ORIGINAL ARTICLES
Polymethylmethacrylate Facial Implant: A Successful Personal Experience in Brazil for More Than 9 Years
Carvalho Costa, Izelda Maria PHD*; Salaro, Cristina Paula MD†; Costa, Mariana Carvalho MD†
Dermatologic Surgery 35(8):p 1221-1227, August 2009. | DOI: 10.1111/j.1524-4725.2009.01216.x
Abstract
BACKGROUND
Synthetic permanent fillers for soft-tissue augmentation have acquired an important role in cosmetic improvement of patients with facial aging, facial atrophic scars, or lipoatrophy leading to facial defects. Polymethylmethacrylate (PMMA) is a filler introduced to the market as one option for long-lasting treatment. PMMA microspheres are purified, and the particles are larger than 20 μm. The product used as a filler has proven to be safe, effective, and long lasting.
OBJECTIVE
To determine the efficacy and safety of PMMA as a facial filler.
METHODS
Two hundred sixty-six patients (aged 17–72; 154 women) received injections of PMMA to correct facial defects. The number of sessions ranged from one to four, with an interval of 40 to 60 days between applications.
RESULTS
Seventy-nine subjects (30%) had facial atrophy related to HIV infection, 159 (60%) had photoaging signs with deep wrinkles and atrophic areas, 25 (9%) had depressive scars from acne process, and three (1%) had residual depressions from lupus profundus. The results were satisfactory and long lasting. Side effects were transient. No late complications were observed.
CONCLUSION
PMMA used for the treatment of atrophy, depressions, and facial wrinkles has been shown to be effective, long lasting, safe, and gratifying to patients and physicians.
The authors have indicated no significant interest with commercial supporters.
Synthetic permanent fillers for soft-tissue augmentation have acquired an important role in cosmetic improvement of patients with facial aging, facial atrophic scars, or lipoatrophy leading to facial defects. Polymethylmethacrylate (PMMA) is a filler introduced to the market as one option for long-lasting treatment. Although a variety of injectable agents are available for soft-tissue augmentation, no perfect filler material exists. However, injectable fillers are important tools in the arsenal of noninvasive rejuvenating procedures. Since the introduction of bovine collagen in 1981 as an augmentation agent to improve the appearance of facial wrinkles, new agents have been developed concurrently to improve effectiveness and safety parameters.1
PMMA is a permanent filler that achieves immediate and long-lasting results. Its molecule is virtually inert and biocompatible, with no animal component in its structure, making this filler biocompatible and stable decades after it is first implanted. Its structure formerly consisted of heterogeneous microspheres, and thus there was high rate of foreign body granuloma formation. It was discovered that irregularities in particle shape, electrostatic charge, and microsphere diameter less than 20 μm seem to induce granuloma formation. Now PMMA microspheres are purified, and the particles are larger than 20 μm. The product used as a filler has proven to be safe, effective, and long lasting.
Commercially know as Plexiglas, Lucite, or Metacrill, O. Roehm first synthesized PMMA in 1902 and patented it in 1928.2,3 Neurosurgeons and orthopedists use PMMA as a bone cement aggregate, dentists use it in denture bases and dental implants, ophthalmologists replace cataracts with intraocular PMMA lenses, plastic surgeons use it to correct bony facial deformities, and cardiologists have pacemaker cases made of PMMA.4,5 The chains of PMMA have gentamicin (amino-glycoside antibiotic) as one of its components, which has allowed the product to be used on infected wounds since 1974.
Metacrill (private lab, Rio de Janeiro, Brazil), the injectable product used broadly in Brazil and the focus of this study, consists of smooth and round polymerized microspheres of PMMA ranging from 30 to 50 μm in size mixed with a magnesium-carboxy-gluconate-hydrolactic gel. The ratio of microspheres to gel is 3:10. It is presented in 10-mL vials or syringes filled with 1 mL of the product that can be stored at room temperature and are ready to be used. The National Health Surveillance Agency (ANVISA),6 a federal governmental agency with similar responsibilities and duties to FDA (Food and Drug Administration) in the United States, has approved its use in Brazil. Metacrill was first introduced in Brazil for commercial use in February 1996.
The indications for use of PMMA approved by ANVISA include augmentation of nasolabial fold and marionette lines and as an adjunct product to rhinoplasty. PMMA can also be used to camouflage or correct deformities of the nose, chin, malar and mandible area, and ears; depressions of the dorsum of the hands due to photoaging or sequelae of Hansen disease; and facial depression due to lipoatrophy with AIDS.
