Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 59
Filter
1.
Plast Reconstr Surg ; 151(4): 592e-608e, 2023 04 01.
Article in English | MEDLINE | ID: mdl-36477154

ABSTRACT

BACKGROUND: The incidence of facial skin necrosis has increased considerably because of the growth in the popularity of dermal fillers. This study describes the patterns and severity of facial skin ischemia, along with associated neuro-ophthalmologic injuries, in the published literature through the introduction of the facial artery, ophthalmic artery, distal external carotid artery, internal maxillary artery (FOEM) facial angiosome scoring system and grading scale. METHODS: A systematic review of all photographic cases of facial skin ischemia attributable to vascular occlusion with dermal fillers and injectable materials was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. RESULTS: A total of 243 cases were identified, with 738 digital clinical photographs retrieved. The facial artery (58% of cases) and ophthalmic artery (48% of cases) angiosomes were most commonly affected. The frontonasal and angulonasal territories were the most common facial skin segments injured by filler-induced vascular occlusion. Cutaneous involvement of the ophthalmic angiosome was significantly associated with neuro-ophthalmologic complications [vision loss, 39% versus 0.8% ( P = 0.00001); stroke, 8% versus 0.8% ( P = 0.0085)]. Injuries with greater cutaneous surface area or cross-angiosome involvement were associated with a higher incidence of severe visual deficits and bilateral stroke. CONCLUSIONS: Facial skin necrosis attributable to vascular occlusion is a rapidly growing problem that has remained poorly characterized in the literature. This study provides the largest descriptive analysis of published photographic reports of skin ischemia to date and proposes a novel scoring system and grading classification to aid in future reporting.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Vascular Diseases , Humans , Dermal Fillers/adverse effects , Ischemia/chemically induced , Ophthalmic Artery , Necrosis/chemically induced , Hyaluronic Acid/adverse effects
2.
JPRAS Open ; 34: 173-177, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36325377

ABSTRACT

The stark rise in the incidence of dermal filler-related adverse sequelae has given rise to a variety of cosmetic distortions related to improper filler placement that include dynamic and static contour deformities of the face. In this article, we describe two instances of post-septal hyaluronic acid filler aggravating existing steatoblepharon and outline potential causative mechanisms responsible for this condition.

3.
J Plast Reconstr Aesthet Surg ; 75(7): 2368-2374, 2022 07.
Article in English | MEDLINE | ID: mdl-35367160

ABSTRACT

BACKGROUND: Social media has become increasingly important for patients when deciding whether they should undergo rhinoplasty. The purpose of this study is to analyze patient satisfaction of rhinoplasty procedures through RealSelf social media reviews. METHODS: We collected data from 583 rhinoplasty reviews published on the RealSelf portal. In posts dated between 2016 and 2020, we included those which were labeled as "Worth It" and "Not Worth It." Posts that were labeled as "Unsure" or were left unlabeled were excluded from the study. In addition, posts not including the cost of their rhinoplasty were excluded. Taking into account patient demographics and cost of the procedure, we analyzed reasons for choosing to undergo surgery, reasons for choosing surgeons, and reasons for liking or disliking their procedure. RESULTS: Of the 583 reviews analyzed, most (45.4%) were categorized from the 18-24 years age group and there was an overall 93.8% satisfaction rate. While there was no statistically significant difference in the cost of rhinoplasty surgeries between "Worth It" and "Not Worth It" groups, the average cost of recorded rhinoplasties was US$ 8043 with a standard deviation ± $3296. According to our analysis, younger patients aged 18-24 years relied more on social media to choose their surgeons and desired a more natural appearance to their nose while older ones preferred compatible physician personalities and increased self-esteem for rhinoplasty. CONCLUSION: This study offers a unique perspective into the distinguishing characteristics of different age groups and the values they place in pursuing rhinoplasty, choosing their surgeons, and why they like/dislike their surgical outcomes.


