Lip Augmentation Risks, Complications and Contraindications

When compared with other elective cosmetic procedures, there are few lip augmentation risks – but there are enough to pay attention and have concern. Lip augmentation risks typically depend on the implant or filler that you choose.

Synthetic Implants: (Gore-Tex, SoftForm, UltraSoft and Advanta)

There can be infection and irritation if the ends of the lip implant are too long for the cavity or not rounded off. The good thing is that it is reversible and can be readily removed. UltraSoft is hollow, allowing your own tissues to grow into the implant. When this tissue growth occurs, infection and rejection are less likely. Extrusion from the body attempting to reject the foreign material, palpability and lessened mobility of the treatment areas are possible. Migration can be an issue as well, although tissue ingrowth can decrease this risk significantly. There may be permanent discolorations from the bruising, possible hematomas resulting in additional surgeries and excessive scarring from delayed healing or trauma. Deformity from excess scar tissue arising from an infection or the hands of an unskilled doctor is also a possibility.

Cadveric and Human Derived Products:

Fascian, AlloDerm, CosmoDerm, CosmoPlast and other forms of cadaveric grafts or tissue derivatives supposedly are absorbed within your body with no after-effects. HIV, AIDS and other infectious diseases are often a concern. Donors and tissue structures are screened thoroughly before processing.

Hyaluronic Acid:

Newer injectable fillers like Restylane, Perlane and Hylaform supposedly have no side effects. However, some patients have reported prolonged swelling and inflammation, and nodules at the injection sites with Perlane.

Hydrophilic Polyacrylamide Gels:

Injectable products made from hydrophilic polyacrylamide gel do have some questionable issues, one being residual unpolymerized acrylamide. Acrylamide is a known carcinogen, mutagen, neurotoxin and also a reproductive toxin. However, the manufacturers do report that the levels are extremely small, less than what you would receive on a daily basis from water and food. The other issue is that bacteria can and does thrive within polyacrylamide implants. Infection is a possibility and may be treated with localized injections of antibiotics, as well as a course of oral antibiotics. Aspiration, and or excision, may be necessary in some cases.

Micro-Implants and Other Permanent Injectables:

Artecoll, Metacrill, silicone and other permanent injectables have their risks as well. Not only can the risks include infection, necrosis, granuloma formation, nidus, severe inflammation, palpability, and extrusion, but the injectables are not easily removed in the event of a problem. If a problem arises, injections of the corticosteroid Kenalog can help alleviate inflammation and reduce fibrous tissue. If the need for repeat injections persists, excision is usually the only option to lessen the amount of product that is triggering an inflammatory response in the tissues. Some surgeons report that that injectable micro-implants, such as Artecoll and Metacrill, tend to have unpredictable inflammatory responses leading to excess scar tissue formation that makes it next to impossible to remove the implants without disfiguring the lips somewhat. Yes, it is impossible to know beforehand who will have a negative response, but it can be dealt with.

Migration

Many of us may be quite concerned with migration of micro-implants such as Artecoll, Bioplastique and Metacrill. Here is an explanation to help you understand what size a substance must be in order to not migrate. Most lower viscosity free silicone, although not proven to cause harm and disorders within the body, are small enough to migrate freely within cell walls and infra-structures. Bioplastique, however, cannot. In order for a substance to remain stationary and be encapsulated by our body's own collagen, its size must be large enough not to be absorbed by the body's cells and vessels and it must not be small enough to be transported to the body's lymph nodes. This could prove dangerous as the particles could cause cells to die off. Bioplastique particles are both large enough and textured, permitting ease of collagen encapsulation (in under 4 weeks). It must be said that while Bioplastique is not approved for lip augmentation in the U.S., it is used off-label for that and soft tissue augmentation both in the U.S. and other countries. It is also used in secondary rhinoplasty and facial contouring.

Silicone Oil

One area of particular concern is the use of silicone oil injections for cosmetic procedures. Injections of silicone oil are not approved for cosmetic use in the United States, period. The Food and Drug Administration has not approved the marketing of liquid silicone for injection for any cosmetic purpose, including the treatment of facial defects or wrinkles or enlarging the breasts. However, the FDA does not prohibit the off-label use of an approved medical device. This means a physician can legally use any FDA approved drug or device, as he or she sees fit, if he or she believes it can effectively treat or cure your complaint.

Such is the case with both Silikon 1000 and Adato Sil-ol 5000 (originally approved under the name "Adatomed Silicone Oil 0P5000"), also known as Adatosil. They are approved only for injection into the vitreous cavity of the eye to treat retinal detachment and/or hemorrhage. The products are intended to help save a person's eyesight and to be aspirated at a later date, once the eye has healed, and not kept inside the body indefinitely. However, doctors do use both products off-label for cosmetic procedures. The FDA prohibits manufacturers or doctors from marketing or promoting unapproved products such as liquid silicone, meaning they cannot legally advertise or sell this material, but can legally offer them to customers/patients.

The injection of silicone oil, and many other injectable tissue augmentation fillers, triggers a foreign body response by the accumulation of phagocytes, macrophages, and lymphocytes in the body. This low grade inflammation causes your body to respond by trying to either break it down, by engulfing the product and moving it to other organs for excretion, or essentially walling it off from your body to lessen the irritation your body is experiencing. The body cannot break down silicone oil, so the lower molecular silicones are engulfed and moved and the higher viscosities remain behind when they are encapsulated. This should only occur in non-homogenized silicone oil products. When your body can't remove it, the macrophage accumulation triggers fibroblasts to begin encapsulating the silicone oil, to guard the rest of the body against the irritant. Imagine the silicone as a grain of sand, and your body as the oyster. The body forms collagen layers around the silicone and eventually augmentation is gained in the form of fibrous tissue. If the body cannot find relief after encapsulating the silicone, it will continue to form more and more collagen around the product, eventually causing a firm nodule. The good thing about encapsulation is that it can help keep the majority of the liquid silicone where it was injected and hinder its migration into the surrounding tissues. Silicone injections depend upon your body's reaction to create augmentation, or in plain English, bigger lips. So remember, the augmentation isn't due to the product itself, so large amounts of silicone oil should not be injected for volume augmentation. The body's inflammatory response triggers the formation of collagen that is the method of augmentation. The amount of collagen formed is dependent upon your own body's sensitivity to the silicone and the purity of the product. Impure oils will cause too much irritation and may cause serious complications.

