Cosmetic facial fillers, which can plump thin lips or erase wrinkles, can go badly and tragically wrong, the Food and Drug Administration warned Thursday.
If the materials used to fill the skin get into a blood vessel, they can cause a stroke, blindness, or kill off big patches of skin, the FDA says in a new warning.
“Unintentional injection can block blood vessels and restrict blood supply to tissues,” the FDA says in its warning to consumers and doctors.
“Unintentional injection can block blood vessels and restrict blood supply to tissues."
“Soft tissue fillers should be injected only by health care providers who have appropriate training and experience and who are knowledgeable about the anatomy at and around the injection site,” it adds.
The places most likely to cause trouble: the skin between the eyebrows and nose (called the glabella), in and around the nose, forehead, and around the eyes.
A team led by Cemile Nurdan Ozturk of the Cleveland Clinic found reports about 61 patients who had severe complications from facial filler procedures, including dead tissue in the nose.
Some of the materials in these fillers include hyaluronic acid, which is the main ingredient in products sold under brand names Restylane, Perlane and Juvederm. They’re injected into wrinkles around the mouth, used to fill out deep scars and pock marks and to plump lips.
A product called Radiesse is made using calcium hydroxyapatite and another called Sculptra uses poly-L-lactic acid, which are both designed to stimulate natural collagen production. Some providers use fat taken from elsewhere in the body.
One study published in the journal Plastic and Reconstructive Surgery found that these autologous fat injections were the most likely to cause permanent blindness. “Some cases of partial visual recovery have been reported with hyaluronic acid and calcium hydroxylapatite fillers,” the researchers wrote.
FDA says patients need to take care to go to providers who know what they are doing.
“Before deciding to have soft tissue filler injections, talk with your health care provider about appropriate treatment injection sites and the risks associated with the procedure,” the agency advises
"Ask your health care provider about their training and experience injecting soft tissue fillers in the face.”
“Be aware that FDA reviewed and approved different products for use in certain areas of the face. The FDA may not have reviewed the use of certain soft tissue fillers for all locations in the body. Ask your health care provider about their training and experience injecting soft tissue fillers in the face.”
Many experts complain that non-specialists, even dentists, are starting to offer these procedures and products.
One product that doesn't have this particular problem is Botox, although fake Botox can cause its own problems. Injected incorrectly, Botox, which uses a natural toxin to freeze muscle temporarily, can cause permanent nerve damage.