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Purpose: To report the long-term follow-up results after surgical excision of migrated Bio-Alcamid fillers to the Periorbita area. Methods: A retrospective case series of all patients who underwent surgical removal of migrated Bio-Alcamid fillers to the Periorbita area with minimal follow-up of 1 year from January 2009 to January 2018 was done. Results: 16 female patients (24–52 y) presented with an upper or lower eyelid swelling 3–7 years following a filler injection in the nasal bridge, temporal or malar area. All patients had surgical excision of a granulomatous mass ranging in size from 1–3.5 cm. The histopathology report revealed a giant cell reaction in all patients. Follow–up periods ranged from 1 to 8 years. One patient developed lid retraction and another had recurrence 3 years later; the remaining had an unremarkable course. Conclusions: Filler migration is one of the potential complications associated with Bio-Alcamid soft tissue injection. It is important for all physicians to assess nodules/masses/swelling in the facial area to be aware that soft tissue fillers may migrate to a location away from their intended site of injection years after the injection. Patients undergoing surgical excision tend to have favorable overall long-term outcomes in terms of aesthetics and incidence of recurrence. Keywords: Polyalkylimide, Filler, Periorbita, Permanent

This article is a follow up to “Early and late complications of polyalkimide gel (Bio-Alcamid)”. 1 It is a summary of late complications that have developed in patients treated with Bio-Alcamid for HIV lipoatrophy following extended follow up of 10 years.

Bio-Alcamid, a polyalkylimide gel, can be injected into subcutaneous tissue as an endoprosthesis for correcting contour deformities and soft tissue defects. We have reviewed its facial uses and longer-term outcomes over a 7-year period, including a patient satisfaction survey. 69 patients were included in the study, 89.9% undergoing treatment secondary to HIV-associated facial lipoatrophy. 55.0% of patients responded to questionnaires: 52.5% experienced severe pain associated with injections, and 50.0% experienced at least one complication (migration, hardening, irregularity). 94.4% stated an improvement in their cheek volume, 77.8% would undergo the procedure again, and 86.1% would recommend the treatment to a friend. Despite the relatively high patient satisfaction, we no longer recommend this treatment to our patients for cosmetic indications, due to significant long-term complication rates.

As our youth-oriented society ages, interest in nonsurgical aesthetic techniques has generated a dramatic rise in the use of filling agents for facial rejuvenation. Backed by multiple published studies documenting safety and efficacy, soft tissue fillers are often viewed as treatments with minimal recovery time and limited risk of complications when compared with traditional surgical interventions. This has led to a genuine demand for fillers with similar safety profiles but ever increasing longevity in their aesthetic corrections. This review addresses many of the permanent soft tissue fillers that are commercially available worldwide as well as important concerns regarding their complications.

Temporary injectable fillers have become so widely accepted within the cosmetic medical industry that permanent fillers with longer lasting effects are fast gaining popularity. Both patients and physicians alike have eagerly sought a product to minimize the inconvenience and cost of repeated injections. However, the fear is that the use of permanent fillers may lead to permanent problems. We describe here an in-office technique to remove permanent injectable fillers that achieves consistent, natural results with minimal risk of scarring.

This case report summarises early and late of complications that have developed inpatients treated with Bio-Alcamid for HIV-associated facial lipoatrophy and describes the management strategy employed to treat the most serious of these cases.

PurposeTo report the late complications associated with permanent filler injections into the malar area for rejuvenation.MethodsA retrospective case series of three patients who presented with lower eyelid swelling several years following injection of polyalkylimide (Bio-Alcamid) into the malar area.ResultsAll patients presented with lower eyelid swelling which developed as a result of spontaneous migration of filler to the lower eyelid. Iatrogenic migration of the filler from the lower eyelid following a trial to remove resulted in an abscess formation which further complicated the removal.ConclusionsLower eyelid swelling may be one of the late complications associated with the permanent fillers into the malar area. An attempt at removal of filler by aspiration or bimanual expression may result in late migration of the product and the development of eyelid swelling.

Patients undergoing standard highly-active antiretroviral therapy for the treatment of human immunodeficiency virus may suffer from severe facial lipotrophy, also known as facial wasting. Facial wasting can impose a devastating psychosocial burden to the affected patients. Injectable filler materials are currently used worldwide for soft-tissue augmentation in various parts of the body. Injectable filler materials can be absorbable, semipermanent, or permanent. Permanent injectable filler materials have been used to augment facial soft-tissue defects, to treat rhytids, or to treat patients affected by facial lipoatrophy secondary to human immunodeficiency virus–associated antiretroviral therapy.

The recent evolution of the philosophy of rejuvenation therapy toward addressing soft tissue loss with aging has prompted growing interest in fat transfer procedures as a means of volume replacement. However, fat transfer has several undesirable characteristics, including the need for a donor site and lack of predictability of fat uptake and volume retention. Injectable fillers are gaining popularity as an alternative to fat transfer because of their lack of donor site morbidity, instant effects, predictability, and vastly reduced recovery period. Because temporary fillers require inconvenient repeat visits, patients have been requesting permanent options. This article describes the author's experience with a permanent adjustable large-volume filler based on polyalkylimide (Bio-Alcamid) and suggests that it could be a preferred and reliable alternative to fat transfer in appropriate patients. Permanent is defined as no decrease in volume of the product over time. However, because the area augmented may eventually decrease from further aging and fat atrophy, more product may need to be reinjected years later.