Subject(s)
Rhinoplasty , Social Media , Surgeons , Adolescent , Adult , Humans , Nose , Patient Satisfaction , Rhinoplasty/methods , Young Adult
4.
Facial Plast Surg ; 37(3): 348-353, 2021 Jun.
Article in English | MEDLINE | ID: mdl-32942313

ABSTRACT

Opposing facial features between animated villains and heroes have historically been used to demonstrate contrasting morality between characters, and this could have an impact on how humans view someone as good or evil in everyday life. Studies have been done investigating classic dermatologic features of villainous characters. This principle can be applied to nasal features as well. A search for "top animated characters" was performed. Characters were chosen from American Film Institute's "The Top Tens," Rolling Stone's "25 Best Pixar Movie Characters," and Screenrant's "The 30 Best Animated Movie Characters of All Time." Twenty villains and twenty hero counterparts from respective films were chosen. Classic nasal features were analyzed. Twenty villains (14 male, 6 female) and 20 heroes (12 male, 8 female) were analyzed. Sixteen villains (80%) had greater than normal nasal frontal angle versus 18 heroes (90%). Thirteen villains (65%) had an acute nasolabial angle versus two heroes (10%). Two villains (10%) had excess columellar show versus seven heroes (35%). Seven villains (35%) and one hero (5%) had a dorsal hump. Twelve villains (60%) had an overprojected chin versus three heroes (15%). Villains in pre-2000s films more frequently had a dorsal hump, overprojected chin, ptotic tip, pollybeak deformity, and bulbous tip. Heroes in pre-2000s films more frequently had an overrotated tip. Villains and heroes commonly have a greater than normal nasofrontal angle. Villains more commonly have an acute nasolabial angle, underrotated tip, overprojected chin, dorsal hump, and pollybeak deformity. Heroes more commonly have a large nasolabial angle and overrotated tip. Further research in conjunction with psychologists is required to obtain concrete data on how this affects whether an individual in real life is seen as good or evil, and the impact this has on interactions in society, including in the medical field.


Subject(s)
Motion Pictures , Nasal Septum , Female , Humans , Male , United States
5.
Otolaryngol Clin North Am ; 53(5): 811-817, 2020 Oct.
Article in English | MEDLINE | ID: mdl-32593429

ABSTRACT

Facial plastic surgery, including septorhinoplasty, aging face procedures, otoplasty, and oculoplastic procedures, has varying levels of evidence for the management of acute pain after surgery. This article discusses the available evidence in these procedures and discusses the authors' recommendations for the treatment of postoperative pain, with a focus on decreasing the reliance on opioid pain medication.


Subject(s)
Acute Pain/drug therapy , Face/surgery , Pain Management/methods , Pain, Postoperative/drug therapy , Surgery, Plastic/adverse effects , Analgesics, Opioid/therapeutic use , Blepharoplasty/adverse effects , Humans , Rhinoplasty/adverse effects , Rhytidoplasty/adverse effects , Surgery, Plastic/methods
6.
Facial Plast Surg Aesthet Med ; 22(4): 309-311, 2020.
Article in English | MEDLINE | ID: mdl-32267793

ABSTRACT

Background: Despite its popularity among otolaryngology residents, there is currently a paucity of knowledge on the match in facial plastics surgery fellowships and the selection criteria that drive the match process. To increase the understanding of this process and to improve the manner in which candidates are vetted, a survey study was designed. Methods: A 24-question online survey was designed to discern desired qualities regarding fellow selection, interview processes, fellow participation, and program director satisfaction with the current process. This survey was sent to all American Academy of Facial Plastic and Reconstructive Surgery fellowship program directors in the United States. Results: Overall, 40 of the 64 fellowship directors responded to the survey for a total response rate of 62.5%. Most fellowship directors reported that the reputation of an applicant's residency was an important component of the selection criteria with 34 of 40 of those who responded rating it at least "somewhat important." With regard to the otolaryngology trainee examination, nearly all fellowship directors (39/40) reported that there was no minimum cutoff score to be offered an interview. When fellowship directors were asked to rank the academic components of an application that they viewed as most important, they most commonly reported that the strength of an applicant's letters of recommendation were most important. Conclusions: With the increasing popularity of fellowships within the field of otolaryngology, having an understanding of which components of the application process are viewed as most important by fellowship directors is crucial in applicants matching into the fellowship of their choice.


