Saline-filled breast implants: a Plastic Surgery Educational Foundation multicenter outcomes study.
In 1993, the Plastic Surgery Educational Foundation commissioned the senior author (Cunningham) to design an 11-center retrospective cohort outcomes study to obtain physician- and patient-reported data on saline-filled breast implants. Data were obtained from 504 patients with 995 saline-filled breast implants placed between January 1, 1980 and December 31, 1989, with a mean follow-up of 6 years. Most (93.8 percent) saline-filled breast implants were placed for breast augmentation. Of the 504 patients, 104 (20.6 percent) required reoperation for open capsulotomy or for replacement or removal of a deflated implant. Complications occurred in 22 patients (4.4 percent), with hematoma being most common. Implant deflation occurred in 55 implants (5.5 percent) and affected 51 patients (10.1 percent) but was underreported by chart abstraction alone. Risk factors for implant deflation included underfilling the implant by more than 25 cc (odds ratio 3.3, p = 0.0400), the use of model 1800 saline-filled breast implants (odds ratio 3.1, p = 0.0010), intraluminal antibiotics (odds ratio 2.6, p = 0.0183), and intraluminal steroids (odds ratio 2.4, p = 0.0711). Based on 44 of 55 saline-filled breast implants with known deflation dates, actuarial survival is 95.7 to 98.0 percent at 5 years and 90.2 to 95.2 percent at 10 years (95 percent confidence interval). Significant periprosthetic capsular contracture affected 103 patients (20.4 percent) during follow-up. Risk factors for capsular contracture included omitting intraluminal antibiotics (odds ratio 16.7, p = 0.0001), omitting intraluminal steroids (odds ratio 12.5, p = 0.0001), submammary placement of the saline-filled breast implant (odds ratio 7.8, p = 0.0001), and use of antibiotics in the implant pocket (odds ratio 6.1, p = 0.0001). Overall patient satisfaction with saline-filled breast implants was rated as high by 94.2 percent, and 94.8 percent of patients would choose saline-filled breast implants again. Dissatisfaction with their saline-filled breast implants was more frequent in patients with significant breast firmness (odds ratio 22.9, p = 0.0001), those undergoing prophylactic mastectomy (odds ratio 8.2, p = 0.0005), and those desiring smaller implants (odds ratio 6.9, p = 0.0001). In conclusion, saline-filled breast implants are a safe alternative to silicone gel-filled breast implants and demonstrate a high rate of patient satisfaction. Underfilling of saline-filled breast implants should be avoided because it contributes to deflation. Although intraluminal antibiotics and steroids protect against capsular contracture, they also contribute to saline-filled breast implant deflation. The incidence of capsular contracture is decreased by placing the saline-filled breast implant in the subpectoral position. Finally, patients should be aware of the possible need for reoperations related to their implants.
Gutowski
K A
KA
Division of Plastic and Reconstructive Surgery, University of Minnesota Medical School, Minneapolis, USA.
Mesna
G T
GT
Cunningham
B L
BL
D000206:Actuarial Analysis; D000900:Anti-Bacterial Agents / Q000627:therapeutic use; D018427:Breast Implants / Q000009:adverse effects / Q000706:statistics & numerical data; D004867:Equipment Design; D004868:Equipment Failure; D005260:Female; D005500:Follow-Up Studies; D005582:Foundations; D006801:Humans; D016462:Mammaplasty; D017063:Outcome Assessment, Health Care; D017060:Patient Satisfaction; D011183:Postoperative Complications / Q000453:epidemiology; D012086:Reoperation / Q000706:statistics & numerical data; D012189:Retrospective Studies; D012828:Silicones; D012965:Sodium Chloride; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration
D000900:Anti-Bacterial Agents; D012828:Silicones; D012965:Sodium Chloride