Background: Prospective long-term data on the occurrence of complications following breast augmentation are sparse and the reported frequencies differ substantially.
Methods: The Danish Registry for Plastic Surgery of the Breast has prospectively registered preoperative, perioperative, and postoperative data for women undergoing breast augmentation in Denmark since 1999. From the Registry, the authors identified 5373 women with a primary cosmetic breast augmentation between 1999 and 2007. The authors calculated incidence proportions of adverse clinical outcomes within three time intervals (0 to 30 days, 0 to 3 years, and 0 to 5 years) after primary implantation. Outcomes of primary interest were capsular contracture, asymmetry/displacement of the implant, hematoma, and infection.
Results: During the entire follow-up period (mean, 3.8 years; range, 0.1 to 8.7 years), 16.7 percent of the women were registered with an adverse event and 4.8 percent of the women were registered with a surgery-requiring complication. The most common adverse events within 30 days were hematoma (1.1 percent) and infections (1.2 percent), whereas the most common adverse events within 5 years were change of tactile sense (8.7 percent) and asymmetry/displacement of implant (5.2 percent). Within 5 years, 1.7 percent of the women had a record of severe capsular contracture. Displacement/asymmetry and capsular contracture were the most frequent indications for reoperation with removal or exchange of the implant.
Conclusions: Population-based complication frequencies among women with cosmetic breast augmentation in a Danish nationwide implant registry were generally lower than those reported in other studies, although frequencies of complications increased with length of follow-up.
Copenhagen, Herlev, and Roskilde, Denmark; Rockville, Md.; and Nashville, Tenn.
From the Institute of Cancer Epidemiology, Danish Cancer Society; the Danish Registry for Plastic Surgery of the Breast; the Department of Plastic Surgery, Herlev University Hospital; the Department of Plastic Surgery, Roskilde Hospital; the International Epidemiology Institute; and the Department of Medicine, Vanderbilt University Medical Center and Vanderbilt-Ingram Cancer Center.
Received for publication November 17, 2008; accepted March 12, 2009.
Presented at the XXXIInd Congress of the Scandinavian Association of Plastic Surgeons, in Aarhus, Denmark, June 12 through 14, 2008.
Disclosure: Allergan, Inc., was not involved in any aspect of the study design, data collection, data analysis, data interpretation, writing, or review of the article. None of the authors has any conflicts of interest regarding the present study. Dr. McLaughlin has served as a consultant to the Inamed Corporation (now part of Allergan, Inc.) during their application to the U.S. Food and Drug Administration for premarket approval of silicone implants.
Gitte B. Hvilsom, M.D., Danish Registry for Plastic Surgery of the Breast, Institute of Cancer Epidemiology, Strandboulevarden 49, 2, 2100 Copenhagen Ø, Denmark, email@example.com