A prospective study of 708 form-stable silicone gel breast implants.

BACKGROUND: Form-stable silicone gel breast implants represent the fifth generation of silicone gel augmentation devices. Additional crosslinking between the silicone molecules allows these implants to retain their shape, especially in the vertical position. OBJECTIVE: The authors evaluate the efficacy of Silimed form-stable silicone gel breast implants. METHODS: A total of 355 patients (708 implants) were enrolled prospectively over a 60-month period. Data were collected on patient demographics, implant factors, complications, and revisions. Chi-square analysis and Fisher's exact test were implemented to compare groups with respect to differences in complication and revision rates. RESULTS: The overall tissue-related complication rate was 8.2% per patient, or 4.1% per breast. The overall implant-related cosmetic complication rate was 2.5% per patient, or 1.3% per implant. The overall implant-related complication rate, which was represented by the capsular contracture (CC) rate, was 1.4% per patient and 0.7% per implant. There were no complications in any of the reconstruction patients. There were no deep vein thromboses, pulmonary emboli, myocardial infarctions, or deaths among the patients in this study. In addition, there were no instances of flap necrosis, hematoma, or loss of implant integrity. The overall complication rate was 9.6% per patient, or 4.8% per implant. The overall tissue-related revision rate was 5.4% per patient, with the most common tissue-related reason for revision being unacceptable scarring. The overall implant-related cosmetic revision rate was 7.6% per patient, with the most common reason for revision in this category being size change. The overall implant-related revision rate was 1.1% per patient and was solely due to CC. CONCLUSIONS: This study demonstrates that form-stable silicone gel breast implants are safe and have a complication profile similar to other models of silicone breast implants, with a lower CC rate and a decreased incidence of wrinkling compared to fourth-generation silicone gel implants (as well as other published studies of fifth-generation implants).

Safe and consistent outcomes of successfully combining breast surgery and abdominoplasty: an update.

BACKGROUND: Combined cosmetic procedures have become increasingly popular. One of the most common combinations of cosmetic procedures includes abdominoplasty and cosmetic breast surgery. The shortened recovery and financial savings associated with combined surgery contribute to the increased demand for these combined surgeries. OBJECTIVE: The goal of this study was to evaluate the safety and efficacy of combined abdominoplasty and breast surgery at a single plastic surgery practice that performs a large volume of these cases. This is an update to a study published in 2006. METHODS: A retrospective review was performed for patients who underwent combined abdominoplasty and cosmetic breast surgery during the last 10 years at a single outpatient surgery center. Abdominoplasty inclusion criteria were defined as lower, mini, full, reverse, or circumferential abdominoplasty. Cosmetic breast surgery inclusion criteria were defined as augmentation, mastopexy, augmentation-mastopexy, reduction, or removal and replacement of implants. Pertinent preoperative and intraoperative data were recorded along with complications and revisions. RESULTS: There were 268 patients during the 10-year period between 1997 and 2007. There were no cases of death, pulmonary embolism, deep venous thrombosis, or other life-threatening complications. The overall complication rate was 34%. Abdominoplasty seroma and scars requiring revision comprised 68% (n = 74) of the complications. The total revision rate was 13%. CONCLUSIONS: Combined abdominoplasty and cosmetic breast surgery was safe and effective in this large series of cases performed at a single plastic surgery practice. The complication and revision rates of the combined surgery were similar to those reported for individually staged procedures.

Clinical experience with a fourth-generation textured silicone gel breast implant: a review of 1012 Mentor MemoryGel breast implants.

BACKGROUND: Since the introduction of fourth- and fifth-generation silicone gel implants, manufacturers have conducted several prospective, multicenter trials to examine their safety and efficacy. However, these studies were not standardized with regard to surgeon skill, pocket placement, operative technique, adjunct therapies, or postoperative management. OBJECTIVE: The purpose of this study was to examine the surgical outcomes of a single surgeon (WGS) in a consecutive series of breast augmentation cases using a fourth-generation cohesive silicone MemoryGel breast implant (Mentor, Santa Barbara, CA). METHODS: A retrospective chart review was conducted to identify all patients who underwent silicone breast augmentation within the Mentor Adjunct Silicone MemoryGel breast implant by a single surgeon (WGS) within a single free-standing outpatient surgical center over a 13-year period (1992 to 2006). For each patient, demographic information, comorbidities, and surgical information (implant size and concomitant surgery) were recorded. In addition, outcomes were analyzed to identify complications and the need for surgical revision. RESULTS: A total of 1012 fourth-generation, textured, cohesive silicone gel implants were placed in 511 patients during the 13-year study period. The overall complication rate per implant was 5.5% (n=56 implants in 43 patients). The most common complication was capsular contracture (n=26; 2.6 %) followed by abnormal scarring (n=11; 1.1%). The overall revision rates per patient and per implant were 8.0% (n = 41 patients) and 6.8% (n = 69 implants), respectively. The average time interval between initial implantation and revision was 18.5 months (range, 2 weeks to 26 months). The most common indication for surgical revision was patient desire for implant size change (n=15 patients) followed by Baker class III or IV capsular contracture (n=13 patients). The presence of previous surgery for capsular contracture was not statistically correlated to the need for revision (P= .326). Age (P= .568), previous history of breast surgery (P= .704), and history of smoking (P= .138) were also not statistically correlated to revision. Placement of the implant in the subglandular position (n=30 implants), however, was statistically correlated with need for revision (P< .01). CONCLUSIONS: Mentor fourth-generation cohesive silicone gel implants possess a complication and revision profile that is superior to earlier-generation silicone gel implants. Implantation with MemoryGel implants, when standardized with regard to surgeon and operative technique, can have significantly reduced complication and revision rates compared to the Mentor Core Data.

The "clamshell" craniotomy technique in treating sagittal craniosynostosis in older children.

OBJECT: Although most patients with sagittal craniosynostosis are recognized and treated in infancy, some children are not referred to craniofacial centers until later in childhood. In this paper the authors describe a novel operative technique for calvarial reconstruction in older children with previously untreated sagittal craniosynostosis. METHODS: The authors report a clinical series of eight patients who were treated using novel single-stage calvarial reconstruction, and they assess the complications and outcomes. The patient is placed supine for the procedure, which consists of a coronal incision, bifrontal craniotomy without orbital osteotomy, and multiple interlocking midline parietooccipital osteotomies and recontouring. Fixation is achieved using a bioabsorbable plate system. Cranial indices were calculated from measurements obtained before and after the reconstructive procedures. Preoperative, intraoperative, and postoperative photographs and three-dimensional computed tomography scans are presented for review. Between November 2003 and April 2005, the authors treated seven boys (age range approximately 1-10 years, mean age 4.2 years) with uncorrected sagittal craniosynostosis and one with bicoronal and sagittal synostosis. The mean operating time was 5.13 hours (range 4.3-8 hours), with a mean blood loss of 425 ml (range 200-800 ml). As a percentage of the estimated circulating blood volume, the mean operative blood loss was 33.5% (range 17-57%). The mean hospital stay was 4.9 days. The cranial index significantly improved from a mean of 65.6 to 71.3% (p = 0.001). No acute or delayed complications have been noted. Follow-up examinations performed at an average of 12 months (range 1-17 months) have confirmed early patient and family satisfaction. CONCLUSIONS: An approach of aggressive calvarial reconstruction with multiple interleaving osteotomies crossing the midline achieves improvements in biparietal narrowing. Combined with a bifrontal reconstruction, early outcomes are excellent, with an acceptable amount of intraoperative blood loss and no significant complications.