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Biofilm Complications in Dermal Fillers

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on 16 November 2013

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Transcript of Biofilm Complications in Dermal Fillers

Recommendations and Treatment Options for Nodules and Other Filler Complications
Rhoda S. Narins, MD, William P. Coleman, III, MD, and Richard G. Glogau, MD
Biofilms and Fillers
Preventative Measures
The causes of biofilms relate to both the types of fillers injected or present from previous treatments and / or a breach in technique as it relates to sufficient reduction in the biological burden before treatment; simple preventative measure may reduce this risk.

A good history is always important to reveal which previous fillers have been injected into the patient, possible bleeding disorders, immunocompromised state, and previous infections.

Adherence to aseptic measure should be followed, even more so for permanent fillers.

Prophylactic antibiotics have been suggested to prevent biofilms in situations where semipermanent or permanent fillers are used initially or later during significant infections.

Smaller gauge needles should be used to minimize trauma and access for bacteria. Patients should be advised to avoid makeup immediately before and after injection.

Evidence of biofilms have been found as early as 10 hours after infection. Once biofilms have been formed they are extremely difficult, if not impossible, to completely eradicate.

The most common example of biofilms is dental plaque. Biofilms are estimated to account for up to 80 percent of all infections.

They are less conspicuous to the immune system and produce substances that individual bacteria are unable to produce alone.

They may interfere with macrophage phagocytosis, and allow for up to 1000-fold resistance to antibiotics, which demonstrates a high degree of specificity and activity when used against bacteria in the non-biofilm state.

The adhesive extracellular matrix traps leucocytes, making them ineffective through immobility.

Biofilm populations can shift from active to dormant depending on exogenous threats. When bacterial proteins turn off cell metabolism and the cell becomes dormant, it becomes antibiotic resistant, as well as difficult, if not impossible to culture. This explains why we have for so long failed to recognize these lumps occurring after filler injections as infections.
Biofilms are:
... defined as a structured community of microorganisms encapsulated within a self-developed polymeric matrix and irreversibly adherent to a living or inert surface.

... also often characterized by surface attachment, structural heterogeniety, genetic diversity, complex community interactions, and an extracellular matrix of polymeric substances.

... characteristics of biofilms essentially make them their own organism, if not superorganism. They respond to stimuli, grow, and maintain a homeostatic environment.

Bacteria may account for up to 95% of the biomass of a biofilm, which forms when planktonic, free floating bacteria adhere to a surface and become sessile.

Many biofilms are almost impossible to culture using current standard microbiology culture technology.
The heterogeneity and channels of a mature biofilm
Risk Factors
Stacking of fillers, especially permanent on top of permanent
Large volume injections
- These have been associated with more inflammation and granuloma formation.

Inappropriate plane of placement is the most common error

Avoid injecting during acne or any other infections. Skin related problem areas should be approached with caution.

Injection of the tear trough may be problematic if lymphatics are blocked.

The lips may actually be the highest risk area for potential biofilm because of the proximity of the oral flora, with over 500 species of bacteria.

Fillers most susceptible to complications from biofilms are combination gels, but Radiesse and homogeneous gels such as silicone and the polyacrylamides may also do so, especially if adulterated or injected in large volumes.
Management of Complications
Determine injected substance before treatment.
Culture should be be immediately sent to lab, to avoid changes, and monitored for up to 21 days for routine culture and atypical infection.
Steroids should only be used if patients are already on antibiotic treatment as steroids can make the inflammation much worse by further activating the biofilm.
If hyaluronidase and steroid treatment is ineffective, the filler can be excised either with a small incision, or by needle extraction.
Soft-Tissue Filler Complications: The Important Role of Biofilms
Rod J. Rohrich, MD, Gary Monheit, MD, Alexander T. Nguyen, MD, Spencer A. Brown, PhD, Steven Fagien, MD
Biofilms and The Immune System
The cause of foreign-body granulomas after soft-tissue filler injection has been hypothesized to be attributable to implantation in one session of volumes that are too large, impurities in the agent, or irregularities of the filler surface, but the impact of biofilms has yet to be established.

All fillers, especially long-lasting products, have the potential for biofilm complications, including granulomas, nodules, inflammation, abscess, and delayed reactions.

As with all other indwelling foreign bodies, biofilms are suspected to be the underlying cause of delayed complications for soft-tissue fillers.

Anecdotally, patients with chronic sinusitis, chronic dental problems, or other infections may have a greater tendency to develop an infection after a filler is injected in the periorbital area or central face. These patients also may be prone to formation of a biofilm around or in the implant caused by injection trauma around the site of a previous filler injection. Many problems that were previously assumed to be foreign body granulomas or allergic reactions on the basis of negative bacterial cultures are now thought to be due to biofilms.

