CoolSculpting® is well-tolerated, safe, and effective
Patients with any of the following contraindications should not be treated with CoolSculpting®:
1. Cryoglobulinemia [kry-o-glob-u-lih-NEE-me-uh].
2. Paroxysmal cold hemoglobinuria [par-UHK-siz-mal cold hemo-glob-in-ur-EE-uh], or PCH.
3. Cold agglutinin disease [cold a-GLU-tin-in disease].
Medical providers must use their clinical judgement to assess the patient further and determine if the patient qualifies for treatment.
CoolSculpting ® system use has not been studied in children, those who are pregnant or lactating, or patients with:
- Known sensitivity to cold such as cold urticaria, Raynaud’s disease, or chilblains (pernio)
- Known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol
- Impaired peripheral circulation in the area to be treated
- Neuropathic disorders such as postherpetic neuralgia or diabetic neuropathy
- Impaired skin sensation
- Open or infected wounds
- Bleeding disorders or concomitant use of blood thinners
- Skin conditions such as eczema, dermatitis, or rashes in the area to be treated
- Recent surgery or scar tissue in the area to be treated
- Hernia in or adjacent to the treatment site
CoolSculpting® does not treat these aesthetic considerations
When assessing the body, it is important to note the presence of skin laxity, cellulite, and stretch marks. When assessing the face, discuss the presence of jowling and platysmal bands.
The CoolSculpting® procedure is FDA-cleared to affect the appearance of lax tissue with submental area treatments.
Common adverse events patients can experience after the procedure
These effects are temporary and generally resolve within days or weeks.
Immediately after the CoolSculpting® procedure:
- Redness and firmness
- Transient blanching and/or mild bruising around the edges of
- the treatment area
- Tingling and stinging
Rare adverse events
Late-onset pain should be discussed with the patient during the consultation.
- Typical onset may occur several days after a treatment
- Believed to be associated with nerve inflammation
- The average onset of the pain is 3 to 4 days after treatment1
- Symptoms are self-limiting and typically resolve within several weeks
- Can be described as deep pain, burning sensations, hypersensitivity, and severe pins and needles
According to clinician recommendations, some side effects may
- Compression garments
- Gabapentin, Neurontin® or Lyrica®
- Benadryl® or Ambien® at night
- Heating pads
- Occurs when the part of the nervous system that regulates heart rate and blood pressure overreacts in response to a trigger
- Symptoms include dizziness, lightheadedness, nausea, flushing, sweating, or fainting during or immediately after the treatment
- First- and second-degree frostbite may occur during treatment
- Typically resolves with proper care
In the days and weeks after treatment:
- Redness, bruising, and swelling
- Tenderness, cramping, and aching
- Itching, skin sensitivity, tingling, and numbness
- Numbness that can persist up to several weeks after a treatment
- Benadryl® or Ambien® at night
- A sensation of fullness in the back of the throat after submental area treatment
- Presents as a generalized hardness and/or discrete nodules within the treatment area
- May present with pain and/or discomfort
- Typically resolves spontaneously
- Presents as visibly enlarged tissue volume within the treatment area, which may develop 2 to 5 months after treatment
- Affected tissue presents with a distinct demarcated bordery
- May appear firm compared to nontreated tissue
- Currently no evidence that suggests spontaneous resolution
- Surgical intervention is required for correction
Please refer to the user manual to review any additional side effects the patient may experience after the CoolSculpting® procedure.
* CoolSculpting® is the treatment doctors use most for nonsurgical fat reduction.
The CoolSculpting® procedure is FDA-cleared for the treatment of visible fat bulges in the submental area, thigh, abdomen and flank, along with bra fat, back fat, underneath the buttocks (also known as banana roll), and upper arm. It is also
FDA-cleared to affect the appearance of lax tissue with submental area treatments.
Reference: 1. Avram M, Dover J, Horowitz S, Kaminer M. Late Onset Pain Associated with Cryolipolysis Procedures. June 16, 2011.
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