FDA MAUDE database reported adverse events on noninvasive body contouring, cellulite treatment, and muscle stimulation from 2015 to 2021.

OBJECTIVE: Noninvasive cosmetic procedures have continued to gain popularity, owing to their short, in-office treatments combined with little to no downtime. These procedures are also highly accessible, even offered at medical spas by nonphysician operators. The coronavirus disease 2019 (COVID-19) pandemic also saw heightened interest in all cosmetic procedures, presumably as social distancing and stay-at-home orders allotted time and space for postop recovery. As the market for these procedures expand, a thorough understanding of potential adverse events is critical for providers to better counsel their patients on risks and expectations when obtaining informed consent. MATERIALS AND METHODS: We employed the Food and Drug Administration (FDA's) Manufacturer and User Facility Device Experience (MAUDE) database (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm), which compiles medical device reports (MDRs) for suspected injuries from device use or malfunction, submitted by manufactures and operators. We focused our query on three main categories: noninvasive body contouring, cellulite treatments, and muscle stimulation therapies that utilize electromagnetic energy. The query was performed in February 2022 using a comprehensive list of product names and manufacturers. RESULTS: The initial search yielded 827 MDRs, which were individually reviewed for duplicate reports or insufficient data. Ultimately, 723 MDRs were analyzed (660 for noninvasive body contouring, 55 for cellulite treatment, and 8 for muscle stimulation). Paradoxical hyperplasia accounted for the majority of MDRs for noninvasive body contouring, while burns and scars were most common for muscle stimulation and cellulite treatments, respectively. Of the 7-year span we surveyed, 2021 accounted for 515 of the 723 total assessed MDRs (71.2%), the majority of which were from cryolipolysis procedures. CONCLUSION: The MAUDE database remains an essential tool to monitor potential adverse events of medical devices, including those utilized for noninvasive, cosmetic procedures. Insight from the MAUDE database can be clinically translated when discussing treatment options with patients, helping to optimize patient safety and satisfaction.

Complications With Noninvasive Fat and Cellulite Reduction Devices: A Cross-sectional Analysis of the US Food and Drug Administration Manufacturer and User Facility Device Experience Database.

BACKGROUND AND OBJECTIVE: The US FDA mandates that manufacturers and device operators disclose medical device reports (MDRs) to monitor suspected injuries and device malfunctions by submitting information to the Manufacturer and User Facility Device Experience (MAUDE) database. Given the rapid growth in the noninvasive fat and cellulite reduction market, it is essential that physicians be aware of associated adverse events. STUDY DESIGN/MATERIALS AND METHODS: Using the MAUDE electronic database on the FDA website, the authors performed a comprehensive search of reported complications of noninvasive fat reduction and cellulite reduction devices from January 1, 2014 to January 1, 2020 at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm. Medical device reports that likely represented medical adverse events from device use were included. RESULTS: The search yielded 165 MDRs, a majority submitted by patients. There were 68 MDRs reported on cryolipolysis (41.2%), 34 MDRs reported on 1,060-nm laser lipolysis (20.6%), 19 MDRs reported on high-intensity focused ultrasound (11.5%), 17 MDRs reported on vacuum-assisted subcision (10.3%), 10 MDRs reported on 1,440-nm laser-assisted subcision (6.1%), 8 MDRs reported on monopolar radiofrequency (4.8%), 6 MDRs reported on focused ultrasound (3.6%), and 4 MDRs reported for a combination infrared light, bipolar radiofrequency energy, massage, and gentle suction treatment (2.4%). CONCLUSION: It can be safely presumed that most physicians do not regularly report adverse events to the FDA; however, the MAUDE database remains the largest global repository of adverse events reported for noninvasive body contouring devices, an area that has grown tremendously over the last few years. Some MDRs may be unrelated and/or unsubstantiated, and MDRs for any given device must be correlated to the total number of procedures performed. Nevertheless, the MAUDE database allows a glimpse into potential adverse events that can occur. The authors hope that physician awareness of this database and the adverse events it reports will help improve patient safety.