Delayed complications. (Left) The patient exhibits nonfluctuant inflammation following hyaluronic acid to the lips. She was successfully treated sequentially with an antibiotic regimen, hyaluronidase, intralesional steriods, and eventual transoral excision. (Right) The appearance of the patient six months post treatment.
Case Study 1
Case Study 2
- A potential complication to all fillers.
- Affected by needle size, location of injection, and type of filler.
- Thin, delicate skin such as the eyelids or the lips may be more likely to show ecchymosis.
- Using a 30-gauge rather than a 27-gauge if possible
- Minimizing the number of needle punctures by careful linear advancement of the needle
- Avoid medications such as aspirin ibuprofen, or other anticoagulants, also herbal supplements such as fish oil, glucosamine, or chondroitin, ideally stop all OTC analgesics and herbal supplements 2 weeks prior to injection.
- Pretreatment and posttreatment icing, Arnica, and bromelain, and immediate ice and pressure to reduce the extent
- HA fillers bind and hold water and cause more swelling than do other classes of fillers.
- 86% incidence of swelling with Juvederm. Poly-L-lactic acid shows a 4 - 7 % incidence
- Edema is typically localized and self-limiting, most noticeable around the eyes and lips, and duck lips are commonly related to fluid retention after injection.
- Posttreatment ice application and head elevation may help
- A short prednisolone taper or antihistamines can help.

- Formation of lumps can be due the the consistency of the filler, reaction to the product, or poor technique. These are usually palpable but not visible.
- Nodules may be noted immediately after the injection or several months after.
- Minimize the occurrence of nodules by ensuring needle is at appropriate depth before injecting, and stop injecting before retraction of the needle.
- Thicker substances should be injected only in mid to deep dermis.
- Nodules resulting from inflammation may respond to intralesional steroids and massage.
- Incising, squeezing or surgically excising the nodule may be required
- Visible ridges seen after injection may represent too superficial a plane.
- Massage and 'scraping' the skin with the fingernail may help disburse the filler and even the contour if identified soon after the injection.
- Redness after injection is common, especiallyif massage is performed immediately after filler placement
- Antihistamines may help control the redness resulting from the initial skin response.
- Injections performed too superficially may also increase the possibility of redness
- Significant erythema may herald necrosis or infection and should be observed
- Mild redness that is prolonged and troublesome can be treated with IPL or intralesional steroids. Light treatmentshave not been shown to diminish the longevity of fillers or increase complications
- some amount of pain during and after injection is common and can be prevented with topical numbing and / or nerve blocks. Topicals should be applied 20 - 40 minutes prior to injection
- A block of the infraorbital and mental nerve with 2% lidocaine with 1;100,000 epinephrine will greatly minimize discomfort.
- the degree of pain is related to the needle size, injection site, filler material and volume introduced.
- The central upper lip and peri-alar regions are quite sensitive, and dental blocks serve well to minimize discomfort
- Some fillers such as calcium hydroxylapatite cause a stinging that may last for hours
- Injections containing lidocaine may minimize posttreatment discomfort
- Significant pain after injection may herald a complication such as abscess or allergic reaction and should be evaluated promptly
- skin necrosis is a well-known complication that has a predilection for certain 'danger zones'. The dorsal nasal artery may cause compromise of skin at the alar region. The supratrochlear vessels are though to be involved in glabellar necrosis.
- Necrosis is heralded by an immediate blanch or color change upon injection, followed by bluish discoloration over the subsequent days. Pustules and necrosis of the skin may ensue.
- Early intervention can help reduce the most feared complication of unsightly skin loss and scarring.
- Injection with a static needle has been attributed to have been related to this complication; injection with needle advancement may lower the risk.
- Upon immediate recognition of intraarterial injection, nitroglycerin paste should be applied to minimize the ischemic effects of the injection.
- It is recommended that filler injections for the glabella be considered for experienced injectors only
- Collagen and hyaluronic acid are commonly injected in the lips. Filler injections in the peri-oral area can induce cold sore formation by reactivation of the latent virus. Stress, swelling, and massage may also contribute.
- Patients with a strong history of cold sore activation or those who have had cold sores with prior injections should be pretreated with an antiviral such as acyclovir.
- Immediate reaction and prompt treatment of cold sore activation may minimize the severity and length of symptoms

