The Research Shows a 6.3% Capsular Contracture Rate – Lower than Silicone Gel Implants
As anyone who has visited my website before or heard my messages on the radio or Facebook LIVE will know, I am a big fan of saline implants. I find them much more versatile than silicone. The only advantage that silicone implants have had over traditional saline implants was a lower risk of palpable rippling. That was, until the Ideal Implant, a structured saline implant, was introduced several years ago. Since that time I have been recommending the Ideal Saline Implant for any women who were fairly thin and might have a problem with rippling.
Just last month an article appeared in Plastic & Reconstructive Surgery, the most respected journal of our specialty. It described a 6-year study of Ideal Implants, comparing them to all other implants (saline and silicone), and found that they are superior in terms of rupture rate and the rate of capsular contracture (the most frequent complication of augmentation surgery). So now, not only have we an answer for the rippling problem in thin women desiring saline implants, those same implants have been shown to be superior to all other implants.
Silicone gel breast implants have a 9.8-16.2% rate of capsule contracture, compared to only 6.3% with the IDEAL IMPLANT–and you can have the same beautiful look and natural feel.
Perhaps it’s time that all patients consider the Ideal Implant for their augmentation.
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.