Injectable Fillers – Smart or Not? | BareFacedTruth.com

Injectable Fillers – Smart or Not?


Injectable dermal fillers aka “facelift in a bottle”

The liquid face lift has been popular for years and for understandable reasons – a more youthful appearance with no downtime, no anesthesia, and no going under the knife. There are even house parties devoted to facial treatments that utilize injectables for facial rejuvenation (for obvious reasons BFT does not recommend doing this.)

 

 

Dermal filler injectables are not to be confused with Botox which is not a filler but rather a low concentration of a bacterial toxin that paralyzes facial muscles by preventing the release of neurotransmitters from the nerve endings that in turn cause muscles to contract. Botox eliminates the distortion (i.e. wrinkles) caused by normal facial muscle activity; dermal fillers do their work by filling in the “voids” or loss of volume within the dermis that causes most wrinkles. Fillers are also used to “plump” underlying tissues including subdermal fat that is lost through the aging process. Dermal (and subdermal) fillers can effectively plump, fill, and re-contour the face.

 

In general, dermal fillers are indicated for injection into mid to deep dermis for the correction of moderate to severe wrinkles and folds. Some products have limited indications for use such as correction of nasolabial folds but are contraindicated for injection in areas other than nasolabial folds. Some dermal fillers are also indicated for use to fill areas of acne scars. All dermal fillers are contraindicated for patients with known sensitivities to the filler material, a history of severe allergy or anaphylaxis, and bleeding disorders.

Precautions

The following precautions apply to all dermal fillers. There are additional warnings that may be product specific, such as those related to a particular material composition.

  • Avoid injection into blood vessels or near major vessels as vascular occlusion may occur and can result in tissue necrosis (death).
  • Avoid injection into areas of infections. Injection should be deferred until infection or inflammation has been controlled or resolved.
  • Injection into patients with a history of previous herpetic eruption may be associated with reactivation of the herpes.
  • The safety in patients susceptible to keloid formation, hyperpigmentation and hypertrophic scarring has not been established.
  • Long term safety and effectiveness of the products beyond the duration of clinical studies have not been investigated.

Common side effects include:

Bruising

Redness

Swelling

Pain

Tenderness

Itching

Rash.

 

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)

 

lumps after filler

 

 

herpes simplex after filler

 

 

 

 

 

 

bluish hue after filler

 

 

forehead necrosis after filler

 

 

 

 

 

 

 

 

 

 

 

 

 

Allergy testing is required for particular types of filler materials, such as those taken from cows (bovine). In rare cases, severe allergic reaction (anaphylactic shock) that requires immediate emergency medical assistance can occur.

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

  • 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)
  • Blurred vision and flu-like symptoms

Materials

It is important to know that not all injectable dermal fillers are created equal, and each has specific purposes for which it is best suited. Most injectable wrinkle fillers have a temporary effect, because over time they are absorbed by the body. The FDA has approved only one product made from a material that remains in the body and is not absorbed. Some wrinkle fillers contain lidocaine, which is intended to decrease pain or discomfort related to the injection.

Absorbable materials (temporary)


  • Collagen: Collagen is a type of protein that is a major part of skin and other tissues in the body. Sources of purified collagen used in wrinkle fillers can be from cow (bovine) or human cells. The effects of collagen fillers generally last for 3-4 months. They are the shortest lasting of injectable filler materials.
  • Hyaluronic acid: Hyaluronic acid is a type of sugar (polysaccharide) that is present in body tissues, such as in skin and cartilage. It is able to combine with water and swell when in gel form, causing a wrinkle smoothing effect. Sources of hyaluronic acid used in wrinkle fillers can be from bacteria or rooster combs (avian). In some cases, hyaluronic acid used in wrinkle fillers is chemically modified (crosslinked) to make it last longer in the body. The effects of this material last approximately 6 – 12 months.
  • Calcium hydroxylapatite: Calcium hydroxylapatite is a type of mineral that is commonly found in human teeth and bones. For wrinkle filling, calcium hydroxylapatite particles are suspended in a gel-like solution and then injected into the wrinkle. The effects of this material last approximately 18 months.
  • Poly-L-lactic acid (PLLA): PLLA is a biodegradable, biocompatible man-made polymer. This material has wide uses in absorbable stitches and bone screws. PLLA is a long lasting filler material that is given in a series of injections over a period of several months. The effects of PLLA generally become increasingly apparent over time (over a period of several weeks) and its effects may last up to 2 years.

