Mentor Contour Profile Gel implants: clinical outcomes at 6 years.
BACKGROUND
MemoryShape (Contour Profile Gel) is a textured contoured implant filled with a cohesive silicone gel intended for use in aesthetic and reconstructive breast surgery. The 6-year summary of the clinical outcomes and satisfaction rates for this device from a 10-year, prospective, open-label, multicenter clinical trial is presented.


METHODS
According to 2006 guidelines set forth by the U.S. Food and Drug Administration, 955 women were enrolled: 572 undergoing primary augmentation, 124 undergoing revision-augmentation, 191 undergoing primary reconstruction, and 68 undergoing revision-reconstruction. The cumulative incidence of selected complications was estimated using the Kaplan-Meier method.


RESULTS
For the primary augmentation cohort, Kaplan-Meier estimated 6-year cumulative incidence rates for key complications by patient were as follows: 2.4 percent Baker grade III/IV capsular contracture, 0.9 percent infection, 7.0 percent explantation, and 18.1 percent any reoperation. Corresponding rates were 9.7, 2.1, 13.6, and 24.1 percent for revision-augmentation; 10.1, 1.6, 21.8, and 44.5 percent for primary reconstruction; and 16.4, 3.0, 34.2, and 45.4 percent for revision-reconstruction. The Kaplan-Meier estimated rupture rate at 6 years was 2.1 percent for primary augmentation, 2.9 percent for revision-augmentation, 1.5 percent for primary reconstruction, and 0 percent for revision-reconstruction. Implantation of Contour Profile Gel breast implants resulted in a significant increase in circumferential chest size in the overall population (mean change, 1.5 inches; p < 0.0001), and 96.6 percent of patients would make the same decision to have Contour Profile Gel breast implant surgery.


CONCLUSIONS
At 6 years postoperatively, Contour Profile Gel breast implants were found to be effective and have an acceptable safety profile in women undergoing breast augmentation, reconstruction, and revision surgery.


METHODS
Therapeutic, II.
Grand Rapids, Mich.; Edina, Minn.; St. Louis, Mo.; and Santa Barbara, Calif. From Partners in Plastic Surgery, MMK Plastic Surgery, Parkcrest Plastic Surgery, and Mentor Worldwide LLC.
Dennis C
DC
Hammond
Mark M
MM
Migliori
David A
DA
Caplin
M Emily
ME
Garcia
Christine A
CA
Phillips
D000293:Adolescent; D000328:Adult; D000368:Aged; D018427:Breast Implants / Q000592:standards*; D018795:Device Approval; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016462:Mammaplasty / Q000523:psychology*; D008875:Middle Aged; D017060:Patient Satisfaction; D011446:Prospective Studies; D011474:Prosthesis Design; D020034:Silicone Gels; D013997:Time Factors; D014481:United States; D014486:United States Food and Drug Administration; D055815:Young Adult
D020034:Silicone Gels