Long-term results of MISTI gold breast implants: a retrospective study.
MISTI Gold breast implants (Bioplasty, St. Paul, Minn.) filled with polyvinylpyrrolidone-hydrogel were developed as a promising alternative to silicone-filled implants. Some studies have reported on the positive effects of the implant, such as improved radiolucency and biocompatibility of the gel; however, there are also reports that such implants increased in volume and were subject to capsular contracture in the human body, resulting in demands for their removal. The purpose of this retrospective study was to analyze the long-term results of a series of patients with MISTI Gold breast implants. Between 1991 and 1993, the authors inserted 83 MISTI Gold implants in 61 patients with an average age of 46 years (range, 16 to 69). The authors were able to follow up 48 patients with 71 MISTI Gold implants. The average follow-up was 68 months (range, 10 to 108 months). The retrospective study found that 59 percent of all MISTI Gold implants were removed after an average period of 4.14 years. The main reason for implant removal was an increase in volume of 38 percent, followed by capsular contracture in 14 percent of all 71 MISTI Gold implants. The average increase in volume of all removed MISTI Gold implants was 43 percent. Capsular contracture was graded as Baker I and II in 63 percent and as Baker III and IV in 37 percent. In conclusion, the authors believe that MISTI Gold implants do not fulfill the criteria of safe breast implants, and they agree with the December of 2000 opinion of the Medical Devices Agency of the Department of Health in London that the hydrogel-filled breast implants should not be used until more information about the filler material and its metabolic fate is available.
Piza-Katzer
Hildegunde
H
Department of Plastic and Reconstructive Surgery, Leopold-Franzens University, Innsbruck, Austria.
Pülzl
Petra
P
Balogh
Brigitte
B
Wechselberger
Gottfried
G
D000293:Adolescent; D000328:Adult; D000368:Aged; D019928:Breast Implantation / Q000009:adverse effects; D018427:Breast Implants / Q000009:adverse effects*; D002921:Cicatrix; D003286:Contracture; D018795:Device Approval; D020878:Device Removal; D005260:Female; D006801:Humans; D020136:Hydrogel, Polyethylene Glycol Dimethacrylate / Q000009:adverse effects*; D008875:Middle Aged; D011183:Postoperative Complications; D011205:Povidone / Q000009:adverse effects*; D011475:Prosthesis Failure; D012086:Reoperation; D012189:Retrospective Studies; D013997:Time Factors; D016896:Treatment Outcome
D020136:Hydrogel, Polyethylene Glycol Dimethacrylate; D011205:Povidone