Long-term safety and effectiveness of style 410 highly cohesive silicone breast implants.

BACKGROUND: In 2006, a single-center Swedish study demonstrated a low rupture rate and high patient satisfaction with the Style 410 shaped, form-stable gel implant. The current study aimed to validate the accuracy of the previously published results across multiple European sites. METHODS: A total of 163 subjects (approximately 70% had augmentation [n = 112], 15% had reconstruction [n = 25], and 15% had revision [n = 26]) underwent a physical examination followed by breast magnetic resonance imaging (MRI) for rupture detection. These subjects had been implanted for 5 to 11 years with at least one Style 410 shaped gel breast implant before examination. The secondary end points included lactation, reproductive and breast disease history before and after implantation, and quality-of-life measurements and complications after implantation. RESULTS: The implant rupture rate was 1.7% a median of 8 years after implantation. Capsular contracture was the most common complication noted at the physical examination, occurring for 5.3% of implants, and there were no cases of grade 4 capsular contracture. The postimplantation rates for lactation and reproductive problems and breast disease were lower than the preimplantation rates. Breast implantation surgery was considered advantageous by 91% of the subjects, demonstrating high patient satisfaction. CONCLUSIONS: The Style 410 anatomically shaped, form-stable gel breast implants demonstrated long-term safety and effectiveness.

Prevalence of rupture in inamed silicone breast implants.

BACKGROUND: Silicone breast implants have been used for decades and are arguably the most studied implantable device. However, the vast body of scientific literature has been unable to establish a definitive rupture rate. Various studies have evaluated implant rupture, but the meaningfulness of these data was confounded by the inclusion of different generations of implants and multiple manufacturers' implants and the selection of subjects who were already suspected of having ruptured implants. The authors' study was designed to acquire long-term rupture data specific to Inamed's third-generation silicone breast implants using magnetic resonance imaging technology. METHODS: A total of 106 women with at least one Inamed silicone breast implant (styles 40, 110, and 120) were enrolled in this multicenter, cross-sectional study. The majority received implants for cosmetic augmentation (n = 77, 72.6 percent), with a smaller number having undergone breast reconstruction (n = 11, 10.4 percent) or revision of previous breast implant operations (n = 18, 17.0 percent). Most subjects were Caucasian (n = 99, 93.4 percent) with a median age at implantation of 34 years (range, 18 to 70 years). Enrolled subjects underwent a physical examination and magnetic resonance imaging screening at one of five sites to determine the prevalence of asymptomatic rupture. RESULTS: A total of 199 implants were evaluated, with a median implantation time of 10.9 years (range, 9.5 to 13.2 years). Overall, 183 implants (92.0 percent) showed no evidence of rupture, 12 (6.0 percent) showed evidence of rupture, and four (2.0 percent) were indeterminate. All indeterminate evaluations were considered ruptures, providing a worst-case rupture prevalence of 8.0 percent. CONCLUSION: The study results establish a rupture prevalence rate of 8.0 percent at 11 years for Inamed's silicone breast implants.

Ultrasound-assisted lipoplasty: a review of over 350 consecutive cases using a two-stage technique.

Ultrasound-assisted lipoplasty (UAL) was developed in Europe and South America. Its introduction into the mainstream of United States surgery in 1997 was initially received with great enthusiasm. Soon, however, anecdotal reports surfaced describing limitations and complications related to the emerging technology. Among the concerns expressed were burns and postoperative seroma formation. The etiology of these complications was speculated to be a result of prolonged ultrasonic energy time. Consequently, some authors recommended limiting the amount of ultrasonic energy time per site and even complete avoidance of UAL in certain body areas. Our review includes over 350 consecutive cases of internal UAL performed by two surgeons utilizing a similar technique. The basic rules of UAL as described by Zocchi were followed without regard to other limitations such as ultrasonic energy site times, body areas, and level of tissue planes. The mechanism of action of UAL and the surgical technique are described. The procedure is a two-stage technique, including tumescent infiltration followed by energy application and simultaneous hollow titanium cannula aspiration. Suction-assisted lipoplasty was not a component of the procedure. The results, including complications, are outlined. Complications were few and not severe. There was no correlation between length of ultrasonic energy time and rate of postoperative complications. The advantages and disadvantages of UAL are discussed. UAL alone is the authors' preferred technique for body contouring to all body areas, except in the female breast.