Title: use of ligasure vessel sealing system versus conventional axillary dissection in breast cancer patients: a retrospective comparative study source: wienerroither et al.Bmc surgery (2022) 22:436 https://doi.Org/10.1186/s12893-022-01888-2ab079.Accepted: 14 december 2022.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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According to the literature, a retrospective study compared outcomes following use of ligasure or electrocautery in women who underwent axillary lymph node dissection for breast cancer treatment between 2013 and 2019.The dissection was performed using either electrocautery or ligasure.There were 35 patients in the ligasure group and postoperative complications included: bleeding, seroma, and wound infection.Reoperation was required for postoperative bleeding.Seromas were treated with aspiration.The number of seroma formation could be a result of early drain removal.
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