Non-absorbable materials (permanent)

  • Polymethylmethacrylate beads (PMMA microspheres): PMMA is a non-biodegradable, biocompatible, man-made polymer. This material is used in other medical devices, such as bone cement and intraocular lenses. PMMA beads are tiny, round, smooth particles that are not absorbed by the body. For wrinkle filling, PMMA beads are suspended in a gel-like solution that contains cow (bovine) collagen and injected into the wrinkle. These products are for use only in treatment of nasolabial folds ( also called “marionette lines”)

Autologous Fat
Autologous fat is fat harvested from one’s own body. Its use eliminates the risks of allergic reaction or rejection by the body, since it is one’s own tissue. However, not all of the live fat cells survive when transplanted into the new site, so a fairly high rate of re-absorption is to be expected. Because of this, the physician will usually overfill the area being treated, which can leave the patient with a result that may look — at least temporarily — abnormal.

The Commercial Fillers (not an inclusive list)

Juvederm is a dermal filler used to fill and smooth moderate to severe facial wrinkles and folds. It is available in modified versions which are useful for adding volume to lift and contour the face. Juvederm is made of hyaluronic acid, a natural substance in the body that helps maintain skin volume and hydration as well as joint lubrication and cushioning. Hyaluronic acid retains moisture, absorbing more than 1,000 times its weight in water. It also binds with collagen and elastin, transporting essential nutrients to these fibers which make up much of the support structure of the skin. The hyaluronic acid in Juvederm and the other dermal fillers listed here is not derived from animal sources.

Restylane is also made from hyaluronic acid, but is used mostly for moderate facial lines and wrinkles as opposed to lifting and contouring purposes. Restylane is often used in conjunction with Botox to enhance and extend the life of results.

Perlane is made by the same company (and from the same hyaluronic acid) as Restylane. The difference is that the gel particles are larger and, therefore, Perlane is more effective at filling in deeper folds and achieving increases in facial fullness. Perlane is also often used to augment lips and other areas of the face that could benefit from a restoration of youthful volume.

Radiesse is made from calcium-based microspheres (hydroxyapatite) suspended in a water-based gel. Radiesse provides both immediate and extended results because it stimulates production of collagen and encourages tissue regeneration. It is most commonly used for the smoothing of nasolabial folds and marionette lines, for cheek augmentation, and to plump up sunken areas below the eyes.

Artefill is the first and only non-reabsorbable dermal filler to be approved by the FDA. Its claim to fame is that it provides a permanent support structure for lasting wrinkle correction, which means that its effects are both immediate and long-term. Artefill is made of polymethylmethacrylate (PMMA) microspheres, a material that has been used for years in surgical implants. However, since it is not a natural substance, there is a risk of allergic reaction. Because the results are considered to be permanent, physicians using Artefill generally prefer to under-fill on the first treatment, adding more at a subsequent appointment, if needed. Generally, full results are seen within six months of the procedure.

Sculptra is generally used as a treatment for facial lipoatrophy, the loss of fat beneath the skin that sometimes causes sunken cheeks, indentations, and hollow eyes. The main component of Sculptra is poly-L-lactic acid, a bio-compatible substance that does not cause damage to surrounding tissues. Unlike other dermal fillers, Sculptra does not produce immediate results. It works by stimulating collagen production, so results appear gradually over a period of a few months. Three to five treatments are usually required, and results can last up to two years or more

So,  are injectable fillers a smart thing to do?  Or not?

We cannot answer that for you, but we can (and have) pointed out the risks & benefits. We report – you decide.

There is a corollary question – do any smart people use fillers?  We cannot answer that either (we could find no clinical trials measuring both intelligence and outcomes for any aesthetic procedure). However, with the magic of Photoshop, we can at least imagine the possibility!

 

BFT thinks this smartie looks better with wrinkles, but that may be because he seems to be suffering post-procedure dyspigmentation.

 

 

References

Gladstone, H. & Cohen, J. Adverse Effects When Injecting Facial Fillers. Seminars in Cutaneous Medicine and Surgery, Volume 26, Issue 1, March 2007, Pages 34–39

8 Comments

  1. Kath says:

    Thanks for the quick reference guide. Someone interested in “doing” fillers would have to do a bit of online searching, I think, to find side effect pics as shown here. I think, maybe, curious people hear or may be told about side effects but seeing the pics of them may really make a brain stand at attention. But I’m sure those who’ve taken the filler route really believe the risks are really minimal anyway i.e. everything you do has side effects anyway.

  2. Dennis says:

    How do you guys feel about permanent silicone implants, such as submalar cheek implants?

