Saline-filled breast implant safety and efficacy: A multicenter retrospective review

Our center undertook an industry-funded, outcomes-based, multicenter, retro spective review to evaluate the safety and efficacy of saline-filled breast implants. Our review was part of a pre-market approval review process mand ated by the U.S. Food and Drug Administration. The design of our review was modeled on a Plastic Surgery Educational Foundation outcomes study previou sly conducted by our center. For this study, several significant changes we re made to our previous protocol, including improved patient tracking, stro nger biostatistical support, and a mandatory 10-year minimum patient follow -up period. Physician-reported and patient-reported data on 450 patients with 882 salin e-filled breast implants placed between January 1, 1980, and June 30, 1986, were obtained. Mean patient follow-up period was 13.0 years. Most implants (93.9 percent) were placed for breast augmentation. Seventy-four percent w ere placed in a submammary position; 25.6 percent, subpectorally; and 0.2 p ercent, subcutaneously. The overall complication rate was 20.2 percent. Reoperation for capsular co ntracture or implant deflation was necessary in 104 of 450 patients (23.1 p ercent). Deflation occurred in 73 implants (8.3 percent) and was underrepor ted according to the physicians' record review alone. This deflation rate i s higher than the 5.5 percent previously reported by our center. However, 2 6 of these 73 deflations (35.6 percent) occurred in a single cohort of pati ents at one center using Surgitek saline implants. if this cohort is exclud ed, the deflation rate drops to 5.8 percent, a figure more consistent with data published in the literature and found in our previous study. Of the 73 deflations, spontaneous deflation was reported for 50 (74.6 percent), and the remainder were iatrogenic. Actuarial survival of the non-Surgitek implants was 98.4 percent to 99.8 pe rcent at 5 years and 96.9 percent to 98.9 percent at 10 years (95 percent c onfidence interval). Risk factors for implant deflation included the use of Surgitek saline-filled implants (odds ratio = 17.5, p < 0.01), use of Heye r-Schulte and Mentor model 1800 implants (odds ratio = 3.0, p < 0.01), and implant size greater than 450 cc (odds ratio = 1.01, p < 0.02).Risk factors for capsular contracture included submammary implant position (odds ratio = 2.05, p = 0.03) and implant size greater than 450 cc (odds ratio = 1.01, P < 0.01). Overall, satisfaction was high: 93 percent of patients were "satisfied" or "very satisfied" with their implants. As in our earlier study, risk factors for patient dissatisfaction were reconstruction after mastectomy (odds rat io = 7.6, p = 0.011), significant breast firmness (odds ratio = 6.2, p < 0. 001), and patient desire for smaller implants (odds ratio = 3.0, P = 0.020) . In conclusion, our review provides additional outcomes-based evidence tha t saline-filled breast implants remain a safe, effective alternative to sil icone gel-filled models.