Background: This study evaluated patients who underwent primary breast surgery within a single group practice from 1994 to 2009. Reoperations were divided by reoperation reason into total reoperations and implant-specific reoperations. The authors hypothesized that the implant-specific reoperation rate will provide the most accurate measurement of complications caused by the breast implant device.
Methods: A total of 812 patients received the same brand of breast implant for primary breast augmentation or augmentation/mastopexy. Safety and efficacy data were recorded and complication rates were calculated. Statistics were applied using Kaplan-Meier estimated cumulative incidence calculations.
Results: This study included 482 patients with saline and 330 patients with silicone implants. The most common complications included capsular contracture, rippling, rupture, infection, and hematoma. A total of 8.2 percent of patients developed Baker grade III/IV capsular contracture by 6 years. The raw incidence of rippling was 7.1 percent, and the rate was significantly increased in underweight patients with subglandular saline implants (p = 0.045). The rate of total reoperation at 1 year was 14.2 percent. While a significantly increased rate of total reoperation was seen for silicone compared with saline implants (p < 0.01), no difference was seen in the rate of implant-specific reoperation for saline compared to silicone implants (p = 0.582).
Conclusions: The use of total reoperation rates as an indication of complications of breast implants can lead to both an overestimation of implant-related complications and the inaccurate conclusion that silicone implants result in higher complication rates than saline implants. The implant-specific reoperation rate may provide a more accurate incidence of implant complications than the total reoperation rate, which includes reoperations for factors unrelated to the implant.
Atlanta, Ga.; and Medellin, Colombia
From the Division of Plastic and Reconstructive Surgery, Emory University; private practice; and Paces Plastic Surgery.
Received for publication November 27, 2009; accepted August 19, 2010.
Disclosure: Mentor Corporation provided funding to Dr. Codner from June of 2008 to be the primary investigator for this research project. Dr. Codner receives educational grants and is a paid consultant for Mentor Corporation and receives royalties for books published by Quality Medical Publishing and Elsevier Publishing Company. Dr. Foad Nahai receives royalties for books published by Quality Medical Publishing. Dr. Farzad Nahai receives royalties from Elsevier Publishing Company and is a consultant for Ethicon. Dr. Hester is clinical advisor for Silimed. Drs. Foad Nahai, Hester, and Codner were investigators for the U.S. Food and Drug Administration Premarket Approval Mentor Core Gel study and Allergan 410 study.
Mark A. Codner, M.D., Paces Plastic Surgery, 3200 Downwood Circle, Suite 640, Atlanta, Ga. 30327, firstname.lastname@example.org