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Fleitz Continuing EducationJeana Fleitz, M.E.D., RT(R)(M)“The X-Ray Lady”6511 Glenridge Park Place, Suite 6Louisville, KY 40222Telephone (502) 425-0651Fax (502) 327-7921Website www.x-raylady.comEmail address xrayladyce@gmail.comBreast Implants&Imaging Considerations UpdateApproved for 3 Category A CE CreditAmerican Society of Radiologic Technologists (ASRT)Approved for 3 Category A CE CreditsCourse Approval Start Date 12/01/08Course Approval End Date 01/01/16Florida Radiation Control: Radiologic Technology ProgramApproved for 3 Category A CE Credits (00 –Technical)Course Approval Start Date 09/15/08Course Approval End Date 01/31/17Please call our office before the course approval end date for course renewal statusPlease let us know if your mailing address or email address changes. Thank you.A Continuing Education Course for Radiation Operators
Course DirectionsCompleting an X-Ray Lady homestudy course is easy, convenient, and can be done from thecomfort of your own couch. To complete this course read the reference corresponding to yourposttest and answer the questions. If you have difficulty in answering any question, refer back tothe reference. The test questions correspond with the reading and can be answered as youread through the text.How Do I Submit my Answers? Transfer your answers to the blank answer sheet provided and fill out your information.Make a copy of your answer sheet for your recordsInteractive Testing Center: Get your score and download certificate immediately! Signup on our website by clicking on the “Online Testing” tab or contact our office.Online Answer Sheet: Visit our website and click on the “Online Testing” tab. Answersheets will be graded in-office daily and certificates emailed within 1-2 business days.Snail Mail: Mail a copy to X-Ray Lady, 6511 Glenridge Park Place Suite 6, Louisville,KY 40222. Allow up to 10 days turnaround time.Fax: If your license expiration date is within 2 weeks of submitting your answers, fax acopy to (502) 327-7921. Please be sure to verify that we received your answer sheet.Certificate IssuanceYour certificate will be scored the same day or next business day. You must score at least a75% to pass the course. The Interactive Testing Center generates your certificate uponsuccessful completion—please print and save your certificate for your records. If you mail,email, or fax your answer sheet certificates will be emailed unless otherwise noted. Allow five toseven business days for mailed certificates.Reporting Completed CreditVerification of awarded continuing education will be submitted to the radiation control boards ofFlorida and Kentucky. For the ARRT and all other state licensure agencies, please self-reportyour earned credits. X-Ray Lady CEJeana Fleitz, M.Ed., RT(R)(M)6511 Glenridge Park Place, Suite 6 Louisville, KY 40222Phone: (502) 425-0651 Email: xrayladyce@gmail.comWebsite: www.x-raylady.com
X-Ray Lady Refund & Exchange PolicyUpdated March 2015By placing an order and/or completing a course with X-Ray Lady , you agree to our refund &exchange policy. The following applies if you do not want your course and have no plans ofcompleting it for credit:Returns or exchanges on unused materials may be made up to 30 days from the original orderdate. After 30 days, customers may receive a credit to use toward future purchases. Creditsexpire one year from issue date. All refunds and exchanges are subject to a 5 re-stocking feeper course. Refunds will be issued in the same tender as the original order. Materials purchasedwith a check will be refunded with a cashier’s check once payment has cleared.Expiring CoursesDue to the nature of our courses, no refunds or exchanges are issued for coursesexpiring within one month of the course approval end date.Courses via USPSNo refunds or credits are made for shipping and handling charges once the course hasshipped to you. Customer is responsible for all shipping charges to return or exchangecourse materials. Refunds and exchanges are issued when the materials are receivedand determined to be in excellent condition. X-Ray Lady claims no responsibility for anygoods lost or stolen in transit or delivery by the U.S. postal service.eBook CoursesNo refunds will be issued once the materials have been sent. Customers wishing toreturn an unwanted eBook will have 30 days from the original order date to receive acredit towards a future purchase minus a 5 processing fee. You cannot order a “testonly” at a later date for an eBook that you have received a credit for.We do not “buy back” used books. If you return your used materials you will not receive a creditand the materials will be discarded. Requests for lost or deleted eBook links after coursecompletion will be fulfilled up to 6 months after the course completion date. X-Ray Lady CEJeana Fleitz, M.Ed., RT(R)(M)6511 Glenridge Park Place, Suite 6 Louisville, KY 40222Phone: (502) 425-0651 Email: xrayladyce@gmail.comWebsite: www.x-raylady.com
