changes in the med-watch reporting program

[Guest guest]

Thanks Lana!Lana Transue <lanadearest@...> wrote: From: "Lana Transue" <lanadearest@...>saxony01@...CC: lanadearest@...Subject: changes in the med-watch reporting programDate: Sat, 12 Aug 2006 09:49:17 -0700In January of this year the FDA announced that they where making changes in the MED Watch reporting program, including hiring a lot of new people and changing some of their old adverse reactions reporting policys.The page link below lists some of the changes that are being made. I would encourage each and everyone of you to write to Med-Watch and request that suspected adverse reactions to ALL breast impants also fall under mandatory reporting. The mandatory reporting should not be limited to the new silicone gel implants but should include all possible adverse

reactions to breast implants. The mandatory reporting of suspected adverse reactions to breast implants should include mandatory reporting of possible adverse side affects on the children of implanted women as well.Send them a list of all the doctors that you saw that did NOT report your possible adverse reactions. If you have a removal surgery report or any supporting medial tests and or pictures send that to them as well.When you compare the adverse reations reports that were made to the FDA's Med Watch program to the number of women listed in the class action lawsuit, the numbers just don't add up!Lanahttp://www.fda.gov/medwatch/how.htmFDA Home Page | About MedWatch | Contact MedWatch | MedWatch PartnersSearch MedWatchMedWatchHome SafetyInformation SubmitReport How ToReport DownloadForms Join theE-listReporting Adverse Experiences to FDAAdverse

Reactions - Product Quality Problems - Product Use ErrorsForms FDA 3500 (voluntary reporting) and FDA 3500A (mandatory reporting) have been revised and re-authorized through an expiration date of 10/31/2008. Mandatory reporters may continue to use the previous version of Form FDA 3500A until 11/01/2006. [posted 11/01/2005]Voluntary ReportingReporting by ConsumersReporting by Health ProfessionalsReporting by Veterinarians and Animal OwnersHIPAA Compliance for Reporters to FDA MedWatchMandatory ReportingContact information for questions about mandatory reportingWhere to send mandatory reporting formsDrug/Biologic/Human Cell, Tissues and Cellular and Tissue-Based Product Manufacturers, Distributors, and PackersHuman Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) Adverse Reaction ReportingMedical Device Manufacturers, Distributors, and

User-facilitiesDownload Mandatory Reporting Form 3500A (PDF format)Information about medical device reportingThis CDRH page provides contact information and answers to questions about mandatory device reportingReferencing FDA's MedWatch ProgramAccess to FDA Safety DataMedWatch Home | Safety Info | Submit Report | How to Report | Download Forms | Join E-list | Articles & Publications | Comments | PartnersFDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home PageFDA/CDER/Office of Drug SafetyWeb page last revised by jlw May 17, 2006