Severe complication due to inappropriate use of polymethylmethacrylate: a case report and current status in Brazil
Complicação grave do uso irregular do PMMA: relato de caso e a situação brasileira atual

INTRODUCTION

Fillers used in aesthetic medicine can be divided into 2 major groups: absorbable fillers and permanent fillers¹. Some of the advantages of absorbable fillers include the reversibility of undesired results, whether by action of an “antidote” or through resorption by the body itself. With permanent fillers, however, complications become a real problem due to persistence of the product and perpetuation of unwanted results².

These complications are inherent to all types of fillers and may be classified as acute or chronic. Acute complications include vascular embolism, necrosis, allergic reactions, and infections. Chronic complications include granuloma formation, deformities, and inflammatory reactions².

The acute complications deserve attention because they depend directly on practitioner qualifications and training. For the most part, this type of complication is more related to treatment technique and not necessarily to the product used³.

The most commonly used permanent filler is polymethylmethacrylate (PMMA). PMMA is available as polymeric microspheres ranging in size from 30 to 103 µm. These spheres are suspended in a vehicle of bovine collagen, carboxymethylcellulose, or sodium hyaluronate, which are resorbed after a few days².

In 2006, the U.S. Food and Drug Administrationapproved ArteFill^ for use by physicians alone, and limited its application to perioral volume augmentation, e.g., nasolabial filling, excluding that of the lips⁴. In Brazil, the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) recommends use by trained medical professionals, and does not contraindicate use for body filling or provide guidelines for aesthetic use⁵.

As PMMA is inexpensive and easily obtained, numerous cases of complications have occurred, arising from use by untrained professionals in substandard aesthetic centers. This case report describes complications due to use of PMMA filler in a clandestine clinic in the city of São Paulo, and discusses the current status of PMMA use in Brazil.

CASE REPORT

A 21-year-old female presented with a history of injection of 900 ml of PMMA in the buttocks 12 days prior. The procedure was performed in a beauty salon by a nonmedical professional. She had pain and ulcerated wounds with purulent secretions at the injection site (Figure 1), and had already received ciprofloxacin and clindamycin for 7 days without improvement, as well as day hospital treatment with ceftriaxone and prednisone.

Figure 1 - Surgical wound appearance after serial debridement. a: left lateral, b: posterior, c: right lateral; I: at 14 days; II: after first debridement; III: after second debridement, circumferential increase in surgical wound hyperemia and coalescence of wounds in the sacral region; IV: after third debridement, circumferential increase in surgical wound hyperemia; V: after fourth debridement, appearance of necrosis in the sacral region.

Figure 1 - Surgical wound appearance after serial debridement. a: left lateral, b: posterior, c: right lateral; I: at 14 days; II: after first debridement; III: after second debridement, circumferential increase in surgical wound hyperemia and coalescence of wounds in the sacral region; IV: after third debridement, circumferential increase in surgical wound hyperemia; V: after fourth debridement, appearance of necrosis in the sacral region.

On admission, the patient was afebrile and hemodynamically stable. Laboratory tests showed leukocytosis and elevated C-reactive protein, and computed tomography showed densification and thickening of the skin and subcutaneous tissue of the gluteal regions, in addition to multiple nodular formations consistent with exogenous material/granulomas (Figure 2), but no evidence of collections.

Figure 2 - 3D tomographic reconstruction on admission. Blue represents infiltration of subcutaneous tissue in the bilateral gluteal regions at PMMA application sites. A: anterior view; B: posterior view. In retrospective analysis, image of infiltrated area coincided with that of debridement area.

Figure 2 - 3D tomographic reconstruction on admission. Blue represents infiltration of subcutaneous tissue in the bilateral gluteal regions at PMMA application sites. A: anterior view; B: posterior view. In retrospective analysis, image of infiltrated area coincided with that of debridement area.

She initially received empirical broad-spectrum antibiotic therapy, but the wound deteriorated. Serial debridement was performed (Figure 1), and continuous negative pressure therapy was applied at 125 mmHg, with sequential exchanges every 3 to 5 days. Suppuration and necrosis of the dermis (Figure 3) and subcutaneous tissue were observed, with nodular formations containing pus and exogenous material in addition to signs of bilateral gluteus maximus fasciitis. Fragments of soft tissue were sent for culture, but no microorganism was identified.

Figure 3 - Skin necrosis in a surgical specimen. A: purplish spots on the surface; B: epidermis folded back to show dermis and subcutaneous tissue with extensive necrosis.

Figure 3 - Skin necrosis in a surgical specimen. A: purplish spots on the surface; B: epidermis folded back to show dermis and subcutaneous tissue with extensive necrosis.

Due to the severity of the inflammatory/infectious process, she remained in the intensive care unit for 14 days, and developed acute renal failure. She showed progressive improvement after the 3^rd debridement.

Given the size of the wound after sequential debridement and the extensive loss of nutrients, hemoglobin, and microelements, bilateral homologous skin grafting was performed over the gluteus maximus (Figure 4), with addition of negative pressure therapy (Figure 5).

Figure 4 - Wound appearance after serial debridement and homologous skin grafting. a: left lateral, b: posterior, c: right lateral; VI: after sixth debridement, showing extension to the sacral region; VII: 1:1.5 mesh graft over the gluteus maximus bilaterally.

