CONGRATULATIONS ON SCHEDULING YOUR COSMETIC PROCEDURE AT ELUMA LASER AND AESTHETICS. USE THE INFORMATION BELOW TO LEARN HOW TO PREPARE FOR YOUR TREATMENT AND HOW TO MAXIMIZE YOUR EXPERIENCE AFTER YOUR PROCEDURE.  

The informed consent form for each procedure also provides important information. Please be sure to read it before signing. Ask an Eluma team member to answer your questions before scheduling your procedure.

Call Eluma with any questions or concerns regarding your treatment at 904-619-7078. After business hours select option 4 for urgent after-hours assistance. If you have an emergency call 911.

TREATMENT PURPOSE

The vaginal rejuvenation procedure is a gynecologic in-office, non-surgical treatment that uses laser energy to treat the vulva and vaginal canal. The Phoenix  medical laser delivers controlled CO2 energy to the tissue, stimulating neo-collagenesis remodeling of connective tissue to improve skin tone, texture, and appearance. The vaginal procedure utilizes the Pheonix C02 device which treats the external and internal gential tissue using a hygienic, single-use hand piece, thereby assuring women of the results and hygiene they expect for treatments to their most intimate area. CO2 technology also provides the ability to treat both superficial and deep skin layers simultaneously with precision control over the intensity, pattern and depth of treatment, allowing for a more customized procedure.

CONSENT FOR TREATMENT

Informed consent documents are used to communicate information about the proposed cosmetic treatment along with disclosure of risks and alternative forms of treatment(s). Despite the Pheonix high level of efficacy and safety, it is not free of side effects. As a patient you have the right to be informed about your treatment so that you may make the decision whether to proceed with the vaginal treatment or decline after knowing the risks involved. This disclosure is to inform you about the risks, side effects and possible complications related to the vaginal procedure prior to your treatment. This disclosure should not be considered all-inclusive in defining other methods of care and risks encountered. Eluma may provide you with additional or different information which is based on all the facts in your particular case and the state of medical knowledge.

RISKS AND TREATMENT EXPERIENCE

There are both risks, and complications associated with the Phoenix vaginal procedure. Although the majority of patients do not experience these complications, you should understand the risks and potential complications.
This is a cosmetic treatment that could potentially conflict with other medically necessary medications used to treat disease. Full disclosure of medical conditions (past and current) is necessary to determine if this treatment is appropriate for you. Complete information on your medical history minimizes your risks from this treatment. If you under a physician’s care for a serious medical condition Eluma may require the permission of your health care provider for cosmetic treatments. The Phoenix is used for the remodeling of the skin in the vaginal and vulvar regions and the external skin of the labia.
This list is not meant to be inclusive of all possible risks associated with the Phoenix as there are both known and unknown side effects associated with any medication or procedure.

Pregnant or nursing women should not have the Vaginal Rejuvenation treatment.
Erythema and edema– Redness and swelling of the treated area can be expected and usually subside within ten days but can take longer. Expect irritation, itching, and/or a mild burning sensation, similar to a moderate or severe sunburn. Blistering, scabbing and temporary bruising are also possible.
Hyperpigmentation (darkening) and hypopigmentation (lightening)– CO2 Laser treatments may potentially change the natural color of your skin. Skin redness usually lasts 2 weeks‑3 months and occasionally 6 months following laser skin treatment. Darkening and lightening of the skin in the treated areas can occasionally occur. Mostly it is transient, lasting up to six months, but in rare cases it can be permanent. Occasionally these pigmentary changes occur despite appropriate protection from the sun. A line of demarcation between normal skin and skin treated with lasers can occur.
Pinpoint bleeding and pattern– Bleeding and/or grid marks may occur during your CO2 Laser Resurfacing treatment. Laser treatment procedures may produce visible patterns within the skin. They typically resolve within 30 days. The occurrence of this is not predictable.
Burns ‑ Laser energy can produce burns. Adjacent structures including the eyes may be injured or permanently damaged by the laser beam. Burns are rare yet represent the effect of heat produced within the tissues by laser energy. Additional treatment may be necessary to treat laser bums.
Eye damage- There is a risk of accidental eye injury by the laser energy or beam, which could cause blindness or burns of the eyeball.
Accutane (Isotretinoin) ‑ Accutane is a prescription medication used to treat certain skin diseases. This drug may impair the ability of skin to heal following treatments for a variable amount of time even after the patient has ceased taking it. Individuals who have taken the drug are advised to allow their skin adequate time to recover from Accutane before undergoing laser skin treatment procedures.
Scarring– Although normal healing after the procedure is expected, abnormal scars may occur both in the skin and deeper tissues. In rare cases, keloid scars may result. Scars may be unattractive and of different color than the surrounding skin. Additional treatments may be needed to treat scarring. Strict adherence to all advised post-operative instructions will reduce the possibility of scarring.
Infections– This treatment has the potential to cause skin damage, so infection is possible. Infection is unlikely but can be life threatening if it does occur and is left untreated, signs and symptoms of infection are redness, fever, pain, pus and swelling. Should infection occur, you should contact Eluma for immediate evaluation and treatment. It is important that you tell your provider if you think you have an infection.
Herpetic outbreaks can be triggered by Vaginal Rejuvenation treatments. This applies to both individuals with a past history of Herpes simplex virus infections and individuals with no known history of Herpes simplex virus infections. Specific medications will be prescribed and taken both prior to and following the laser treatment procedure in order to suppress an infection from this virus. An outbreak increases the risk of scarring
Pain- You may experience pain after the procedure. If you feel significant discomfort after the treatment, you may take over the counter pain medication to minimize the pain. If pain increases or persists, contact Eluma for immediate evaluation and treatment. Very infrequently chronic pain may occur after laser skin treatment procedures.
Bruising- You may experience some temporary bruising in the treated area which will subside with healing.
Blistering– You may experience some temporary Blistering / Bullae in the treated area which will subside with healing.
Numbing agent reactions- Your skin may be numbed using an analgesic agent(s) as part of your  vaginal procedure. Analgesics typically include but are not limited to benzocaine, lidocaine, tetracaine and epinephrine. There is the possibility of complications, injury, and even death from analgesics.
Prescribed medications– Systemic reactions may result from drugs used during the procedure.
Fire ‑ Inflammable agents, drapes and tubing, hair, and clothing may be ignited by laser energy. Laser energy used in the presence of supplemental oxygen increases the potential hazard of fire.
Laser Smoke (plume)‑ Laser smoke is noxious to those who come in contact with it. This smoke may represent a possible bio‑hazard.
Clinical results may vary depending on individual factors, including but not limited to medical history, skin type, patient compliance with pre- and post-treatment instructions, and individual response to treatment.

