Med-Watch must enforce compulsory reporting of adverse reactions!

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Please respond directly to Lana! - RogeneLana Transue <lanadearest@...> wrote: From: "Lana Transue" <lanadearest@...>saxony01@...Subject: Med-Watch must enforce compulsory reporting of adverse reactions! Date: Sun, 12 Nov 2006 11:51:10 -0800Ladies,I need your help. I need to know how many women were listed in the class action lawsuit. How many women opted out and filed for a court date? I also need to know the number of possible adverse reactions reports made to the FDA by physicians and the number of reports made to the FDA by the women themselves.Also, I just read somewhere that (350?) reports were made about possible adverse reactions in children of implanted women. May I please get a copy of that information? Does anyone know how many, if any, of those

reports were made by doctors.Can someone help me find these numbers and the documentation? If possible, could you please forward these questions to other support groups that you're in contact with?Thank you,Lana_________________________________________________________________Get FREE company branded e-mail accounts and business Web site from Microsoft Office Live http://clk.atdmt.com/MRT/go/mcrssaub0050001411mrt/direct/01/

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Lana ... and not a moment to soon ...

I still remember watching you on Sally Jessie 's show with your family ... from the home of Lale in Sacramento around 8 years ago. Here's the study.

Breast Implant Surveillance Reports to the U.S. Food and Drug Administration: Maternal-Child Health Problems.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed & cmd=Retrieve & dopt=AbstractPlus & list_uids=17073570 & itool=pubmed_DocSum

Brown S, Todd JF, Cope JU, Sachs HC. Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Epidemiology Branch, Center for Devices & Radiologic Health, Food and Drug Administration, c/o Seattle District Office, 22201 23rd Dr. SE, HFR-PA300, Bothell WA 98021-4421. There is continuing concern that women who receive breast implants may be at increased risk for adverse reproductive outcomes or experience problems with breastfeeding. It is unknown whether exposure to biomaterials in breast implants may have teratogenic effects or leach into breast milk causing postnatal problems. We studied the Food and Drug Administration (FDA) experience by analyzing a case series of adverse event reports received and entered into the FDA's Manufacturer and User Facility Device Experience (MAUDE) database or the Device Experience Network (DEN) database by December 31, 2002 regarding women with breast implants. Reports were critically reviewed for lactation difficulties, reproductive problems (spontaneous abortion, delayed conception) and medical conditions among offspring, including neonatal, infant, and childhood diseases and congenital defects that were attributed to implants. We identified 339 reports that described maternal-child adverse events. Nearly half of these reports (46%) described actual problems with breastfeeding or expressed concern that implants would be unsafe or interfere with breastfeeding. Forty-four percent of reports (n = 149) described either nonspecific or specific signs, symptoms, or illnesses in children. An additional 3.5% of reports (n = 12) detailed a congenital anomaly believed by the reporter to be caused by breast implants. ~~~~~~~~~~~~~~~www.BreastImplantAwareness.org