There are no references in the literature to severe adverse effects of acrylates, such as oncogenicity, based on the observation of several years of practice in orthopedics, for which PMMA has been used as a cement implant in total hip replacement and as a vertebral stabilization agent in patients with osteoporosis.
The literature has demonstrated the efficacy and reliability of products containing PMMA in its structures, such as Artecoll and Artefill, mixed in a bovine collagen vehicle.
These are classified as permanent fillers and consist of microspheres of PMMA ranging from 30 to 42 μm suspended in a solution of 3.5% partially denatured bovine collagen. Such products have been used in Europe since 1994 and in Canada since 1998, mainly as facial implants in correction of deep wrinkles and marionette lines.
Although the bovine collagen that acts as a vehicle for PMMA particles degrades within 1 to 3 months after being injected, the microspheres of PMMA remain in the area and are not reabsorbed. A fibrous tissue is created surrounding the microspheres that becomes a long-lasting filler.
Physicians in several countries around the world have experience with PMMA mixed with collagen, and in 2005, the number of treated patients reached more than 250,000. Side effects may occur. Of these, only 0.01% were of granuloma formation.7,8 Those patients received treatment with corticosteroid intralesional injections, such as triamcinolone acetonide and betamethasone, and responded well.
Recently,9 a woman presented disfiguring facial edema after administration of interferon for hepatitis C. The major affected sites had been treated with PMMA containing the permanent filler Artecoll 10 years earlier. Thus, there is a potential long-term risk of interaction between interferon and a permanent filler, and physicians should be aware of this novel medication interaction.
Materials and Methods
During the past 9 years, we have performed facial implants with Metacrill on 266 patients. The product was obtained from a private commercial company in Brazil.
Exclusion criteria were previous receipt of facial augmentation filling, treatment with anticoagulants or immunosuppressive medication, autoimmune disease, pregnancy, and breastfeeding. All patients signed an informed consent form.
Evaluation of the results based on clinical examination and photography was performed at each session, at 1 and 6 months, and then every year.
One hundred fifty-four patients were female, and 112 were male. Seventy-nine (30%) had facial atrophy due to AIDS, named immunodeficiency virus-associated lipoatrophy or HIV-related lipoatrophy, in sites such as the cheeks and temporal area and chin and for marionette lines, according to the degree of facial atrophy due to loss of fat tissue.
There were 159 (60%) patients who had photoaging signs with deep wrinkles, marionette lines, and/or atrophic areas due to photoaging process. Twenty-five cases (9%) presented depressed but distensible scars from acne process, and three patients (1%) had residual depressions from cutaneous lupus profundus.
Topical anesthesia with 4% lidocaine was enough to induce numbness in a minority of patients that referred some pain even after topical anesthesia. These two techniques are the most indicated because they avoid deformities in the area to be treated. The product was applied with 24-, 23-, or 26-gauge needles.
The application was always at a deep level, at the subcutaneous tissue or subdermal layer. The point of insertion of the needle was at least 0.5 cm from the target area, and the technique was continuously retrograde, avoiding discontinuation to diminish occasional irregularities.
The volume of implanted material varied from 1 mL, as used in mild facial aging, up to 8 mL, as in atrophic facial areas of patients with HIV infection.
Because the product is viscous, after injection, the site was gently massaged with the fingers so that good internal shaping and appropriate distribution of the product could be achieved. The number of sessions varied from one to four, within intervals of approximately 40 to 60 days between applications.
Results
Overall, 266 patients underwent treatment between January 1999 and August 2007.
Table 1 shows the distribution according to sex and age; 112 (48%) were male, and 154 were female (52%), and most were aged 40 to 50. The youngest was 17, and the oldest was 72.
Sex and Age Distribution of Patients Undergoing Polymethylmethacrylate Augmentation
Indications for treatment with PMMA can be seen in Figure 1. The most common indication was facial lines and depressions due to intrinsic and extrinsic skin aging, especially the nasolabial fold. Figure 2 shows the volume of PMMA injected per session, which varied from 1 to 8 mL. Figure 3 shows the number of sessions of PMMA performed per patient, ranging from one to four.
Indications for polymethylmethacrylate augmentation in the study.