Treatment of Hypertrophic Burn and Traumatic Scars With a 2,940-nm Fractional Ablative Erbium-doped Yttrium Aluminium Garnet Laser: A Pilot Study.

BACKGROUND: In recent years, fractional ablative lasers at low density have proven to be the centerpiece in a multimodality approach to treating hypertrophic burn scars. OBJECTIVE: To determine the safety and efficacy of fractional ablative erbium-doped yttrium aluminium garnet (Er:YAG) laser in the treatment of hypertrophic burn scars. METHODS: Eleven patients received 3 fractional ablative Er:YAG laser to hypertrophic burn scars at 400 to 800 µm, density 11%, no coagulation, and single pass at 4-week intervals. RESULTS: Overall, average improvement was noted to be 2.27 of 3 as determined by blinded observers. A significant improvement was noted in all measured parameters including dyschromia, atrophy hypertrophy, vascularity, and texture. CONCLUSION: This is a pilot study showing the safety and efficacy of fractional ablative Er:YAG laser treatment is a safe and effective treatment modality in the treatment of hypertrophic scars.

Treatment of Hypertrophic Scars Using Laser-Assisted Corticosteroid Versus Laser-Assisted 5-Fluorouracil Delivery.

BACKGROUND: As the mortality of individuals suffering severe cutaneous injuries decreases, there is an increased need to improve the methods by which physicians treat the resultant scars. Fractional lasers, which create zones of ablation at variable depths, provide a powerful tool in the management of scar complications and deformities. After disruption of the normal skin barrier, these zones may be used to deliver drugs that may enhance scar resolution. OBJECTIVE: To determine the differences in clinical outcome for hypertrophic scars treated with laser-assisted corticosteroid delivery, as compared to laser-assisted 5-fluorouracil delivery. METHODS: In this prospective, double-blinded, single-subject study of 20 individuals with hypertrophic scars, subjects underwent 3 treatment sessions at 1-month intervals consisting of fractional ablative laser treatment, followed by postoperative application of either topical triamcinolone acetonide (20 mg/mL) or topical 5-fluorouracil (50 mg/mL). RESULTS: Three sessions of laser-assisted triamcinolone acetonide and 5-fluorouracil delivery both produced reductions in overall scar area. When compared with one another, there were no statistically significant differences in area reduction between the 2 modalities (p = .603). However, scars treated with 5-fluorouracil were not associated with side effects seen with corticosteroid therapy, such as dermal atrophy or telangiectasia formation. CONCLUSION: As 5-fluorouracil was associated with fewer adverse events, these findings support the use of a nonsteroidal agent in the management of traumatic scars by laser-assisted therapy.

Successful treatment of Becker's Nevus with long-pulsed 1064-nm Nd:YAG and 755-nm alexandrite laser and review of the literature.

BACKGROUND: Becker's Nevus is an aesthetically troublesome condition secondary to hyperpigmentation and hypertrichosis. Although several lasers have been employed with varying degrees of success, the exact devices and treatment parameters have yet to be elucidated. OBJECTIVE: To assess the combination Nd:YAG and alexandrite laser as a safe and efficacious treatment for Becker's Nevus. METHODS: In a 20-year-old Fitzpatrick Skin Type IV male, a Becker's Nevus was treated with six sessions of long-pulsed 1064 nm Nd:YAG laser at six-week intervals followed by five sessions of long-pulsed 755 nm alexandrite laser at three-month intervals. RESULTS: This patient experienced a significant reduction in both hyperpigmentation and hypertrichosis after these treatment sessions. No serious adverse events were reported. CONCLUSION: This case supports the use of combination long-pulsed 1064 nm laser and 755 nm laser as a safe and efficacious treatment for Becker's Nevus.

Nodular cutaneous amyloidoma of the extremity secondary to chronic granulomatous inflammation in setting of sarcoidosis.

