Crypolysis Coolplas

The procedure is not for everyone. You should not have the treatment in areas with metal, electrical, or electronic implants/devices like cardiac pacemakers, implanted hearing devices, implanted defibrillators, implanted neurostimulators, drug pumps, or hearing aids.

Tell your doctor if you have any medical conditions as should not be used over a menstruating uterus, over areas of the skin that lack normal sensation, in patients with fever, malignant tumour, haemorrhagic conditions, epilepsy, recent surgical procedure, pulmonary insufficiency, or pregnancy.

Cryopolysis and the EMS should be used with caution in patients with Graves’ disease (an autoimmune disorder that causes overactive thyroid), active bleeding disorders, or seizure disorders.

Women who are close to menstruation may find that it comes sooner, or cramping is increased or intensified with CoolTone® treatments, therefore, it is recommended to not undergo treatment during this time of the month.

Cryopolysis and EMS should not be used in the heart or head areas, areas of new bone growth, over the carotid sinus nerves, or over the neck or mouth. Cryopolysis should not be applied over swollen, infected, inflamed areas or skin eruptions. Caution should be used for patients with suspected or diagnosed heart problems.

Common side effects may include, but may not be limited to, muscular pain, temporary muscle spasm, temporary joint or tendon pain, and redness at or near the treatment site.

Ask your Healthcare Provider if is right for you.

The Cryopolysis coolplas procedure has not been studied in children, those who are pregnant or lactating, or patients with any of the below conditions. If you have one of the following conditions, inform your  Cryopolysis coolplas  provider as you may not be an appropriate candidate Cryopolysis coolplas  treatment. 

• Known sensitivity to cold such as cold urticaria or Raynaud’s disease, pernio, or Chilblains 
• Known sensitivity or allergy to isopropyl alcohol, propylene glycol, fructose, or glycerine
• Impaired peripheral circulation in the area to be treated 
• Nerve pain such as post-herpetic neuralgia or diabetic neuropathy 
• Impaired skin sensation 
• Open or infected wounds 
• Bleeding disorders or simultaneous use of blood thinners
• Recent surgery or scar tissue in the area to be treated 
• Hernia in or adjacent to the treatment site 
• Skin conditions such as eczema, dermatitis, or rashes in the area to be treated.
• Active implanted device such as pacemaker or defibrillator 
• Chronic pain 
• Anxiety disorder What are possible side effects? The following effects can happen frequently in the treatment area during and after a treatment. These effects are temporary and generally resolve within days or weeks. During a treatment: 
• Sensations of pulling, tugging, and mild pinching at the treatment site 
• Intense cold, tingling, stinging, aching, cramping. These sensations lessen as the area becomes numb Immediately after a treatment: 
• Redness and firmness 
• Transient blanching and/or mild bruising around the edges of the treatment area 
• Tingling and stinging One to two weeks after a treatment:
• Redness, bruising, and swelling 
• Tenderness, cramping, and aching 
• Itching, skin sensitivity, tingling, and numbness. Numbness can persist up to several weeks after a treatment 
• Sensation of fullness in the back of the throat after submental area treatment There are other side effects that can happen with submental and submandibular area treatments:
• Cold exposure to the hypoglossal nerve may cause tongue deviation following treatment of the submental and submandibular areas. 
• Cold exposure to the marginal mandibular nerve may cause lower lip weakness following treatment of the submental and submandibular areas.
• Cold exposure to the submandibular gland may cause dry mouth or decrease in saliva production following treatment of the submental and submandibular areas.

The following side effects can happen in the treatment area, during and after a treatment. The risk for the side effects listed below is small, but possible. We can estimate how likely it is that a side effect could happen. We do this by first counting how many of these side effects have been reported by people treated with .

Then we count the number of treatment cycles of Cryopolysis coolplas  used around the world. Rare side effects are not reported by people as often, this can make them difficult to measure. We have provided estimates for how likely it is that you could have a certain side effect. These are listed in the parentheses below. Rare side effects may happen in 1 to 10 out of 10,000 Cryopolysis coolplas treatments (between 0.01% to 0.1%). These include:

• Paradoxical hyperplasia: (About 1 out of 3,000 treatments, 0.033%) The gradual development of a visibly enlarged tissue volume, of varying size and shape, in the treatment area two to five months after the treatment. This is distinguished from temporary swelling and will not resolve on its own. Surgical intervention may be required.
• Severe pain: (About 1 out of 6,000 treatments, 0.017%) Patients may experience pain of varying severity, which more commonly can be described as mild to moderate, and in rare instances, can be severe. 
• Late-onset pain: (About 1 out of 6,000 treatments, 0.017%) A typical onset several days after a treatment and resolution within several weeks. Very rare side effects may happen in less than 1 out of 10,000 Cryopolysis coolplas treatments (less than 0.01%). These include: 
• Hyperpigmentation: (About 1 out of 11,000 treatments, 0.009%) Dark coloration of the skin may happen after treatment. Typically, it resolves spontaneously. 
• Freeze burn (“frostbite”): (About 1 out of 15,000 treatments, 0.006%) First- and second-degree freeze burn which may happen during treatment. It typically resolves without additional side effects with proper care.
• Treatment Area Demarcation (TAD): (About 1 out of 20,000 treatments, 0.005%) An aesthetic outcome of treatment in which the patient experiences excessive fat removal in the treatment area, resulting in a visible disruption to the continuous contour of fat, or unwanted indentation in the treated area. 
• Vasovagal symptoms: (About 1 out of 30,000 treatments, 0.003%) Dizziness, light-headedness, nausea, flushing, sweating, or fainting might happen during or immediately after the treatment.
• Subcutaneous induration: (About 1 out of 30,000 treatments, 0.003%) Generalized hardness and/or discrete nodules within the treatment area, which can develop after the treatment and be accompanied by pain and/ or discomfort. 
• Cold panniculitis: (About 1 out of 60,000 treatments, 0.002%) Cold panniculitis results from injury to adipose tissue exposed to cold and may result in a mild to severe inflammatory response. In mild cases, the symptoms are self-resolving and may include redness, swelling, skin nodules, warmth, tenderness, and possible low-grade fever. These cases typically resolve without long-term side effects. In more severe cases, an intense inflammatory response may result in more extensive tissue damage, including fat tissue death, which may require medical or surgical intervention.
• Hernia: (About 1 out of 185,000 treatments, 0.001%) Treatment may cause new hernia formation or worsen pre-existing hernia, which may require surgical repair.

TBA