Total volume of polymethylmethacrylate injected per session in the study.
Number of sessions required per patient in the study.
Ninety percent of subjects were satisfied with the results and achieved significant improvement in self-esteem; 10% were dissatisfied (Table 2). Table 3 indicates the occurrence of adverse events with PMMA augmentation procedure in this study.
Comparative Percentage of Satisfaction of Patients Undergoing Polymethylmethacrylate Augmentation
Occurrence of Adverse Effects with Polymethylmethacrylate Augmentation
Figures 4 to 10 show the good cosmetic results achieved.
Patient with acne scars before and 1 year after two sessions of polymethylmethacrylate augmentation.
Patient with nasolabial grooves before and just after one session of polymethylmethacrylate augmentation (immediate results).
Patient with aging before and 6 months after one session of polymethylmethacrylate augmentation.
Patient with lupus profundus–induced lipoatrophy before, 1 month after, and 7 years after one session of polymethylmethacrylate augmentation.
Patient with lipoatrophy due to antiretroviral therapy before and 1 year after two sessions of polymethylmethacrylate augmentation.
Patient with lipoatrophy due to antiretroviral therapy before and 18 months after 3 sessions of polymethylmethacrylate augmentation.
Patient with nasolabial grooves before, 6 months after, and 8 years after one session of polymethylmethacrylate augmentation.
PMMA led to persistence of significant aesthetic correction; adverse effects, such as temporary swelling, erythema, and bruising, which were observed in 20% of patients, were transient and required no intervention, resolving spontaneously (Table 3 and Figure 11).
Patient with (temporary) bruising as an adverse effect after one session of polymethylmethacrylate augmentation.
Long-term follow-up (≥5 years post-treatment) was achieved in 141 patients (53%), illustrating the long-lasting characteristic of the implant (Figures 9 and 10 and Table 4).
Post-Treatment Follow-Up
Until the submission of this article, no late complications had been observed.
Discussion
There have been numerous recent efforts to offer a safe and long-lasting filler that could be used as a soft-tissue augmentation agent in multiple conditions leading to facial deformities.
In the present study, the results achieved with PMMA as a facial implant in different types of conditions and pathologies were highly encouraging.
Regarding HIV-related facial lipoatrophy, the psychological effect is known as being devastating. Treatment options for this condition are not always satisfactory.10 A study by Jones11 suggested that micro-injections of silicone in 77 patients with AIDS could be a safe procedure with facial atrophy. The disadvantages are the large number of sessions needed and the fact that, even though silicone is an excellent filler, it has not been approved for use in most countries.
Instead, the use of Metacrill appears to be an efficient, safe, low-cost procedure for the treatment of facial lipoatrophy. It leads to a high degree of satisfaction and improves self-esteem, especially in patients with HIV, in whom facial depressions can be nonesthetic, inflicting isolation, social exclusion, and emotional distress. All patients with HIV-related lipoatrophy were highly satisfied. Excellent results were noticed in facial lipoatrophy in patients with HIV, which also led to social inclusion. The average number of sessions was four, and the average volume of product used was higher than in other cases, on average 8 mL per session.
Patients who were not satisfied were the ones with considerable photoaging, presenting laxity of the skin. Although they had asked to be treated with PMMA in a last attempt before surgery, the ideal approach would have been a lifting procedure.
Results in atrophic distensible scars from acne treated with PMMA were also good. These results could be noticed immediately after the second session.
Similar results were also found in three patients with lupus profundus–induced lipoatrophy.
Patients need to be aware that a single treatment with PMMA will not last for the rest of their lives. According to Lamperle, 0.02% of the patients described new depressions or worsening of the same lines, requiring final touches and new procedures.12
Odo and Chichierchio13 found in histopathologic studies with PMMA that, 2 years after implantation, there was still product left in the injected regions, in addition to fibrous tissue.
One advantage of PMMA is that previous skin testing is not needed. Because microspheres are 100% polymerized, an allergic or toxic effect from residual monomers is unlikely. Another advantage is that PMMA can be kept and stored at room temperature.
According to Morhenn,14 microspheres larger than 20 μm are less likely to suffer phagocytosis and, as such, less likely to have tumor necrosis factor alpha stimulation production leading to an inflammatory or granulomatous reaction when injected in human tissue.
