Breast augmentation is largely defined by the implant that is used to create it. At one time in the history of this surgery, from 1991 to 2006, the saline breast implant was the only commercial implant available. Essentially being water in a bag, it has advantages of being able to be inserted through small incision and at a lower cost. Its disadvantages were some of its aesthetic issues such as implant rippling and near immediate deflation when the device failed. It is these disadvantages that caused it to be replaced with more form-stable implants became available again.
While the silicone gel breast implant has continued to evolve, it was thought that no new changes had been done to the saline implant. But that is not true. A new saline-filled breast implant has been under development and clinical study.
In the September 2012 issue of Aesthetic Surgery Journal, a clinical study was published on a novel, double-lumen, saline-filled breast implant. The development of the new implant was spurned on to overcome the known disadvantages of current single-lumen saline breast implants by using an internal baffle to control saline movement and providing internal support to implant edges. This report covers the first two years of patient data that is ultimately part of a 10 year FDA clinical trial that is evaluating the safety and effectiveness of this new breast implant. The data was obtained from 35 study sites and included just over 500 women who had either primary augmentation (75%) or replacement of existing implants. (25%) The study looked at the incidences of implant wrinkling, capsular contracture and patient satisfaction.
They report that 94% and 92% of patients who had primary and replacement breast implant surgery respectively were satisfied. Concurrently, surgeon satisfaction was 97% and 93% for both type of implant procedures. Problematic capsular contracture rates (Grades III and IV) were around 4% in primary augmentations and 12% in replacement surgeries. Deflations occurred in slightly less than 5% of primary and 3% of replacement procedures. Deflated implant evaluations showed none occurred due to a fold flaw on the shell. These numbers show that the new baffled saline implant design has a lower incidence of wrinkling and capsular contracture at 2 years from surgery that is known to occur in presently used saline breast implants.
Implant wrinkling and failure (deflation) are the two biggest negatives of saline implants. This new baffled structure redistributes the normal unrestricted flow of a saline implant without such baffles. Besides less wrinkling and very acceptable rates of capsular contracture, patients and surgeons both report that these new saline implants feel much more like that of existing silicone breast implants. This has to do with the three internal baffle shells that are unattached but are perforated. This allows the saline fluid to move slowly between the various compartments, giving it more of a gel-like feel. (more like a natural breast) The difference in this new implant can also be visually seen when placed on a convex surface like the chest wall as the implants will more mimic the underlying chest wall curve. Unlike current saline implant designs, its outer edge sits lower and the outer surface does not collapse inward.
This new baffled saline breast device, known as the Ideal Implant, will hopefully soon be available for commercial sale and implantation. Since it uses no new materials or methods in its manufacture, one would assume that the FDA regulatory process would be unduly prolonged. The manufacturer reports that it may soon be approved and will only be sold to implanting doctors who are board-certified plastic surgeons.
Given the data that is reported and with its innovative design, the Ideal Implant appears to be ‘ideal’ for those women who want a satisfactory alternative to silicone implants for their breast augmentation.
Dr. Barry Eppley
Indianapolis, Indiana