Dr. Mandal offers photos for your viewing and encourages you to make an appointment for a consultation so she can learn your aesthetic surgical goals.

view more »

"For the first time in my life, I do not have bags under my eyes. I am thrilled I am thrilled with the results..."

-LH, West Palm Beach

read more »

Click here to like us on Facebook

Visit our Facebook Page for more information from Dr. Anita Mandal.

Click Here »

Posted: 9:19 a.m. Monday, Jan. 12, 2015

By Anita Mandal, M.D.
Question: A plastic surgeon advised Bellafill® for my under eye hollows. Is Bellafill® safe for my dark circles even if it’s only FDA approved for the nasolabial smile lines?

Answer: Bellafill®, like most injectable fillers, is FDA approved for use in specific facial areas only. However, treatment of other facial areas with Bellafill®, even if not FDA approved, is the norm when it’s a “common practice consistent with the high quality of standards set by the medical profession.”

Bellafill®’s limited FDA approval for injection in the smile line does not mean it cannot be injected in other facial areas. FDA approval is necessary for an injectable filler to be legally used in the U.S. Medical products not FDA approved for any use or area are not used in the U.S. Medical products that are FDA approved for a given area or problem can be used in other facial areas if treating other areas is consistent with “commonly accepted standards of practice.”

While Bellafill® is FDA approved for the nasolabial folds, it is commonly used for hollows in the cheeks, temples, forehead and under eyes, most facial areas and the hands. Treating these areas is consistent with “commonly accepted practice.”

Also, even though the FDA requires a skin allergy test prior to treatment, most high-volume Bellafill® injectors do not administer this test to most patients. Allergic reactions to Bellafill® are very rare, temporary, and a negative test doesn’t mean you won’t have an allergic reaction to treatment.

 

Original Source:

Date of Birth

Enter the characters below:
captcha
*required
Find A Plastic Surgeon
We offer 0% financing to our patients. Visit our financing page to learn more.

click here »

Dr. Mandal's practice is located in the heart of Palm Beach Gardens. Take a tour!

click here »

Click here to ask Dr. Mandal a question and she will personally get back to you (no fees given via e-mail).

click here »

Bella Diamond Award