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Risque des benzocaine topique

26 avril; Auteur: admin

http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2011/2011_59-fra.php

Pour la liste complète des produits.
http://webprod.hc-sc.gc.ca/dpd-bdpp/dispatch-repartition.do?lang=fra

Mise à jour
2011-59

Le 19 avril 2011
Pour diffusion immédiate

OTTAWA – Santé Canada rappelle aux Canadiens, y compris aux parents et responsables d’enfants, les risques sanitaires associés à l’utilisation de produits à base de benzocaïne topique, dont une maladie du sang rare mais potentiellement grave, la méthémoglobinémie (MHb). Santé Canada continue de recevoir des rapports d’effets indésirables associés à la benzocaïne, comme la MHb. Nous continuons à évaluer l’innocuité des produits à base de benzocaïne à la lumière de ces rapports et prendrons les mesures réglementaires appropriées au besoin.

Les produits à base de benzocaïne topique sont offerts en vente libre en diverses concentrations et formulations, notamment en vaporisateurs, gels, liquides et crèmes. Ils sont utilisés pour soulager la douleur associée au maux de gorge, à la poussée des dents, aux maux de dents, à la stomatite aphteuse, à l’irritation de la bouche et des gencives, aux brûlures, piqûres et morsures d’insectes, aux démangeaisons et aux hémorroïdes. Ils sont aussi utilisés par les professionnels de la santé lors d’interventions chirurgicales, dentaires ou autres afin d’engourdir la bouche et la gorge.

La MHb compromet la capacité des globules rouges de transporter l’oxygène dans le corps. Les signes et les symptômes de la MHb comprennent une peau, des lèvres ou des lits d’ongle pales, gris ou bleutés, un essoufflement, de la fatigue, de la confusion, des maux de tête, une sensation d’étourdissement, des nausées et une altération du rythme cardiaque. Ces symptômes peuvent apparaître dans un délai de quelques minutes ou d’une à deux heures après la prise de benzocaïne. Ils peuvent survenir après la première ou plusieurs utilisations. Dans des cas rares et graves, la MHb peut entraîner de la stupeur, un coma, voire la mort.

D’autres effets secondaires associés aux produits à base de benzocaïne topique comprennent des difficultés respiratoires ou de déglutition, une enflure de la langue ou de la bouche, un rythme cardiaque irrégulier, des malaises, une fibrillation de la peau, une hypersensibilité, des brûlements, des rougeurs, des démangeaisons, une éruption cutanée et de l’irritation au site d’injection. Chez les personnes sensibles, ces effets être causés par n’importe quel produit à base de benzocaïne topique, peu importe le type de produit ou la concentration de benzocaïne.

Comme pour tout produit de santé, les Canadiens doivent lire et suivre attentivement les consignes d’utilisation. Si vous pensez que vous-même ou votre enfant éprouve des effets secondaires, y compris des signes ou des symptômes de la méthémoglobinémie, consultez un professionnel de la santé. Si vous avez des questions ou des préoccupations au sujet d’un produit à base de benzocaïne topique, consultez un professionnel de la santé.

Santé Canada a d’abord communiqué les risques de la MHb dans un avis public et un avis aux hôpitaux en novembre 2006. Santé Canada a reçu depuis sept rapports d’effets indésirables graves impliquant la benzocaïne topique, dont quatre étaient des rapports de MHb associée à la prise de benzocaïne chez des adultes.

Pour une liste des produits à base de benzocaïne homologués par Santé Canada, y compris les produits topiques offerts en vente libre, consultez la Base de données des produits de santé naturels homologués ou la Base de données sur les produits pharmaceutiques (utilisez le nom de l’ingrédient actif benzocaïne pour la recherche) de Santé Canada.