Subject(s)
Education, Medical, Graduate/standards , Fellowships and Scholarships/standards , Otolaryngology/education , School Admission Criteria , Surgery, Plastic/education , Face/surgery , Humans , Internship and Residency , Otolaryngology/standards , Surgery, Plastic/standards , Surveys and Questionnaires , United States
7.
Pediatr Emerg Care ; 36(3): 119-124, 2020 Mar.
Article in English | MEDLINE | ID: mdl-28953099

ABSTRACT

OBJECTIVE: The aim of this study was to determine the national incidence of facial trauma among toddlers and delineate patterns of injury and their causes. METHODS: A retrospective review was designed to explore patterns of maxillofacial trauma within toddler-aged children using the National Electronic Injury Surveillance System from the Consumer Product Safety Commission. The database was searched for emergency department visits involving facial trauma sustained by children 12 months through 3 years of age from 2010 through 2014 and analyzed for patient demographics, primary diagnosis, and associated products/activities. Subset analyses were performed between age groups to determine the relationship between causes of injury and age using extrapolated national incidences. RESULTS: A sample of 45,249 patients extrapolated to an estimated 1.3 million emergency department visits for facial trauma in toddlers from 2010 to 2014, averaging 260,000 annually. Injuries involving foreign bodies and fractures had a higher incidence in toddlers 2 years or older, and fractures comprised fewer than 1% of facial injuries in any age group. Furniture was the most common source of trauma overall, with a higher frequency among toddlers aged 12 to 17 months. Trauma in the setting of sports was more common in toddlers aged 3 years. CONCLUSIONS: The low incidence of facial fractures further supports recommendations against routine imaging in toddler facial trauma and suggests that more focus should be placed on investigating for concurrent traumas and soft tissue injuries where fractures are involved. Our findings highlight prevention opportunities, particularly in furniture-related injuries for toddlers aged 12 to 17 months and sports-related traumas in toddlers aged 3 years. Our study also suggests restricting certain toys from 3-year-old toddlers to decrease the risk of aspiration.


Subject(s)
Emergency Service, Hospital/statistics & numerical data , Maxillofacial Injuries/epidemiology , Athletic Injuries/epidemiology , Child, Preschool , Databases, Factual , Facial Bones/injuries , Female , Humans , Incidence , Infant , Male , Retrospective Studies , Skull Fractures/epidemiology , Soft Tissue Injuries/epidemiology
8.
Ann Otol Rhinol Laryngol ; 129(4): 401-410, 2020 Apr.
Article in English | MEDLINE | ID: mdl-31762301

ABSTRACT

OBJECTIVE: The safety and efficacy of extracorporeal septoplasty (ECS) has long been debated. Our objective was to determine this technique's functional and aesthetic outcomes and complications through a systematic review of the literature. DATA SOURCES: PubMed/MEDLINE, Embase, Cochrane Library, and Web of Science databases were evaluated for studies detailing functional or aesthetic outcomes of ECS. REVIEW METHODS: Bias was evaluated using the Cochrane Risk of Bias Tool and the Methodological Index for Non-randomized Studies (MINORS) score. Aesthetic and functional outcomes in addition to complications were evaluated using subjective and objective measures. Meta-analyses were performed when appropriate. RESULTS: Seventeen studies encompassing 1418 patients were included. The average MINORS score for observational studies was 9.2. Overall there was a significant improvement in subjective nasal function with a preoperative average Nasal Obstruction Symptom Evaluation (NOSE) score of 75 (±16) decreasing to 19.5 (±16.5) postoperatively for a mean difference (MD) of -55 (95% confidence interval (CI): -60 to -49.5). In terms of objective nasal function, at 6 months postoperatively, there was an improvement of nasal flow measured by rhinometry ranging from 70 to 71% across studies. Anthropometric measurements were utilized for objective aesthetic outcomes. There was a significant improvement in I-shaped deviations (MD: -2.7°, 95% CI: -5.6 to -0.16) and C-shaped deviations improved by 11.9° (95% CI +2.8-+21.2). Complication rates ranged from 0 to 18%. CONCLUSION: ECS can achieve significant improvements in the subjective and objective function of the nose. The associated complication rate is low but variable between surgeons.