Figure 4 - Wound appearance after serial debridement and homologous skin grafting. a: left lateral, b: posterior, c: right lateral; VI: after sixth debridement, showing extension to the sacral region; VII: 1:1.5 mesh graft over the gluteus maximus bilaterally.

Figure 5 - Negative pressure therapy at homologous graft sites. A: left gluteal wound with 1:1.5 mesh graft and right gluteal wound with non-adherent gauze on the graft; B: negative pressure dressing sponge in place; C: continuous vacuum at 125 mmHg.

Figure 5 - Negative pressure therapy at homologous graft sites. A: left gluteal wound with 1:1.5 mesh graft and right gluteal wound with non-adherent gauze on the graft; B: negative pressure dressing sponge in place; C: continuous vacuum at 125 mmHg.

After 3 weeks of treatment with biological dressings (homologous grafts) and improvement of nutritional parameters, autologous skin grafting was performed (Figure 6) with 1:1.5 mesh. The graft showed good integration (Figure 7) without functional deficits, and the patient was discharged after 68 days of hospitalization.

Figure 6 - Wound appearance after 3 weeks with homologous grafting and subsequent immediate autologous grafting. a: left lateral; b: posterior; c: right lateral; VIII: after ninth debridement and 3 weeks of homologous grafting over the gluteus maximus; IXa: 1:1.5 mesh graft over gluteus maximus after debridement of hypertrophic granulation and epidermal remnants of previous homologous graft; IXc: appearance of wound bed after debridement of previous homologous graft.

Figure 6 - Wound appearance after 3 weeks with homologous grafting and subsequent immediate autologous grafting. a: left lateral; b: posterior; c: right lateral; VIII: after ninth debridement and 3 weeks of homologous grafting over the gluteus maximus; IXa: 1:1.5 mesh graft over gluteus maximus after debridement of hypertrophic granulation and epidermal remnants of previous homologous graft; IXc: appearance of wound bed after debridement of previous homologous graft.

Figure 7 - A: Sixth postoperative day. Appearance of partial, autologous 1:1.5 skin mesh graft. B: 1-month postoperatively, showing integration of graft and wound.

Figure 7 - A: Sixth postoperative day. Appearance of partial, autologous 1:1.5 skin mesh graft. B: 1-month postoperatively, showing integration of graft and wound.

DISCUSSION

Based on the data for the last decade, concerns about these procedures are inevitable. Despite the significant and immediate results in aesthetic filling, the unregulated popularization of PMMA use, in addition to its use in large volumes with inadequate technique, have shown that PMMA can be harmful when misused for this purpose.

In Brazil, the regulation and supervision of aesthetic medical centers by responsible agencies remain inadequate. In addition, despite the efforts of medical societies, misinformation is widely disseminated, made worse by increasing exposure on social media. This misinformation exposes patients to unsafe procedures.

With reports of significant adverse outcomes in the Brazilian media in recent years, including mutilating and fatal cases, medical societies have spoken out against the use of PMMA for aesthetic purposes. In 2018, both the SBCP and the Brazilian Society of Dermatology (Sociedade Brasileira de Dermatologia, SBD) issued a warning on the use of PMMA, with a contraindication for use in large amounts, reinforcing the unpredictability of results and requesting the recategorization and restriction of its use by ANVISA¹⁷.

Reports of adverse outcomes related to PMMA are rare in the medical literature, with complication rates ranging from 0.01% to 3%^2,18. Although small, these numbers deserve attention, since underreporting of complications is known to occur, both because they may be delayed and also due to omission of reporting in the medical record³. Furthermore, it may be unclear whether complications are caused by PMMA itself or poor technique. Complications caused by permanent fillers deserve special attention, because they create chronic problems and are difficult to treat. Despite the availability of protocols, there is no consensus on standardization of treatment¹⁹.

Complications, such as necrosis, are even rarer (0.003%)¹⁸. Technical failure is attributed to the application of needles in flat surfaces and not necessarily to PMMA. In one author’s account of personal experience with more than 5,000 cases published in 2012²⁰, a complication rate of 0.01% was reported, with no necrosis observed. This was ascribed to adherence to 3 principles: deep plane application, use of a microcannula, and use of pure and certified PMMA.

In the case described herein, both the quality of the product and the technique used were questionable. The combination led to severe complications.

Acute local inflammation within the first hours after treatment was an important warning sign that required close monitoring. With progression to necrosis, aggressive surgical debridement combined with negative pressure therapy were imperative for treatment of inflammation and preparation of the wound bed²¹. Debridement surgery is challenging, because healthy tissue is invaded by necrotic tissue, creating a false impression of satisfactory treatment. Coverage of the wound after proper cleaning is also challenging, however, and sequelae and deformities may not be be fully corrected by plastic surgery.

The use of diagnostic tomography in the present case was a predictor of the extent of necrosis, since it revealed densification of affected tissue, even in areas that still appeared clinically healthy. The findings coincided with the debrided areas. There are no comparable studies in the literature.

CONCLUSION

Despite low published complication rates in Brazil, an excessive number of repair procedures are needed to correct complications from use of PMMA. The severity of the reported case highlights the need to combat bad practice by untrained practitioners, as well as the need for greater regulation of the commercialization of PMMA. Complications can lead to death and permanent deformity, and treatment is challenging.