Contraindications. If you have any of the following it is important they were included in your medical history review prior to your vaginal rejuvenation treatment:
Abnormal cell cytology.
Evidence of dysplasia and occult or active infection.
Injury or bleeding in external vaginal area or undiagnosed vaginal bleeding.
Active malignancy or history of malignancy in the past five years.
Active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
Implants or mesh in the treatment area.
Suffering from significant concurrent illness, such as cardiac disorders, diabetes (type I or II), lupus, porphyria or pertinent neurological disorders (i.e., any disease state that in the opinion of the physician would interfere with the treatment or healing process).
Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of use as per the patient physician’s discretion).
History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
Suffering from hormonal imbalance, whether related to thyroid, pituitary, or androgen.
History of significant lymphatic drainage problems.
History of cancer which required lymph node biopsy or dissection.
Suffering from significant conditions in the treated areas or inflammatory conditions, including but not limited to open lacerations or abrasions of the treatment area prior to treatment or during the treatment course.
History of keloid scarring, abnormal wound healing and/or prone to bruising.
History of epidermal or dermal disorders (particularly if involving collagen or microvascularity), including collagen vascular disease or vasculitic disorders.
Use of isotretinoin (Accutane®) within six months of treatment or during treatment.
On systemic corticosteroid therapy six months prior to and throughout the course of treatment.
Dysplastic nevi in the area to be treated.
Surgery or any other procedure for Vaginal Tightening in the last 12 months.
Uterine prolapse, cystocele or rectocele.
Urinary tract infection.
Pelvic infection.
Active malignancy or cancer treatment within the last five years.
Melanoma history.

Excessively tanned skin in the treatment area from sun, sun beds or tanning creams.

PRE TREATMENT INSTRUCTIONS

It is prudent to follow some simple guidelines before your treatment. These guidelines can reduce possible side effects associated with the procedure and make all the difference between a fair result and a great result.
Hydrate– We recommend that for seven days pre-treatment you moisturize skin in the morning and evening, drink at least 8 glasses of water per day to completely hydrate your skin and optimize treatment results.
Vaginal health screening– Have an up-to-date, normal PAP smear done within one year prior to treatment.
Menstruation– No active menstruation at time of treatment.
Shaved– Please have pubic hair fully shaved.
Over the Counter Medications- Avoid aspirin, Motrin and Ibuprofen for one week prior to your treatment. Inform your provider if you are taking blood thinners or regularly take aspirin or Ibuprofen.
Sun exposure– No tanning bed or self-tanners for four weeks prior to treatment.
Prescription Medications– We will provide you with an antiviral prescription to fill and take before your appointment to decrease the risk of a herpetic outbreak. Take your first tablet 24 hours before your treatment and follow instructions on the bottle. Take other medications that may be prescribed for anxiety or pain management as instructed on the bottle. Stop taking prescription medications that may increase the risk of bruising as instructed and in coordination with your physician.
Over the Counter Medications– Avoid aspirin, Motrin and Ibuprofen for one week prior to your treatment. Inform your provider if you are taking blood thinners or regularly take aspirin or Ibuprofen.
Supplements- Avoid fish oil, Gingko Biloba, Garlic, Flax Oil, Cod Liver Oil, Vitamin A, Vitamin E, or any other supplements one week before treatment.
Alcohol- Avoid alcohol for two days prior to treatment.
Accutane– Inform your provider if you have taken Accutane (oral acne medication) in the past year.
Ice Packs– Store ice packs in your freezer for use after you get home from procedure.
Secure a ride for after treatment- You must secure a ride home if you choose to take pain and/or anxiety medication.

