V-EMF therapy: A new painless and completely non-invasive treatment for striae gravidarum.

BACKGROUND: The appearance of striae gravidarum (SG) during pregnancy is a common problem. The most common SG are abdominal striae, which can cause the greatest sequelae after pregnancy, and in the long term. There are several solutions to prevent and treat these striae, but not all are completely effective, and not without side effects. AIMS: The aim of this study was to evaluate the effectiveness of a treatment that applies an electromagnetic field under vacuum (V-EMF therapy) on the abdominal SG. METHODS: A retrospective analysis was conducted on the medical records of 26 women affected by abdominal SG and treated with V-EMF therapy. The results were evaluated using two different 5-point Likert Scales: one administered to the treated subjects to evaluate their satisfaction, and one to the doctors who performed the treatment, to evaluate the improvement of the striae. The presence of side effects, and the effects of sun exposure after treatment were also considered. RESULTS: Only two treated subjects rated their level of satisfaction with a Score III on the Liker Scale. Everyone else expressed higher levels of satisfaction. Only one doctor rated the improvement of the striae with a Liker scale score of III. All the others reported greater improvements. No discomfort or side effects were noted either during the individual treatment sessions, or at the end of the treatment. The striae showed a newfound ability to tan. CONCLUSIONS: V-EMF therapy proves to be a valid, safe, and effective treatment modality for SG.

Inflammatory immune-mediated adverse reactions induced by COVID-19 vaccines in previously injected patients with soft tissue fillers: A case series of 20 patients.

BACKGROUND: Adverse events (AE) after COVID-19 vaccines, particularly, but not solely, with those messenger RNA (mRNA)-based vaccines, have rarely been reported in patients previously treated with dermal fillers (DF). OBJECTIVE: To evaluate the morphology, clinical characteristics, the timing of presentation, and outcomes of inflammatory AE appeared in patients injected with DF, after anti-COVID-19 vaccination. METHODS: Descriptive study of a case series of 20 consecutive patients collected after the occurrence of AE in previously filled areas post COVID-19 vaccination. RESULTS: From January 2021 to July 2021, we analyzed 20 AE reactions triggered by COVID-19 vaccines in the previously mentioned cohort. They were vaccinated with Pfizer/Biontech (11; 55%), Moderna (5; 25%), Astra-Zeneca (3; 15%), and Sputnik (1; 5%). The most common manifestations were oedema/swelling, angioedema, erythema, skin induration, and granuloma. Less common reactions included myalgia and lymphadenopathy. In 13/20 (65%) cases, the AE appeared after the first dose of vaccine. These inflammatory AE appeared more rapidly after the second dose than after the first one. In 13/20 (65%) cases, the symptomatology subsided with anti-inflammatory/antihistaminic drugs, while spontaneously in 3/20 (15%). The manifestations are ongoing.in the remaining four cases (20%). CONCLUSION: Although probably rare, both RNA-based and adenovirus-based anti-COVID-19 vaccines can cause inflammatory bouts in patients previously treated with DF. In these cases, caution should be paid on subsequent vaccine doses, considering a tailored risk/benefit for any case before next vaccination.

Autoimmune/inflammatory syndrome induced by adjuvants-ASIA-related to biomaterials: analysis of 45 cases and comprehensive review of the literature.

Systemic autoimmune or granulomatous disorders related to biomaterials of human use have rarely been described. The aim of this study was to report cases of autoimmune/inflammatory syndrome induced by adjuvants (ASIA) related to biomaterial injections and prostheses, mainly silicone, hyaluronic acid, acrylamides and methacrylate compounds in a Spanish patient cohort. This study is a retrospective analysis of clinical, laboratory, histopathological and follow-up data of 45 cases of patients suffering from late-onset, non-infectious inflammatory/autoimmune disorders related to bioimplants. Late onset was defined as 3 months or more post injection. Data were obtained through a further non-systematic but comprehensive review of the literature. Forty-five cases of late-onset adverse reactions related to biomaterial injections or prostheses were reviewed. All cases had systemic complaints that could be categorised as ASIA. In all but four patients, inflammatory features at the implantation site preceded distant or systemic manifestations. Abnormal blood tests were common. Localised inflammatory nodules and panniculitis in 40/45 (88.88%) evolved into a variety of disorders, viz., primary biliary cirrhosis, Sjögren's syndrome, sarcoidosis, human adjuvant disease, vasculitis, inflammatory bowel syndrome and inflammatory polyradiculopathy. Five (11.11%) cases presented primarily with systemic autoimmune disorders. Biomaterials and prostheses can provoke late-onset systemic autoimmune disorders fulfilling ASIA criteria, or present primarily local/regional inflammatory reactions that may eventually evolve into systemic autoimmune and/or granulomatous disorders which fall under ASIA.

Tacrolimus in the treatment of chronic and refractory late-onset immune-mediated adverse effects related to silicone injections.

BACKGROUND: Although currently not authorized in many countries, medical-grade silicone (MGS) injections have been used for 50 years. Sometimes chronic and severe adverse effects refractory to usual therapy other than corticosteroids appear. OBJECTIVE: To evaluate the effectiveness of tacrolimus in the treatment of refractory cases of late-onset adverse effects related to MGS injections. METHODS: Case-series study of seven patients with late-onset adverse effects related to MGS injections. Cases had been treated with a mean of six drugs with poor response before low-tacrolimus dose was introduced. Patients who had received MGS injections with immediate adverse effects or drug responsiveness were excluded. Patients underwent clinical management and follow-up. RESULTS: Average latency period to onset of symptoms was 65 months (range: 6-144 months). Large, tender, inflammatory nodules; plaques; angioedema; and severe panniculitis were commonly seen. An average of 18 months after tacrolimus administration, five patients were experiencing mild, sparse bouts of inflammatory processes, including nodules, plaques, angioedema, and panniculitis. that were rapidly reversible, and two were in remission. No side effects related to tacrolimus had appeared. CONCLUSION: Tacrolimus is an effective and well-tolerated drug in cases of severe and refractory late-onset inflammatory reactions, including large panniculitis, that complicate silicone gel injections.