Earning CE CreditThis activity may be available in multiple formats or from different sponsors. Continuingeducation credit can be awarded only once for the same activity in the same or any subsequentbiennium.This course has been evaluated and approved for a specified amount of continuing educationby the agencies listed on the course cover. X-Ray Lady CE does not imply or guarantee thatcompletion of this course automatically ensures renewal or initial issuance of any state, national,or federal x-ray certification or licensure requirements.It is the responsibility of the individual completing this course to understand and to comply withstate, national, and federal x-ray certification and licensure regulations regarding initial andcontinuing requirements. Further, X-Ray Lady CE claims no responsibility for determining if thetopic or amount of continuing education credit is appropriate for the person completing thecourse.The field of medical imaging and medicine is ever changing. Readers are advised to check themost current product information provided by equipment and supply manufacturers. X-RayLady CE does not assume any liability for any injury and/or damage to persons or propertyarising from information contained in this course. The information contained in this courseshould not be used for medical diagnosis or treatment. Users of this information areencouraged to contact their physician or health care provider for any health related concerns.The X-Ray Lady CE is neither responsible nor liable for any claim, loss, or damage resultingfrom the use of this course.Copyright NoticeAll rights reserved. No part of this work may be reproduced or transmitted in any form or by anymeans, electronic or mechanical, including photocopy, recording, or any information storageand retrieval system, without prior expressed permission from X-Ray Lady CE . X-Ray Lady CEJeana Fleitz, M.Ed., RT(R)(M)6511 Glenridge Park Place, Suite 6 Louisville, KY 40222Phone: (502) 425-0651 Email: xrayladyce@gmail.comWebsite: www.x-raylady.com
Breast Implants & Imaging Considerations UpdateApproved for 3 Category A CE CreditsCourse DescriptionThis course provides updated information concerning the availability of breast implants,potential risks, answers to the most frequently asked questions by consumers, reporting ofserious problems, chronology of FDA activities related to breast implants, and breast implantresource groups. Imaging considerations are presented for breast implants in general andspecifically for mammography, ultrasonography, and magnetic resonance imaging. Theimaging consideration section has been updated and expanded to include information aboutcurrently available imaging modalities. This course provides over 50% new information and assuch has been awarded a new course approval number by the American Society of RadiologicTechnologists. Technologists, who may have completed an earlier version of this course, maytake this new updated and expanded version.Objectives--Upon completion of this course, the participant will be able to:1.Recall important facts concerning the FDA (2007) approval of silicone gel-filled breastimplants.2.Recall facts, indications, and contraindications about the most common types of breastimplants.3.Identify risks associated with breast implants and explain their impact on mammography,ultrasonography (US), and magnetic resonance imaging (MRI).4.Define terminology associated with breast implants.5.Recognize resource groups that can provide additional information about breastimplants.6.Describe advantages and disadvantages to the use of mammography, MRI, and US inwomen with breast implants.7.Select correct statements about mammography and breast health.
Breast Implants & Imaging Considerations UpdateApproved for 3 Category A CE CreditsCourse Content OverviewThe mammographer is a key link between the patient and the radiologist. Many timesthe mammographer is asked to be a public information advocate about the importance ofmammography in the early detection of breast cancer. The mammographer may also be calledupon to serve as an education coordinator to patients, staff, and the general public concerningwomen’s issues and particularly breast health and the indications and contraindications of thevarious imaging modalities available for diagnosis of breast diseases. To provide themammographer with essential information, this course contains the following information. U.S. Food and Drug Administration (FDA) November 17, 2006 press release concerningapproval of silicone gel-filled breast implants. FDA Breast Implant Consumer Handbook (2004) Breast Implants & Imaging Considerations
FDA NEWS RELEASEFOR IMMEDIATE RELEASEP06-189November 17, 2006FDA Approves Silicone Gel-Filled Breast Implants After InDepth EvaluationAgency Requiring 10 Years of Patient Follow-UpAfter rigorous scientific review, the U.S. Food and Drug Administration (FDA) today approvedthe marketing of silicone gel-filled breast implants made by two companies for breastreconstruction in women of all ages and breast augmentation in women ages 22 and older. Theproducts are manufactured by Allergan Corp. (formerly Inamed Corp.), Irvine, Calif., and MentorCorp., Santa Barbara, Calif.