Subject(s)
Nasal Septum/surgery , Nose Diseases/surgery , Outcome Assessment, Health Care , Rhinoplasty , Humans , Recovery of Function , Rhinoplasty/adverse effects , Rhinoplasty/methods , Rhinoplasty/standards
9.
Facial Plast Surg ; 35(2): 204-209, 2019 Apr.
Article in English | MEDLINE | ID: mdl-30849781

ABSTRACT

There has been widespread coverage of cosmetic procedures, particularly facial fillers, as minimally invasive options for facial rejuvenation. The authors' objective was to characterize news media's coverage of facial fillers and its role in shaping public perception of these products over the past decade. Public view plays a significant role in policymaking, assisting patient communication, and addressing preconceived notions. Google News was searched for online news coverage related to "facial fillers" from 2008 to 2017. News articles from various sources were reviewed and analyzed with multiple objectives including complications listed, advantages, disadvantages, physician specialties, overall theme of the articles as positive, negative, or neutral and other parametrics. A chi-square test was used for statistical analysis. Of 426 articles meeting inclusion criteria, international news (20.4%), tabloids (18.8%), online health sites (18.3%), and national news (16.9%) were represented. Of articles containing adequate information, coverage was 44.7% positive, 29.9% neutral, and 26.1% negative with no significant change from 2008 to 2017. In addition, 46.0% of papers discussed complications including vascular injury and blindness associated with fillers, with significant increase by 2017 (p < 0.05). Facial fillers media coverage was overall positive, with broad coverage at both national and international levels. Complications were discussed often, and although vascular injury and vision damage are rare complications of fillers, they were frequently cited, potentially leading the public to believe they occur frequently. There were also significant concerns in the news media about greater regulation of products used as facial fillers, and practitioners administrating them. Altogether, these findings provide a comprehensive overview of patient perception and expectations of an increasingly popular and expanding cosmetic procedure.


Subject(s)
Cosmetic Techniques , Face , Public Opinion , Rejuvenation , Blindness , Cosmetic Techniques/adverse effects , Humans
11.
Laryngoscope ; 129(3): 671-683, 2019 03.
Article in English | MEDLINE | ID: mdl-30134500

ABSTRACT

OBJECTIVE: To perform an evidence-based review with recommendations that evaluates the indications and utility of negative pressure wound therapy (NPWT) in the head and neck. METHODS: The authors searched the PubMed, Medline, Embase, Web of Science, and Cochrane Library databases for relevant literature. The primary outcome was successful intended use of NPWT, be it for granulation tissue formation, infection control, or complete wound closure. Patient demographics, etiology, and other clinical characteristics were explored. Meta-analysis of observational studies was used to examine response rates and wound sizes. RESULTS: Fifty-seven articles encompassing 522 patients were included. The most common etiologies reported included: neoplasm (343 patients [65.7%]), oro-/pharyngocutaneous fistula (9.8%), infection (10.5%), and trauma (9.6%). The majority of wounds treated were in the neck (61.6%). Potential risk factors that may compromise wound healing were noted in 217 of 522 patients (41.6%). Of these 217 patients, 135 had properly documented risk factors, with the most common being prior irradiation (63%). The overall mean response across studies was 85.7% (95% confidence interval: 0.806-0.896, P < 0.001, I2 = 0 %). CONCLUSION: Negative pressure wound therapy is useful for the management of head and neck wounds and should be considered for patients in whom wound healing is progressing insufficiently, including those with a history of head and neck cancer, oro-/pharyngocutaenous fistula, and trauma. Randomized controlled trials further comparing NPWT versus other modalities may be invaluable in further delineating its appropriate role. Laryngoscope, 129:671-683, 2019.


