Wednesday, October 3, 2007

Is GORTEX Really that unsafe compared to Silicone?

A Multicenter evaluation of the safety of Gore-Tex as an implant in Asian rhinoplasty Authors: Jin, Hong-Ryul; Lee, Joo-Yeon; Yeon, Je-Yeob; Rhee, Chae-Seo Source: American Journal of Rhinology, Volume 20, Number 6, November-December 2006 , pp. 615-619(5) Publisher:
OceanSide Publications, Inc Background: A retrospective multicenter study examined the safety of Gore-Tex as a nasal implant in rhinoplasty. Methods: This study involved 853 patients (656 primary surgeries and 197 secondary surgeries) who had undergone rhinoplasty and used Gore-Tex either at the dorsum or at the nasal tip. Data were extracted from the medical records by surgeons and entered on a standard form. Data included the information about the demographics and history of the patient, method and results of surgery, complications, follow-up, and various factors believed to predispose to complications. Results: The average follow-up period was 18 months. Overall complication rate associated with Gore-Tex was 2.5% (21 cases). Infection was the most common complication (18 cases; 2.1%) followed by two cases of seroma and one case of persistent nasal swelling. Among the 21 suffering complications, 19 patients (91%) needed graft removal. Nine cases of infection developed in primary surgeries (1.4%) and nine cases developed in secondary surgeries (4.6%), which represented a statistically higher complication rate in those undergoing secondary surgery (p = 0.0062). Infections developed within 1 month in five cases and nine cases developed infection >6 months postoperatively. Other complications including esthetic problems were identified in 16 cases (1.9%). [color=red]Conclusion: Gore-Tex should be used judiciously in rhinoplasty because of a 2.1% infection rate, a risk that is higher still after secondary surgery; moreover, once infected, Gore-Tex implants usually require removal. Document Type: Research article DOI: 10.2500/ajr.2006.20.2948 Problems of Expanded Polytetrafluoroethylene (Gore-Tex(R)) in Augmentation Rhinoplasty. Yang SJ, Lee JH, Tark MS. Dr. Yang's Institute of Rhinoplasty, Korea. Department of Plastic and Reconstructive Surgery, College of Medicine, Soonchunhyang University, Seoul, Korea. Augmentation rhinoplasty is one of the most popular aesthetic procedures in Asians. Numerous alloplastic implants have been used, however alloplastic implants may cause many problems in nasal and perinasal areas because of thin soft tissue cover. For these reasons, an ideal implant should be nonpalpable, readily exchangeable and biocompatible. Among these alloplastic implants, Gore-Tex(R) is a polymer of carbon bound to fluorine composed of solid nodes connected by very fine fibers. It has been reported that this material become permeated and surrounded by mature connective tissue, forming a strong supporting envelop for the material, yet the implant is easily removed because of limited tissue ingrowth. Since it's development, Gore-Tex(R) has found many applications in the field of facial plastic and reconstructive surgery. From November, 2001 to December, 2002, Gore-Tex(R) implants were removed from 17 patients due to several problems such as; decreased dorsal height, tip deformity, chronic inflammation. The implants were very hard to remove and coinciding injury of the surrounding tissue were inevitable. An analysis of the length and thickness changes in these removed implants was made. The results showed, decrease in length and thickness with a volume loss averaging, 46.3% in 45x4.0mm implants, 49.3% in 50x5.0mm implants. In view of the experiences of 17 cases of Gore-Tex(R) implants in rhinoplasty, we have concluded that Gore-Tex(R) implants were structurally unstable, fibrovascular tissue ingrowth into pores were minimal, the implants were very hard to remove and the implants caused a postoperative volume reduction. Therefore, Gore-Tex(R) use in augmentation rhinoplasty should be approached with caution.[/color]

2 comments:

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