“FDA has reviewed an extensive amount of data from clinical trials of women studied for up tofour years, as well as a wealth of other information to determine the benefits and risks of theseproducts,” said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health,FDA. “The extensive body of scientific evidence provides reasonable assurance of the benefitsand risks of these devices. This information is available in the product labeling and will enablewomen and their physicians to make informed decisions.”Now that the products have been determined to be safe and effective, FDA will continue tomonitor them by requiring each company to conduct a large postapproval study following about40,000 women for 10 years after receiving breast implants. FDA often requires postmarketstudies to answer important questions that can only be answered once a product is in broaderuse, such as the incidence of rare adverse events.FDA’s decision to approve these implants was based on a thorough review of each company’sclinical (core) and preclinical studies, a review of studies by independent scientific bodies anddeliberations of advisory panels of outside experts that heard public comment from hundreds ofstakeholders. In addition, FDA conducted inspections of each company’s manufacturingfacilities to determine that they comply with FDA’s Good Manufacturing Practices. Some of thecomplications reported in the core studies included hardening of the area around the implant,breast pain, change in nipple sensation, implant rupture and the need for additional surgery.However, the majority of women in these studies reported being satisfied with their implants.In the past decade, a number of independent studies have examined whether silicone gel-filledbreast implants are associated with connective tissue disease or cancer. The studies, includinga report by the Institute of Medicine, have concluded there is no convincing evidence that breastimplants are associated with either of these diseases. However, these issues will be addressedfurther in the postapproval studies conducted by the companies.“The silicone breast implant is one of the most extensively studied medical devices,” saidSchultz. “We now have a good understanding of what complications can occur and at whatrates. We also know that women who get these devices will probably need to have additionalbreast implant surgery at least once. This is valuable information for women who may beconsidering these products.”1
Full information about the risks and benefits of the devices can be found in the package andpatient labeling mandated by FDA. The patient labeling outlines some of the important factorswomen should consider when deciding whether to get silicone gel-filled breast implants. Someof these factors are: breast implants are not lifetime devices and a woman will likely needadditional surgeries on her breast at least once over her lifetime; many of the changes to awoman’s breast following implantation are irreversible; rupture of a silicone gel-filled breastimplant is most often silent, which means that usually neither the woman nor her surgeon willknow that her implants have ruptured; and a woman will need regular screening MRIexaminations over her lifetime to determine if silent rupture has occurred. The device labelingstates that a woman should have her first MRI three years after her initial implant surgery andthen every two years thereafter. The cost of MRI screening over a woman’s lifetime mayexceed the cost of her initial surgery and may not be covered by medical insurance. Thelabeling also states that if implant rupture is noted on an MRI, the implant should be removedand replaced, if needed.FDA approved the silicone gel-filled breast implants with a number of conditions, includingrequiring each company to: conduct a large postapproval study; continue its core study through10 years; conduct a focus group study of the patient labeling; continue laboratory studies tofurther characterize types of device failure; and track each implant in the event, for example,that health professionals and patients need to be notified of updated product information.The postapproval studies will continue to gather information about the safety and effectivenessof the implants. Information will be collected about rates of local complications, rates ofconnective tissue disease and its signs and symptoms, rates of neurological disease and itssigns and symptoms, potential effects on offspring of women with breast implants, potentialeffects on reproduction and lactation, rates of cancer, rates of suicide, potential interference ofbreast implants with mammography, and MRI compliance and rupture rates.The postapproval studies will be closely monitored by FDA. FDA anticipates that data from thestudies will provide important information for patients and physicians, and may lead toimprovements in device labeling.For more information, visit www.fda.gov/cdrh/breastimplants.2
TABLE OF CONTENTSGLOSSARY . 1INTRODUCTION . 7DEVICE DESCRIPTION. 10Saline-Filled Breast Implants . 11Silicone Gel-Filled Breast Implants . 12Alternative Breast Implants. 13STATUS / AVAILABILITY. 14Saline-Filled Breast Implants . 14Silicone Gel-Filled Breast Implants . 15Alternative Breast Implants. 16LOCAL COMPLICATIONS & REOPERATIONS. 17Reoperation. 19Removal. 20Rupture/Deflation . 22Capsular Contracture . 28Breast Pain. 29Nipple and Breast Sensation Changes. 30DISEASES. 32Connective Tissue Diseases (CTDs) and Related Disorders . 32Cancers . 35Neurological Symptoms/Diseases. 36SPECIFIC ISSUES TO CONSIDER. 37Mammography . 37Breast Feeding . 39Effects on Children. 39Suicide . 40Gel Bleed . 41Platinum. 41Silicone Sensitivity. 42Polyurethane Foam-Coated Breast Implants. 43Trilucent Breast Implants . 44i
BREAST IMPLANT SURGERY & RELATED ISSUES . 46Choosing a Surgeon. 46Choosing an Implant. 47Choosing the Surgical Incision Site . 48Choosing the Type of Implant Placement . 49General Description of Breast Implant Surgery . 50After the Surgery . 51Choices in Reconstructive Procedures . 52Breast Reconstruction with Breast
the marketing of silicone gel-filled breast implants made by two companies for breast reconstruction in women of all ages and breast augmentation in women ages 22 and older. The products are manufactured by Allergan Corp. (forme
