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Incidence and Severity of Short-Term Complications After Breast Augmentation: Results From a Nationwide Breast Implant Registry

Henriksen, Trine F. MD*†; Hölmich, Lisbet R. MD†‡; Fryzek, Jon P. PhD§; Friis, Søren MD; McLaughlin, Joseph K. PhD§; Pernille Høyer, Annette MD, PhD; Kjøller, Kim MD; Olsen, Jørgen H. MD, DSc

doi: 10.1097/01.sap.0000096446.44082.60
Original Articles
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The frequency and severity of local complications remain the primary safety issues with silicone breast implants. The Danish Registry for Plastic Surgery of the Breast (DPB), established in 1999, prospectively collects pre-, peri- and postoperative information regarding Danish women undergoing breast augmentation. Through DPB, we conducted a prospective follow-up study of short-term local complications among 1090 women who underwent cosmetic breast implantation from June 1999 through October 2002. Nineteen percent of women who underwent initial implantation developed at least 1 adverse effect. Forty percent of the adverse effects occurred within 3 months of implantation; 79%, within 6 months. Capsular contracture grade II-IV was observed among 4.1% of women in the 2-year follow-up period. Overall, 97 (29%) of the 344 adverse effects among 55 (6%) of the 971 women required surgical intervention. A higher incidence of adverse effects typically occurred after subsequent implantations. According to the DPB experience, we conclude that most short-term postoperative adverse effects following cosmetic implantation are clinically insignificant and do not require treatment and that short-term complications requiring adjuvant treatment are rare.

A review of 1090 Danish women undergoing cosmetic breast implantation over a three-year period disclosed 344 adverse effects among 15% of the patients, including 8% with sensory change (mostly temporary) and 4.1% with capsular contracture. More serious events—including infection, hematoma, seroma, wound separation, skin wrinkling, and pain— each occurred in less than 1%.

*The Danish Registry for Plastic Surgery of the Breast, Copenhagen, Denmark; †Institute of Cancer Epidemiology, Danish Cancer Society, Copenhagen, Denmark; ‡Department of Plastic Surgery, Copenhagen University Hospital, KAS Herlev, Denmark; §International Epidemiology Institute, Rockville, MD; and ∥Department of Medicine, Vanderbilt University Medical Center, Vanderbilt-Ingram Cancer Center, Nashville, TN.

Received March 25, 2003, and accepted for publication April 18, 2003.

Reprints: Trine F. Henriksen, MD, The Danish Registry for Plastic Surgery of the Breast, Strandboulevarden 49, DK-2100 Copenhagen, Denmark.This study was funded by the International Epidemiology Institute, Maryland, which received funds from the Dow Corning Corporation.

This study was funded by the International Epidemiology Institute, Maryland, which received funds from the Dow Corning Corporation.

© 2003 Lippincott Williams & Wilkins, Inc.