In the last years new and numerous materials for the correction of defects and wrinkles have been developed. One of these materials is Bio-Alcamid®, a non reabsorbable gel polymer constituted by meshes of poly-alkyl-imide, without known adverse effects. We report a 34-year-old woman that had Bio-Alcamid® implants for acne scars and several months after presented nodular lesions together with a painful inflammatory nodule. The nodule was drained and culture of the purulent material yielded Streptococcus viridans. A cytology and a cellular block of that material showed a granulomatous inflammatory reaction together with a foreign body. The different types of reactions to implants and their pathogenic mechanism are discussed. It is important to know these possible reactions to filler materials given their increasing use and the potential medico-legal consequences.

Bio-Alcamid is a new nonbiodegradable substance which is easy to use and which allows one to create volume on both the body and the face. This substance is extractable even after several years. This allows more patients to use a nonbiodegradable substance for esthetic problems of lipoatrophy treatment or for posttraumatic or therapeutic atrophy of subcutaneous tissue.

Bio-Alcamid (Polymekon Research, Brindisi, Italy) is a permanent soft tissue filler that has been injected for the correction of contour deformities. It has a number of indications, including pectus excavatum. Infection and migration seem to be the most common complications with this product. The authors report an illustrative case of pectus excavatum deformity treated with Bio-Alcamid. Results highlight the successful treatment of gel migration with liposuction, which has not been recommended by the manufacturer nor reported in the literature to date.

Background Given the recent boom of the cosmetic industry, there is a wealth of new products available to patients and physicians, including soft-tissue fillers. Bio-Alcamid polyacrylamide gel (Polymekon, Milan, Italy) is a filler that has potential to cause adverse reactions. Observations Two patients who had previously been treated with Bio-Alcamid outside of the United States presented with different manifestations of inflammatory responses to the product. These reactions were challenging to treat. Conclusions Despite claims of safety, Bio-Alcamid and possibly other soft-tissue fillers available worldwide have the potential to cause adverse reactions. Physicians should be aware of the various presentations and treatment options for these reactions.

Bio-alcamid is one of the newest agents on the market for soft tissue augmentation. Seven studies were documented in the medical literature that examined the safety of Bio-alcamid (Polymekon, Brindisy, Italy); all reported no cases of tissue migration, foreign body granulomas, allergenicity, or interference with the control of cell proliferation. On 2 separate occasions, a woman who had recently undergone lip augmentation presented at our hospital with submucosal nodules of the lip. Histologic examination revealed multiple foreign body-type granulomas composed of giant cells, epithelioid cells, and chronic inflammation of the lip. Efforts to produce a cosmetic material that fulfills all the criteria as an "ideal" agent has not yet been found because all injectable foreign agents have the potential to induce adverse reactions. Caution must be exercised in all cases and the risks explained to the patient before its use.

Bio-Alcamid (BA) (polyalkylimide) was introduced in Europe in 2001. It is a nonresorbable injectable filler for soft tissue augmentation, indicated for a wide variety of clinical applications in reconstructive and cosmetic surgery in conditions where subcutaneous volumetric compensation is required. Although BA biocompatibility was approved by a European Union Certificate (CE), the substance is not a natural component of biologic tissues, and thus inflammation and infection are still potential risks. The authors present a case of BA infection after minor trauma 3 years after bilateral injections to the malar regions in a 43-year-old woman, causing an abscess that required surgical drainage and parenteral antibiotics. Aesthet Surg J

Background: Highly active antiretroviral therapy for HIV-infected patients causes metabolic changes known as the lipodystrophy syndrome. Autologous fat injections, dermal fat grafts, malar implants and injected fillers have been reported as treatment options. Objective: To evaluate the results of HIV-infected patients treated with Bio-Alcamid for facial lipoatrophy. Methods and Materials: Over a 3-year period, 13 HIV-infected patients with facial lipoatrophy had Bio-Alcamid injections for aesthetic purposes. The procedure was done under local anesthesia, and the amount of the injected material varied from 5 to 13 ml. Results were independently evaluated by patients and physicians. Results: Most of the patients felt they had good to excellent results. Touch-ups were necessary for 2 patients; the added volume was 2–3 ml for each. No major complications were recorded. A small hematoma was noted in 1 patient. Overcorrection was attained in 2 cases, and some of the filler was removed at the patient’s request. Conclusion: One of the greatest advantages of this filler is that, although permanent, it can be removed easily. We consider Bio-Alcamid to be a safe and useful correcting tool for patients suffering from drug-induced facial lipoatrophy.

Injectable filler materials can be valuable to aesthetic surgeons. To date, hardly any short-term and no long-term complications of polyalkylimide injections (Bio-Alcamid) have been reported. We present and discuss the history of 18 patients who had such complications. The patients were between 31 and 55 years of age. The time between injection and the onset of complications of polyalkylimide ranged from 1 month to 3 years. Additional invasive therapy at, or near, the site of injections triggered the onset of infection in 10 patients. By use of T2-weighted MRI with fat suppressing spectro-presaturation inversion recovery (SPIR) the filler material can be visualised. Once infection or migration of the permanent filler occurs, the therapeutic options are limited to surgical removal by a direct approach. Polyalkylimide should be handled under strict antiseptic circumstances. This does not only apply at the time of initial injections, but even more during any subsequent invasive treatment such as evacuation of surplus deposits or additional surgical procedures at, or near, the site of injection.