    • drgeorge says:

      Permanent implantable silicone devices have a long history of safe and successful use in esthetic medicine, particularly in restoring shape following traumatic loss of tissue, or where a defect is congenital. These are typically molded into a relatively firm shape and are in no way similar to the soft jelly-like silicone encased in a plastic envelope used in breast implants. The complications from such devices are post-operative bleeding with hematoma (blood clot) formations, infection, local tissue erosion including of the skin, or migration out of position. Experienced surgeons with very low complication rates operating in accredited operating facilities should be sought out. Each case is different. Hope this helps.

  3. SavvyGo says:

    Smart people do facial exercises! They are extremely effective in shortening muscles that are slack from gravity and un-use. There is a woman in her 80’s and two in their 60’s that look 20 years younger that have great facial exercise programs: Eva Fraser, Carole Maggio, & Carolyn’s Facial Fitness. I don’t understand why everyone isn’t doing these exercises, it’s only 15 minutes a day!!!! I just found out about them and cannot believe I did not know about them. Why isn’t everyone doing them? I guess it’s the same reason people don’t exercise their bodies.

  4. Louise B Andrew says:

    Interesting post, and I love the illustrations, especially the first few.

    I do agree that Einstein looks better pre treatment, but that is because we have all grown to know and love his face (which I believe was one of the models used for ET). If it was a woman, I’m sure we’d have a different reaction… maybe Eleanor Roosevelt would look better uncorrected, but she was never really a “looker”, rather a doer and thinker.

    I have one correction, you state at one point in the PMMA discussion “nasolabial folds ( also called “marionette lines”)”…in fact, marionette lines are “melomental folds”, below the mouth. I’m sure you can find a great graphic to illustrate. Later you use the terms nasolabial folds and marionette lines, so obviously you know the difference.

    Then I have a question. Have you heard of Ellanse? Polycaprolactone, which has been FDA approved and used for years as an absorbably suture and I believe for several other indications.
    I understand that it has been in use in Australia, NZ, Europe and Israel as a facial filler for years and is the only filler that has been actually demonstrated by MRI to increase facial volume over its (extended) duration, unlike even calcium hydroxyapatite that shows volume loss almost as soon as the initial edema has subsided, despite CHA’s purported ability to stimulate collagen production.

    For some reason, its FDA approval as a filler is now languishing 3 years after it was anticipated, so it is still not available legally in North America.

    Since Ellanse can last up to 4 years, I strongly suspect that the makers of 3 month to 1 year HA type fillers may be influencing FDA (pharma funded) decisionmakers. But this is of course a scientific and not a political forum.

    Can you help to enlighten us on the possible science behind polycaprolactone as a semi-permanent filler? Or any anticipatable hazards, other than of course the permanency factor if not used correctly? It would seem in many ways to be ideal.

    Thanks!

    • drgeorge says:

      Louis, thank you for your thoughtful question. By the way, I know well the difference between nasolabial folds and marionette lines. My mirror instructs me more and more about them with each passing year. As to your question about polycaprolactone as a filler, some background about biomedical polymers for our readers.

      Absorbable synthetic polymers have played an important role in the advancements of modern medicine. Being biodegradable they have the advantage of being broken down and absorbed over time, removing them after they have served their function. They are used in sutures, drug delivery devices, bone plates, implantable mesh, suture anchors, and the like. Use of synthetic degradable polymers began in the 1960’s.

      Degradable polymers possess labile chemical bonds that can be broken down via hydrolysis, the addition of a water molecule. Several types of chemical bonds are susceptible including esters, anhydrides, acetals, carbonates, amides, urethanes and phosphates. A major feature that determines the suitability of a particular polymer for biologic use is the rate of degradation.

      In addition, other important properties must be considered. The material must (1) not evoke a sustained inflammatory response; (2) possess a degradation time coinciding with their function; (3) have appropriate mechanical properties for their intended use; (4) produce non-toxic degradation products that can be readily resorbed or excreted; and (5) include appropriate permeability and processability for designed application.

      Polycaprolactone has a 40 year history of safe use in biomedical applications. It has been approved by the FDA of use in drug delivery devices, suture, adhesion barriers, and as a scaffold for tissue engineering. Unlike Europe and elsewhere, it has not been approved for use as an injectable volume enhancer, despite the fact there appears to be several highly favorable characteristics to this polymer.

      1. It is “tunable” as to its duration. This is accomplished by varying the molecular weight of the component polymer used to make the filler. Products with durations of 1, 2, 3, and 4 years are available.
      2. Despite differences in durations, the ease of injection is similar and surprisingly easy compared to other filler products with higher viscosities. Injection of the different duration polycaprolactone fllers into the skin is described as “almost effortless.”
      3. Animal studies show that the product stimulates production of collagen.