Soft tissue amyloidoma is a rare condition that presents primarily in the abdomen and/or mediastinum and more uncommonly on the extremities. Soft tissue amyloidomas on the extremities have been associated with chronic inflammation, particularly when accompanied by AA-type amyloid deposition as seen in local trauma, surgery, hypertension and diabetes. To our knowledge, this is the first reported case of nodular cutaneous amyloidoma in the setting of systemic and cutaneous sarcoidosis. A 65-year-old woman presented with an asymptomatic subcutaneous nodule above her left lateral malleolus. Histopathology of the lesion showed an inconspicuous epidermis with amorphous eosinophilic material deposited in masses within the entire dermis. Congo red and crystal violet stains were positive. Based on the clinical and pathologic findings she was diagnosed with nodular cutaneous amyloidoma. We hypothesize that this process developed secondary to the chronic granulomatous inflammation of sarcoidosis.

Microfocused Ultrasound for Facial Photorejuvenation: A Review.

Microfocused ultrasound is a unique technology to treat skin laxity of the brow, lower face, and the rhytides of the décolletage. Over the past several years, the efficacy and safety of this device has been well documented and its adoption widespread. By delivering focused acoustic energy, which is converted to heat, this device creates predictable and reproducible microcoagulative zones that initiate a concentrated inflammatory wound response. By targeting the deep reticular dermis and superficial muscle and fascial planes, such as the superficial musculoaponeurotic system, platysma, and pectoralis muscle fascia, this nonablative technology increases neocollagenesis and neoelastogenesis in a novel fashion, while avoiding many of the complications related to epidermal heating observed in several other nonablative devices. Although the results are not equivalent to those of a rhytidectomy, microfocused ultrasound provides an excellent noninvasive means to achieve a regenerative effect on the face, neck, and décolletage when performed in the appropriate patient population.

The Diagnostic Role of Optical Coherence Tomography (OCT) in Measuring the Depth of Burn and Traumatic Scars for More Accurate Laser Dosimetry: Pilot Study.

BACKGROUND: In recent decades, a number of optimal diagnostic technologies have emerged to assist in tissue visualization. Real-time monitoring of skin during laser therapies will help optimize laser parameters for more ef cient therapies. One of these technologies, optimal coherence tomography (OCT), may be used to help visualize burn and traumatic scars. When lasing severe scars, lasers have tunable pulse energies, which are made proportional to the scar thickness as estimated by palpation and the physician eye. This has historically been estimated by the clinician with no objective data. OCT is an emerging non-invasive imaging technique that provides a cross-sectional image of tissue micro-architecture from a depth of 0.7 - 1.5 mm. The signal intensity is related to the tissue optical scattering properties, which in turn is related to tissue constituents such as collagen density. Thus, OCT may provide an objective non-invasive measurement of scar depth. STUDY: Thirty burn and traumatic scars were imaged with quality, traceable, and veri able OCT data from burn and trauma patients both pre- and post- laser therapy. OCT was rapid and ef cient (approximately 2 minutes) to scan skin to visualize real-time scar tissue in different areas of heterogenous scars. The OCT image of the scar was compared to that of normal tissue in order to identify scar tissue and estimate its depth. Laser parameters were then dialed to treat full thickness of the scar. RESULTS: Clinical and OCT correlation between atrophic versus hypertrophic scars was found. However, in most cases the clinicians underestimated the depth of the scar in the dermis. CONCLUSION: The treatment of burn and traumatic scars for both civilian and wounded warriors can be challenging. As these scars are often very deep, OCT allows for non-invasive examination of the thickness of the scar allowing the physician better accuracy for laser settings in the treatment for the full thickness of the scar tissue. J Drugs Dermatol. 2016;15(11):1375-1380..

Nail Alterations in Cutaneous T-Cell Lymphoma: A Case Series and Review of Nail Manifestations.

BACKGROUND: Cutaneous T-cell lymphoma (CTCL) encompasses a broad range of lymphoproliferative diseases affecting the skin and can be clinically misleading due to its variable presentation. Nail alterations commonly appear in advanced-stage mycosis fungoides and true Sézary syndrome; however, they may be present in any stage of the disease. Although proper recognition of nail involvement in CTCL has both clinical and therapeutic value, specific nail findings have been infrequently described in the current literature. OBSERVATIONS: We describe 4 patients with CTCL who presented with clinically significant nail alterations. The most common findings were nail discoloration, thickening, crumbling, onycholysis, and onychomadesis. Other notable findings included splinter hemorrhages, subungual hyperkeratosis, and anonychia. CONCLUSIONS AND MESSAGE: The described cases illustrate many of the documented nail findings associated with CTCL and emphasize the variable nature of nail manifestations. The presence of specific nail alterations should increase the clinical suspicion of CTCL - especially in patients with concomitant systemic and/or cutaneous manifestations - and early biopsy specimens should be taken for diagnosis. Nail alterations should also be accurately described and monitored in all patients with biopsy-confirmed CTCL to help identify treatment response and detect disease recurrence.

