| Ilena Rose 2005-01-03, 7:11 pm |
| J Womens Health (Larchmt). 2004 May;13(4):371-8; discussion 379-80.
www.fda.gov/cdrh/breastimplants/b-adverse-events.html
Breast Implant Adverse Events During Mammography
An FDA study on problems with mammography for women with breast
implants was published in the Journal of Women’s Health in May, 20041.
The preliminary results of this study were presented at the FDA
Science Forum in April, 2003
The study was a review of adverse event reports from the FDA’s
Manufacturer and User Facility Device Experience (MAUDE) database
(http://www.fda.gov/cdrh/databases.html). Researchers found 66 reports
that mentioned problems with mammography for women with breast
implants. The majority (62.1%) of problems reported were for breast
implant rupture that was suspected to occur during mammography.
Rupture during compression for mammography was reported for both
silicone gel-filled and saline-filled breast implants. Other adverse
events reported to FDA included implants crushed by mammographic
compression, pain during mammography attributed to the implants,
inability to perform mammography because of capsular contracture or
because of fear of implant rupture, and delayed detection of cancer
attributed to the breast implants. It is unknown how often these
problems occur because the MAUDE database cannot be used to determine
rates of problems occurring.
FDA researchers also reviewed published medical literature on
mammography for women with breast implants. Their review found medical
reports describing:
an additional 17 reported cases of breast implant rupture during
mammographic compression
breast implant interference with imaging breast tissue, with between
22% and 83% of mammographically visualizable breast tissue obscured by
breast implants
special techniques needed to maximize breast tissue visualization for
women with breast implants
a delay in breast cancer detection in women with implants, but without
increased mortality to women with implants.
The risk for breast cancer does not differ in women with breast
implants compared to other women. Recommendations for breast cancer
screening also apply to women with breast implants. Women considering
breast implants should be aware of potential issues with mammography
in order to make an informed decision. Women who already have breast
implants should always inform the mammography center that they have
breast implants when they make an appointment and always remind the
mammography technician that they have breast implants when they go for
their exam.
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1Brown SL, Ferlo Todd J, Luu H-MD. Breast implant adverse events
during mammography: reports to the Food and Drug Administration.
Journal of Women’s Health. Volume 13, Number 4, 2004.
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www.BreastImplantAwareness.org
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