Thermiaesthetics Orange County Thermi Aesthetics™ RF Skin Tightening
The following information has been prepared to familiarize you with facts about the surgical treatments known as the ThermiAesthetics® family of radiofrequency procedures. These include the minimally invasive, ThermiTight® skin tightening procedure, ThermiRase® nerve ablation for glabellar frown lines, the ThermiSmooth® non invasive surface treatments for wrinkles or cellulite and fat deposits.
ThermiDry® percutaneous ablation of axillary sweat glands for patients with excessive sweating, and ThermiVa® non invasive vaginal and labial tightening procedures for patients wishing a more youthful vagina or labia.You are requested to read this information thoroughly and to discuss any questions which might arise with your surgeon before you give your consent to proceed with this procedure. You are also requested to keep this form as a reference in the postoperative period.
Orange County Plastic Surgery was the first medical practice in Orange County to acquire this unique new technology in 2012, the hottest new radiofrequency procedure now available. Dr. Juris Bunkis has developed an extensive experience with this technology and has been asked by the manufacturer, ThermiAesthetics®, to be on the company’s Clinical Advisory Board and to serve as a teacher to other physicians wishing to use this technology. Other physicians come to the Orange County Surgery Center in Newport Beach for teaching session with Dr. Bunkis.
The ThermiAesthetics® unit is manufactured in Texas as a compact, multi platform system utilizing radiofrequency energy to address a number of clinical concerns – wrinkle reduction, skin tightening, non-invasive body contouring, decreasing axillary sweating and vaginal/labial tightening. Its first application, ThermiRase®, has been FDA approved for facial nerve ablation. A nerve stimulator is used to locate the nerves which cause the vertical “11’s” between the brows, the radiofrequency probe inserted through a needle type hole, placed against the nerve, and the nerve ablates, treating the same nerve which Botox® could be used for to inactivate. Current studies two years post treatment show that 85% of the patients treated with this modality still do not have sufficient muscle movement to warrant another application or a Botox® treatment. This treatment is more complex and costly than a Botox® injection, but in the long term can be more cost effective and will minimize the need for frequent Botox® injections. Before this treatment was developed, there was a need for a longer lasting, quicker acting, non toxin alternative to Botox®. This procedure can be performed in a surgical suite under local anesthesia as a stand along procedure, or can be combined with other procedures as an add-on to other cosmetic procedures, with minimal down time.
ThermiAesthetics® has submitted FDA applications for all of its treatment modalities and has received approval. Approval for the ThermiSmooth® is expected later this year, and until them, ThermiSmooth® treatments are considered “off label”. The most common use of this technology in our practice has been the minimally invasive, ThermiTight® skin tightening procedures. Patients who have an excessive amount of skin excess will still be better served with a facelift, tummy tuck, arm lift, thigh lift or other traditional procedure. But this procedure is ideal for any patient who is not bad enough for the aforementioned procedures but wishes a tighter neck, tighter inner arm, less folds above the bra in front of the axilla, less abdominal or back folds, with cellulite, or inner thigh laxity, not severe enough to warrant a skin excision. Our most common application has been to tighten necks, inner arms and abdomens in patients who do not have enough laxity to benefit from a facelift, an arm lift or tummy tuck. Scientist have discovered that heating the deep dermis to 50 degrees Celsius will cause the skin to shrink – this company is the first to develop an accurate and predictable way to deliver this energy to the deepest layer of the skin without causing surface burns! Traditional light based treatments like lasers and IPL’s don’t penetrate deep enough into the tissues to impact the desired skin tightening without damaging the skin surface. ThermiTight® accomplishes this skin tightening via a tiny probe, thinner than a ballpoint refill, which is inserted through a little stab wound, to target the deepest layers of the skin without damaging the surface - moving the probe around in an organized pattern until the internal temperature averages 50 degrees Celsius, and at the same time, keeping the external skin below 42 degrees Celsius to avoid external burns! Significant skin shrinkage occurs over a four month period following the treatment. Excellent skin tone will accentuate the improvement – this treatment will not help someone with very poor tone and a very significant skin excess. This treatment can be done in conjunction with a liposuction if an excess of fat is present, or as a solo procedure if excess fat is not an issue. The ThermiTight® procedure does not produce as dramatic a result as a skin excision – but is a far more minor procedure and does not leave the patient with surgical scars. This treatment is performed in a surgical suite, usually with an anesthesiologist present to administer sufficient sedatives to keep the patient comfortable during the procedure. Very small areas, like a neck, may be treated solely with a local anesthetic if the patient is sufficiently stoic – but most patients will be far more comfortable if an anesthesiologist is involved.
The ThermiDry® percutaneous ablation of axillary sweat glands has been designed for patients with excessive sweating called hyperhydrosis – a condition characterized by abnormally increased perspiration in excess of that required for the normal regulation of body temperature. This condition affects 2.8% of Americans, some 7.8 million people, and half of these suffer from axillary hyperhidrosis. Botox® will help dry up these hyperactive sweat glands but very large quantities (100 units per side), high cost, painful and frequent injections are required to control this condition with Botox®.