Subject(s)
Negative-Pressure Wound Therapy , Wound Healing , Evidence-Based Medicine , Head , Humans , Neck , Observational Studies as Topic
12.
Laryngoscope ; 129(6): E200-E212, 2019 06.
Article in English | MEDLINE | ID: mdl-30585326

ABSTRACT

OBJECTIVES/HYPOTHESIS: Opioid misuse and diversion is a pressing topic in today's healthcare environment. The objective of this study was to conduct a review of non-opioid perioperative analgesic regimens following septoplasty, rhinoplasty, and septorhinoplasty. STUDY DESIGN: Evidence-based systematic review. METHODS: PubMed, MEDLINE, Cochrane Library, and Embase databases were reviewed for articles related to perioperative analgesic use in septoplasty, rhinoplasty, and septorhinoplasty. Quality of studies were assessed via the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) criteria, Jadad scores, and the Cochrane bias tool. Patient demographic data and clinical outcomes, including medication type, dose, administration time, pain scores, and adverse events, were obtained from included studies. Summary tables detailing the benefits and harms of each investigated regimen are included. RESULTS: Thirty-seven studies met inclusion criteria for this evidence-based review. The quality of the studies was determined to be of moderate quality based off of GRADE standardized criteria with a mean Jadad score of 3.1. A preponderance of evidence showed reduced perioperative pain scores and rescue analgesic requirements, supporting the use of local anesthetics for analgesic control. Nonsteroidal anti-inflammatory drugs (NSAIDs) demonstrated similar decreased visual analog scores and postoperative analgesic demand; however, increased adverse events in this class warrant caution. CONCLUSIONS: Contemporary literature supports the use of NSAIDs, gabapentin, local anesthetics, and α-agonists as effective perioperative analgesic opioid alternatives for septoplasty and septorhinoplasty. Local anesthetic use is a cost-effective option resulting in decreased postoperative pain scores and rescue analgesic requirements. Further large-scale, multi-institutional, controlled studies are needed to provide definitive recommendations. LEVEL OF EVIDENCE: NA Laryngoscope, 129:E200-E212, 2019.


Subject(s)
Analgesia/methods , Analgesics/therapeutic use , Nasal Septum/surgery , Pain, Postoperative/prevention & control , Perioperative Care/methods , Rhinoplasty , Humans , Pain Measurement , Pain, Postoperative/diagnosis
14.
Facial Plast Surg ; 34(4): 423-428, 2018 Aug.
Article in English | MEDLINE | ID: mdl-29954023

ABSTRACT

A decision tree was constructed to determine the incremental cost-effectiveness ratio (ICER) of grafting techniques used to prevent Frey Syndrome. The authors performed a sensitivity analysis to calculate what the probability of preventing Frey Syndrome would have to be and maximum costs associated with using grafting techniques to warrant their use as more "cost-effective" choice than using neither. Decision pathways utilized were uses of (1) free fat graft (FFG), (2) acellular dermis, and (3) no grafting. The probability of developing Frey syndrome and costs were extracted from previous studies to construct the decision tree. The primary effectiveness was the ICER of FFG or acellular dermis to prevent Frey syndrome. The initial outcomes included preventing Frey syndrome (effectiveness = 1) or developing Frey syndrome (effectiveness = 0). Compared with not using a graft, the ICER of using FFG and acellular dermis were $10,628 and $50,813, respectively. Frey syndrome was found in 2.6% of patients postoperatively in FFG group, 9.8% of patients in acellular dermis group, and 30.7% of patients who did not have a graft. The ICER shows absolute dominance of FFG with lower cost and high effectiveness over acellular dermis. This economic evaluation strongly supports the use of FFG over acellular dermis as cost-effective approach for prevention of postparotidectomy Frey syndrome.


Subject(s)
Acellular Dermis/economics , Adipose Tissue/transplantation , Parotid Gland/surgery , Postoperative Complications/economics , Sweating, Gustatory/economics , Cost-Benefit Analysis , Decision Trees , Humans , Postoperative Complications/prevention & control , Sweating, Gustatory/prevention & control , Transplantation, Autologous/economics
16.
Int Forum Allergy Rhinol ; 8(7): 837-849, 2018 07.
Article in English | MEDLINE | ID: mdl-29645361

