Breast implant patients are eager to know more about the new Ideal Breast Implant, which is soon to be made available to the public. Dr. Larry Nichter, one of the lead FDA investigators into the safety and performance of the new implant, discusses the advantages offered by the latest breast implant in an interview with the American Society of Plastic Surgeons:
How is this implant superior to current saline or silicone breast implants?
The IDEAL IMPLANT was developed to combine the most desirable features of both current implants: the natural result of silicone gel with the safety of saline for “Peace of Mind.” It is what many women have been asking for – an improved saline implant, with the natural appearance and tissue-like feel of a silicone gel implant, but without the wrinkling, bouncing and globular look of the current single-lumen saline implant.
Why would a woman prefer this implant over current saline or silicone implants, or even future implants like the gummy bear silicone implants?
Many women considering breast augmentation would like to have only saline in their implants because of their feelings about health and safety. Scalloping or wrinkling is a well-known problem with current single-lumen saline implants. The only alternative women have for a more natural result is silicone gel-filled implants, which some will not accept, regardless of its “cohesivity.” This may be a significant part of the reason that 31% of US women chose saline-filled implants for breast augmentation in 2011. The IDEAL IMPLANT was designed to meet women’s need for an implant that gives a natural result, yet is filled with only saline.
Does the implant produce a more natural looking breast, as compared to current saline or silicone implants?
This new double-lumen saline implant was designed so the implant edge lies lower and closer to the convex chest wall, for a better contour to the chest wall than current single-lumen saline implants.
What are they made out of, i.e., do they still contain saline?
The IDEAL IMPLANT uses the same materials and manufacturing processes as current single-lumen saline implants. They are filled with only saline.
What is a double-lumen? What is an internal baffle structure and what is made out of?
Double-lumen means that the implant has two separate saline-filled lumens or spaces. An inner implant shell defines the inner lumen and the outer implant shell defines the outer lumen, which is between these two shells.
In the outer lumen, there are one to three implant shells, perforated and free-floating, that act as a baffle structure. This baffle structure is designed to control movement of the saline filler so there is no bouncing, to support the upper pole of the implant so it does not collapse when the patient is upright, and to support the edge of the implant so scalloping and wrinkling are minimized.
Does this implant look any different than current saline or silicone implants?
On the outside, it looks like any breast implant. On the inside, the IDEAL IMPLANT contains a series of implant shells of increasing size nested together (inner shell, outer shell and baffle shells in between).
Who is the manufacturer? Is this the first study done on this implant?
The manufacturer is Ideal Implant Incorporated, a company majority owned by plastic surgeons. The IDEAL IMPLANT is manufactured in the United States.
Is this the first study done on this implant?
Currently, where is this implants at in the FDA clinical trial process?
The PMA has been submitted to FDA in modules over the last year, including US clinical trial results, pre-clinical testing data and manufacturing information.
Approximately, how long until the implant will be available to patients?
FDA approval could be granted by year-end.
Will the cost of augmentation surgery with these new implants be comparable to current prices?
The IDEAL IMPLANT will be priced the same as current silicone gel implants and will be marketed directly to women. It will only be sold to ABPS certified plastic surgeons.