Reporting Problems with Breast Implants to FDA --- Much Needed to Protect Our Future

Contacting Med Watch
If you have never filed a Med Watch report ... Or if you have had additional surgeries or injuries since you filed  please update the FDA.

Individual reports are on FDA’s MedWatch website. To access these reports, follow the links for: “Medical Device Reporting,” “Access to FDA Safety Data,” and “Manufacturer and User Facility Device Experience Database (MAUDE).”
Submissions under the Alternative Summary Reporting Program (ASR) can be obtained by following instructions under the Freedom of Information Act (FOI), available via access to the main FDA website (www.fda.gov). FOI requests can also be faxed to 301-443-1726 or mailed to: Food and Drug Administration, FOI Staff, HFI-35, 5600 Fishers Lane, Rockville, MD 20857.

Why do companies file summary reports of adverse events, instead of individual MDR reports for breast implants? Summary reporting is an alternative way of reporting to FDA for well known and well documented adverse events. It has been in effect for silicone gel-filled and saline-filled breast implants for many years. Summary reporting for these types of events promotes more efficient processing and analytic review for FDA and the companies.

Companies are required to file individual MDR reports for any unexpected or unusual adverse events that may be related to breast implants. Deaths must always be reported individually. 

Breast Implant Registry
The organization Birth Defect Research for Children, Inc is collecting data on disabilities that may be related to breast implants through an ongoing research project, The National Birth Defect Registry. To learn more about the registry including its development and history, visit: http://www.birthdefects.org Please note that the Birth Defect Research for Children, Inc questionnaire does not have a specific area regarding breast implants, so mothers are asked to enter the information in "Other Exposures Not Listed" at the end of the Maternal Exposure section. Please contact Betty Mekdeci for more information about registering birth defects after implantation. Betty Mekdeci
Executive Director
Birth Defect Research for Children E-mail:
betty@birthdefects.org
Website:
http://www.birthdefects.org


 Rosie

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