Empower Forma V, V-Tone and M8V FAQ

WHAT IS FORMA V?

FormaV provides non-invasive, gentle RF heating for internal and external contraction. Temperature regulated and uniform RF heating is applied for gentle thermal muscle stimulation, relaxation and blood circulation.

WHAT IS V-TONE?

vTone applicator provides electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress urge and mixed urinary incontinence in women.

WHAT IS M8V (MORPHEUS 8 V)

Morpheus8V applicator is a fractional device with programmable needle penetration depth and energy delivery. RF energy is delivered through arrays of needle electrodes providing deep tissue remodeling. Simultaneously, directional RF energy generates bulk sub-necrotic heat in the treated area.

WHAT IS THE PRETTY PINK TULIP?

It is a new, safe, and effective solution for delivering life-changing technologies for womens’ wellness utilizing a combination of Forma V and M8V or V-Tone and Forma V. This innovative treatment is designed specifically to treat a broad range of conditions such as stress, urge, and mixed urinary incontinence, weak pelvic floor muscles, blood circulation, and pain relief.

WHAT IS THE DOWNTIME?

Depending on the intensity of the treatment, there is little to no downtime. Most patients may have slight discomfort during and immediately after treatment. Some patients will experience no discomfort at all.

WHAT ARE CONTRAINDICATIONS FOR TREATMENT?

  • Active electrical implant/device in any region of the body, including pacemaker or internaldefibrillator
  • Permanent implant in the treated area such as metal plates, screws or silicon, metalpiercing or other.
  • Vaginal or pelvic surgery within the past 12 months.
  • Current or history ofskin cancer and genital area cancer, or current condition of any othertype of cancer, or pre-malignant moles.
  • Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy,uncontrolled hypertension, and liver or kidney diseases.
  • History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragileskin.
  • History of bleeding coagulopathies or use of anticoagulants except for low-dose aspirin.
  • Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex inthe treatment area, may be treated only following a prophylactic regimen.
  • Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or useof immunosuppressive medications.
  • Pregnancy and nursing
  • Poorly controlled endocrine disorders, such as Diabetes, or thyroid dysfunction andhormonal virilization.
  • Isotretinoin (Accutane) within last 6 months.
  • Any active condition in the treatment area, such as sores, Psoriasis, eczema, and rash, openlacerations,abrasions or lesions, infection in the area to be treated, current urinary tractinfection or pelvic infection, uterine prolapse, cystocele, rectocele.
  • Any surgical procedure in the treatment area within the last 12 months or before completehealing.
  • Having received treatment with light, laser, RF, or other devices in the treated area within 2-3 weeks for non-ablative procedures, and 6-12 weeks for ablative fractional laser resurfacing (according to treatment severity) prior to treatment, except special recommendations.
  • Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen-containing agents) one week before and after each treatment session, as per the practitioner’s discretion.
  • As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

WHAT ARE THE POSSIBLE SIDE EFFECTS?

  • Although these side effects are rare and temporary, they should be reported immediately to a physician for proper treatment. These are the side effects that may appear in the treatment area:
  • Pain
  • Excessive skin redness (erythema)
  • Damage to natural skin texture (crust, blister, burn)
  • Change of pigmentation (hypo-or hyper-pigmentation)
  • Bruising
  • Vaginal discharge during or after treatment (extreme vaginal atrophy)\
  • Infection When using Tone applicator minor, short term muscle spasm/pain may occur

HOW TO PREPARE FOR TREATMENT?

Hair should be shaved - not waxed or chemically removed - in the treatment area 2-4 days prior to treatment.
Remove any jewelry in the treatment area.
Empty the bladder before the procedure.

HOW MANY SESSIONS ARE REQUIRED?

Your service provider will determine the best treatment plan for you. The majority of patients have 2 - 3 sessions; however, most notice a difference after only 1 treatment. The number of sessions depends on your treatment concerns, your personal goals, and if you plan to us e a combination treatment or a single treatment approach.

WHAT IS POST-TREATMENT?

  • Apply emollient cream or healing ointment to the Morpheus8V external treatment area.Vaniply, Vaseline, antibiotic ointment or Aquaphor may be used.
  • Use the restroom to urinate immediately after treatment.
  • Antibiotics may be prescribed if infection is suspected. Patient is to contact the physician if there is any indication of infection, excessive swelling, redness, undue pain, or any other unusual symptom.
  • Tiny scabs may appear after 1-3 days and stay for several days following the treatment.The scabs should not be touched or scratched even if they itch and should be allowed to flake off naturally.
  • Blisters may be treated with a prescribed antibiotic ointment or burn treatment cream as per physician’s discretion.
  • During the first 2 days following FormaV/vTone treatment, any mechanical or thermal damage to the area must be avoided.
  • During the first 2-7 days followingMorpheus8V treatment, any mechanical or thermal damage to the area must be avoided.
  • In case of vaginal discharge, a panty liner may be worn for the first day after treatment.

IS EMPOWER FDA CLEARED? WHAT IS IT CLEARED FOR?

Yes. EmPower is a safe and effective treatment for feminine health. EmPower is beneficial for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel exercises (tightening of the muscles of the pelvic floor to increase muscle tone)

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