Two-stage breast reconstruction using form-stable, anatomically shaped implants.
Authors: P McGuire, C Nathan, M Reidy, A Tiburzi
Journal: Cancer Research (2009)

Abstract Abstract #4151 Background: Two-stage breast reconstruction using a tissue expander followed by a permanent implant is a reconstruction option offered woman undergoing mastectomy for treatment of breast cancer or for prophylactic mastectomy. Form-stable, anatomically shaped implants can be used as permanent implants and offer more options for shape and size than currently available round implants. The Allergan Inc., Style 410 implant has a matrix of 144 implants with 12 shapes and offer more options for reconstruction in breast cancer patients. These implants are currently available under study protocol in the United States to a limited number of plastic surgeons.&amp;#x2028; Methods: The charts and satisfaction surveys of 104 patients who underwent 2-stage breast reconstruction using Allergan's Style 410 implant were reviewed. All patients had 2-stage breast reconstruction performed with placement of a tissue expander followed by a second stage procedure 3-9 months after the first stage. The authors performed all of the second-stage procedures. Four patients had their first-stage procedure performed by other physicians.&amp;#x2028; Results: A total of 154 breasts were reconstructed. Allergan Style 410 implants were used in all patients at their second stage. Seventy-one patients had an immediate reconstruction; 33 delayed. The patients ranged in age from 24 to 70 years old at the time of their first operation. Follow up ranged from 6 to 80 months. Two patients have been lost to follow up but were followed for at least 2 years postoperatively. There were 11 reoperations in 10 patients: 4 patients required reoperation to a larger size implant after weight gain; 1 patient required exchange to a latissimus flap after exposing her implant after radiation therapy; 2 patients had skin revision after mastectomy; 1 patient had 2 procedures for rotation of the implant; and 2 patients requested removal of their implants because of pain associated with implant rotation. Fifteen patients received radiation therapy postoperatively. Of these patients, 2 had Grade 4 capsular contracture and 2 had Grade 3; the rest had Grade 1 or 2. None of the patients who did not receive radiation had more than a Grade 2 capsule. Seventy-seven patients reported that they were very satisfied with the result of their reconstruction, 22 patients reported they were somewhat satisfied, 1 patient reported being neither satisfied or dissatisfied, and 3 patients reported they were dissatisfied.&amp;#x2028; Conclusion: Anatomically shaped form-stable implants show a high patient satisfaction rate of 95% and low reoperation rate in women undergoing mastectomy and reconstruction. The capsular contracture rate of 2.6% compares favorably to the Inamed Core Gel study presented to the FDA, which showed a capsular contracture rate of 14.1% at 4 years with responsive gel implants. The reoperation rate of 5.8% also compares favorably to the Core Gel study that reported a reoperation rate of 40.9% at 4 years. The rotation rate of the anatomically shaped implants was 2.6%. Further follow up is needed to see if these favorable outcomes remain with time. Citation Information: Cancer Res 2009;69(2 Suppl):Abstract nr 4151.