ABSTRACT

BACKGROUND: Misuse and diversion of prescription opioids have been critical in facilitating the opioid epidemic. Our objective was to perform a systematic evidence-based review delineating perioperative regimens (including opioid alternatives) evaluated for endoscopic sinus surgery. METHODS: PubMed/MEDLINE, Cochrane Library, and EmBase databases were evaluated for studies detailing analgesics employed after endoscopic sinus surgery. Studies were assessed for level of evidence. Bias risk was evaluated using the Cochrane Bias tool and GRADE criteria. Medication, administration, adverse effects, pain scores, and rescue analgesic consumption were evaluated. A summary of evidence detailing benefits, harm, and cost was prepared. RESULTS: Thirty-two studies encompassing 1812 patients were included. The GRADE criteria determined the overall evidence to be of moderate quality. Perioperative acetaminophen had few adverse events and reduced immediate need for opioid rescue after sinus surgery; studies evaluating acetaminophen demonstrate a preponderance of benefit over harm. Nonsteroidal anti-inflammatory drugs (NSAIDs) also reduce postoperative opioid consumption, although a small portion of patients undergoing sinus surgery harbor the potential for NSAID intolerance. The aggregate level of evidence for studies evaluating NSAIDs was grade A, whereas the aggregate grade of evidence for several other agents was grade B. CONCLUSION: There is evidence supporting the use of NSAIDs and gabapentin for the control of pain after endoscopic sinus surgery. Acetaminophen, α-agonists, and local anesthetics are also viable options for postoperative analgesia. Familiarity with these data is essential to facilitate the use of opioid alternatives. Further large-scale, multi-institutional, randomized trials are needed to provide conclusive recommendations for these perioperative analgesics.


Subject(s)
Acetaminophen/therapeutic use , Analgesia , Analgesics, Opioid/therapeutic use , Analgesics/therapeutic use , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Pain, Postoperative/drug therapy , Paranasal Sinuses/surgery , Endoscopy , Evidence-Based Medicine , Humans , Pain Measurement , Perioperative Care
17.
Laryngoscope ; 128(7): 1576-1581, 2018 07.
Article in English | MEDLINE | ID: mdl-29446449

ABSTRACT

OBJECTIVES/HYPOTHESIS: There has been growing recognition of the roles prescription drug misuse and diversion play in facilitating the ongoing opioid epidemic. Our objective was to evaluate opioid prescription patterns among practicing otolaryngologists. STUDY DESIGN: Retrospective review of a CMS database. METHODS: Medicare Part D beneficiary data (2015) were accessed for a list of otolaryngologists. Opioid prescription rates, amount, and supply were calculated. Factors including board certification, experience, gender, and location were obtained for the 9,068 unique otolaryngologists represented in this dataset. RESULTS: In 2015, otolaryngologists wrote 133,779 opioid prescriptions for 922,806 days (6.9 days/per prescription). The majority was for hydrocodone-acetaminophen (64.0%). Most otolaryngologists (51.2%) prescribed ≤ 10 opioids; 6.1% offered > 50 opioid prescriptions. Men wrote more prescriptions on average. Opioid prescription rates were greatest in the Midwest (4.6%) and least in the Northeast (1.8%), and the highest/lowest rates were in Delaware (8.6%) and New York (1.3%). Midcareer (11 -20 years) otolaryngologists were most likely to write >50 prescriptions. The opioid prescription rate declined with greater experience. CONCLUSIONS: Opioid prescriptions written by otolaryngologists may play a significant role in the availability of these agents, as otolaryngologists wrote nearly 1 million days worth of opioids to Medicare beneficiaries in 2015. Although the majority of otolaryngologists write fewer than 11 prescriptions annually, those writing more prescriptions also write lengthier courses. There is significant geographic variation in prescribing patterns, highlighting a lack of consensus, and midcareer otolaryngologists are more aggressive in offering opioids. These findings highlight an urgent need for strengthening educational resources aimed at minimizing unnecessary prescriptions. LEVEL OF EVIDENCE: NA. Laryngoscope, 128:1576-1581, 2018.