Questions To Ask Your Physician When Getting Silicone Injections: (Printer-friendly Version)

What is your medical training and title? Are you an M.D., a D.O. an R.N. or a P.A.? Independently verify their credentials, if necessary.
Is silicone oil approved? If the doctor says “yes”, it's a misleading answer because silicone oil is approved for last ditch efforts to stop bleeding in retinal detachments and ocular hemorrhaging. If they say “yes”, ask, "For cosmetic use?" If they say “yes” again, walk out the door. You don't want a liar working on you. If they say no, I usually say nothing.
How long have you been injecting silicone?
What type/brand of silicone have you worked with in the past and what do you prefer and use now? Remember which products are approved for injection into the human body. Also, if they simply say Silicone 1000, ask who manufactures it. Silicone 1000 only indicates that it is a 1000 centistoke silicone oil. Even if they say it is medical grade, there are medical grades that are intended to lubricate cutting surfaces, not to be injected into the body. One such oil is Dow-Corning 360 Medical Fluid. This oil is not intended for injection into the body. It is a cheaper alternative that many illegal injectors use on their clients.
Have any of your patients had problems with granulomas, severe inflammation or migration?
Does migration occur over time?
What's the longest you have been in contact with one of your patients post-treatment?
Can silicone be safely injected over other products and vice versa?
What do you use for pain relief? EMLA, regional (field block, dental block), local only?
What can I expect during the procedure?
How many cc/ml do you think I will need for my particular procedure?
How much do you charge per cc/ml? This is important. If you are charged per treatment, how much per treatment?
How much can be injected in one area without disrupting vascularity, causing migration and other problems? It is reported no more than .5 to .7 cc/ml per treatment on average for a set of lips should be injected. But, I have also seen others claim no more than .2 cc/ml per lip should be injected at a time.
How many cc/ml do you inject per treatment?
What if I need only .5 cc/ml at one point, am I charged for the whole cc?
Do you use a tunneling technique in the vermilion border? Do you use a microdroplet or other technique?
Will you be crossing the midline? Crossing the lower midline can cause an unnatural look in a lot of people, but this depends on what you personally find attractive.
What can I expect post-treatment?
What post-treatment instructions must I follow?
Do you recommend massage or does this increase the risk of migration?
Do you recommend taping?
Do you recommend flossing the midline of the lower lip each night to create a "pillow"? This is done by placing a piece of floss between your bottom front teeth, pulling it slightly taut over the midline of your lower lip and taping it to your chin. This creates a very slight indentation in the middle of the lower lip that many refer to as a pillow.]
How long must I wait between treatments? Three months is usually best, 4 is even better. You must wait until your collagen has stopped forming to truly know your needs after each treatment. Going too fast can result in overfilled lips and may lead to "lip greed". This occurs when you become accustomed to the swelling and when it subsides your result is eventually a little smaller than it was from the initial treatment (although it will grow, or fluff), prompting you to want more. Take before-and-after photos to judge your overall facial balance before demanding more. You do not want to look like a fish.
If I have a problem, what treatment options do you offer (Kenalog, excision, etc.)?
If no treatments are offered at your practice, who can help me if my lips need to be reduced or the implant needs to be removed?

Where Not to Get Silicone Injections

Liquid silicone can be found in the U.S. on the black market, as well as at salons and from traveling injectors using non-medical and medical grades intended for lubrication of surgical instruments. The term “medical grade” does not equal “intended for use in human injection.” I implore you not go to any of these places to get silicone injections for any reason. There is no quality control, sterility is questionable and if the person is operating outside of a medical office, there is a reason. Please do not choose to get silicone injections from an unlicensed person, in a hotel, in a salon, at someone's home, or at your own home. Always be sure what you are getting. Do not take their word for it. Always insist on seeing the packaging and the updraw. It is best to ask about this in advance so you do not waste your time if the person shows up with pre-filled syringes of questionable product.

If you still want to get silicone injections, please research your physician extensively and follow up on his or her credentials. Please view updated photos (dated if possible) of the physician's past patients. Also ask what type of silicone they are using and ask to see the vial. The most commonly used products are Silikon 1000 or Adatosil 5000. Dow-Corning does not make a silicone oil intended for injection into the human body, no matter what the person says.

Contraindications of Most Lip Enhancing Procedures

Any of the following may mean you are not a good candidate for lip augmentation:

Use of Accutane for six months prior or following the procedure. Accutane may increase your chances of keloid-like scarring.
Collagen/scarring/connective tissue disorders
Lupus in patients seeking bovine or porcine collage. Other products may cause flare-ups as well.
Active diseases, like diabetes, may affect outcome or increase risks
Problems with clotting
Excessive oral plaque or dental abscesses

Also a consideration for lip augmentation is the beauty of your smile. If you have decided to invest in improving the appearance of your lips, you may want to visit a dentist to learn more about how to enhance your teeth. Visit the Consumer Guide to Dentistry to find local dentists and learn about Invisalign invisible braces. Sometimes, the dentist and plastic surgeons work together to craft a complete solution for your smile and lips makeover.