Merkel cell carcinoma.

A 92-year-old man presented for evaluation with a 1-month history of a rapidly growing asymptomatic pink nodule on his forearm. Biopsy results of the lesion demonstrated pathology consistent with Merkel cell carcinoma (MCC). Immunohistochemical studies displayed positive cytoplasmic staining for cytokeratin AE1/AE3, positive dot-like perinuclear staining for cytokeratin-20, diffuse cytoplasmic staining for neuron specific enolase, and no significant staining for S-100. Subsequent positron emission tomography did not reveal evidence of metastatic disease. Wide excision of the lesion was performed along with a sentinel node biopsy of his left axilla. The sentinel nodes were negative for MCC. Adjuvant radiation treatment of the tumor site was provided because the pathologist noted MCC within 2 mm of the deep margin.

Prospective efficacy and safety evaluation of laser treatments with real-time temperature feedback for fungal onychomycosis.

BACKGROUND AND OBJECTIVES: Onychomycosis affects five percent of the worldwide population. Onychomycosis is a therapeutic challenge. Current therapies on the market are either ineffective or require patient monitoring. Laser and light technologies are being investigated as a possible treatment option for onychomycosis. The proposed mechanism of action is unknown. All infectious agents may be killed by heat (except prions). One possible theory is the photothermal effect from water absorbing lasers creates bulk heating in the nail plate to kill fungal hyphae. Laser technology may be a promising new treatment option for onychomycosis. This is a prospective trial with real-time temperature feedback to evaluate efficacy and safety of laser therapy for onychomycosis. METHODS: Twenty-one patients with PAS or culture proven fungal onychomycosis were prospectively treated with laser until target temperature of 46 - 48 degrees Celsius was achieved using real-time infrared temperature feedback. The laser and light therapies used were 1319 nm, 1064 nm and BroadBand Light. Exclusion criteria included mixed infection and no other prior therapeutic interventions. Subjects received four treatment sessions one week apart. Assessments included PAS & cultures at one, three and six months post treatment. Patients also were asked a pain score from 1-10 during treatment. RESULTS: Patients tolerated the procedures well with high satisfaction. Average treatment time was 10 minutes. No adverse events were noted. Patients reported mild-moderate transient discomfort during treatment. Six-month culture results revealed 20/21 negative for fungal organisms. CONCLUSION: Laser therapy offers a safe and effective new option for onychomycosis. This may be the optimal therapy for a large market that needs alternative or adjunct to current therapies. Laser is quick, painless therapy that does not require any oral medications or blood test for monitoring. Additional larger scientific studies are needed to confirm our pilot study results.

Pediatric nail conditions.

Pediatric nail findings are plentiful and can range from benign processes to the initial signs of a systemic condition. The examination of the nail is an essential part of the pediatric physical examination. The nail unit consists of the nail plate, the nail matrix, the hyponychium, the nail bed, and the surrounding nail folds. Conditions that affect the nail unit have a variety of etiologies; these include inflammatory, congenital, and hereditary conditions as well as tumors and trauma. This review describes many of the nail conditions that are seen in the pediatric population.

Additive effect of propranolol and pulsed dye laser for infantile hemangioma.

The combination of propranolol and pulsed dye laser for the treatment of infantile hemangiomas may be superior to either alone. This case report illustrates the additive effect of propranolol and pulsed dye laser for an infantile hemangioma in a high-risk location. Although thorough clinical trials are needed, combination therapy for infantile hemangiomas may prove to be optimal for efficacy.

