Silicone does have a role in the medical field. Silicone is used in surgical dressing, implants, and ointments for scar treatment. In addition, the FDA approved liquid silicone in 1994 for the management of retinal detachment caused by a cytomegalovirus in patients suffering of AIDS. In 1997, the first commercial formulation using liquid silicone was approved by the FDA under the name of Silikon 1000 ( Alcon, USA). Subsequently, in 2001, the FDA approved another commercial formulation called Adatosil 5000 (Baush and Lamb) for the same ophthalmologic indications.
If the FDA approved the liquid silicone, it must me safe to use it anywhere? Sign me on! Not so fast. According to Alcon USA, Silikon 1000 and Adatosil are indicated for use as a prolonged retinal tamponade in selected cases of complicated retinal detachments where other interventions are not appropriate for patient management. In addition, even for this specific indication, the silicone oil is intended to be removed after maintenance of retinal reattachment in order to minimize significant eye complications.
Silicone is not even approved for cosmetics purposes including butt, breasts, or any soft tissue augmentation. Really? Yes, really… So why do some license practitioners use silicone for facial augmentation and wrinkle reductions and don’t get into trouble? The FDA allows the use off label of any product for any condition as described in the Food and Drug Administration Modernization Act Amendment of 1997:
FOOD AND DRUG ADMINISTRATION MODERIZATION ACT OF 1997 SEC. 214. PRACTICE OF MEDICINE. Chapter IX is amended by adding at the end the following: <<NOTE: 21 USC 396.>> “SEC. 906. PRACTICE OF MEDICINE.
“Nothing in this Act shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that is part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.”
In simple words, it is legal for any license practitioner to use silicone if he or she believes this will be beneficial to you for the treatment or management of your condition. The FDA has no power directly over the practice of medicine.
This is why I am writing these blogs about liquid silicone injection. Because there is a loop hole that allows silicone to be used off label (meaning the use of a product FDA cleared for one indication for a total different application) Scary, doesn’t it? Wait until you read the next few blogs about silicone injection complications.