Risks involved with the use of soft tissue fillers

Risks involved with

the use of soft tissue fillers

(Dermal Fillers)Dr. Mohammad Baghaei

Pharmacist & Cosmetic Scientist Reference : FDA

Risks involved with the use of soft tissue fillers

Soft Tissue Fillers, also known as injectable implants, dermal fillers, or wrinkle fillers are medical device implants approved by the Food and Drug Administration (FDA) for use in helping to create a smoother and/or fuller appearance in the face, including nasolabial folds, cheeks and lips and for increasing the volume of the back of the hand.

Dr. Mohammad Baghaei Pharmacist & Cosmetic Scientist

Reference : FDA


Risks

As in any medical procedure, there are risks involved with the use of soft tissue fillers. That is why it is important for you to understand their limits and possible risks.

Any soft tissue filler can cause long-term side effects, permanent side effects, or both. However, most side effects associated with soft tissue fillers happen shortly after injection and most go away in less than two weeks. Swelling and pain after hand treatment may last a month or more. In some cases side effects may appear weeks, months or years after injection.

Allergy testing is required for particular types of filler materials, such as those taken from animals (e.g., cows, rooster combs).


Reference : FDA


The following risks are for FDA-approved uses of Soft Tissue Fillers. The risks associated with unapproved uses are not known.

Bruising

Redness

Swelling

Pain

Tenderness

Itching, rash

Difficulty in performing activities (only observed when injected into the back of the hand)


Reference : FDA


Less common side effects include:

Raised bumps in or under the skin (nodules or granulomas) that may need to be surgically removed

Infection

Open or draining wounds

A sore at the injection site

Allergic reaction

Necrosis (tissue death)


Reference : FDA


The following rare side effects have also been reported to FDA:

Severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance

Migration/ movement of filler material from the site of injection

Leakage or rupture of the filler material at the injection site or through the skin (which may result from tissue reaction or infection)

The formation of permanent hard nodules in the face or hand

Vision abnormalities, including blindness

Stroke

Injury to the blood supply,

Damage to the skin or the lips


Reference : FDA


If you choose to have these fillers removed through surgery, you may experience the same adverse events typically associated with surgery. You should be aware that it may be difficult to remove the filler material.


Reference : FDA


You should NOT use some of these products if any of the following applies:• Your skin is inflamed or infected. If you have an active inflammatory condition, (cysts,

pimples, rashes, or hives) or infection, soft tissue filler injection should be delayed until this inflammatory condition has been managed.

• You have a bleeding disorder.• You have severe allergies or have a history of anaphylaxis (acute allergic reaction).• You are allergic to collagen or eggs (when considering soft tissue fillers that contain collagen

or egg-derived products).• You are allergic to animal products (when considering soft tissue fillers that contain

materials from animals).• You are allergic to lidocaine (when considering soft tissue fillers that contain lidocaine). • You are allergic to bacteria (when considering soft tissue fillers that contain hyaluronic acid

material derived from bacteria fermentation).• You have joint, tendon, or vascular disease affecting the hand (when considering hand

augmentation).


Reference : FDA

Education

Risks involved with the use of soft tissue fillers