by Nichter, Larry S.; Hardesty,
Robert A.; Anigian, Gregg M.
Background: The
structured breast implant uses different technology than saline or silicone gel
implants, making it a third type of implant. The U.S. Food and Drug
Administration and Health Canada granted approval in November of 2014. This
implant is filled with saline but has an internal structure consisting of a
series of nested shells that support the upper pole when upright and control
fluid movement. It combines certain key features and benefits of saline and
silicone gel implants. As with saline, the filler is only saline, which women
like for peace of mind in case of rupture/deflation. As with silicone gel, it
has a natural feel, but without the risk of silent rupture and U.S. Food and
Drug Administration–recommended magnetic resonance imaging scans—women can
simply look in the mirror and know their implants are intact. Methods: This
U.S. trial enrolled 502 women: 399 primary augmentations and 103 replacements
of existing augmentation implants. Investigators were 45 American Board of
Plastic Surgery–certified plastic surgeons at 35 sites. Of the 502 women
enrolled, 438 (87.3 percent) completed 6-year follow-up visits, a higher
percentage than other Core breast implant trials. Results: At 6 years, patient
satisfaction was 89.7 percent for primary and 91.6 percent for replacement
augmentations; surgeon satisfaction was 92.6 percent for primary and 94.0
percent for replacement augmentation. Kaplan-Meier adverse event rates were as
follows: Baker grade III and IV capsular contracture, 5.7 percent for primary
and 11.5 percent for replacement augmentation; and rupture/deflation, 1.8
percent for primary and 4.7 percent for replacement augmentation. Conclusion:
Six-year results from 438 women show that the structured breast implant has
high patient and surgeon satisfaction, a low rate of capsular contracture, and
a low rate of rupture/deflation. CLINICAL QUESTION/LEVEL OF EVIDENCE:
Therapeutic, IV.
