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Prevalence of Rupture of Silicone Gel Breast Implants Revealed on MR Imaging in a Population of Women in Birmingham, Alabama

S. Lori Brown1, Michael S. Middleton2, Wendie A. Berg3, Mary Scott Soo4 and Gene Pennello1

1 Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., HFZ-541, Rockville, MD 20850.
2 Department of Radiology, University of California at San Diego School of Medicine, 410 W. Dickinson St., San Diego, CA 92103.
3 Division of Breast Imaging, Department of Radiology and Greenebaum Cancer Center, University of Maryland School of Medicine, 22 S. Greene St., Baltimore, MD 21201.
4 Department of Radiology, Duke South Hospital, Duke University Medical Center, Box 3808, Second Floor, Red Zone, Durham, NC 27710.



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  		Fig. 1. —Representative MR image of 310-mL single-lumen silicone gel—filled implant placed December 13, 1973, shows characteristic appearance of rupture. Arrow identifies location of silicone gel outside implant shell (i.e., keyhole, inverted teardrop, noose appearance).

 


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  		Fig. 2. — Representative MR image of 220-mL single-lumen silicone gel—filled implant placed December 20, 1982, shows presence of multiple-layered wavy lines representing collapsed implant shell surrounded by silicone gel (i.e., linguine or wavy-line appearance).

 


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  		Fig. 3. —Representative MR image of Hartley-type standard double-lumen implant, originally with 225 mL of inner-lumen silicone gel, placed April 27, 1984, shows characteristic appearance of rupture. Note thicker single posterior shell patch attached to both inner and outer lumen shells on both sides, with thickened central part where gel was originally injected into implant and sealed, all entirely surrounded by silicone gel. Saline was absent from outer lumen at time of this scan.

 


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  		Fig. 4. —Representative MR image of migration of silicone shows contiguous spread of silicone gel from intracapsular to extracapsular space. Single-lumen (220 mL) silicone gel—filled implant was placed January 2, 1979.

 


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  		Fig. 5. —Estimated implant ages for probabilities of ruptured implants. CI = confidence interval.

 


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  		Fig. 6. —Estimated implant ages for probabilities of ruptured or indeterminate implants. CI = confidence interval.

 

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