      Of particular interest is polycaprolactones are suitable for use in the burgeoning field of 3-D printers, now used to create objects of very complex shape through repetitious layering of thin 2-D “sheets” one atop another. I wonder if “The Graduate” was looking that far into the future when he was told the future was summed up in one work – “plastics.”

      As to your question about the FDA’s reluctance (refusal?) to approve polycaprolactones for use as volume enhancers and fillers in the U.S., there can be no doubt the political influence of Big Pharma is sizable. It does not strain credulity to impune a possible role being played by these large companies to keep competitors out of the market. That’s one “conspiracy” that seems plausible, perhaps even probable.

  5. Pat says:

    Since you wrote this blog, is there any research out there that has found that the body can eventually reverse facial lipoatrophy, without having to rely on treatments utilizing facial fillers? Thanks.

    • drgeorge says:

      For our readers, a little background before a list of current treatment options. (There is no preventative treatment.)

      Facial lipoatrophy is loss of subcutaneous fat that flattens the convex contour of the face, something that distinguishes the appearances of the young and old looking face. It is part of the normal aging process but can also be a manifestation of chronic diseases. Loss of facial fat in the cheeks, temples and orbits (areas around the eyes) starts to be visible in the early 20’s. By age 30, changes in facial contour begin to become visible.

      Facial volumetric correction includes surgical and dermatological procedures such as autologous adipose (fat) transfer and injectable dermal fillers. Facial fillers involve either the dermis or the hypodermis (subcutaneous space or subcutis). Most facial fillers involve injections into the dermis, to thicken the skin. Some facial fillers involve injections into the subcutis to fill the space once containing fat. Because these layers are only millimeters thick, expertise is required to ensure that the injections are performed safely and that the product is injected or inserted into the correct layer of the dermis.

      Autologous fat transplant
      Fat cells derived by liposuction are sometimes enriched with adipose derived stem cells, which helps promote new blood vessel formation and reduces the rate of fat reabsorption.

      Collagen (Bovine: Zyderm and Zyblast; Human: CosmoDerm and CosmoPlast)
      Collagen has been used for more than 25 years for cosmetic purposes in the United States, most notably as a filler for facial wrinkles. Disadvantages include the need for frequent touch-ups—collagen injections only last two to three months.

      Hyaluronic Acid (Restylane, Restylane SubQ, Perlane, Hylaform)
      Hyaluronic acid is naturally found in human connective tissues. Injections of hyaluronic acid have been shown to last six to 12 months. Over the long term, they remain cheaper than many other products, given that fewer touch-ups are needed. Hyaluronic acid fillers can also be easily reversed by injecting hyaluronidase.

      Calcium hydroxylapatite (Radiesse, Radiance)
      Calcium hydroxylapatite is a natural substance found in bones and teeth. It is primarily used in the reconstruction of bony structures. When it is injected into the dermis layer of skin, natural collagen forms around the calcium hydroxylapatite, providing long-term, natural-looking fullness. Even though it is considered to be a temporary filler, it appears to have a longer lasting effect than most other temporary fillers.

      Poly-l-lactic acid (Sculptra)
      Sculptra is an injectable poly-L-lactic acid (PLA) implant in the form of a sterile lyophilized cake. It contains microparticles of poly-L-lactic acid, a biodegradable synthetic polymer from the alpha-hydroxy-acid family. Even though it is synthetic, it is eventually broken down and removed by the body, meaning that its effects are temporary. Poly-L-lactic acid is injected into the deep dermis or the subcutaneous layer.

      Silicone
      Silicone comes in solid formulations and liquid formulations. Solid silicone, which can be used for cheek and chin implants, “is excellent for correcting bony defects in patients who don’t have prominent cheekbones,”

      Polymethylmethacrylate (PMMA; Artecoll, Artefill)
      PMMA is best known for its use in manufacturing hard contact lenses and Plexiglass. These products contain small particles (microspheres) of PMMA that are surrounded by bovine collagen. Approximately three months after it is injected, the bovine collagen is broken down and removed from the body, but is replaced by natural collagen. The PMMA molecules and the surrounding collagen persist indefinitely. The FDA has indicated that is safe and effective for the correction of facial wrinkles, lines, and furrows, but has not yet officially approved the product.

      Expanded Polytetrafluoroethylene (ePTFE) Implants (Gore-Tex, Gore SAM, SoftForm)
      These solid implants require minor surgery, via a small incision, under local anesthesia. They have been used for many years to help restore deep facial defects and may be useful for HIV-associated lipoatrophy in terms of filling large, sunken areas.

      Polyalkylamide (Bio-Alcamid)
      Polyalkylamide is a synthetic product that can be injected in high volume.

Leave a Comment

UA-45553914-1