Subject(s)
Analgesics, Opioid/therapeutic use , Drug Prescriptions/statistics & numerical data , Otolaryngologists/statistics & numerical data , Practice Patterns, Physicians'/statistics & numerical data , Acetaminophen/therapeutic use , Drug Combinations , Female , Humans , Hydrocodone/therapeutic use , Male , Medical Overuse/statistics & numerical data , Medicare Part D , Retrospective Studies , United States
18.
JAMA Facial Plast Surg ; 20(3): 244-248, 2018 May 01.
Article in English | MEDLINE | ID: mdl-29346485

ABSTRACT

IMPORTANCE: Facial implants represent an important strategy for providing instant and long-lasting volume enhancement to address both aging and posttraumatic defects. OBJECTIVE: To better understand risks of facial implants by examining national resources encompassing adverse events and considerations facilitating associated litigation. DESIGN, SETTING, AND PARTICIPANTS: A cross-sectional study reviewed complications following facial implants. The procedures reviewed were performed on patients at locations throughout the United States from January 2006 to December 2016. Data collection was completed in March 2017. The Manufacturer and User Facility Device Experience database, which contains medical device reports submitted to the US Food and Drug Administration (FDA), was searched for complications that occurred from January 2006 to December 2016 involving facial implants made by Implantech, MEDPOR, Stryker, KLS Martin, and Synthes. Furthermore, the Thomson Reuters Westlaw legal database was searched for relevant litigation. MAIN OUTCOMES AND MEASURES: The complications of facial implants were analyzed in relation to the location of implant and severity of complication. Litigation was analyzed to determine which factors determine outcome. RESULTS: Thirty-nine instances of adverse events reported to the FDA were identified. Sixteen (41%) involved malar implants, followed by 12 chin implants (31%). The most common complications included infection (18 [46%]), implant migration (9 [23%]), swelling (7 [18%]), and extrusion (4 [10%]). Thirty-two patients (83%) had to have their implants removed. Infection occurred at a mean (SD) of 83.3 (68.8) days following the surgery. One-third of complications involved either migration or extrusion. The mean (range) time to migration or extrusion was 381.1 (10-2400) days. In 12 malpractice cases identified in publicly available court proceedings, alleged inadequate informed consent and requiring additional surgical intervention (ie, removal) were the most commonly cited factors. CONCLUSIONS AND RELEVANCE: Infection and implant migration or extrusion are the most common complications of facial implants. Most of these complications necessitate removal. These considerations need to be discussed with patients preoperatively as part of the informed consent process, as allegedly inadequate informed consent was cited in a significant proportion of resultant litigation, and there were overlapping considerations among adverse events reported to the FDA and factors brought up in relevant litigation. Cases resolved with settlements and jury-awarded damages encompassed considerable award totals. LEVEL OF EVIDENCE: NA.


Subject(s)
Face/surgery , Informed Consent/legislation & jurisprudence , Malpractice/legislation & jurisprudence , Maxillofacial Prosthesis/adverse effects , Postoperative Complications , Compensation and Redress/legislation & jurisprudence , Cross-Sectional Studies , Databases, Factual , Device Removal , Female , Humans , Male , United States , United States Food and Drug Administration
19.
JAMA Facial Plast Surg ; 20(3): 207-214, 2018 May 01.
Article in English | MEDLINE | ID: mdl-29270603

ABSTRACT

IMPORTANCE: Injectable fillers are increasing in popularity as a noninvasive option to address concerns related to facial aging and volume loss. To our knowledge, there have been no large-scale analyses of adverse events and associated litigation related to filler injections. OBJECTIVES: To determine risks of injectable fillers and analyze factors raised in litigation related to injectable fillers. DESIGN, SETTING, AND PARTICIPANTS: In this cross-sectional review, the US Food and Drug Administration's (FDA) manufacturer and user facility device experience (MAUDE) database was evaluated for complications from the use of the following fillers: Juvederm, Restylane, Belotero, Sculptra, Radiesse, Artefill, Bellafill, and Juvederm Voluma from 2014 to 2016. The Westlaw Next database was used to identify jury verdicts. MAIN OUTCOMES AND MEASURES: Complications were organized by type of filler used, location of injection, and severity. Intra-arterial injections without sequelae and those resulting in blindness or necrosis were considered severe complications. Factors raised during the litigation process were also analyzed. RESULTS: Of 1748 adverse events analyzed, most cases stemmed from cheek (751 [43.0%]) or lip (524 [30.0%]) injection. Commonly reported adverse events reported included swelling (755 [43.2%]) and infection (725 [41.5%]). Among FDA-reported complications, blindness was significantly associated with dorsal nasal injections (P < .001). Vascular compromise with and without sequela of dermal necrosis and blindness were significantly associated with Radiesse injections P < .001. Of the 9 malpractice cases identified, two-thirds involved allegations of inadequate informed consent, and the median award in cases resolved with payment was $262 000. CONCLUSIONS AND RELEVANCE: Although specific complication profiles vary by material and injection site, common adverse events associated with injectable fillers include swelling and infection. More serious events include vascular compromise, resulting in necrosis and blindness; these events are also raised in cases involving litigation. This analysis illustrates the importance of outlining these risks in a comprehensive preoperative informed consent process. LEVEL OF EVIDENCE: NA.