The ThermiDry® radiofrequency treatment can treat this condition equally effectively by heating the subdermal glands and knocking out their function during a one hour, minimally invasive procedure. Here again, an anesthesiologist is optional, but most patients will be more comfortable with intravenous sedatives. This procedure is not meant for patients with a normal sweating pattern, and we would not consider taking someone to surgery to control sweating in such normal patients as an isolated procedure. But we have found this procedure to be a popular and useful adjunct for patients who wish to decrease sweating and are already in the surgical suite for an unrelated procedure and wake up with the added bonus of requiring less antiperspirant after the procedure.
The ThermiSmooth® treatment in a non-surgical, non-invasive procedure, performed in an office setting, in which radio frequency energy is directed superficially at the external skin to treat minor wrinkling, or deeper to treat the superficial fat to sculpt the body non-surgically, to tighten the skin and to improve cellulite. A series of 4-6 treatments are recommended for maximal improvement. Here again, patients with a large excess of fat will still be better candidates for a liposuction or other body contouring surgical procedure. Minimal improvement will be provided for minimal wrinkling. For patients with deeper wrinkles, a more aggressive treatment with a laser or deep peel will be more effective.
ThermiVa® is a noninvasive application of this technology designed for vaginal and labial rejuvenation and in most patients, improves the quality of the orgasm. Currently this is the only non-invasive solution for vaginal laxity and labial reduction. A 2009 survey reported that 71% of women expressed concern about vaginal laxity and expressed interest in a non invasive treatment to tighten the vaginal lining – this implies that 6-8 million women are candidates for vaginal rejuvenation. The ThermiVa® probe is designed to heat the labia and to slip into a vagina to heat the lining to the target temperature to induce the desired tightening. A series of three procedures is recommended for optimal tightening and should be followed with a treatment every six months. This is a non painful, non invasive office procedure that does not require sedation or an anesthetic.
A common question is, "How long will the results of this procedure last?" This is impossible to state in every case. Factors affecting the length of the improvement include overall health, physical conditioning, type of skin, and alterations in weight. It may be necessary to repeat this procedure to maintain the optimal result. Should a patient wish to repeat a treatment, regardless of the length of time since the initial procedure, each patient will be responsible for the cost of a subsequent procedure.
THERMIAESTHETICS PREOPERATIVE PREPARATION
The ThermiVa® and ThermiSmooth® treatments are office procedures and no special preoperative preparation will be necessary. A series of 4-6 ThermiSmooth® or ThermiVa® procedures are recommended for optimal results. The ThermiRase®, ThermiTight® or ThermiDry® procedures may be performed in an operating room or in the office, with or without an anesthesiologist, depending on the areas treated. You may visit your surgeon as many times as you wish, to have all of your questions answered. At your final preoperative visit (which takes up to an hour), your final questions will be answered and you will confirm that you understand the procedure to be performed, that this material has been explained to you, that you have read and understand these information sheets, and that you accept the risks by signing the informed consent forms. You will be given prescriptions for surgical soap that will be used before surgery, as well as for pain pills and antibiotics, along with instructions for their use.
Certain laboratory tests will also be required within two weeks of surgery. If you are having a procedure in the operating room and are over the age of 50 or have had any cardiac problems, you will have to obtain a cardiogram at your doctor’s office or any licensed laboratory. You may have your blood drawn at your family doctor’s office or other laboratory (e.g. Kaiser Hospital, etc.). Smoking constricts blood vessels and hinders normal healing - all smokers will be asked to stop smoking a month prior to surgery in an effort to maximize your body’s ability to heal following the procedure.
With the ThermiTight®, ThermiRase® and ThermiDry® procedures, particularly if liposuction will also be performed, it will be necessary to scrub the surgical area for ten minutes the evening prior to surgery and a final time the morning of surgery before leaving home. Washing the surgical site these two times with Hibiclens® soap will lower the possibility of an infection occurring after surgery.
Your anesthesiologist will discuss the anesthetic care plan with you in the morning, at the Surgery Center, prior to your procedure. You must make arrangements to have someone drive you to and from the Surgery Center (Orange County Surgery Center in Newport Beach) and stay with you for the rest of the day afterwards if you receive an anesthetic.
The ThermiSmooth® and ThermiVa® procedures are non-invasive, are performed in an office setting and do not require any special preparation. A radio frequency device will be applied to the skin, labia or vaginal mucosa (no incisions are necessary) to bring the tissues to the target temperature. No special aftercare is required with these procedures.
The ThermiRase®, ThermiTight® and ThermiDry® procedures will be performed in an outpatient facility or office under sedation or light general anesthesia, supplemented by local anesthetics, or under straight local anesthesia. With the ThermiRase®, ThermiTight® and ThermiDry® procedures, stab wounds will be made to provide an entry point for the radio frequency probes to be inserted. An internal temperature sensor and an external temperature sensor will be monitored as the probe delivers the desired amount of energy to the targeted tissues.
Multiple passes are required and it takes approximately an hour and a half to do the average inner arms and axillary areas. Once the procedure has been completed, a drop of surgical glue will be placed over the opening and, if appropriate, a dry dressing applied.