Pour signaler un effet indésirable présumé à un produit de santé, veuillez communiquer avec le Programme Canada Vigilance de Santé Canada en composant sans frais le 1-866-234-2345 ou en remplissant un Formulaire de déclaration de Canada Vigilance et en nous le faisant parvenir de l’une des façons suivantes :

•Télécopieur : 1-866-678-6789
•Internet : www.santecanada.gc.ca/medeffet
•Courrier : Programme Canada Vigilance
Direction des produits de santé commercialisés
Ottawa (Ontario), IA 0701E
K1A 0K9

La contracture capsulaire est une des complications les plus fréquentes suites à l’augmentation mammaire. Une étude préliminaire montre que singulair(Montelukast) améliore principalement les contractures capsulaires de stade léger à modéré. Celui-ci est bien toléré et présente peu d’effet secondaire.

Aesthet Surg J. 2010 May;30(3):404-8.

Effects of Singulair (montelukast) treatment for capsular contracture.
Huang CK, Handel N.

Division of Plastic and Reconstructive Surgery, David Geffen School of Medicine at University of California, Los Angeles, CA, USA.

Comment in:

Aesthet Surg J. 2010 May;30(3):485-6.
Aesthet Surg J. 2010 May;30(3):409-10.

Abstract
BACKGROUND: Capsular contracture (CC) is one of the most common complications of breast augmentation surgery. Leukotrienes are implicated in the inflammatory cascade and have been postulated to be involved in the formation of CC. Therefore, leukotriene antagonists Accolate and Singulair have been prescribed by plastic surgeons off-label to treat and prevent CC. To date, there are no studies investigating the efficacy of Singulair on CC.

OBJECTIVE: The authors retrospectively review a series of patients treated with Singulair to determine whether it improves CC after breast implant surgery.

METHODS: Nineteen patients treated with Singulair by the senior surgeon (NH) after implant placement from March 2006 to November 2009 were included in this study. Follow-up on Singulair efficacy was obtained by a combination of office chart review and standardized telephone questionnaire. Results were characterized as complete improvement, improvement, no change, or worse.

RESULTS: Seventeen patients presented with CC resulting from a variety of breast operations. Two patients who had a history of recurrent CC were prescribed Singulair prophylactically immediately after surgery. Twenty-one breasts with existing CC were included in the total. Two (11%) patients became worse, three (16%) patients had no change, five (26%) improved, seven (37%) completely improved, and two (11%) were prevented from having CC formation.

CONCLUSION: Our preliminary study shows that Singulair improves CC. Breasts with mild CC (Baker score < III) appeared to have better improvement with Singulair compared to those with more severe contracture (Baker score III and IV). Singulair is well tolerated with minimal side effects and can be administered to patients after breast implant surgery to improve CC.

PMID: 20601564 [PubMed - in process]

Le transfert de gras est une technique sécuritaire et efficace, mais le manque de donnée scientifique pour supporter les résultats amène la communauté médicale à ne pas recommander ce traitement pour l’instant.

Aesthet Surg J. 2010 May;30(3):381-7.

Department of Plastic and Reconstructive Surgery, Nippon Medical School, 1-1-5 Sendagi Bunkyo-ku, Tokyo, Japan.

Comment in:

Aesthet Surg J. 2010 May;30(3):387-9.

Abstract
Recent technical advances in fat grafting and the development of surgical devices such as liposuction cannulae have made fat grafting a relatively safe and effective procedure. However, new guidelines issued by the American Society of Plastic Surgeons in 2009 announced that fat grafting to the breast is not a strongly recommended procedure, as there are limited scientific data on the safety and efficacy of this particular type of fat transfer. Recent progress by several groups has revealed that multipotent adult stem cells are present in human adipose tissue. This cell population, termed adipose-derived stem cells (ADSC), represents a promising approach to future cell-based therapies, such as tissue engineering and regeneration. In fact, several reports have shown that ADSC play a pivotal role in graft survival through both adipogenesis and angiogenesis. Although tissue augmentation by fat grafting does have several advantages in that it is a noninvasive procedure and results in minimal scarring, it is essential that such a procedure be supported by evidence-based medicine and that further basic scientific and clinical research is conducted to ensure that fat grafting is a safe and effective procedure.