- Infection is fortunately quite rare after filler injection.
- Localized cellulitis may occur if filler is injected in an acutely inflamed area, such as skin with active acneic breakouts. Focal or systemic infections should be considered a contraindication to injection.
- Oral intibiotics that cover Streptococcus and Staphylococcus are the mainstay of treatment.
- Focal abscesses may result from inadequate cleansing of the skin or reactivity to the injectable. Such cystic pockets must be opened with a large needle or small blade and drained.
- True allergic reactions are quite rare with HA, calcium hydroxylapatite, and poly-L-lactic acid.
- Allergic reactions have been noted in bovine collagen fillers such as ArteFill, and Elevess, an HA filler with lidocaine and sulfites.
- immediate allergic reactions are manifected by significant swelling, itching and pain. Swelling may involve the oral cavity, lips, and tongue, depending on the severity of reaction and location of injection.
- Patients should be assessed for patency of airway in severe reactions. Hospitalization is seldom required, but allergic reactions remain the most common cause of hospital admission after filler injection
- A steroid taper combined with antihistamines remain effective in teating acute allergic reactions.
- Patients should avoid future reinjection of the same class of fillers without prior skin testing and allergy treatment. Delayed reactions related to hypersensitivity may occur months to years after injection.
- Granuloma formation, lumps, persistent erythema and late onset sterile abscesses may be seen.
- Skin testing for HA is not standard or required by the manufacturer but should be considered in atopic individuals. Despite the rare nature, hypersensitivity to HA of the derivatives of its preparation may still be seen in < 1% of patients injected.
- A granuloma is a form of localized nodular inflammation. It sometimes can be difficult to distinguish between this and a nodule or small cystic abscess.
- Granulomas typically appear late, months to years after injection, and remain localized to the injection site. They are typically soft, and dark red or purple.
- Biopsy may be necessary to rule out infectious processes, but surgical treatment is seldom effective. Intralesional steroids remain the mainstay of granuloma treatment. Other options, such as oral steroids, pulsed dye laser, or intralesional injections of bleomycin or allopurinol remain anecdotal.
- Patient counselling, and management of patient expectations can help prevent dissatisfaction. Discuss recommended number of syringes to be used, the possibility that more or less will be required, and the cost involved.
- Achieving "full" correction may help the product achieve greater longevity. Touch-up corrections may help achieve best correction after resolution of swelling. An expectation of some degree of swelling after injection may encourage physicians to assess the correction after several weeks.
- Injecting in the appropriate dermal level will optimize results. Injections in the subdermal fat will provide little correction and will be short-lived. Ensuring that the needle is not visible through the skin but can still be 'tented' downward will help ensure proper needle placement in the mid to deep dermis.
- There is great variability in filler longevity from patient to patient, and averages are the best reasonable expectation to counsel. A short longevity with one HA filler does not necessarily mean another brand will have the same brevity of duration.
- Perhaps the most dreaded complication because of its unsightly nature and permanence, a scar can result from an injection or a complication thereof.
- Hypertrophic scarring and keloid formation remain rare but have anecdotally been seen after filler injections.
- Treatment of scars includes intralesional steroid, pulsed dye laser or IPL treatments, pressure, and silicone. Excision of unsightly mature scars may be required to improve the cosmetic outcome.
- The safety of fillers in patients prone to hypertrophic scars and keloid formation has not been well studied, and darker skin types have been underrepresented in controlled trials for fillers.
- Filler placement can induce skin discoloration, especially if placed too superficially. A bluish discoloration of the lower eyelid after tear-trough injection is frequently seen but typically resolves with filler dissipation. It is not clear if this represents visible filler or is simply the skin color and vascularity becoming more prominent.
- True hyperpigmentation or hypopigmentation can result from localized inflammation, infection, or too superficial an injection.
- Hyperpigmentation can be improved with topical 4% hydroquinone, with or without the addition of topical tretinoin and steroids. IPL therapy may also minimize spotchy areas of darkened skin.
- Hypopigmentation is difficult to treat. Surrounding skin color can be blended with bleaching creams, laser treatment or chemical peels.
- Hyperpigmentation and hypopigmentation in Fitzpatrick Types IV to VI have not been well studied, as they tend to be underrepresented in clinical skin trials.
The Management of Filler Complications
Catherine P. Winslow, MD, FACS
Day 1
32 year old female, fillers augmentation for mid cheek, dorsum of nose and brow lifting on 20th December 2012.
No immediate complication post-treatment

Follow up consultation at +2 weeks and +4 weeks normal and uneventful
Post treatment 3 months
Presented 25th March 2013 with sudden onset swelling of left cheek and dorsum of nose with hard palpable localized nodule. Patient reported UTI, mild cold sores and stye on left eye one month prior to swelling. On 26th March patient returned with right cheek and left medial eyebrow swelling.
27th March 2013
29th March 2013
8th April 2013
Case Studies - BWMC
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