Subject(s)
Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Malpractice/legislation & jurisprudence , Skin Aging/drug effects , Cross-Sectional Studies , Databases, Factual , Humans , Risk Factors , United States , United States Food and Drug Administration
20.
JAMA Facial Plast Surg ; 20(1): 24-30, 2018 Jan 01.
Article in English | MEDLINE | ID: mdl-29121158

ABSTRACT

IMPORTANCE: Given the increase in opioid addiction and overdose in the United States, reasoned opioid use after outpatient surgery may affect prescription medication abuse. OBJECTIVES: To examine patient use of opioids after rhinoplasty and establish an optimal postrhinoplasty pain management regimen. DESIGN, SETTING, AND PARTICIPANTS: In this case series, opioid use was evaluated in 62 patients who underwent rhinoplasty performed by 3 fellowship-trained facial plastic surgeons, 2 in private practice in Texas and 1 in an academic setting in Michigan, from February 2016 to September 2016. MAIN OUTCOMES AND MEASURES: Opioid use, pain control, and adverse effects were examined and opioid use was compared across patient demographic and surgical procedure characteristics, including rhinoplasty and septoplasty, open vs closed techniques, revision vs primary operations, reduction of turbinates, and use of osteotomies. Opioid use was self-reported as the number of prescribed tablets containing a combination of hydrocodone bitartrate (5 mg) and acetaminophen (325 mg) that were consumed. RESULTS: The mean (SEM) age of the patients was 38.7 (16.4) years and included 50 female patients (81%). Of the initially prescribed 20 to 30 hydrocodone-acetaminophen combination tablets, the 62 patients included in this study used a mean (SEM) of 8.7 (0.9) tablets, only 40% of those prescribed after rhinoplasty. In addition, 46 patients (74%) consumed 15 or fewer tablets, whereas only 3 patients (5%) required refills of pain medication. Sex, age, concurrent septoplasty or turbinate reduction, use of osteotomy, and history of a rhinoplasty were not associated with the number of tablets used. The most common adverse effects included drowsiness in 22 patients (35%), nausea in 7 (11%), light-headedness in 3 (5%), and constipation in 3 (5%). CONCLUSIONS AND RELEVANCE: To mitigate the misuse or diversion of physician-prescribed opioid medications, surgeons must be steadfast in prescribing an appropriate amount of pain medication after surgery. A multifaceted pain control program is proposed to manage postoperative pain and ascertain the balance between controlling pain and avoiding overprescribing narcotics. LEVEL OF EVIDENCE: NA.


Subject(s)
Analgesics, Opioid/therapeutic use , Drug Utilization/statistics & numerical data , Inappropriate Prescribing/statistics & numerical data , Pain, Postoperative/drug therapy , Practice Patterns, Physicians'/statistics & numerical data , Rhinoplasty , Adult , Combined Modality Therapy , Female , Humans , Inappropriate Prescribing/prevention & control , Male , Michigan , Middle Aged , Opioid-Related Disorders/prevention & control , Pain Management/methods , Pain Measurement , Pain, Postoperative/diagnosis , Pain, Postoperative/therapy , Prescription Drug Misuse/prevention & control , Self Report , Texas
SELECTION OF CITATIONS
SEARCH DETAIL
...