PMID: 20601560 [PubMed - in process]

GUEX J. J. ; HAMEL-DESNOS C. (1) ; GILLET J. L. ; CHLEIR F. ; PERRIN M. ;

(1) Centre Hospitalier Privé Saint Martin, 18, rue des Roquemonts, 14000 Caen, FRANCE

Résumé

Le traitement des varices des membres inférieurs a été profondément modifié par l’apparition de la sclérothérapie écho-guidée à la mousse. Cette technique allie les avantages de l’écho-Doppler pulsé couleur et l’efficacité de la mousse sclérosante : – évaluation ultrasonore préalable nécessaire au diagnostic précis de la maladie, – guidage des ponctions et des injections, – vérification du remplissage des segments cibles, – contrôle des résultats thérapeutiques, -recherche et surveillance des effets secondaires éventuels, -régularité et homogénéité de l’attaque de la paroi veineuse sur de longs segments veineux, -réduction des quantités de sclérosant, – obtention d’un veino-spasme, – efficacité immédiate avec bonne tenue au moins à moyen terme. Efficace et sûre lorsqu’elle est pratiquée par des médecins compétents et entraînés, la méthode permet la prise en charge simple, peu vulnérante et économique de la maladie veineuse chronique superficielle dont on sait qu’il s’agit d’une affection très fréquente, invalidante et coûteuse pour la société. Les résultats très satisfaisants observés à moyen terme nous laissent à penser que la technique va s’imposer largement et perdurer. La stratégie thérapeutique des varices s’en trouve fortement modifiée pour le plus grand bien des patients.

Revue

Phlébologie   ISSN 0031-8280   CODEN PHLBA2 

2008, vol. 61, no3, pp. 261-270 [10 page(s) (article)] (40 ref.)

Ed. phlébologiques françaises, Paris, FRANCE  (1958) (Revue)

Pour obtenir l’article complet:

http://cat.inist.fr/?aModele=afficheN&cpsidt=20998461

Zakia Rahman, MD 1, Heather MacFalls, MS 2, Kerrie Jiang, MSN, NP 2, Kin F. Chan, PhD 2, Kristen Kelly, MD 3, Joshua Tournas, MD 3, Oliver F. Stumpp, PhD 2, Vikramaditya Bedi, MS 2, Christopher Zachary, MD 3

Lasers in surgery and medicine 41:78-86

Abstract
Background and Objective
Due to the significant risk profile associated with traditional ablative resurfacing, a safer and less invasive treatment approach known as fractional deep dermal ablation (FDDATM) was recently developed. We report the results of the first clinical investigation of this modality for treatment of photodamaged skin.
 
Twenty-four subjects received treatments on the inner forearm with a prototype fractional CO2 laser device (Reliant Technologies Inc., Mountain View, CA) at settings of 5-40 mJ/MTZ and 400 MTZ/cm2. Clinical and histological effects were assessed by study investigators 1 week, 1 month, and 3 months following treatment. Thirty subjects were then enrolled in a multi-center study for treatment of photodamage using the same device. Subjects received 1-2 treatments on the face and neck, with energies ranging from 10 to 40 mJ/MTZ and densities ranging from 400 to 1,200 MTZ/cm2. Study investigators assessed severity of post-treatment responses during follow-up visits 48 hours, 1 week, 1 month, and 3 months following treatment. Using a standard quartile improvement scale (0-4), subjects and investigators assessed improvement in rhytides, pigmentation, texture, laxity and overall appearance 1 and 3 months post-treatment.
Results
Clinical and histologic results demonstrated that fractional delivery of a 10,600 nm CO2 laser source offers an improved safety profile with respect to traditional ablative resurfacing, while still effectively resurfacing epidermal and dermal tissue. Forearm and facial treatments were well-tolerated with no serious adverse events observed. Eighty-three percent of subjects exhibited moderate or better overall improvement (50-100%), according to study investigator quartile scoring.
Conclusions
FDDATM treatment is a safe and promising new approach for resurfacing of epidermal and deep dermal tissue targets.