Microspheres of PMMA are approximately 40 μm in diameter, which means that they are large enough to avoid phagocytosis and small enough to be injected with a 26G needle, in addition to being capable of penetrating among collagen fibers of deep layers of skin.14
In our study, PMMA was shown to be safe, because there were no late complications but only transient ones related to needle introduction. We have also observed a high rate of patient satisfaction, corroborating product efficacy and good results even after several years of the procedure. PMMA has been shown to be a filler of long-lasting durability.15,16 Another advantage of PMMA, as a nonanimal product, is that there is no risk of prion diseases.
Nonetheless, as in any dermatological surgical procedure, skill training development is required, trying to inject at the right level and observing potential long-term risks, which, as a consequence, prevents serious adverse effects.
Conclusion
PMMA used for the treatment of atrophy, depressions, and facial wrinkles has been shown to be effective, long-lasting, safe, and gratifying to patients and physicians.
References
1. Matarasso SL, Beer K. Colágenos Injetáveis [Injectable collagen]. In: Carruthers J, Carruthers A, Dover JS, editors. Técnicas de Preenchimento [Filling Techniques]. Amsterdam: Elsevier, 2005, p. 21–33.
2. Monheit GD, Hinderks Davis BA. Tratamento das Pregas Nasolabiais [Management of Nasolabial Folds]. In: Carruthers A, Carruthers J, Dover JS, editors. Técnicas de Preenchimento [Filling Techniques]. Amsterdam: Elsevier, 2005, p. 125–45.
3. Millard PT, Zeena IO. Artecoll: the Arizona experience and lessons learned. Dermatol Surg 2005;31:1566–76.
4. Reichnberger MA, Stoff AS, Ritcher D. Polymethymethacrylate for managing frontal bone deformities. Aesth Plast Surg 2007;31:397–400.
5. Frazer RQ, Byron RT, Osborne PB, West KP. PMMA: an essential material in medicine and dentistry. J Long Term Eff Med Implants 2005;15:629–39.
6. Munhoz O, Serra M, Trope B, Keiko L, Tellini RMC. Tratamento da Lipoatrofia facial em pacientes portadores de HIV/AIDS com polimetilmetacrilato—PMMA [Management of facial lipoatrophy in HIV/AIDS patients with polymethylmethacrylate—PMMA]. Ministério da Saúde. Secretaria de Vigilância em Saúde. Programa nacional de DST/AIDS [Ministry of Health, Health Surveillance Department. Brazilian STD/AIDS Program] 2006.
7. Gelfer A, Carruthers A, Carruthers J, et al. The natural history of polymethylmethacrylate microspheres granulomas. Dermatol Durg 2007;33:614–20.
8. Carruthers A, Carruthers J. Polymethylmethacrylate microspheres/collagen as a tissue augmentation agent: personal experience over 5 years. Dermatol Surg 2005;31:1561–5.
9. Fischer J, Metzler G, Schaller M. Cosmetic permanent fillers for soft tissue augmentation- A new contraindication for interferon therapies. Arch Dermatol 2007;143:507–10.
10. Jones D. HIV facial lipoatrophy: causes and treatment options. Dermatol Surg 2005;31:1519–29.
11. Jones DH, Carruthers A, Orentreich D, et al. Highly purified 1000-cSt silicone oil for treatment of human immunodeficiency virus-associated facial lipoatrophy: an open pilot trial. Dermatol Surg 2004;30:1279–86.
12. Lemperle G, Rullan PP, Gaulthier-Hazan N. Avoiding and treating dermal filler complications. Plast Reconstr Surg 2006;118(3 Suppl):92S–107S.
13. Odo MEY, Chichierchio AL. Práticas em Cosmiatria e Medicina Estética: evolução dos implantes e toxina botulínica [Practices in Cosmetic and Esthetic Medicine: progression of implants and botulinum toxin]. São Paulo: Tecnopress; 2000. p. 133.
14. Morhenn V, Lemperle G, Gallo R. Phagocytosis of different particulate dermal filler substances by human macrophages and skin cells. Dermatol Surg 2002;28:484–90.
15. Cohen SR, Berner CF, Busso M, et al. Five-year safety and efficacy of a novel polymethylmethacrylate aesthetic soft tissue filler for the correction of nasolabial folds. Dermatol Surg 2007;33Suppl 2:S222–30.
16. Werschler WP, Weinkle S. Longevity of effects of injectable products for soft- tissue augmentation. J Drugs Dermatol 2005;4:20–7.