Linear morphea and leg length discrepancy: treatment with a leg-lengthening procedure.

A 15-year-old Colombian boy with a 10-year history of linear morphea presented to a pediatric orthopedic clinic with a leg length discrepancy. The morphea had been previously treated with methotrexate, oral and topical steroids, and topical vitamin D, but the lesion persisted, extending down the entire medial aspect of the left leg across the popliteal fossa. The patient had atrophy and growth retardation of the left leg, resulting in lower extremity bone and joint pain and a 3-cm limb length disparity at maturity. The patient preferred left tibial lengthening to improve the limb length disparity.

Treatment of hypertrophic scars using laser and laser assisted corticosteroid delivery.

BACKGROUND AND OBJECTIVES: Hypertrophic scars and contractures are common following various types of trauma and procedures despite skilled surgical and wound care. Following ample time for healing and scar maturation, many millions of patients are burdened with persistent symptoms and functional impairments. Cutaneous scars can be complex and thus the approach to therapy is often multimodal. Intralesional corticosteroids have long been a staple in the treatment of hypertrophic and restrictive scars. Recent advances in laser technology and applications now provide additional options for improvements in function, symptoms, and cosmesis. Fractional ablative lasers create zones of ablation at variable depths of the skin with the subsequent induction of a wound healing and collagen remodeling response. Recent reports suggest these ablative zones may also be used in the immediate post-operative period to enhance delivery of drugs and other substances. We present a case series evaluating the efficacy of a novel combination therapy that incorporates the use of an ablative fractional laser with topically applied triamcinolone acetonide suspension in the immediate post-operative period. METHODS: This is a prospective case series including 15 consecutive subjects with hypertrophic scars resulting from burns, surgery or traumatic injuries. Subjects were treated according to typical institutional protocol with three to five treatment sessions at 2- to 3-month intervals consisting of fractional ablative laser treatment and immediate post-operative topical application of triamcinolone acetonide suspension at a concentration of 10 or 20 mg/ml. Three blinded observers evaluated photographs taken at baseline and six months after the final treatment session. Scores were assigned using a modified Manchester quartile score to evaluate enhancements in dyschromia, hypertrophy, texture, and overall improvement. LIMITATIONS: Small sample size and lack of a control arm. RESULTS: Combination same session laser therapy and immediate post-operative corticosteroid delivery resulted in average overall improvement of 2.73/3.0. Dyschromia showed the least amount of improvement while texture showed the most improvement. CONCLUSION: Combination same-session therapy with ablative fractional laser-assisted delivery of triamcinolone acetonide potentially offers an efficient, safe and effective combination therapy for challenging hypertrophic and restrictive cutaneous scars.

Treatment of burn scars with the 1,550 nm nonablative fractional Erbium Laser.

BACKGROUND: Scarring is a major source of morbidity in patients with burns. Burn scars are difficult to treat and are among the worst scars seen in clinical medicine. Fractional laser resurfacing is a promising treatment option because of its unique wound healing response and depth of penetration. OBJECTIVE: To evaluate the efficacy of nonablative fractional resurfacing as a therapeutic option for extensive cutaneous scarring in burn patients. METHODS: Prospective, single-arm, pilot study. Ten subjects with second and third degree burn scars were treated with five nonablative fractional resurfacing treatments given at 4-week intervals. Three independent investigators evaluated subject outcomes at 3 months post-treatment (primary outcome); patients also provided subjective assessments of improvement (secondary outcome). RESULTS: Nonablative fractional resurfacing resulted in overall improvement in 90% of subjects, as determined by independent investigators; improvements were moderate to excellent in 60%. Ninety percent of subjects had improved skin texture, 80% had improved dyschromia, and 80% had improved hypertrophy/atrophy. Patients' self-reports also revealed moderate to excellent improvements (on average) in burn scar area, and significant improvements in self-esteem at 3 months post-treatment (P = 0.03). LIMITATIONS: Small sample size and lack of control group. CONCLUSIONS: Fractional resurfacing is a promising new treatment modality for burn scars. We should continue to identify novel approaches and management strategies for the spectrum of diverse burn scars so that we can better treat this patient population.