Lasers Surg. Med. 41:78-86, 2009. © 2009 Wiley-Liss, Inc.

http://www3.interscience.wiley.com/journal/122208683/abstract

 

May/June 2009: Dr. McCafferty’s Research Published in Aesthetic Surgery Journal
Background

Plastic surgeons and manufacturers of breast implants have been examining the complication and reoperation rates of primary breast augmentations for more than 18 years. The seemingly high rates reported by the manufacturers to the United States Food and Drug Administration (FDA) were the impetus for this multicenter study.

 Objective

This paper reports on data pooled from three plastic surgery practices that were geographically distributed across the United States and examines the reoperation rate, time to reoperation, the reason for reoperation, and specific complications in 177 consecutive primary breast augmentation patients. These data are statistically compared to the manufacturers’ 2005 and 2008 FDA data. In addition, the significance of selected variables from our data are examined as predictors for reoperation.

 Methods

Data were retrospectively collected from 177 consecutive primary breast augmentations performed between 2001 and 2004 from three surgical practices. Direct physician-to-patient follow-up periods ranged from 12 to 58 months, with 100% of patients having at least one year of follow-up. Each practice extracted chart data on variables and complications, including reoperations. These data were independently collated and sent to an independent biostatistician for analysis.

 Results

Our three year Kaplan–Meier (KM) reoperation rate (8%) and capsular contracture rate (2%) were both lower than the manufacturers’ KM 3-year rates for reoperation (13%-21%) and capsular contracture (8.2%-9%). Logistic regression identified only simultaneous mastopexy and preexisting ptosis as predictors of reoperation.

 http://www.aestheticsurgeryjournal.org/article/S1090-820X(09)00095-8/abstract

Volume 29, Issue 3, Pages 209-212 (May 2009) Aesthetic surgery journal

Thrombophlebitis of the thoracoepigastric system of veins is a benign disease and, despite its localized involvement and presentation, the condition is known as Mondor disease (MD). A transverse incision made on the thoracoabdominal wall divides the axially arranged superficial veins at a right angle and the presence of unidirectional valves prevents retrograde blood flow, leading to stasis and thrombus formation. The incidence of MD in oncologic breast cases and aesthetic mammaplasties is reported to be 0.95% and 1.07%, respectively. Siliconeadenitis of axillary nodes, on the other hand, is uncommon and has only been reported occasionally. Extensive MD of the left axilla and inner arm is presented following excision of axillary nodes secondary to siliconeadenitis after cohesive gel silicone breast implant rupture.

http://www.aestheticsurgeryjournal.org/article/S1090-820X(09)00104-6/abstract

According to the author, autologous fat transplantation is an ideal technique to correct facial atrophy, providing a stable and potentially long lasting alternative to « off the shelf » fillers. Structural augmentation with fat involves multilayer blunt fat infiltration designed around concepts of volume expansion and resultant tissue shifting. The author has found that retention varies in different parts of the face and fat seems to « take » best in areas in which fat atrophy is the problem, such as in the cheek, periorbital area, and mandible. When fat is being used to replace bony remodeling or mucosal atrophy (both occur in the perioral area), retention can be unpredictable.

Lisa M Donofrio

http://www.biomedsearch.com/nih/Techniques-in-facial-fat-grafting/19083599.html

 Jorge Planas, M.D.The authors report their experience in five years of creating breast implant capsular contractures with an external ultrasonic device that facilitates the closed capsulotomy technique. A set of 52 patients have been treated with a 82.6% of improvement at a year follow up. Methods of application and results are discussed.
 

1, Valerio Cervelli, M.D.2, and Gabriel Planas, M.D.2

http://www.springerlink.com/content/c635tjyul5nyqf94/fulltext.pdf

After successfully treating breast implant capsular con¬tracture with ultrasound, the author asks, « If it is demonstrated that ultrasound is effective for treating already existing contractures, could it be also effective in preventing them? » Here he presents his protocol and preliminary results of prophylactic application of ultrasound for the avoidance of capsular contractures. (Aesthetic SurgJ 2002;22:205-207.)

http://www.clinicaplanas.com/fundacion/articulos/articulo11/articulo11.htm