considerations for Patient Consent to Treatment

Any potential complications related to dermal filler injections:

  • Bruising
  • Vascular compromise
  • Infection
  • Concomitant procedures and dermal fillers

Guarantees

  • Setting realistic expectations 
  • Expected outcomes and potential need for multiple treatments

Before and After Photos Consent

Refund/Payment Consent

Other

CONSENT TO TREATMENT

I have carefully read and understand this consent in its entirety, and I have discussed the benefits and risks of treatment with my physician or his or her representative.

It is important that you read the above information carefully and have all of your questions answered before signing.

 I consent to treatment and understand that there are potential risks to this treatment and that there are alternatives to this treatment.  I also understand that this consent is valid for future treatments unless the policies of the office or the known risks for the product change. By signing this form, I acknowledge that guarantees as to the final results of my treatment have not been made. Additionally, I agree to have my photos taken to be used for documentation purposes.

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