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The Effect of Silicone Gel Bleed on Capsular Contracture: A Generational Study

Moyer, Hunter R. M.D.; Ghazi, Bahair H. M.D.; Losken, Albert M.D.

Plastic and Reconstructive Surgery: October 2012 - Volume 130 - Issue 4 - p 793–800
doi: 10.1097/PRS.0b013e318262f174
Experimental: Original Articles

Background: Capsular contracture has multiple causes, all of which lead to increased inflammation and scarring. There have been five generations of silicone breast implants; the most recent are filled with a highly cohesive gel thought to reduce capsular contracture. No independent data exist to support this claim.

Methods: Eight Göttingen swine were each implanted with eight 50-cc custom gel implants. In phase 1 of the study, the implant shells were photochemically altered to produce a low-bleed shell or a high-bleed shell to simulate a second-generation implant. In phase 2, both the third/fourth generation and the newest, fifth generation (highly cohesive gel) devices were implanted. Half the implants were punctured with a 3-ml punch biopsy to simulate a ruptured implant. Capsule and implant specimens were harvested at 1 and 3 months and analyzed with a Bose strain gauge. Intracapsular fluid was tested for silicon levels with atomic emission spectrometry. Histologic analysis was prepared with hematoxylin and eosin, Masson trichrome, and α-smooth muscle actin immunohistochemistry stains.

Results: Gel bleed correlated with capsule stiffness in a dose-dependent manner (p < 0.05). High-bleed second-generation implants had the stiffest capsules, and nonruptured third- and fourth-generation implants had the softest. Histologic examination revealed an intermediate layer of spindle-like cells staining positive for α-smooth actin in the most contracted capsules.

Conclusions: There is a dose-dependant relationship between silicone gel bleed and capsule compliance that is independent of the cohesivity of the silicone. Capsule thickness and a fibrotic, α-smooth muscle actin–positive layer are present within the most contracted capsules.

Atlanta, Ga.

From the Division of Plastic Surgery, Emory University.

Received for publication April 18, 2012; accepted April 23, 2012.

Disclosure:Dr. Losken is a speaker for LifeCell Corporation. The other authors have no financial interests to declare.

Hunter R. Moyer, M.D., Atlanta Plastic Surgery, 975 Johnson Ferry Road, NE, Suite 100, Atlanta, Ga. 30342,

©2012American Society of Plastic Surgeons