The FDA is alerting health care providers that injecting soft tissue fillers into a patient’s face may cause vision impairment, blindness, stroke, and damage and/or death of the skin (necrosis) and underlying facial structures. The FDA's alert, directed to dermatologists, plastic surgeons, cosmetic surgeons, ophthalmologists, and neurologists, along with consumers, addresses the possibility of rare, but serious, injuries that may occur due to unintentional injection of soft tissue filler into blood vessels in the face.
Soft tissue fillers, also called dermal fillers, injectable facial implants, or wrinkle fillers, can create a smoother or fuller appearance of the face. They are FDA-approved to reduce the appearance of wrinkles or to augment lips or cheeks. Soft tissue fillers are injected directly into a treatment area. Successful results will depend on the patient’s overall health and skin condition, the skill of the health care provider, the location of injection and the type of filler used. Patients may need more than one injection to get the desirable smoothing/filling effect.
The FDA has reviewed information that suggests unintentional injection of soft tissue fillers into blood vessels in the face can result in rare, but serious side effects. Unintentional injection can block blood vessels and restrict blood supply to tissues. Sometimes this can result in embolization. This means the filler material has traveled to other parts of the body. This can cause vision impairment, blindness, stroke and damage and/or death of the skin and underlying facial structures.
While unintentional injections into blood vessels may occur with injection sites anywhere on the face, the FDA’s review of literature and adverse event reports submitted to the FDA identifies certain injection locations where blood vessel blockage have been reported more often. These sites include the skin between the eyebrows and nose (glabella), in and around the nose, forehead, and around the eyes (periorbital region). The FDA has 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.
Health care providers are asked to not inject soft tissue fillers if they do not have the appropriate training or experience, to thoroughly inform the patient of all risks of the procedure and the specific product that will be used, and to take extra care when injecting the filler—injecting slowly and applying the least amount of pressure necessary. They are asked to immediately stop the injection if a patient exhibits any signs or symptoms associated with injection into a blood vessel, such as changes in vision, signs of a stroke, white appearance (or blanching) of the skin, or unusual pain during or shortly after the procedure. Patients should be told that they should seek immediate medical attention after the procedure if they experience signs and symptoms associated with injection into a blood vessel. Health care providers should educate their office staff about the signs and symptoms of blood vessel blockage and how to make referrals for appropriate medical care.
After reviewing additional information on this subject, the FDA is working with manufacturers to update their labeling. The requests ask that the labeling include additional warnings, precautions, and other statements about the risk of unintentional injection into blood vessels, consistent with the recommendations in this communication, so that both health care providers and patients would have a better understanding of the risks.
The FDA continuously monitors reports of injuries caused by soft tissue fillers. With the increased popularity of soft tissue fillers, more information is available about unintentional injection into blood vessels. While current labeling includes some information about this risk, the FDA believes that additional information can be included in the labeling to better inform health care providers and patients.
See the FDA Medical Device Safety Communication
See also Medical Law Perspectives, September 2012 Report: Cosmetic Surgery Gone Wrong: High Hopes Meet Unexpected Results
See also Medical Law Perspectives, December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death
See also Medical Law Perspectives, April 2012 Report: Using Medical Devices Off-Label: False Claims, Overpromotion, Malpractice, and Other Dangerous Territory