Our center undertook an industry-funded, outcomes-based, multicenter, retrospective review to evaluate the safety and efficacy of saline-filled breast implants. Our review was part of a pre-market approval review process mandated by the U.S. Food and Drug Administration. The design of our review was modeled on a Plastic Surgery Educational Foundation outcomes study previously conducted by our center. For this study, several significant changes were made to our previous protocol, including improved patient tracking, stronger biostatistical support, and a mandatory 10-year minimum patient follow-up period.
Physician-reported and patient-reported data on 450 patients with 882 saline-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 were placed in a submammary position; 25.6 percent, subpectorally; and 0.2 percent, subcutaneously.
The overall complication rate was 20.2 percent. Reoperation for capsular contracture or implant deflation was necessary in 104 of 450 patients (23.1 percent). Deflation occurred in 73 implants (8.3 percent) and was underreported according to the physicians' record review alone. This deflation rate is higher than the 5.5 percent previously reported by our center. However, 26 of these 73 deflations (35.6 percent) occurred in a single cohort of patients at one center using Surgitek saline implants. If this cohort is excluded, 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 percent at 5 years and 96.9 percent to 98.9 percent at 10 years (95 percent confidence interval). Risk factors for implant deflation included the use of Surgitek saline-filled implants (odds ratio = 17.5, p < 0.01), use of Heyer-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 ratio = 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 that saline-filled breast implants remain a safe, effective alternative to silicone gel-filled models. (Plast. Reconstr. Surg. 105: 2143, 2000.)
Although available since 1965, the saline-filled breast implant was consigned a secondary role in favor of the silicone gel-filled implant for the vast majority of patients undergoing breast augmentation or reconstruction. This changed dramatically in 1992 after the U.S. Food and Drug Administration established a moratorium on silicone gel-filled implants for breast augmentation. Since that time, the saline-filled breast implant has become the prosthesis of choice.
The Food and Drug Administration felt bound to restrict the use of silicone gel-filled implants in large part because of the rapid evolution of breast prosthesis surgery and the paucity of well-controlled, scientific studies of their efficacy and safety. The Food and Drug Administration has since mandated an extensive cooperative pre-market approval review process for the saline-filled implant, partnering with plastic surgeons and implant manufacturers.
In 1996, as part of this pre-market approval process, the senior author (B.L.C.) was commissioned by two U.S. saline implant manufacturers (Mentor Corporation and McGhan Medical Corporation, both in Santa Barbara, Calif.) to perform a multicenter retrospective outcomes study. The goal was to obtain physician-reported and patient-reported data on saline-filled breast implant deflation, capsular contracture, complications, and satisfaction. A pilot study was completed in 1996. 1 It demonstrated low overall deflation (5.5 percent) and complication (4.4 percent) rates and high patient and physician satisfaction.
To extend that pilot study and address several issues raised by an epidemiology panel of the Food and Drug Administration, we were commissioned to conduct a second multicenter retrospective outcomes-based evaluation of the safety and efficacy of saline-filled breast implants. The study design was modified to ensure a 10-year minimum patient follow-up period, to minimize perceived physician selection bias by providing an open invitation to all members of the American Society of Plastic and Reconstructive Surgeons (renamed American Society of Plastic Surgeons in October of 1999) to participate, to strengthen biostatistical support, and to reduce patient selection bias by improving patient tracking for a higher patient participation rate.