Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Electrosurgical Clip Cutting System. Final order.

The Food and Drug Administration (FDA or we) is classifying the endoscopic electrosurgical clip cutting system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the endoscopic electrosurgical clip cutting system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; General and Plastic Surgery Devices; Classification of the Electrosurgical Device for Over-the-Counter Aesthetic Use. Final order.

The Food and Drug Administration (FDA) is classifying the electrosurgical device for over-the-counter aesthetic use into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the electrosurgical device for over-the-counter aesthetic use's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Comparison of recurrence rates with contour-loop excision of the transformation zone (C-LETZ) and large loop excision of the transformation zone (LLETZ) for CIN.

AIM: To compare recurrence rates of large loop excision of the transformation zone (LLETZ) with those of contour-loop excision of the transformation zone (C-LETZ) in the management of cervical intraepithelial neoplasia (CIN). MATERIALS AND METHODS: The medical records of 177 patients treated consecutively by LLETZ and C-LETZ for CIN at Rajavithi Hospital between 2006 and 2009 were retrospectively reviewed. RESULTS: Of the 87 women in the C-LETZ group, 2 cases (2.30%) had recurrence compared with 13 cases (14.4%) of the 90 women in the LLETZ group, the higher recurrence rate in the latter being statistically significant (p<0.05). Median times of follow up in the C-LETZ and LLETZ groups were 12 months and 14 months respectively (p>0.05). The C-LETZ group showed less intraoperative bleeding compared to the LLETZ group, but the rate of achievement of single specimens and positive margins were similar in the two groups. CONCLUSIONS: The present study demonstrated the superiority of C-LETZ over LLETZ in terms of efficacy; C-LLETZ is associated with a lower recurrence rate and also carries a smaller risk of intraoperative bleeding than LLETZ. The rotating technique still has a potential role in treating precancerous lesions of the cervix.

Use of electrosurgery and lasers in the presence of dental implants.

Use of electrosurgery or laser surgery in the presence of metallic implants has been implicated in generating heat-induced injury to peri-implant bone, with the subsequent loss of osseointegration. Studies involving lasers offer conflicting results, while in the case of the electrosurg, little research has been published supporting or refuting these claims. This study measured local heat effects created by use of a unipolar electrosurgical unit, a bipolar electrosurgical unit, and a neodymium:yttrium-aluminum-garnet (Nd:YAG) laser. Absolute temperature increase was measured during an in vitro uncovering surgical procedure performed with each unit. Analysis of variance for repeated measures was performed. Second, absolute temperature increase for each unit was compared with a theoretical clinical limit of a 10 degrees C increase. The findings suggest that use of the unipolar electrosurgical unit should be avoided, while judicious use of both the bipolar unit or the laser unit should produce temperature profiles well within clinical limits.