COBLATION™ (VISAGE System™) SKIN RESURFACING – SPECIFIC SURGICAL RISKS

DESCRIPTION                   

q       Radiofrequency technology has been used by plastic surgeons as a surgical instrument for many years.  Radiofrequency energy can be used to cut, vaporize, or selectively remove skin and deeper tissues.  The Visage™ System, employing the COBLATION™ process, has been cleared by the FDA for the treatment and reduction of facial wrinkles.

q       Conditions such as wrinkles, sun damaged skin, scars and some types of skin lesions/disorders may be treated with the COBLATION process.  Certain surgical procedures may use the COBLATION process as a cutting instrument.  In some situations, COBLATION treatments may be performed at the time of other surgical procedures.

q       Skin treatment programs may be used both before and after COBLATION skin treatments in order to enhance the results.

RISKS

q      INFECTION: Although infection following COBLATION skin treatment is unusual, bacterial, fungal, and viral infections can occur.  Herpes simplex virus infections around the mouth, can occur following a COBLATION treatment.  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 in the mouth area.  Specific medications must be prescribed and taken both prior to and following the COBLATION treatment procedure in order to suppress an infection from this virus.  Should any type of skin infection occur, additional treatment including antibiotics may be necessary.

q      BURNS: Radiofrequency energy can produce burns. Burns are rare, yet represent the effect of heat produced within the tissues by radiofrequency energy.  Additional treatment may be necessary to treat such burns.

q       COLOR CHANGE: COBLATION treatments may potentially change the natural color of your skin.  Skin redness usually lasts 1-2 months following COBLATION skin treatment.  There is the possibility of irregular color variations within the skin including areas that are both lighter and darker.  A line of demarcation between normal skin and skin treated with COBLATION can occur. 

q      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 or surgery for a variable amount of time even after the patient has ceased taking it.  Individuals who have taken this drug are advised to allow their skin adequate time to recover from Accutane before undergoing COBLATION skin treatment procedures.

q      SKIN TISSUE PATHOLOGY: Radiofrequency energy directed at skin lesions may potentially vaporize the lesion.  Laboratory examination of the tissue specimen may not be possible.

q      VISIBLE SKIN PATTERNS: COBLATION treatment procedures may produce visible patterns within the skin.  The occurrence of this is not predictable.

q      PATIENT FAILURE TO FOLLOW THROUGH:  Patient follow through following a COBLATION skin treatment procedure is important.  Post operative instructions concerning appropriate restriction of activity, use of dressings, and use of sun protection need to be followed in order to avoid potential complications, increased pain, and unsatisfactory result.  Your physician may recommend that you utilize a long-term skin care program to enhance healing following a COBLATION skin treatment. 

q       DISTORTION OF ANATOMIC FEATURES: COBLATION skin treatments can produce distortion of the appearance of the eyelids, mouth, and other visible anatomic landmarks.  The occurrence of this is not predictable.  Should this occur, additional treatment including surgery may be necessary.

q       DAMAGED SKIN: Skin that has been previously treated with chemical peels or dermabrasion, or damaged by burns, electrolysis (hair removal treatments), or radiation therapy may heal abnormally or slowly following treatment by COBLATION or other surgical techniques.  The occurrence of this is not predictable.  Additional treatment may be necessary. 

q      UNSATISFACTORY RESULT: There is the possibility of an unsatisfactory result from these procedures. COBLATION treatment procedures may result in unacceptable visible deformities, skin slough, loss of function, and permanent color changes in the skin. You may be disappointed with the final result from COBLATION treatments.

q      SKIN CANCER/SKIN DISORDERS: COBLATION skin treatment procedures may not offer protection against developing skin cancer or skin disorders in the future.

q      PAIN: Very infrequently, chronic pain may occur after COBLATION skin treatment procedures.

q      LACK OF PERMANENT RESULTS: COBLATION or other treatments may not completely improve or prevent future skin disorders, lesions, or wrinkles.  No technique can reverse the signs of skin aging.  Additional surgical procedures may be necessary to further tighten loose skin.

q      DELAYED HEALING: It may take longer than anticipated for healing to occur after COBLATION treatments.  Skin healing may result in thin, easily injured skin.  This is different from the normal redness in skin after a COBLATION treatment.

q      UNKNOWN RISKS:  There is the possibility that additional risk factors of COBLATION skin treatments may be discovered.  The results of performing skin tightening surgery and COBLATION treatments is unknown in terms of the combination effect of the two procedures and potential complications, depending on the area treated.

q      ALTERNATIVES:  Alternative forms of treatment include not undergoing the proposed COBLATION skin treatment procedure. Other forms of skin treatment (chemical peel) or surgical procedures (dermabrasion or excisional surgery) may be substituted. 

q      In certain situations, the COBLATION process may offer a specific therapeutic advantage over other forms of treatment.  Alternatively, COBLATION procedures in some situations may not represent a better alternative to other forms of surgery or skin treatment when indicated. Risks and potential complications are associated with alternative forms of treatment that involve skin treatment(s) or surgical procedures.