In the spring of 2000, the U.S. Food and Drug Administration issued a ban on the use of Betadine (povidone-iodine; Purdue Frederick, Stamford, Conn.) in association with saline breast implants, because data seemed to indicate a higher rate of implant deflation in association with Betadine. Betadine has been used for many years because studies have shown a decrease in the rate of capsular contracture when the breast pocket is irrigated with Betadine at the time of augmentation.
Breast augmentations performed from January of 1998 through September of 2005 were reviewed. The review included an analysis of how Betadine was used at the time of each augmentation, along with the incidences of implant deflation and capsular contracture. Findings were compared with data used by the Food and Drug Administration in their breast implant literature.
The deflation rate was significantly lower than that reported in the data from the Food and Drug Administration and the Institute of Medicine (0.24 percent versus 7 to 10 percent). The capsular contracture rate was lower than that in the Food and Drug Administration data, especially when Betadine was used as indicated in the final phase (0.5 to 2.2 percent versus 10 to 11 percent).
This article confirms other studies reporting that the use of Betadine has no effect on the rate of deflation of a saline breast implant. It also shows that the incidence of capsular contracture is significantly decreased with the proper use of Betadine.
Received for publication August 17, 2006; accepted August 22, 2006.
Presented at the Annual Meeting of the Texas Society of Plastic Surgeons, in San Antonio, Texas, October 23, 2005.
Thomas C. Wiener, M.D., 2323 Clear Lake City Boulevard, Suite 152, Houston, Texas, 77062, firstname.lastname@example.org