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,
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.
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.orgPlease 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: [email protected] Website: http://www.birthdefects.org