TREATMENT DAY INSTRUCTIONS

Treatment Area– Please arrive with clean skin. No lotion, powder oils or other products on treatment area.
Take prescription medications– Take prescribed medications as directed.
Transportation arrangements – Some medications may restrict your ability to drive home after your procedure. Please coordinate transportation home after your procedure if you chose to take such medications.

POST TREATMENT INSTRUCTION

You may experience temporary erythema (redness) and edema (swelling), mild bleeding, tissue retraction, as well as heat and tightening sensations for up to a few hours after the treatment.
Treatment Area– Wash your skin with a gentle cleanser twice a day and pat dry (do not scrub).
You may notice light spotting, mild burning, itching, swelling or mild cramping for a few days. Do not have intercourse for 1 week. Do not insert tampons or anything else into the vagina for 1 week. Do not use a douche, cleanser, suppositories, or any other products in the vagina for 1 week.

No Jacuzzis, tub baths, or swimming for 1 week.

No tanning beds or self-tanning cream for 1 week.

No heavy exercise for 1 week.
At-Home Care– Apply hydrocortisone cream as needed for itching. Apply antibiotic ointment as needed for any sores or irritated areas. You may apply an ice pack as needed for discomfort (no more than 10 minutes per hour with cotton barrier).
Hydration and comfort-Keep yourself well hydrated. You may take Tylenol for discomfort.
Post Treatment Kit (use as needed)
Hydrocortisone cream
Antibiotic ointment
Panty liners
Report any pain, fever or unusual discharge immediately to Spa 35.

TREATMENT SCHEDULE

We recommend re-treatment every 4 weeks, with a total of 3 treatments in a row. After a series has been completed, treat 1-2 times per year or as needed.

ALTERNATIVE TREATMENTS

Having no treatment is an alternative to Intima vaginal treatment. Procedures based upon other devices are also alternatives. There may be surgical options for your concerns. Pelvic floor exercises may be an alternative option

ACKNOWLEDGEMENT

I have read and understand the Informed Consent documentation. I agree to follow the pre and post care instructions carefully. I understand that compliance with recommended pre and post procedure guidelines are crucial for healing, prevention of scarring, and other side effects and complications.

I completed an accurate medical history document. If there are any issues that are not covered by the medical history form which I think are relevant to my treatment, I will inform Spa 35 prior to my treatment. I will also notify Eluma of any changes in my health or medical care as they occur during my treatment program.

I confirm that I am not pregnant or breastfeeding at this time. I also have completed an accurate medical history document and been informed about what I must do and “not do” before, during and after the series of treatments.

Photographs: I give permission for my photographs to be used to help document my treatment course. Complete confidentiality will be maintained.

No guarantee, warranty, or assurance has been made to me as to the results that may be obtained.  I am aware that follow-up treatments may be necessary for desired results. Clinical results will vary per patient. I agree to adhere to all safety precautions and regulations during the treatment. Some people are unable to complete the treatment due to discomfort. No refunds will be given for treatments received.

I recognize that during the course of the treatment, medical treatment or anesthesia, unforeseen conditions may necessitate different procedures than those above. I therefore authorize Eluma providers to perform such other procedures that are in the exercise of his or her professional judgment necessary and desirable. The authority granted under this paragraph shall include all conditions that require treatment and are not known to the provider at the time the procedure is begun.

I understand and agree that all services rendered to me are charged directly to me and that I am personally responsible for payment.

The nature and purpose of the treatment have been explained to me.  I have read and understand this agreement. All of my questions have been answered to my satisfaction and I consent to the terms of this agreement. Alternative methods of treatment and their risks and benefits have been explained to me and I understand that I have the right to refuse treatment.

If I experience any major or life-threatening symptoms, I will call 911 immediately.  For non-emergency questions I will call Spa 35 at 904-619-7078

I release Eluma, medical staff, and specific technicians from liability associated with this procedure. I certify that I am a competent adult of at least 18 years of age. This Consent Form is freely and voluntarily executed and shall be binding upon my spouse, relatives, legal representatives, heirs, administrators, successors, and assigns.

Please contact the Eluma team if you have questions about the Intima vaginal procedure and/or information on this webpage.