Are bacterial growth and/or chemotaxis increased by filler injections? Implications for the pathogenesis and treatment of filler-related granulomas.

BACKGROUND: As microbial agents have been associated with late adverse effects related to fillers antibiotic treatment has been envisaged. OBJECTIVE: To determine whether biomaterials favor bacterial growth and/or attract bacteria. METHODS: Hyaluronic acid, semi-permanent fillers, such as calcium hydroxylapatite, and permanent fillers, such as polyalkylimide/polyacrylamide, were used. Experiments were performed with Escherichia coli, strain HVH-U47. Bacteria were transferred to Sven-Gard agar to test mobility. Striae of this bacterial strain with a MacFarland 1 turbulence pattern were seeded from a spot of inoculated biomaterial using Müller-Hinton medium. The chemoattractive properties of the biomaterials were analyzed 10 days after inoculation. Bacterial growth over the biomaterial and in-depth growth were assessed as well. RESULTS: Semi-permanent fillers did not stimulate bacterial growth but they allowed bacterial colonization over the filler. Permanent acrylic compounds neither presented chemoattractant properties nor showed bacterial growth over the biomaterial. Similar results were obtained when performing in-depth cultures. CONCLUSIONS: Permanent and semi-permanent fillers did not facilitate bacterial growth when flagellated E. coli HVH-U47 was used. Our results do not argue in favor of antibiotics as the mainstay of therapy in late granulomas related to permanent fillers. In the case of resorbable/semi-permanent fillers, more studies are needed before recommending antibiotic therapy.

Late-onset immune-mediated adverse effects after poly-L-lactic acid injection in non-HIV patients: clinical findings and long-term follow-up.

BACKGROUND: It has been thought that poly-L-lactic acid (PLLA) injections do not have inflammatory side effects. Recent evidence shows that local/regional/systemic delayed adverse effects may appear with its use. OBJECTIVE: To evaluate the clinical complaints, treatment response and long-term follow-up of non-HIV patients with delayed immune-mediated adverse effects related to PLLA injections. METHODS: Prospective, case series study of 10 patients with delayed adverse effects related to PLLA injections. The inclusion criterion was defined as the onset at least 6 months after PLLA use, with 1 or more of the following clinical signs: oedema, skin induration, swelling/tender nodules with or without discharge of pus or filler material. Several systemic manifestations were also included. Patients with immediate side effects were excluded. Patients underwent clinical management and long-term follow-up. RESULTS: The average latency period to the onset of symptoms was 19.2 months (range: 6-60). Tender, inflammatory nodules and facial oedema were commonly seen. One case presented a systemic granulomatous disorder as a complication. After 50.2 months of average follow-up (range: 38-78), 5 patients are in remission, 4 have recurrent bouts and the last case has been lost to follow-up. CONCLUSION: Although infrequently, local and/or regional and/or systemic delayed and recurrent granulomatous reactions may complicate PLLA gel injections.

Delayed immune-mediated adverse effects related to polyacrylamide dermal fillers: clinical findings, management, and follow-up.

BACKGROUND: It has been thought that polyacrylamide (PA) injections do not have inflammatory side effects. Recent evidence shows that local and regional delayed adverse effects may appear with its use. OBJECTIVE: To evaluate the clinical complaints and follow-up of patients with delayed immune-mediated adverse effects related to PA injections. METHODS: Prospective, case-series study of 10 patients with delayed adverse effects related to PA injections. Only patients with intermediate or delayed adverse effects related to polyacrylamide injection were included. Patients with immediate side effects were excluded. Patients underwent clinical management, follow-up, and when possible, blood tests and biopsy. RESULTS: Average latency period to onset of symptoms was 10 months (range 2-36). Tender, inflammatory nodules--granulomas--with pseudo-abscesses were commonly seen. Laboratory abnormalities were found in all analyzed cases. After 20.1 months average follow-up, five patients were in remission, two had recurrent bouts, and three were lost to follow-up, one of them in remission. CONCLUSION: Although it happens infrequently, local and regional delayed and recurrent granulomatous reactions may complicate PA gel injections.

Delayed immune-mediated adverse effects of polyalkylimide dermal fillers: clinical findings and long-term follow-up.

OBJECTIVE: To evaluate the clinical complaints, laboratory data, treatment, and follow-up of patients with delayed adverse effects related to polyalkylimide implants (PAIs). DESIGN: Prospective case series of patients injected with PAIs. SETTING: A university tertiary teaching hospital. PATIENTS: A prospectively acquired series of 25 patients with severe and/or persistent delayed adverse effects after PAI injection. The patients underwent clinical follow-up, a battery of blood tests, and when possible, biopsy and chest radiography. MAIN OUTCOME MEASURES: Clinical evaluation of granulomas, skin manifestations, and other local and systemic immune-mediated disorders possibly related to PAIs. RESULTS: The average latency period for onset of symptoms was 13.4 months. Eight patients were previously injected with another implant. Tender inflammatory nodules were seen in 24 patients. Systemic or distant manifestations appeared in 6 cases. Laboratory abnormalities were found in 20 cases. After an average of 21.3 months of follow-up, 11 patients appeared to be free of adverse effects, and 10 still had recurrent bouts. CONCLUSION: Although infrequent, delayed and recurrent chronic inflammatory and granulomatous reactions may complicate PAI fillers.