Although EMSCULPT is very safe, as with most medical procedures, there are some contraindications. The most important contraindications are related to the presence of metal or implanted electrical devices within the patient. This is because EMSCULPT uses strong electromagnetic energy, similar to the energy of an MRI machine. Other contraindications arise out of an abundance of caution or because these patients were not included in clinical studies which established the safety and efficacy of the medical device.
The following are contraindications for EMSCULPT:
· Any implanted device including cardiac pacemaker, cardiac defibrillator, neurostimulator, insulin pump or other medication pump, any type of electronic implant.
·Metal or metal implant including orthopedic hardware, surgical staples and metal-containing contraceptive devices (e.g., Essure, some IUD's) in or near the treatment area.
· Malignancy (cancer).
· Epilepsy or seizure disorder.
· Heart disorders including abnormal rhythm, such as atrial fibrillation.
· Pulmonary insufficiency.
· Hemorrhagic conditions (such as hemophilia).
· Anticoagulant therapy (or “blood thinner”).
· Recent surgical procedure in area to be treated (because muscle contractions may disrupt the healing process).
· Skin infection, rash or wound in area to be treated.
· Lack of normal sensation in area of skin to be treated.
· Pain in the area to be treated, including neuropathy such as sciatica. (Persons with pain associated with a nerve which runs through or near the treatment area may experience worsening of pain due to muscle contractions.)
· Abdominal hernia in region being treated, such as umbilical hernia.
· Severe or anaphylactic allergy to latex (because the belt used for placement of the applicator during treatment contains latex).