THERMIAESTHETICS POST-OPERATIVE CARE
No special postoperative care will be necessary for patients following the ThermiSmooth® or ThermiVa® procedures – just avoid any activity which causes discomfort.
For ThermiRase®, ThermiTight® and ThermiDry® patients, adequate pain medication will also be prescribed. All patients who receive intravenous sedatives or a general anesthetic must have a ride to and from the surgery center and arrange for an adult to spend the rest of the day with the patient. This can be a family member and does not have to be a trained nurse. Following ThermiTight®, especially if liposuction was performed, the surgical area will be wrapped with a compressive dressing for the first two to five days. Applying ice to the dressings may decrease swelling and discomfort. Generally, no dressings are required following a ThermiRase® or ThermiDry® procedure. High bulk foods are highly encouraged and laxatives may be necessary to prevent straining associated with constipation. Patients will be encouraged to walk as much as possible after surgery as this will reduce the possibility of pneumonia or of clots forming in your calf veins. The incisions are covered with Dermabond, a surgical glue, which will wash/peel off spontaneously over a few weeks. Patients will be allowed to shower the day following their procedure.
Your first post-operative visit will generally be scheduled four or five days after the procedure. If a liposuction or other more invasive surgical procedure is performed, you will be given a prescription for antibiotics for the first few days after the procedure. It would be helpful to have someone drive you to the office for your first postoperative visit if liposuction was performed. Most patients find that they can gradually increase their activity levels thereafter. You may drive a car with caution, wearing a safety belt, beginning 48 hours after your last pain pill or sedative, if you feel comfortable and physically able to do so.
Social activity should be limited while the patient is uncomfortable. A concomitant liposuction or other more invasive procedure will increase the level of postoperative discomfort. A good general rule of thumb is that patients should avoid any physical activity that causes discomfort.
There is no set time table for resuming strenuous activity – just avoid activities that cause discomfort. Basically, most patients find that they can return to normal activity as the discomfort of the operation fades away.
THERMIAESTHETICS POSSIBLE COMPLICATIONS
Serious complications after any aesthetic procedure are relatively uncommon. The stab wounds usually heal without a noticeable scar. Very rarely a blister may form and this may heal with a permanent scar.
Infections are extremely rare. Even more rarely, as is possible with any surgical procedure, phlebitis may develop in leg veins and even more rarely, blood clots could travel to the lungs, potentially leading to a fatal complication.
Perfect symmetry does not exist before or after any aesthetic procedure. Minor asymmetries will persist after any ThermiAesthetics® procedure. The most significant dissatisfaction comes from patients who expect more than the technology can deliver! It should be stressed that this is an ideal procedure in situation where minor correction is desired. Borderline candidates will have to decide if they would prefer some improvement with a minor procedure without surgical scars, or a more significant improvement following a longer, more invasive procedure and longer surgical scars. Patients with extensive skin excess, very deep wrinkles, very redundant labia or massive vaginal laxity will not be candidates for ThermiAesthetics® procedures and will be better candidates for traditional, more invasive procedures.
Secondary procedures may occasionally be desirable to achieve more improvement. The patient will be responsible for all costs associated with secondary surgical procedures.
It is not possible to list every conceivable complication. As with any operation, there could be potential complications, which could even be fatal. The foregoing is not intended to frighten or upset you but to enable you to make your decision with an understanding of some of the involved risks.
Insurance does not pay for purely cosmetic procedures and will not pay for most ThermiAesthetics® procedures. Very rarely, insurance companies may reimburse patients for treatment of axillary hyperhydrosis with either Botox® or ThermiDry®, or glabellar muscle treatments with ThermiRase® for patients with migraine headaches - but we have to emphasize, RARELY! We will provide you with the diagnosis and procedure codes and you will be responsible for contacting your insurance carrier and submitting the bill directly to them.
If you wish to contact your insurance carrier, you might be reimbursed for a portion of the Surgery Center bill and of the professional fees. In some instances, it may be possible to verify the amount covered by your insurance carrier in advance. The office staff will provide you with the necessary information to submit to your insurance carrier. All fees are due prior to the surgical procedure and, if any portion of your procedure will be covered by your carrier, you will be reimbursed directly by your insurance company.
In compliance with suggestions adopted by the American Society of Plastic Surgeons, it is customary for the patient to pay all fees for cosmetic procedures prior to the desired treatment. This insures that the patient is sincere in his/her motivation and can afford the surgery, thus creating a better patient/physician relationship. A non-refundable deposit will be required to secure your desired surgery date when booking your procedure. The remainder of the fees must be paid prior to the surgery, usually at the time of the preoperative visit, but never later than two weeks before surgery. Additional fees are also required for laboratory tests, surgical facility fees and the anesthesiologist. If additional surgical procedures become necessary, additional facility, laboratory, anesthesia, and professional fees will be incurred. The surgical facility and anesthesiologist fees quoted will be based on our best faith estimate; the final fee may vary as these fees are based on surgical time, and it is not always possible to predict exactly how long a procedure will take to complete. It is important that you understand that the patient is responsible for all costs associated with all secondary surgical procedures or for the treatment of any complications that may arise as a result of this elective surgery.
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