The Danish Registry for Plastic Surgery of the Breast: establishment of a nationwide registry for prospective follow-up, quality assessment, and investigation of breast surgery.
Although numerous epidemiologic studies have examined the long-term safety of silicone breast implants during the past decade, there is a relative lack of surveillance data on short-term health effects and complications following cosmetic surgery of the breast. The Danish Registry for Plastic Surgery of the Breast, established in May of 1999, provides plastic surgeons with a nationwide system for the collection of preoperative, perioperative, and postoperative data on women undergoing breast implantation, breast reduction, or mastopexy. The purpose of the Registry is to examine short-term and, eventually, long-term local complications and possible health effects, and to contribute to an ongoing evaluation of surgical results and surveillance of the products. Furthermore, the Registry will allow the identification of new areas for research into cosmetic and reconstructive breast surgery. Women accepting registration in the Danish Registry for Plastic Surgery of the Breast complete a self-administered questionnaire focusing on medical history and demographic and behavioral factors. Preoperative blood samples are drawn for storage. Surgical data, postoperative results, and complications are registered following surgery and at postoperative visits. Currently, registration has been initiated at 24 private and public clinics, representing more than 80 percent of the plastic surgery clinics in Denmark. As of November of 2001, a total of 1472 women with breast implants and 560 women with breast reduction were included in the Registry. These figures are expected to increase annually by 1000 women undergoing breast implantation and 500 women undergoing breast reduction or mastopexy. The authors present their experience of establishing the first nationwide comprehensive clinical-epidemiologic database and biological bank for cosmetic and reconstructive surgery procedures.
Henriksen
Trine F
TF
Danish Registry for Plastic Surgery of the Breast, and Institute of Cancer Epidemiology, Danish Cancer Society, Copenhagen, Denmark. trine@cancer.dk
Hölmich
Lisbet R
LR
Friis
Søren
S
McLaughlin
Joseph K
JK
Fryzek
Jon P
JP
Pernille Høyer
Annette
A
Kjøller
Kim
K
Olsen
Jørgen H
JH
D018427:Breast Implants / Q000706:statistics & numerical data*; D003625:Data Collection / Q000706:statistics & numerical data; D016208:Databases, Factual / Q000706:statistics & numerical data; D003718:Denmark; D005069:Evaluation Studies as Topic; D005260:Female; D006801:Humans; D016462:Mammaplasty / Q000706:statistics & numerical data*; D010043:Outcome and Process Assessment, Health Care / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology* / Q000209:etiology; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data*