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Breast Implant Adverse Events During Mammography

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.

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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Updated April 23, 2004

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